bioforum edition 43

Upload: kartack

Post on 19-Oct-2015

34 views

Category:

Documents


0 download

DESCRIPTION

Bioforum Edition 43

TRANSCRIPT

  • BioForum Edition 43 Quarter 3 FY13 April 2013

    A changing market creates opportunities for Life Sciences companies

    www.pwc.com.au/bioforum

  • Highlights

    Highlights

    2

    Key development for the quarter Zoetis,Pfizersanimalpharmaceuticalsspin-off,raised

    USD$2.24binthelargestUSIPOsinceFacebook.

    TheAustraliangovernmentpromiseda$350minjectionintotheInnovationInvestmentFundandproposedtenIndustryInnovationPrecinctsatanestimatedcostof$500m.

    Thereweremultiplemajorclinicaltrialdevelopmentsduring the quarter: - PharmaxiswasknockedbackbytheFDAforBronchitoluseincysticfibrosispatientsandwillrequirefurtherclinicaltrials

    - QRxresubmitteditsFDAapplicationforthepain-killerMoxDuo foranexpectedresponseinAugust

    - TheEuropeanCommissionMedicalDevicesGroupmeetingvotedthatTissueTherapiesVitroGrotreatmentshouldberegulatedinEuropeasamedicine,notamedicaldevice

    - ANovogenstudyshoweditsCS-6moleculewashighlyactive againstovariancancerstemcells

    Q3FY13KeyStatistics- LifeSciencesindexup7.1%(up9.4%Q2FY13)

    - LifeSciencesexmajorsup7.7%(down8.2%Q2FY13)

    -AllOrdinariesup6.8%(up5.9%Q2FY13)

    -NASDAQCompositeup7.3%(down3.1%Q2FY13)

    -NASDAQBiotechup16.7%,(down3.7%Q2FY13)

  • PwC | BioForum: April 2013

    Introduction

    pwc.com.au/privateclients

    Manoj Santiago PwC Private Clients

    3

    In the third quarter.

    The Australian Life Sciences Index recorded another positive quarter at 7.1 per cent, led by ex-major firms. The Index finished largely in line with All Ordinaries Index, which grew 6.8 per cent, its highest level since late 2008.

    The NASDAQ Biotech Index rose by 20.4 per cent off the back of the NASDAQ Composites continuing positive run (7.3 per cent increase).

    Biotechs have had a strong quarter, with a changing Australian economy encouraging investors to cast a shrewd eye over the Life Sciences industry in search of promising returns, said Manoj Santiago, PwC Life Sciences partner.

    Sector performance

    Life Sciences Index ex majors marginally outperformed the Life Sciences Index at 7.7 per cent but the index is still trailing by 42 per cent for the year to date.

    The improved performance of the ex-majors was led by non-major Medical Devices companies, with the sub- index up by 12.1 per cent. The overall Pharma/Biotech index was up 8.9 per cent in comparison, but non major Pharma/Biotech firms underperformed due to mixed clinical trial results from a few participants, up 5.6 per cent for the quarter.

    IPOs and secondary raisings

    Although there were again no Australian IPOs, there are promising signs coming from the US, with eight IPOs this quarter totalling $2.42b including the $2.2b Zoetis float, Pfizers animal pharmaceutical spinoff.

    A further ten IPOs are publicly know to be in preparation as at the end of March. However, post IPO performance has been largely negative for these companies, down approximately 5 per cent on average to the end of March. Some commentators have suggested that this is due to post IPO profit taking as opposed to fundamental concerns regarding the companies.

    The Australian secondary financing market had a strong quarter, with the $207m total raisings largely due to Mesoblasts $170m raising to fund clinical trials.

    Secondary funding remains strong in the Australian market with the hope that the US IPO strength may flow through to Australia, said Mr Santiago. Anecdotally this appears to be happening with an increase in IPOs expected in Australia in the next 12 months.

    Commentary

    Against this current backdrop of optimism we have seen markets remain unforgiving on companies which dont reach clinical trial endpoint, said Mr Santiago. It takes a combination of skill, patience and a little luck to manage a clinical trial to ensure the best return on investment is achieved.

    As Australian investors look for new sources of returns, its important to note that the fundamentals of the Life Sciences sector remain strong: an ageing population, continued demand for innovation and cost efficiency for the health sector, sustained government attention and increasing support.

    Introduction

    Secondaryfundingremains strong in the Australianmarketwiththe hope that the US IPO strengthmayflowthroughtoAustralia,saidMrSantiago.Anecdotallythisappears to be happening withanincreaseinIPOsexpectedinAustraliainthenext12months.

  • PwC | BioForum: April 2013

    Sirtex is a global life-sciences company that develops and delivers oncology treatments using novel small particle technology. Sirtexs main commercialised product is a targeted radiation treatment for liver cancer called SIR-Spheres microspheres. The product is currently in Phase 4 clinical trials. PwC spoke to Mr Darren Smith, CFO and Company Secretary and Dr David Cade, Chief Medical Officer, about the companys success to date.

    Since receiving FDA approval in 2002 for its core product, SIR-Spheres, Sirtex has gone from strength to strength. CFO Darren Smith attributes the companys success to two key things: an ability to stick to the fundamentals, and living up to shareholder expectations to maintain long-term loyalty.

    If you look at our share registry, youll see that 75 percent represents the top 20 holders, says Smith. Within that, the top four or five holders have something like 60 percent. They are very strong believers in the technology. There are a lot of long-term investors, and they have advised us that they are maintaining their holding as they are looking to the future.

    It seems that loyalty is about to pay off: Sirtex has five large randomised controlled trials in the post marketing phase with data likely to be ready to be presented to the market in early 2015. And according to Dr David Cade, Sirtex Chief Medical Officer, that data is likely to drive further growth beyond the compound 23 per cent growth weve seen over the last four or five years.

    Sirtexs key product was developed back in the 80s by Professor Bruce Gray. By the time Sirtex Medical Limited listed in August 2000, the product had already been through clinical trials the IPO capital raising was to fund the regulatory dossier.

    The company received FDA approval in 2002, shortly followed by the CE mark for European regulatory approval, Smith says. Then they commenced commercial sales. The clinical trials that they ran were small, only around 70 patients, but it was sufficient to get approval.

    But this still wasnt enough to gain wider approval among oncologists, according to Cade.

    The pivotal clinical trial conducted at the University of Western Australia was enough to get regulatory approval and early reimbursement in the marketplace, but insufficient to convince the oncology community that they should change their practice of medicine and adopt this newly available therapy into their standard practice, says Cade.

    So thats why weve been on the market now for a decade and have been selling product commercially, but we still dont have large amounts of clinical data from very big randomised controlled trials off of which to market the product very effectively.

    Smith is confident that the results of the $60 million trial program will be positive, but stresses that the companys bottom line is already healthy.

    Over the last three years, weve built the clinical team that is able to administer and promote the trials to ensure they are successfully completed. Running these studies is similar to running the business itself. If youre not out there promoting it, if youre not out there making sure youve got people being recruited on to the program; its not just going to happen.

    This is really the long-term strategy for the growth of the business. Whats happening in the meantime, and for the existing commercial businesses, is that weve also seen strong growth in the organisation in spite of the fact that we havent got these clinical trials results to take out to oncologists. And thats been more of a matter of going back to fundamentals.

    Over that last five-year period our commercial sales have more than doubled, he says. In 2008, we turned over $38 million, and last year we turned over around $80 million.

    Smith says while the company is happy to point to its track record, its been reluctant to talk up the potential of the company given the fickle nature of the life sciences sector.

    Sirtex has always been very conservative in its communications with the investment community, he says. We havent gone out there and pushed the blue sky. We do talk about being less than 1 percent of the market, but we dont go out there and say were going to get 100 percent or even 50 percent of it.

    What we do point out is our performance in the past. If we say were going to go out and do something, well go out and do it and achieve it. Thats what the organisation has done.

    4

    An interview with Sirtex

  • The thing about this industry is that deadlines are almost impossible to calculate. Even to get an approval from the FDA, theres no guarantee that theyll accept the data that you provide, or that itll be sufficient, or that they dont come back and ask other questions that will extend the period, even if theres no issue around it. Sometimes its best not to talk about what you cant control. So we dont talk about the markets were trying to get into; we talk about the ones weve got.

    Theres also an awareness of the need for some kind of back-up plan, which includes new technologies, and new markets.

    The organisation has a portfolio of new technologies which are in pre-clinical, and were continuing to developmarkets in Malaysia and the Philippines on top of our presence in India, Korea, Taiwan and Hong Kong.

    Other markets were looking to get into are Japan and China. Both are considerably larger markets, and obviously more valuable, but both are considerably more complex to enter. Those two markets are probably a two to four year process for us.

    So what advice does the pair have for other companies in the Life Sciences space?

    Firstly, if you look at healthcare, I think invariably therapeutics is more attractive [than diagnostics] because you can potentially command much higher margins, says Cade. And [within that], therapeutics in oncology is a very attractive place to be, because there remain significant areas of high unmet clinical need one of which is the area that were in, which is liver cancer; whether its primary liver cancer which is a disease of Asia and Mediterranean Europe, or bowel cancer that has spread into the liver, which is a disease of the West.

    The second thing I would say is that in the Australian market in the life sciences space, way too many entities list as a funding exercise rather than as an exit for the founders.

    5

    In the case of Sirtex, Cade says, the founder developed a product while on staff at a university in WA with funding from research grants as well as Rotary and Lions Club.

    It only went to market to raise capital to take the data from that pivotal trial to package it up into a dossier to submit to the FDA, says Cade.

    So right at the pre commercial stage all of the hard work had been done, and the market was only providing the capital for the penultimate step, prior to getting to commercial stage. Thats really when the market is appropriate to go and source capital from not when you go to the market to raise capital for a phase 1 trial, in a 10 or 12 year development process, and youve got to go back cap in hand and dilute your early investors.

    Smith agrees that many biotech companies in Australia list too early.

    There are biotechs in Australia that seem to use listing on the stock exchange as a business model; raise the money, spend it, raise the money, spend it. It doesnt give the industry a very good name. Youre basically burning your bridges with going back to the market all the time.

    My philosophy is that you really shouldnt be coming to market until youve got a product that you know is going to be commercial. Otherwise youre kidding yourself.

    Also, youve got to pick your investors for what youre doing. We make money, we show a return and weve got a large potential for growth so were perfect for investors with a growth focus.

    Dr David Cade Chief Medical Officer Sirtex

    Mr Darren Smith Chief Financial Officer Sirtex

    Michelle Chiang Life Sciences Partner PwC

  • PwC | BioForum: April 2013

    08 Quarterly key findings

    10 Market performance

    20 Announcements

    27 Appendix

    31 Methodology

    33 Contacts

    Contents6

    Contents

  • 701Quarterly key findings

  • PwC | BioForum: April 2013

    Quarterly key fi

    ndings8

    Quarterly key findings

    Market performance Q3 FY13 Page

    Life sciences industry total MCap A$47,754m 11

    Life sciences industry growth 7.1%

    Pharma/biotech sector total MCap A$34,870m 12

    Pharma/biotech sector growth 9.0%

    Medical device sector total MCap A$12,884m 13

    Medical device sector growth 2.3%

    Individual company performance

    Top individual performer Cryosite Limited 18

    Change in market cap over the past four quarters 308%

    Bottom individual performer Bioxyne Ltd 19

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

    Financing

    Australian IPO count 0 14

    Total raised A$m

    US IPO count 8 14

    Total raised A$2,415m

    Australian secondary financing count 32 16

    Total raised A$207m

    US secondary financing count 57 16

    Total raised A$1,796m

    Announcements Q3FY13 Page

    Australia

    Partnerships 14 21

    Mergers & acquisitions 5 22

    Clinical trials 22 23

    Regulatory 19 24

    Other 6 26

  • 902Market performance

  • PwC | BioForum: April 2013

    5.9%6.8%

    -3.1%

    7.3%

    -3.7%

    16.7%

    9.4%7.1%

    -8.2%

    7.7%

    -10.0%

    -5.0%

    0.0%

    5.0%

    10.0%

    15.0%

    20.0%

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

    Life Sciences ex majors (market cap A$m)

    % Change (Sep-Dec) % Change (Dec-Mar)

    -60%

    -40%

    -20%

    0%

    20%

    40%

    60%

    80%

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

    31-Mar-11 30-Jun-11 30-Sep-11 31-Dec-11 31-Mar-12 30-Jun-12 30-Sep-12 31-Dec-12 31-Mar-13

    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

    -2%

    0%

    4%

    8%

    12%

    16%

    20%

    31-Dec 04-Jan 11-Jan 18-Jan 25-Jan 01-Feb 08-Feb 15-Feb 22-Feb 01-Mar 08-Mar 15-Mar 22-Mar 31-Mar

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

    Market perform

    ance10

    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-Sep-12 31-Dec-12 31-Mar-13% Change (Sep-Dec)

    % Change (Dec-Mar)

    ASX All Ordinaries (Index) 4,406 4,665 4,980 5.9% 6.8%

    NASDAQ Composite (Index) 3,116 3,020 3,239 -3.1% 7.3%

    NASDAQ Biotech (Index) 1,486 1,431 1,669 -3.7% 16.7%

    Life Sciences (market cap A$m) 40,786 44,604 47,754 9.4% 7.1%

    Life Sciences ex majors (market cap A$m) 8,249 7,573 8,157 -8.2% 7.7%

  • -10.0%

    0.0%

    10.0%

    20.0%

    30.0%

    40.0%

    50.0%

    13.5% 12.7%

    ASX All Ordinaries (Index)

    15.9%

    4.8%

    NASDAQ Composite (Index)

    31.9% 30.3%

    NASDAQ Biotech (Index)

    42.0%

    36.1%

    Life Sciences (market cap A$m)

    -0.6%

    -6.3%

    (market cap A$m)Life Sciences ex majors

    % Change (Dec11-Dec12) % Change (Mar12-Mar13)

    11

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

    -5%

    0%

    5%

    10%

    15%

    20%

    31-Dec-12 07-Jan-13 14-Jan-13 21-Jan-13 28-Jan-13 04-Feb-13 11-Feb-13 18-Feb-13 25-Feb-13 04-Mar-13 11-Mar-13 18-Mar-13 25-Mar-13

    Figure 3: Quarterly performance of the Australian life sciences sector and subsectors

    Graph 2: Yearly performance of the Australian life sciences sector by market capitalisation compared to major indices

    Market perform

    ance

    Table 2: Yearly performance of the Australian life sciences sector by market capitalisation compared to major indices

    % Change (Dec11-Dec12) % Change (Mar12-Mar13)

    31-Dec-11 31-Dec-12 % Change 31-Mar-12 31-Mar-13 % Change

    ASX All Ordinaries (Index) 4,111 4,665 13.5% 4,420 4,980 12.7%

    NASDAQ Composite (Index) 2,605 3,020 15.9% 3,092 3,239 4.8%

    NASDAQ Biotech (Index) 1,085 1,431 31.9% 1,281 1,669 30.3%

    Life Sciences (market cap A$m) 31,420 44,604 42.0% 35,099 47,754 36.1%

    Life Sciences ex majors (market cap A$m) 7,622 7,573 -0.6% 8,708 8,157 -6.3%

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

    MCap (A$m)

    % of total value

    Companies with share price gains

    Proportion of subsector

    up

    Companies with share

    price losses

    Proportion of subsector

    down

    Companies with share

    price flat

    Proportion of subsector

    flat

    Total number of companies

    Pharma/Biotech 34,870 73% 19 35% 30 55% 6 11% 55

    Pharma/Biotech ex CSL 5,411 66% 18 33% 30 56% 6 11% 54

    Med Device 12,884 27% 18 49% 14 38% 5 14% 37

    Med Device ex COH, RMD

    2,746 34% 17 49% 13 37% 5 14% 35

    Life Sciences 47,754 100% 37 40% 44 48% 11 12% 92

    Life Sciences ex majors 8,157 100% 35 39% 43 48% 11 12% 89

  • PwC | BioForum: April 2013

    Market perform

    ance12

    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-Mar-11 30-Jun-11 30-Sep-11 31-Dec-11 31-Mar-12 30-Jun-12 30-Sep-12 31-Dec-12 31-Mar-13

    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

    11.3%

    8.9%

    -6.9%

    5.6%4.6%

    2.3%

    -10.8%

    12.1%

    9.4%

    7.1%

    -15.0%

    -10.0%

    -5.0%

    0.0%

    5.0%

    10.0%

    15.0%

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

    -8.2%

    7.7%

    Life Sciences ex majors

    % Change (Sep-Dec) % Change (Dec-Mar)

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

    Market capitalisation (A$m)

    30-Sep-12 31-Dec-12 31-Mar-13% Change (Sep-Dec)

    % Change (Dec-Mar)

    Pharma/Biotech 28,744 32,006 34,870 11.3% 8.9%

    Pharma/Biotech ex CSL 5,501 5,123 5,411 -6.9% 5.6%

    Med Device 12,041 12,598 12,884 4.6% 2.3%

    Med Device ex COH, RMD 2,747 2,450 2,746 -10.8% 12.1%

    Life Sciences 40,786 44,604 47,754 9.4% 7.1%

    Life Sciences ex majors 8,249 7,573 8,157 -8.2% 7.7%

  • 13

    0

    10

    20

    30

    40

    50

    Q3FY12 Q4FY12 Q1FY13 Q2FY13 Q3FY13

    Capi

    tal R

    aise

    d (A

    $m)*

    Medical Devices Biotech

    40

    Medical Devices Biotech

    158 187 49229

    2,361

    12 954

    55

    0

    500

    1,000

    1,500

    2,000

    2,500

    3,000

    Q3FY12 Q4FY12 Q1FY13 Q2FY13 Q3FY13

    Cap

    ital

    Rai

    sed

    (A$m

    )*

    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

    Q3FY13 - - 12

    Q2FY13 - - 17

    Q1FY13 - - 9

    Q4FY12 - 1 13

    Q3FY12 - - 12

    Table 7: Total of quarterly US IPO listings

    Biotech Med Devices

    Q3FY13 6 2

    Q2FY13 3 1

    Q1FY13 1 1

    Q4FY12 3 1

    Q3FY12 3 -

    Table 6: Listing of quarterly Australian IPO listings

    Company Listing date

    Capital raised

    (A$)Valuation on listing Sector

    None

    Total -

    Table 8: Listing of quarterly US IPO listing

    Company Listing date

    Capital raised

    (A$m) Sector

    LipoScience Inc 24/01/2013 43 Med Devices

    Stemline Therapeutics Inc 28/01/2013 32 Biotech

    KaloBios Pharmaceuticals Inc 31/01/2013 67 Biotech

    Zoetis Inc 31/01/2013 2,132 Biotech

    Imprimis Pharmaceuticals Inc

    07/02/2013 9 Biotech

    TherapeuticsMD Inc 14/03/2013 48 Biotech

    Tetraphase Pharmaceuticals Inc

    19/03/2013 72 Biotech

    Electrical Geodesics Inc 27/03/2013 12 Med Devices

    Total 2,415

  • PwC | BioForum: April 2013

    Market perform

    ance14

    Medical Devices Biotech

    0

    100

    200

    300

    400

    500

    600

    Capi

    tal R

    aise

    d (A

    $m)

    FY09 FY10 FY11 FY12 FY13

    724

    145

    360

    352

    Medical Devices Biotech

    1,662

    368586

    2,638

    6

    251

    458107

    154

    0

    500

    1,000

    1,500

    2,000

    2,500

    3,000

    FY09 FY10 FY11 FY12 FY13

    Capi

    tal R

    aise

    d (A

    $m)

    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 10 4

    FY12 12 4

    FY11 6 8

    FY10 7 2

    FY09 - 1

    Yearly financing

    Table 9: Number of IPO listings in Australia

    Biotech Med Devices ASX

    FY13 - - 12

    FY12 - 2 75

    FY11 1 1 127

    FY10 1 - 53

    FY09 1 - 24

  • Quarterly financing

    Secondary finance market

    15

    Medical Devices Biotech

    9 928

    111

    201

    928

    5

    25

    6

    0

    50

    100

    150

    200

    250

    Q3FY12 Q4FY12 Q1FY13 Q2FY13 Q3FY13

    Capi

    tal R

    aise

    d (A

    $m)

    Medical Devices Biotech

    2,027 1,767 1,055

    15,541

    1,323

    207 389

    721

    349

    473

    0

    2,000

    4,000

    6,000

    8,000

    10,000

    12,000

    14,000

    16,000

    18,000

    Q3FY12 Q4FY12 Q1FY13 Q2FY13 Q3FY13

    Capi

    tal R

    aise

    d (A

    $m)

    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 (AU)

    Biotech

    Avg. amount

    raised ($m)

    Med Devices

    Avg. amount

    raised ($m)

    Q3FY13 25 8.0 7 0.9

    Q2FY13 22 5.1 12 2.1

    Q1FY13 24 1.2 8 0.6

    Q4FY12 21 0.4 12 2.3

    Q3FY12 16 0.6 9 1.0

    Table 12: Number of secondary deals (US)

    Biotech Med Devices

    Q3FY13 33 24

    Q2FY13 52 18

    Q1FY13 29 21

    Q4FY12 41 20

    Q3FY12 32 9 M

    arket performance

  • PwC | BioForum: April 2013

    Yearly financing

    Market perform

    ance16

    Medical Devices Biotech

    0

    500

    1,000

    1,500

    2,000

    2,500

    Capi

    tal R

    aise

    d (A

    $m)

    FY09 FY10 FY11 FY12 FY13

    2,081

    71

    246

    271

    383

    95

    294

    55

    340

    36

    Medical Devices Biotech

    3,3305,974

    1,279

    5,250

    17,919

    719

    2,400

    5,578781

    1,543

    0

    5,000

    10,000

    15,000

    20,000

    25,000

    FY09 FY10 FY11 FY12 FY13

    Capi

    tal R

    aise

    d (A

    $m)

    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

    FY13 71 27

    FY12 99 39

    FY11 154 43

    FY10 107 39

    FY09 87 41

    Table 14: Number of US secondary raisings

    Biotech Med Devices

    FY13 114 63

    FY12 125 43

    FY11 66 121

    FY10 122 57

    FY09 48 24

  • Market perform

    ance

    17

    Performers over past four quarters

    Top 10

    01 CryositeLtdReturn: 308% Closing price: $0.53 MCap: A$24.72m

    Cryosites revenue rose 15.9% and its profit was up 60.2% compared to the prior half-year period. It has forecast profit in the range of $1.2-$1.4m for the year ended 30 June 2013.

    02 MedicalDevelopmentsInternationalLtdReturn: 230% Closing price: $1.85 MCap: A$105.76m

    Sales and EBIT both increased by 23% for the half-year ended 31 December 2012. A phase III trial of Penthrox was completed with all primary end points met.

    03 NusepLtdReturn: 195% Closing price: $0.07 MCap: A$8.66m

    The company recorded EBITDA of $428k for the half year ended 31 December 2012. It received accreditation in November 2012 from the Therapeutic Goods Administration for manufacture of in-vitro diagnostics medical devices and received an undisclosed legal settlement from NxGen Pharmaceuticals.

    04 CellmidLtdReturn: 127% Closing price: $0.03 MCap: A$20.25m

    Quest Diagnostics subsidiary Celera is soon to conduct a clinical evaluation of its lung cancer test, using Cellmids midkine diagnostics technology, after which Cellmid will be entitled to royalties. However, two significant share price increases in February 2013 prompted queries from the ASX.

    05 UscomLtdReturn: 122% Closing price: $0.20 MCap: A$12.63m

    Half-year results showed a 41% reduction in net operating loss. The company raised $1.2m in H1FY13 and released a paper showing its technology significantly reduced sepsis deaths and hospital costs.

    06 SirtexMedicalLtdReturn: 113% Closing price: $11.07 MCap: A$617.35m

    Sirtex posted a 34th consecutive quarter of growth with revenue up 25% for the half-year ended 31 December 2012. Profit before tax increased 30% and dividends paid were up 43%. Sirtex was added to the ASX200 index early in 2013.

    07 NovogenLtdReturn: 98% Closing price: $0.18 MCap: A$21.13m

    A Mazor Oncology study showed CS-6 was highly active against ovarian cancer stem cells.

    08 SudaLtdReturn: 88% Closing price: $0.03 MCap: A$19.92m

    Sudas revenues for the half year to 31 December 2012 increased 13.8% and it decreased its net loss after tax by 49.6% to $966k. Suda signed an option to acquire the oromucosal platform technology NovaMist from US drug company NovaDel Pharma.

    09 ITLLtdReturn: 78% Closing price: $0.24 MCap: A$22.33m

    Profit for the half-year period was up 36% to $1.47m and management bought back $3.4m in shares. The company completed a restructure involving the sale of its Malaysian distributor for $1.1m.

    10 CloverCorporationLtdReturn: 72% Closing price: $0.62 MCap: A$102.41m

    Clover increased revenues for the half-year period by 12.5% to $20.17m and profit 56.6% to $2.66m. A final dividend of 1.75c per share was declared for 2012, or $2.89m in total.

    CTEMVP

    NSPCDY

    UCMSRX

    NRT

    SUDITD

    CLV

    0% 50% 100% 150% 200% 250% 300% 350%

  • PwC | BioForum: April 2013

    10 BionicheLifeSciencesIncReturn: -62% Closing price: $0.23 MCap: A$23.99m

    Bioniche Life Sciences ended a phase III clinical trial of Urodocin due to slower than expected patient enrolment and discussions with the FDA concerning trial design.

    09 TissueTherapiesLtdReturn: -64% Closing price: $0.160 MCap: A$37.67m

    Tissue Therapies was advised that a European Commission Medical Devices Group meeting voted that VitroGro ECM should be regulated as a medicine and not a device, contrary to an independent assessors advice. The company will appeal any formal vote to change the classification but a failed appeal will mean a clinical trial will be necessary for the product to be sold in the EU.

    08 PharmaxisLtdReturn: -75% Closing price: $0.33 MCap: A$101.82m

    The committee advising the Food and Drug Administration made a negative recommendation regarding the use of Bronchitol for cystic fibrosis patients. The FDA has recommended another clinical trial.

    07 BioprospectLtdReturn: -75% Closing price: $0.00 MCap: A$2.87m

    The companys loss for the half year ended 31 December 2012 decreased 86% to $733k after winding back its human health and skin care and agricultural and animal health projects.

    06 ImpedimedLtdReturn: -82% Closing price: $0.09 MCap: A$15.96m

    Revenue for the half-year period was down 7% on the prior period compared with a 20% increase in worldwide lymphoedema revenue over the same period, although this was largely due to currency fluctuations. Net assets decreased 26% to $12.8m.

    05 BoneMedicalLtdReturn: -85% Closing price: $0.002 MCap: A$1.71m

    The companys revenues effectively fell to zero with a net loss of $896k. Bone Medical is in a negative working capital position and will require further funding to continue R&D activities.

    04 ImmuronLtdReturn: -86% Closing price: $0.00 MCap: A$2.49m

    The company announced a fully underwritten rights issue of $1.86m in addition to share issues of $2.4m in calendar 2012. Revenue decreased 23.8% to $160k and its net loss increased 13% to $1.48m.

    03 HealthlinxLtdReturn: -89% Closing price: $0.001 MCap: A$.97m

    A heads of agreement with Mane DX involving the sale of HealthLinxs ovarian cancer assets expired in December following due diligence and financing issues. HealthLinx posted a net loss for the calendar year of $2.78m. CEO Nick Gatsios resigned in November.

    02 AgenixLtdReturn: -92% Closing price: $0.02 MCap: A$1.33m

    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 has secured funding with Baycrest Capital of up to $3m over three years.

    01 BioxyneLtdReturn: -93% Closing price: $0.015 MCap: A$2.45m

    The companys phase IIb COPD trial had disappointing results, revealing no statistically significant clinical benefit across the entire cohort of patients. However, clinical benefits were observed for patients under 65 years.

    Market perform

    ance18

    Performers over past four quarters

    Bottom 10

    BNC

    TIS

    PXS

    BPO

    IPD

    BNE

    IMC

    HTX

    AGX

    BXN

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

  • Announcements

    19

    03

  • PwC | BioForum: April 2013

    Announcem

    ents20

    Australia partnershipsCompany Partner Application Value (A$m) Comments

    Biotechnology Total 4

    Biodiem Ltd (BDM) US Army Medical Research Institute of Infectious Diseases

    Biological weapons counter-measure

    N/A BioDiem renewed its material transfer agreement with the US Army Medical Research Institute of Infectious Diseases, including moving research to animal-based studies.

    Bioniche Life Sciences Inc (BNC)

    Trophogen Inc. N/A N/A The company terminated its exclusive global veterinary licence agreement with Trophogen.

    Cellmid Ltd (CDY) Fujikura Kasei Co Ltd Anti-midkine diagnostic antibodies

    N/A Cellmid signed an option agreement to supply its anti-midkine diagnostic antibodies for validation on Fujikuras latex platform. Cellmid will receive an initial fee and a further payment should Fujikura elect to exercise its licence option and also receive royalties on any future midkine diagnostic products sold by Fujikura.

    Circadian Technologies Ltd (CIR)

    Santa Cruz Biotechnology Inc

    Cancer therapy Unknown upfront payment and royalities

    Circadians wholly owned subsidiary, Vegenics, has entered into a non-exclusive worldwide licence agreement with Santa Cruz Biotechnology to market antibodies to Circadians proprietary molecules VEGF-C, VEGF-D and VEGFR-3.

    Medical Devices Total 6

    Anteo Diagnostics Ltd (ADO)

    One World Lab Surface chemistry products

    N/A Anteo entered into a sales partnership program with One World Lab to provide Anteos Mix&Go surface chemistry products to academic and industry researchers.

    Atcor Medical Holdings Ltd (ACG)

    Major internation pharmaceutical company

    Non invasive blood pressure measurement

    US$0.8m The company expanded an existing contract to supply SphygmoCor systems and clinical trial support services to a major international pharmaceutical company.

    Gi Dynamics Inc (GID)

    CMS Medical Type II diabetes and obesity

    Unknown The company entered into an agreement with CMS Medical to distribute EndoBarrier, its treatment for type II diabetes and/or obesity in Brazil, following regulatory approval.

    Gi Dynamics Inc (GID)

    GlaxoSmithKline and Medtronic

    Type II diabetes and obesity

    N/A GI Dynamics and Medtronic agreed to collaborate on research focused on understanding how Medtronics EndoBarrier treatment affects continuous glucose levels and to evaluate hormonal changes in response to EndoBarrier respectively.

    Impedimed Ltd (IPD)

    3M Australia Lymphoedema Unknown Impedimed signed a three-year exclusive agreement with 3M Australia for the sale and co-marketing of L-Dex lymphoedema products in Australia and New Zealand.

    Medical Australia Ltd (MLA)

    North Middlesex University Hospital

    Irrigation and IV administration sets

    N/A Medical Australia signed a five-year supply agreement with North Middlesex University Hospital to provide irrigation and IV administration sets for the facility.

  • 21

    Announcem

    ents

    Mergers, acquisitions and divestments

    Company Partner Application Value (A$m) Comments

    Pharma Total 4

    Novogen Ltd (NRT) The Ingham Institute Cancer therapy N/A Novogen and the Ingham Institute signed an MOU to cooperate in developing a new class of super-benzopyran molecules as comprehensive anti-cancer drugs.

    Phylogica Ltd (PYC) Bio-Link Australia Pty Ltd

    Anti-inflammatory Phylomer peptides

    N/A The company signed an agreement with Bio-Link Australia, a specialist life sciences business development company, to commercialise a family of anti-inflammatory phylomer peptides for pharmaceutical use.

    Phylogica Ltd (PYC) Janssen Biotech Inc. Peptide-drug candidates

    N/A Phylogica extended a collaboration with Janssen Biotech to discover, develop and commercialise new classes of peptide-drug conjugates from its phylomer drug discovery platform.

    Starpharma Holdings Ltd (SPL)

    Makhteshim Agan Group

    Crop protection Unknown Starpharma and Makhteshim Agan Group agreed on a program that will apply Priostar technology to crop protection formulations across Makhteshims crop protection product portfolio.

    Dominant company Other company Type of deal Value (A$m) Comments

    Biotechnology Total 3

    Acuvax Limited (ACU)

    Biolife Science Ltd Takeover $5m Acuvax signed a binding under which Biolife Science will purchase 100% of its issued capital. The new company will have a market value of about $11.3m and be renamed Biolife Science.

    Cordlife Limited (CBB)

    Favorable Fort Ltd Sale US$8.65m The company completed the sale of its interest in Shandong Cord Blood Bank to Favorable Fort.

    Nusep Limited (NSP)

    PREMIER Biosoft Divesment Unknown NuSep sold its ProteoIQ software to Premier Biosoft. The company advised that the software was a non-core asset.

    Medical Devices Total 1

    Neurodiscovery Limited (NDL)

    Enigma Therapeutics Ltd

    Takeover $2.25m NeuroDiscovery entered into an SPA with Enigma Therapeutics, a UK-based cancer company. Enigmas lead product is a targeted brachytherapy.

    Pharma Total 1

    Mayne Pharma Group Limited (MYX)

    GlaxoSmithKline Ltd Asset acquisition $14m Mayne completed the acquisition of Kapanol and related assets in Australia from GSK.

  • PwC | BioForum: April 2013

    Announcem

    ents22

    Clinical trialsCompany Drug Application Comments

    Phase I Total 2

    Biotron Limited (BIT) BIT225 HIV infection The phase 1b/2a trial has demonstrated that Biotrons BIT225 targets HIV replication in monocyte cells in treated patients and significantly reduced virus levels in these cells.

    Phosphagenics Limited (POH) TPM transdermal skin pathc

    Opiod delivery The company advised that it had achieved all end points of its phase I trial of its oxymorphone patch.

    Phase II Total 2

    Allied Healthcare Group Ltd (AHZ)

    CardioCel Congenital heart defect reapir

    A phase II extension study showed patients whose congenital heart defect had been repaired with CardioCel showed no signs of calcium build-up.

    Mesoblast Limited (MSB) Neofuse Mesenchymal Precursor Cells

    Spinal fusion Trials using Mesoblasts allogeneic, or off-the-shelf, Mesenchymal Precursor Cells demonstrated rates of fusion success that were comparable to the gold standard bone autograft.

    Phase III Total 2

    Alchemia Limited (ACL) HA-Irinotecan Metastatic colorectal cancer treatment

    Enrolment was completed for a trial with 390 metastatic colorectal cancer patients, comparing Alchemias HyACT technology in a combination with the standard chemotherapy drug irinotecan against irinotecan alone.

    Medical Developments International Limited (MVP)

    Penthrox Acute pain Penthrox was shown to offer clinically significant pain reduction and to be a highly effective analgesic, with the primary end point and all secondary end points of the study met.

    Pre-clinical and other Total 16

    Actinogen Limited (ACW) N/A Aactinomycetes that produce plant growth hormones

    The company announced it had discovered actinomycetes that produce plant growth hormones and has commissioned further independent trials to test their performance.

    Allied Healthcare Group Ltd (AHZ)

    CardioCel Congenital heart defect reapir

    A joint study with the CSIRO showed CardioCel tissue patches were better in promoting stem cell survival and growth than gold-standard tissues now in surgical use.

    Allied Healthcare Group Ltd (AHZ)

    ADAPT Abdominal hernia repairs

    Allied announced positive results of a comparative study which used ADAPT-treated tissue as a bioprosthetic substitute for abdominal hernia repairs as well as pelvic floor reconstructions in an experimental model. It showed ADAPT-treated tissue was superior or equal to the comparative synthetic implant.

    Antisense Therapeutics Limited (ANP)

    ATL1102 Mutliple sclerosis Antisense agreed with Pharmaron, a contract research organisation in China, to conduct a chronic toxicology study to support a potential future phase IIb study of ATL1102 in multiple sclerosis patients.

    Bioxyne Ltd (BXN) N/A Chronic obstructive pulmonary disease

    A post-hoc analysis of Bioxynes previous study HI-H005 confirmed benefits to patients in excess of 65 years of age.

    Bone Medical Limited (BNE) BN006 Treatment of musculoskeletal diseases

    A proof of concept studys initial findings showed that BN006 reduces inflammation in the collagen-antibody induced arthritis model that the experiment used, and that the improvement increased with the dose of BN006.

    Calzada Limited (CZD) ADO9604 Osteoarthiritis Calzadas AOD9604 peptide showed positive results in an animal model of osteoarthritis.

    Cellmid Limited (CDY) MK-Ab Anti-midkine antibodies Cellmid released positive data relating to a midkine antibody study in kidney disease. Anti-midkine antibodies reduced mortality rate and kidney damage in a mouse model of the disease.

    Gi Dynamics Inc (GID) EndoBarrier Type II Diabetes and obesity

    Clinical research was published which demonstrated a statistically significant decrease in mean HbA1c and total cholesterol levels over a one-year period in patients treated with GI Dynamics EndoBarrier therapy.

  • 23

    Announcem

    ents

    RegulatoryCompany Product Application Comments

    Biotechnology Total 10

    Acrux Limited (ACR) N/A Underarm administration of testosterone formulations

    Acrux announced that the US patent office granted its application for a patent on the underarm administration of testosterone formulations.

    Acrux Limited (ACR) AXIRON Confirmed androgen deficiency

    Acrux announced that the US patent office granted its application for a patent on the underarm administration of testosterone formulations.

    Alchemia Limited (ACL) HA-Irinotecan Metastatic colorectal cancer treatment

    Alchemia was granted a patent for its proprietary drug HA-Irinotecan, currently being evaluated in a 400-patient phase III trial.

    Antisense Therapeutics Limited (ANP)

    ATL1102 Mutliple sclerosis The US patent office has allowed Antisenses patent Methods for treating multiple sclerosis using antisense oligonucleotides, which extends coverage of the ATL1102 compound for the treatment of relapsing-remitting multiple sclerosis patients until 2029 with potential for extension to 2034.

    Antisense Therapeutics Limited (ANP)

    N/A N/A Antisenses technology partner Isis Pharmaceuticals received US FDA approval for Kunamro, an antisense drug with a similar platform chemistry to those in Antisenses pipeline.

    Company Drug Application Comments

    Immuron Limited (IMC) IMM-529 Prophylaxis for C.difficle infection

    Immuron released results showing IMM-529 is effective in preventing C.difficile symptoms in mice.

    Novogen Limited (NRT) CS-6 Ovarian cancer A study conducted by Mazor Oncology showed CS-6 was highly active against ovarian cancer stem cells.

    Patrys Limited (PAB) PAT-SM6 Anti cancer product A pre-clinical study showed PAT-SM6 to work in combination with existing multiple myeloma drugs and was highly effective in a multiple myeloma animal model

    Prana Biotechnology Limited (PBT)

    PBT2 Parkinsons disease The company presented new data demonstrating PBT2 can reduce damage to brain cells caused by the accumulation of the tau protein and prevent subsequent cognitive impairment.disease.

    Prana Biotechnology Limited (PBT)

    PBT434 Parkinsons disease PBT released key findings that PBT434 reduces the aggregation and accumulation of the key protein alpha-synuclein in multiple transgenic animal models of Parkinsons disease.

    Uscom Limited (UCM) Sepsis and septic shock treatment

    Independent data shows Uscoms guided treatment of sepsis and septic shock has significant life-saving and cost reduction benefits.

    Starpharma Holdings Limited (SPL)

    Dendrimer based formulation of doxorubicin

    Breast cancer tumours An animal study showed that a dendrimer-based formulation of doxorubicin was substantially more efficacious in treating secondary tumours of breast cancer in lungs than the drug alone.

  • PwC | BioForum: April 2013

    Announcem

    ents24

    Company Product Application Comments

    Avita Medical Ltd (AVH) N/A N/A Avita Medical announced that it received formal notification that it completed an annual ISO Quality Recertification Audit with no non-conformances identified.

    Benitec Biopharma Limited (BLT)

    N/A Sliencing DNA constructs

    The companys patent Methodsand means for obtaining modified phenotypes has been allowed by the US Patent and Trademark Office.

    Biodiem Limited (BDM) BDM-I Serious infection treatment

    BioDiem announced the grant of a Chinese divisional patent, which expands protection of the companys antimicrobial compound BDM-I.

    Cellmid Limited (CDY) N/A Midkine expression prevention in blood vessel walls

    The company advised that the European Patent Office indicated that it intends to grant the patent application entitled Pharmaceutical composition for vascular occlusive disease.

    Imugene Limited (IMU) Linguet Drug delivery platform

    Japans patent office accepted a key foundation patent application protecting Imugenes Linguet drug delivery technology.

    Medical Devices Total 1

    Allied Healthcare Group Ltd (AHZ)

    CardioCel Congenital heart defect reapir

    Allied received its ISO 13485 certification, a key part of the European CE approval process.

    Pharma Total 8

    Mesoblast Limited (MSB) N/A Drugs based on Mesenchymal Precursor Cell adult stem cell technology platform.

    Mesoblast announced that it has been granted three key new patents by the US patent authority and Chinas Intellectual Property Office.

    Novogen Limited (NRT) N/A Anti cancer fucntions Novogen announced it has filed a provisional patent application covering technology associated with the manufacture and use of a new class of molecules referred to as super-benzopyrans, which display a range of anti-cancer functions.

    Pharmaxis Ltd (PXS) Bronchitol Cystic fybrosis The company received a negative recommendation from a committee advising the FDA on the use of Bronchitol for cystic fibrosis patients.

    Pharmaxis Ltd (PXS) Bronchitol Cystic fybrosis The FDA denied Pharmaxis approval to market Bronchitol in the US and has recommended an additional clinical trial.

    Phylogica Limited (PYC) N/A Phylmer library A core patent was granted for a broad range of phylomer peptide compound libraries.

    Psivida Corp. (PVA) ILUVIEN Vision impairment The Spanish Agency of Drugs and Medical Devices granted pSivida approval to market Iluvien for the treatment of vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies.

    Qrxpharma Limited (QRX) Moxduo Pain relief QRX said the FDA has set 26 August 2013 as the date for action on its new drug application for Moxduo.

    Tissue Therapies Limited (TIS)

    VitroGro ECM The British Standards Institute advised Tissue Therapies that a European Commission Medical Devices Group meeting voted that VitroGro ECM should be regulated as a medicine and not a device, contrary to advice from an independent assessor. The company will appeal any formal vote to change the classification but a failed appeal will mean a clinical trial will be necessary to sell the product in the EU.

  • 25

    Announcem

    ents

    Other newsCompany Product Application Comments

    Biotechnology Total 1

    Alchemia Limited (ACL) N/A N/A Former CFO Charles Walker became the CEO of the company after Dr Peter Smith stepped down.

    Medical Devices Total 4

    Resmed Inc (RMD) N/A N/A Michael Farrell, previously senior vice-president of the companys sleep business unit, was appointed CEO. Mr Farrell is the son of ResMed founder Peter Farrell.

    Universal Biosensors, Inc. (UBI)

    OneTouch Verio Strips Glucose monitoring Lifescan advised UBI that it had initiated a voluntary recall of its OneTouch Verio meters. The test strips which UBI manufactures were not affected. The company advised this would have some effect, but not materially, on strip sales.

    Gi Dynamics Inc (GID) EndoBarrier Type II Diabetes EndoBarrier Therapy, GI Dynamics non-surgical, non-pharmaceutical treatment for type II diabetes and obesity, was selected as BioSpectrum Asias Product of the Year 2013.

    Sunshine Heart, Inc. (SHC)

    N/A N/A Sunshine Heart has advised that it intends to delist from the Australian Securities Exchange in the first half of the 2013 calendar year.

    Pharma Total 1

    Living Cell Technologies Limited (LCT)

    N/A N/A Living Cell Technologies was awarded the 2013 Janssen Industry Excellence Award for Company of the Year, in recognition of innovative research, pipeline development and portfolio strength.

  • PwC | BioForum: April 2013

    Appendix

    04

    26

  • Closing MCap (A$m) Quarterly return Annual return

    Medical device

    AMT Advanced Surgical Design & Manufacture Limited 5.804 0% -56%

    AHZ Allied Healthcare Group Ltd 30.020 38% 0%

    ADO Anteo Diagnostics Limited 44.660 -8% -28%

    ACG Atcor Medical Holdings Limited 14.021 33% 18%

    BRC Brain Resource Company Limited (The) 24.712 6% 2%

    CLV Clover Corporation Limited 102.413 7% 72%

    COH Cochlear Limited 3881.636 -14% 10%

    CGS Cogstate Ltd 29.872 18% 44%

    CMP Compumedics Limited 9.071 -24% -25%

    CYC Cyclopharm Limited 6.975 -29% -33%

    ELX Ellex Medical Lasers Limited 16.133 0% 0%

    GBI Genera Biosystems Limited 7.894 -21% -50%

    GID Gi Dynamics Inc 183.249 16% -39%

    HIN Heartware International, Inc 1371.928 9% 33%

    IPD Impedimed Limited 15.956 10% -82%

    ISN Isonea Limited 17.472 14% -14%

    ITD ITL Limited 22.332 17% 78%

    LBT Labtech Systems Limited 4.671 -18% -11%

    MLA Medical Australia Limited 4.085 13% -36%

    MGZ Medigard Limited 1.365 -6% 0%

    MDV Medivac Limited 3.238 -17% -44%

    MDG Medtech Global Limited 3.509 0% -30%

    NAN Nanosonics Limited 125.558 -1% -11%

    NDL Neurodiscovery Limited 3.686 52% 19%

    OBJ OBJ Limited 18.338 -32% -38%

    OIL Optiscan Imaging Limited 15.398 8% -30%

    OSP Osprey Medical Inc 49.626 19% 20%

    RMD Resmed Inc 6256.324 11% 45%

    RVA Reva Medical 170.793 4% -20%

    SFP Safety Medical Products Limited 1.982 -38% -29%

    SOM Somnomed Limited 41.556 18% 12%

    SUD Suda Limited 19.916 -6% 88%

    SHC Sunshine Heart, Inc. 57.059 -9% -12%

    TDX Tyrian Diagnostics Limited 1.022 0% 0%

    UNS Unilife Corporation 188.664 1% -44%

    UBI Universal Biosensors, Inc. 120.032 -25% -7%

    UCM Uscom Limited 12.634 0% 122%

    27

    Companies in the Pw

    C Life Sciences Index

    Companies in the PwC Life Sciences Index

  • PwC | BioForum: April 2013

    Closing MCap (A$m) Quarterly return Annual return

    Pharma and Biotech

    ACR Acrux Limited 646.104 36% -3%

    ACW Actinogen Limited 1.875 110% 0%

    ACU Acuvax Limited 2.457 0% 0%

    AGX Agenix Limited 1.326 -1% -92%

    ACL Alchemia Limited 103.910 -14% -35%

    ALT Analytica Limited 12.320 0% -8%

    ANP Antisense Therapeutics Limited 14.380 -9% -44%

    AVX Avexa Limited 14.411 -11% -45%

    AVH Avita Medical Ltd 37.411 -4% -52%

    BLT Benitec Biopharma Limited 14.388 -7% -28%

    BDM Biodiem Limited 5.116 -14% -60%

    BNC Bioniche Life Sciences Inc 23.988 -28% -62%

    BNO Bionomics Limited 156.041 6% -21%

    BPO Bioprospect Limited 2.873 0% -75%

    BIT Biotron Limited 26.254 -15% -32%

    BXN Bioxyne Ltd 2.446 7% -93%

    BNE Bone Medical Limited 1.714 0% -85%

    CZD Calzada Limited 17.332 6% -14%

    CDY Cellmid Limited 20.255 127% 127%

    CIR Circadian Technologies Limited 13.131 -23% -45%

    CUV Clinuvel Pharmaceuticals Limited 84.560 31% 34%

    CBB Cordlife Limited 8.980 16% -5%

    CTE Cryosite Limited 24.719 39% 308%

    CSL CSL Limited 29459.262 10% 65%

    GTG Genetic Technologies Limited 35.660 6% -18%

    HTX Healthlinx Limited 0.969 -50% -89%

    HCT Holista Colltech Limited 8.424 -11% -43%

    IMC Immuron Limited 2.485 -40% -86%

    IMU Imugene Limited 3.081 -18% 13%

    IDT Institute Of Drug Technology Australia Limited 10.582 11% -21%

    IVX Invion Limited 17.304 -21% -46%

    LCT Living Cell Technologies Limited 17.136 -4% -40%

    MYX Mayne Pharma Group Limited 270.219 60% 60%

    MVP Medical Developments International Limited 105.756 11% 230%

    MSB Mesoblast Limited 1936.090 16% -22%

    NLS Narhex Life Sciences Limited 2.581 -14% -33%

    NEU Neuren Pharmaceuticals Limited 40.215 -3% 42%

    NRT Novogen Limited 21.133 9% 98%

    NSP Nusep Limited 8.656 -13% 195%

    PAB Patrys Limited 15.728 -18% -9%

    Companies in the Pw

    C Life Sciences Index28

  • 29

    Companies in the Pw

    C Life Sciences Index

    Closing MCap (A$m) Quarterly return Annual return

    Pharma and Biotech (continued)

    PXS Pharmaxis Ltd 101.819 -73% -75%

    POH Phosphagenics Limited 132.628 -10% -45%

    PYC Phylogica Limited 10.256 -8% -51%

    PBT Prana Biotechnology Limited 73.991 2% 39%

    PRR Prima Biomed Ltd 102.342 -13% -60%

    PBP Probiotec Limited 19.050 -19% 15%

    PGL Progen Pharmaceuticals Limited. 6.177 -17% 25%

    PVA Psivida Corp. 51.719 71% 14%

    QRX Qrxpharma Limited 169.234 30% -32%

    SIE Scigen Limited 22.091 0% -11%

    SRX Sirtex Medical Limited 617.353 -16% 113%

    SPL Starpharma Holdings Limited 307.778 -17% -37%

    TEO Telesso Technologies Limited 0.602 0% -41%

    TIS Tissue Therapies Limited 37.668 -48% -64%

    VLA Viralytics Limited 26.181 -10% -20%

  • PwC | BioForum: April 2013

    05Methodology

    30

  • 31

    Methodology

    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 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 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. 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.

    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 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.

    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

  • PwC | BioForum: April 2013

    06

    32

    Contacts

  • PwC Australia Life Sciences and Innovation Practice contacts

    33

    Australian Industry Leaders Life Sciences

    PwC Australia Life Sciences

    Craig Lawn P: +612 8266 0147 E: [email protected]

    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]

    Tax and Legal

    Craig Lawn P: +612 8266 0147 E: [email protected]

    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 | BioForum: April 2013

    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

    Acknow

    ledgements

    Acknowledgements

    34

  • 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.

    2013 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.

    PricewaterhouseCoopers201 Sussex StreetSydney NSW 2000+61 2 8266 0000

    WL12700225

    www.pwc.com.au/bioforum