Industry AUSTRALIA BIOTECHNOLOGY

Industry N0.: 3647 SnapShots Up to date business intelligence reports covering developments in the world’s fastest growing industries AUSTRALIA BIO...
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Industry N0.: 3647

SnapShots

Up to date business intelligence reports covering developments in the world’s fastest growing industries

AUSTRALIA BIOTECHNOLOGY C o n t e n t s • News and Commentary • Media Releases • Latest Research • The Industry • Leading Companies in the Industry

27 October 2015

This Week’s News

• Australian Life Scientist - Antibody technology as a cancer imaging agent 23/10/2015 The agreement is a key milestone for the company as it prepares to further exploit the potential of its antibody technology. For the complete story see: http://www.lifescientist.com.au/content/health-medical/news/antibody-technology-as-acancer-imaging-agent-960401714

• Scientist Live - Virtual screening software for cancer research - 23/10/2015 Blaze will be used to run virtual screening projects to translate Australia’s innovative research discoveries into new cancer drugs. For the complete story see: http://www.scientistlive.com/content/virtual-screening-software-cancer-research • Australian Life Scientist - Nanodelivery trials get the go-ahead - 23/10/2015 Medlab Clinical has been granted ethics approval to begin two separate human trials using its nanotechnology delivery platform. For the complete story see: http://www.lifescientist.com.au/content/biotechnology/news/nanodelivery-trials-get-thego-ahead-1324134143

Other Stories

• Proactive Investors Australia - Pharmaxis pumps up cash as partnerships and products add value - 23/10/2015 • Fierce Vaccines - CSL to buy back $723M of its shares - 21/10/2015

Media Releases

• Benitec Biopharma Limited (ASE: BLT) – Benitec Biopharma’s Abstract Accepted for Presentation at the Aasld Liver Meeting 2015 – 22/10/2015 • Dorsavi Limited (AU: DVL) - Continued momentum for dorsaVi sales globally Quarterly Cashflow for Period Ended 30 September 2015 0- 22/10/2015 • Phosphagenics Limited (ASE: POH) - Phosphagenics Signs Development Agreement with tesa Labtec GmbH for its TPM®/Oxymorphone Patch – 22/10/2015

Latest Research

• Cancer 2015: A longitudinal whole-of-system study of genomic cancer medicine - By David M. Thomas, Stephen Fox, Paula K. Lorgelly, David Ashley, Gary Richardson, Lara Lipton, John P. Parisot, Mark Lucas, John McNeil, Michael Wright

Overviews of Leading Companies

Acrux Limited (ASX: ACR) Agenix Limited (ASX: AGX) Avexa Limited (ASX: AVX) Benitec Biopharma Limited (ASE: BLT) Circadian Technologies Limited (ASX: CIR) Clinuvel Pharmaceuticals Ltd (ASX: CUV) CSL Limited (ASE: CSL) Cynata Therapeutics Limited (ASX: CYP) Dorsavi Limited (AU: DVL) Genera Biosystems Limited (ASX: GBI) Genetic Technologies (ASX: GTG) Healthlinx Limited (ASX: HTX) IDT Australia Limited (ASX: IDT) Immuron Ltd (AU: IMC) Imugene Limited (ASX: IMU) Mayne Pharma Group Limited (ASX: MYX)

Industry SnapShots N0.: 3647

AUSTRALIA BIOTECHNOLOGY Medical Developments International Limited (ASX: MVP) Mesoblast Limited (ASE: MSB) Patrys Limited (ASX: PAB) Phosphagenics Limited (ASE: POH) PolyNovo Limited (ASE: PNV) Prana Biotechnology Limited (ASE: PBT) Probiotec Limited (ASX: PBP) pSivida Corp. (NASDAQ: PSDV) Rhinomed Limited (AU: HCG) Starpharma Holdings Limited (ASX: SPL) Vita Life Sciences Ltd (ASX: VSC) # Details of a newly released 56-page Global UAV Market Research Report on the world’s UAV market (industry overview, equities research, leading company data) produced by our sister company can be found at www.macrosourcemedia.com #

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Oceania – Australia Biotechnology

News and Commentary Australian Life Scientist - Antibody technology as a cancer imaging agent - 23/10/2015 The agreement is a key milestone for the company as it prepares to further exploit the potential of its antibody technology. For the complete story see: http://www.lifescientist.com.au/content/health-medical/news/antibody-technology-as-a-cancer-imaging-agent960401714 Scientist Live - Virtual screening software for cancer research - 23/10/2015 Blaze will be used to run virtual screening projects to translate Australia’s innovative research discoveries into new cancer drugs. For the complete story see: http://www.scientistlive.com/content/virtual-screening-software-cancer-research Australian Life Scientist - Nanodelivery trials get the go-ahead - 23/10/2015 Medlab Clinical has been granted ethics approval to begin two separate human trials using its nanotechnology delivery platform. For the complete story see: http://www.lifescientist.com.au/content/biotechnology/news/nanodelivery-trials-get-the-go-ahead-1324134143 Proactive Investors Australia - Pharmaxis pumps up cash as partnerships and products add value 23/10/2015 The specialist pharmaceutical developer’s cash holdings were up 102% compared to the same time last year For the complete story see: http://www.proactiveinvestors.com.au/companies/news/65250/pharmaxis-pumps-up-cash-as-partnerships-andproducts-add-value-65250.html Fierce Vaccines - CSL to buy back $723M of its shares - 21/10/2015 CSL has launched a AU$1 million share buyback. For the complete story see: http://www.fiercevaccines.com/story/csl-buy-back-723m-its-shares/2015-10-21 Globe News Wire - Atara Biotherapeutics and QIMR Berghofer Medical Research Institute Announce Exclusive License and Research Agreements - 21/10/2015 The exclusive license and research agreements provide an exciting opportunity for global expansion of QIMR Berghofer’s CTL therapy program.” For the complete story see: http://globenewswire.com/news-release/2015/10/21/778449/0/en/Atara-Biotherapeutics-and-QIMR-BerghoferMedical-Research-Institute-Announce-Exclusive-License-and-Research-Agreements.html

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Media Releases Benitec Biopharma Limited (ASE: BLT) – Benitec Biopharma’s Abstract Accepted for Presentation at the Aasld Liver Meeting 2015 – 22/10/2015 Sydney Australia, 22 October 2015: Benitec Biopharma Limited (ASX: BLT; NASDAQ: BNTC; NASDAQ: BNTCW) is pleased to announce that clinical data on its Phase I/IIa study of TT-034 for hepatitis C will be presented in the ‘latebreaking poster’ session at The Liver Meeting® 2015, the 66th Annual Meeting of the American Association for the Study of Liver Disease (AASLD) being held in San Francisco on November 13-17, 2015. The abstract, which has been published on the conference website, details interim results from patients in the first three cohorts in Benitec’s Phase I/IIa study of TT-034, a DNA-directed RNA interference agent (ddRNAi). The primary endpoint that this study is monitoring is safety of this first-in-man gene therapy-based gene silencing drug. Key findings include: • The three doses of TT-034 administered to date have been well tolerated in human subjects infected with the hepatitis C virus (HCV) and there have been no reported serious adverse events related to administration of the study drug; • The initial dose (4E10 vg/kg) resulted in very low levels of transduction as expected. • The second dose (1.25E11 vg/kg) resulted in the detection of substantially higher levels of TT-034 in the hepatocytes, the predominant cell type in the liver, yielding 0.48, 3.65 and 10.44 copies of TT-034 DNA per cell in the three patients respectively; • The first subject administered with the third dose (4.00E11 vg/kg) had 17.74 copies of TT- 034 per cell, indicating that a significant portion of their hepatocytes may have been transduced, and expression of anti-HCV shRNAs was clearly detected in the transduced hepatocytes. Benitec’s Chief Scientific Officer, Dr David Suhy said, “We are pleased to be given the opportunity to present this interim data at the AASLD Liver Meeting next month. The results show that a single infusion of TT-034 is reaching the liver and that it has a very favourable safety profile at the doses tested to date. In the patient that has received the highest dose to date, we are able to detect that anti-HCV shRNAs have been expressed in the liver without any drugrelated serious adverse effects, indicating that so far the trial is achieving its primary outcome. We are pleased with the progress of the trial to date.” http://blt.live.irmau.com/IRM/Company/ShowPage.aspx/PDFs/162110000000/BENITECABSTRACTACCEPTEDFORAASLDMEETING Dorsavi Limited (AU: DVL) - Continued momentum for dorsaVi sales globally Quarterly Cashflow for Period Ended 30 September 2015 0- 22/10/2015 Key points: • Cash receipts from customers of A$564,000 up from A$319,000 (77%) in the June 30, 2015 quarter • Total cash receipts – including interest and grant income - of A$1.23M • Recognised revenue (customer revenue) exceeded A$608,000; doraVi’s highest revenue quarter to date, representing quarter-on-quarter growth of 24% (A$492,000) • Quarterly cash outflow A$1.7M, down 19% on previous quarter ($2.1M) • Cash at hand A$10.79M

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Melbourne, Australia: 22 October 2015. Wearable sensor medical device company dorsaVi Ltd (ASX: DVL) has today released its Appendix 4C – Quarterly Cashflow report for the period ended September 30, 2015. Cash receipts for the period were A$1.23M including receipts from customers of $564,000, up 77% on the previous quarter (A$319,000), R&D tax refund of A$649,000 and A$18,000 in interest income. dorsaVi is experiencing continued momentum across its three key geographies (US, UK and Australia). Recognised revenue for the quarter, which reflects the dollar amount invoiced to customers, was A$608,000, representing the best performing quarter to date, and up 24% on the previous best quarter (A$492,000). The most significant customer contract signed during the period was with UK physiotherapy network YourPhysioPlan to market and sell ViMove in the United Kingdom and Ireland. The three year deal includes minimum sales targets of 100, 300 and 600 ViMove units to be purchased or leased consecutively each year over this period. If minimum sales targets are achieved, the deal has the potential to generate more than A$9M over the three years. The first order exceeding A$120,000 was invoiced during the quarter. Other new customer contracts include Sodexo Australia Pty Ltd, Design Inc, Silver Chain, New England Patriots (NFL), Washington Wizards (NBA), Ohio State University, Marquette University and Heathrow Airport. dorsaVi now has more than 230 active customers across its three priority geographies, the UK, US and Australia. Net operating cash outflow for the quarter was A$1.7 million, and down 19% from the previous quarter of A$2.1. Cash at hand is A$10.79M and includes the receipt of A$4 million in a successful Placement to sophisticated investors and an underwritten Rights Issue, which raised an additional A$3.2 million. http://dorsavi.com/wp-content/sharelink/20151022-appendix-4c---quarterly-77584134669885223.pdf Phosphagenics Limited (ASE: POH) - Phosphagenics Signs Development Agreement with tesa Labtec GmbH for its TPM®/Oxymorphone Patch – 22/10/2015 22 October 2015, Melbourne: Australian drug delivery company, Phosphagenics Limited (ASX: POH; OTCQX: PPGNY), has entered into a development agreement with tesa Labtec GmbH, the German transdermal formulation specialists, to undertake the continued development of its transdermal TPM®/Oxymorphone patch. The objective is to build on the work done to date and create a transdermal patch product with suitable characteristics for development through to commercialisation. Once formulated, the patch will then be progressed towards an Investigational New Drug (IND) application with the US Food & Drug Administration. Phosphagenics previously worked with tesa to develop the TPM®/Oxycodone patch, which is presently being investigated in a Phase 2 proof-of-concept study for Postherpetic Neuralgia (PHN). Dr Ross Murdoch, CEO, said, “We assessed proposals from several potential partners before selecting tesa. We have confidence in their specialist skills and in their ability to complete the reformulation to a standard that will enable us, or a partner, to advance the program to commercialisation. Our previous work with TPM® and Oxymorphone has already demonstrated that it is possible to achieve impressive transdermal delivery and plasma levels within the recognised therapeutic range. This collaboration is designed to take that accumulated know-how and build it into a patch with all the desirable characteristics necessary for successful commercialisation by ourselves or potential partners.” http://www.phosphagenics.com/wp-content/uploads/2015/10/2015-Oct-22-Phosphagenics-Signs-DevelopmentAgreement-with-tesa-Labtec-for-TPM-Oxymorphone-Patch.pdf

# Reportal: a vast archive of corporate documents from listed companies around the world www.reportaldata.com #

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Latest Research Cancer 2015: A longitudinal whole-of-system study of genomic cancer medicine David M. Thomas, Stephen Fox, Paula K. Lorgelly, David Ashley, Gary Richardson, Lara Lipton, John P. Parisot, Mark Lucas, John McNeil, Michael Wright Abstract Genomic cancer medicine promises revolutionary change in oncology. The impacts of ‘personalized medicine’, based upon a molecular classification of cancer and linked to targeted therapies, will extend from individual patient outcomes to the health economy at large. To address the ‘whole-of-system’ impact of genomic cancer medicine, we have established a prospective cohort of patients with newly diagnosed cancer in the state of Victoria, Australia, about whom we have collected a broad range of clinical, demographic, molecular, and patient-reported data, as well as data on health resource utilization. Our goal is to create a model for investigating public investment in genomic medicine that maximizes the cost:benefit ratio for the Australian community at large. http://www.sciencedirect.com/science/article/pii/S1359644615003864

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The Industry Pharmaceuticals Industry Profile Pharmaceutical is a knowledge-based, technology-intensive industry that is uniquely placed to develop and commercialise the outcomes of Australia’s long term investment in medical research. The Australian pharmaceuticals industry comprises bio-medical research, biotechnology firms, originator and generic medicines companies and service-related segments including wholesaling and distribution. With exports of $3.9 billion in 2012-13, pharmaceuticals were one of Australia’s major manufactured exports. The industry employed approximately 16,500 people in manufacturing and spent around $404 million on pharmaceutical manufacturing R&D in 2011-12. Sales of complementary medicines are worth around $2 billion a year (Complementary Healthcare Council of Australia Annual Report 2011-12). Australia’s population only represents approximately 0.3 per cent of the world population. However, Australians consume large amounts of medicines. Pharmaceutical sales in Australia made up a significant share of the global market, making Australia the 12th largest world market in 2012 (IMS Institute for Healthcare Informatics Report 2012). Pharmaceuticals industry receives significant financial support from the Australian Government through the sales of medicines listed in the Pharmaceutical Benefits Scheme (PBS). There are just under 140 separate firms listed as suppliers to the PBS. The Government Pharmaceutical Benefits expenditure on accrual accounting basis was around $9.0 billion in 2012-13. During the same period, the largest firm by PBS sales was AstraZeneca. Its sales represent 12.4 per cent of the value of total sales made to the PBS. The top 10 suppliers by sales contributed more than 67 per cent of the value of total sales made to the PBS. Alphapharm is the largest firm by number of prescriptions on the PBS, accounting for 13 per cent of all prescriptions dispensed under the PBS. The top 10 firms by the number of prescriptions account for a total of just over 73 per cent of total prescriptions written. These data suggest that the Australian market is serviced by a variety of suppliers which is consistent with the global industry structure. Australian industry developments have gained worldwide recognition. They include:

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CSL's development of a Swine Flu (N1H1) vaccine

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The discovery and development of the Gardasil vaccine for Human Papilloma Virus through a partnership between Merck Sharp and Dohme and CSL

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Australian biotechnology company Cytopia's $274 million deal with Novartis to develop orally active, small molecule therapeutics targeting JAK3 kinase for the prevention of transplant rejection and the treatment of multiple indications in autoimmune diseases such as rheumatoid arthritis

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The development by Biota Holdings of the flu drug Relenza

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Acrux's US$335 million deal (plus royalties) with Eli Lilly to market Acrux's US FDA approved Axiron®

The Department encourages the development of an internationally competitive pharmaceuticals industry with policies which enhance the operating environment for the industry by:

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Providing policy advice to the Minister for Industry on developments in the global pharmaceuticals industry and how they might impact on the Australian operating environment

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Providing Secretariat support to the joint industry and Ministerial Pharmaceutical Industry Working Group

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Working with key industry stakeholders including the Pharmaceuticals Industry Council

Global Context The pharmaceuticals industry spans a spectrum of activity from the technology intensive R&D segment associated with innovative drugs through to the production of generic and over-the-counter medicines. The industry is dominated

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by horizontally and vertically integrated multinational entities and is more research intensive than most other industries. The IMS Institute for Healthcare Informatics estimate that annual global spending on medicines will reach about $US 1.2 trillion by 2016, despite slowing growth, reduced contribution from developed markets due to patent expiries and the sustained impact of the global economic crisis.

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In developed markets (including the US, Europe and Japan) spending is predicted to decline to 57 per cent from 73 per cent in 2006.

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In emerging markets (including China, Brazil, India, Russia and Mexico), spending is predicted to increase from 14 per cent in 2006 to 30 per cent in 2016.

Industry R&D activity Developing a new drug is expensive. Current estimates of the full cost of bringing a new chemical or biological entity to market are around US$1.3 billion. Longer development and approval times, larger and more complex clinical trials, increased expenditures on new technologies, and shifts in product portfolios towards riskier, more expensive therapeutic categories have contributed to a real increase in the development costs. Accordingly, pharmaceuticals R&D expenditure is rising. The industry spent $404 million on pharmaceutical product manufacturing R&D in Australia in 2011-12. With 0.3 per cent of the world’s population, Australia produces two per cent of global health and medical research (McKeon’s Review) and has a proud history of eight Nobel laureates in medicine:

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Howard Florey (1945: development of penicillin)

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Frank Macfarlane Burnet (1960: research on organ transplantation)

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John Eccles (1963: research on the transmission of nerve impulses)

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Bernard Katz (1970: discoveries on the humoral transmittors in the nerve terminals and the mechanism for their storage, release and inactivation)

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Peter Doherty (1996: discoveries concerning the specificity of the cell mediated immune defence)

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Barry Marshall and J. Robin Warren (2005: discovery of the bacterium Helicobacter pylori and its role in gastritis and peptic ulcer disease).

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Elizabeth Blackburn (2009: research on telomeres, structures at the end of chromosomes that protect the chromosome).

This is in large part due to the importance the Government places on investing in Australian scientific research. In the health and medical area, this funding is allocated through a variety of R&D providers and there is considerable interaction between these entities. The bulk of the funding is provided through:

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The National Health and Medical Research Council (NHMRC)

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The Australian Research Council (ARC)

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Cooperative Research Centres (CRCs)

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The Commonwealth Scientific and Industrial Research Organisation (CSIRO)

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Universities

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Hospitals

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In addition, the Government also supports the industry with R&D funding, an R&D Tax Incentive. Many pharmaceutical and biotechnology companies have access to the R&D support when they conduct eligible R&D activities in Australia. http://www.industry.gov.au/industry/IndustrySectors/PharmaceuticalsandHealthTechnologies/Pharmaceuticals/Pages/ PharmaceuticalsIndustryProfile.aspx Industry overview Respected commentators and intellectuals agree that biotechnological innovation is the foundation-stone of our future, and a ‘game changer’. It is anticipated that it will underpin our economy and provide solutions to intractable problems of human and animal diseases, climate change, fuel alternatives, food security – as well as improving our quality of life. Juan Enriquez also coined the term ‘bio-economy’ which is closely linked the biotechnology industry. The term was first defined by Enriquez and Rodrigo Martine, Life Sciences Chief Strategist at IDEO. Enriquez was the founding director of the Harvard Business School Life Sciences Project, and was a member of Craig Venter's marine-based team to collect genetic data from the world's oceans, which he later used to map the human genome. The OECD describes the bio-economy, from a broad economic perspective, as “the set of economic activities relating to the invention, development, production and use of biological products and processes. If it continues on course, the bio-economy could make major socioeconomic contributions... These benefits are expected to improve health outcomes, boost the productivity of agriculture and industrial processes, and enhance environmental sustainability.” For our part, Australia is well on its way to achieving this vision of a successful bio-economy. The latest Scientific American, Worldview Scorecard 2013 ranked Australia number seven in biotechnology in the world up from number ten in last year. We ranked best in the world for the “Best growth in public markets” and second globally for “Greatest public company revenues” and the “Most public companies”. Australia’s 88 ASX-listed biotechnology companies are valued at more that $51 billion (BioForum, April 2014) – a great contribution to the bio-economy. Despite the challenges of the global economy and the degree of difficulty in building a biotechnology and life sciences sector from scratch, Australia is doing very well by any comparative measure, with an impressive return on investment from a maturing stock of quality companies. Australian biotechnology boasts a raft of success stories and a world-class industry. Since its emergence in the early to mid-nineties, the biotechnology industry in Australia has achieved a great deal. The year 2014 dawned with news that biotechnology has become a ‘20-year overnight success’ with The Age and Sydney Morning Herald (4 Jan 14) reporting that “biotech has finally boomed”. The article reported the array of successes of 2013, which included IPOs, four to nine-fold surges in share prices for a number of companies, high profile investors turning their attention to biotech and a steady flow of capital raisings that totalled $739.1 million (Biotech Daily, 2 Jan 14), the highest amount since 2007. Biotech Daily reported that its ‘Top 40’ Index of listed biotechnology companies ended 2013 up 18.1% for 2013, compared to the benchmark S&P ASX 200 15.1% up for the year and the majors (Cochlear, CSL and ResMed) up 17.9%. News from Western Australia (The Australian, 23 Dec 13) details a shift in financier’s choices from mining to biotech companies, including Andrew Forrest taking a million-dollar stake in Admedus. The PricewaterhouseCoopers (PwC) ten year report was released in October 2012, showing the PwC Australian Life Sciences Index had consistently outperformed the NASDAQ Composite Index and the All Ordinaries since mid-2006. Excluding the three majors (CSL, ResMed and Cochlear) from the Life Sciences Index, in 2008 the Index parted ways with the All Ordinaries and dramatically outperformed it in the reporting period, almost quadrupling its performance. In four years (2008 – 212) the often-cited All Ordinaries Index had failed to come anywhere close to biotechnology’s performance. The NASDAQ Biotech Index, perhaps the best comparative measure of US biotechs, hit a 12-year high in July 2012, but nevertheless still trailed behind the Australian Life Sciences Index.

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Australia’s comparative advantage comes from its world-class science and medical research, its capacity for international partnerships, cost effectiveness, and a transparent and effective regulatory system. Jobs of the future will be found in the biotech and pharmaceuticals sector, and the medical technology sector. In addition, there are many thousands of direct jobs in the agricultural and industrial biotechnology sectors and indirect jobs in dependent areas such as clinical trial teams, high-tech manufacturing, medical research and supplies to the medical technology sector and in services such as those provided by patent attorneys. Innovative industries provide high-skilled jobs with long-term prospects. • CSL is Australia’s largest biotechnology company. • The emerging trends of foodtech and cleantech have gained momentum, and the medtech sector is surging forward, to follow in the footsteps of medtech industry pioneers, Cochlear and ResMed. • Australia is home to numerous world class medical research organisations, including the Garvan Institute, Institute for Molecular BioScience, Menzies Research Institute, John Curtin School of Medical Research, Walter and Eliza Hall Institute of Medical Research (WEHI), Australian Institute of Bioengineering and nanotechnology, Brain Insititute, Diamentina Institute, The Lowy Research Centre, Victor Chang Cardiac Research Institute, Baker Medical Research Institute, The Burnett Centre and South Australian Research & Development Institute. • Most states of Australia’s mainland are now able to commercially cultivate 3 types of GM crops that have been approved by the GM regulator. • Australian state governments are developing and implementing independent regional initiatives. Each has strong medical research programs, some having specialist expertise in areas including tropical medicine, bio-discovery, regenerative medicine, bioremediation, agricultural/industrial biotech and medical devices. http://www.ausbiotech.org/content.asp?pageid=25

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Leading Companies Acrux Limited (ASX: ACR) Acrux announces 2015 Financial Result and Dividend Acrux (ASX: ACR) today announced its financial result for the year ended 30 June 2015 and also declared a dividend of 6 cents per share, fully franked. “We are pleased to declare a tax-free dividend of 6 cents per share, closing the year with a strong cash position”, said Acrux Chairman Mr. Dobinson. The record date for entitlement to the dividend is 20 August 2015 and the estimated date for dispatch of payment is 3 September 2015. Financial highlights: · Cash at 30 June 2015, $23.1 million; · Net profit after tax $11.1 million for 2014/15 year; · Earnings per share 6.7 cents per share; · Final dividend of 6 cents per share, fully franked o Record date 20 August 2015 o Expected payment date 3 September 2015 Mr. Kotsanis, Acrux CEO and Managing Director commented “Acrux is a successful Australian company with some exciting development prospects and is well placed to execute its future strategic priorities, aimed at increasing shareholder returns.” Shareholders and analysts are encouraged to join the Investor Conference Call, to be held on Thursday 13 August 2015. Details of the Conference Call were released in a separate announcement on 12 August 2015. Acrux will discuss the financial results for the year ended 30 June 2015 and will provide an update on strategy. The audited Financial Report for the year ended 30 June 2015, Appendix 4E and Appendix 4G are attached to this announcement. About Acrux § Acrux is an Australian drug delivery company, developing and commercialising a range of patient-preferred, patented pharmaceutical products for global markets, using its innovative technology to administer drugs through the skin. § The Acrux technology, used in marketed products including AXIRON®, Evamist® and Recuvyra™, is based on a fast-drying, small volume, accurately dosed solution, containing penetration enhancers, that when applied topically, deposit drug through the skin for long acting delivery. § Acrux has three products marketed by licensees in the USA, three products approved in Europe, and further products at earlier stages of development.

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http://investors.acrux.com.au/FormBuilder/_Resource/_module/NFYtO6lmRkalc6H49CMdjw/docs/fin-reports/axruxfinancial-result-dividend-2015-08-13.pdf Agenix Limited (ASX: AGX) For the Year Ended 30 June 2015 Operational and Financial Review Financial Position In August 2014 Agenix Biopharmaceutical Co (Shanghai) Limited received the equivalent of $2,079,124 from the successful sale of its burdensome AGX-1009 project. The sale proceeds of AGX-1009 currently reside in China and the Chinese authorities have restrictions on foreign exchange transactions in RMB from China to other countries. All foreign transactions in China must be approved by the Chinese authorities and may be subject to quota. Accordingly this cash has a significant present restriction on its use. As a result of the restrictions, directors at the time being Messrs Chapman, Lee and Gallagher and or their related entities have advanced unsecured loan funds to Agenix Limited to ensure that it can meet its obligations. At the date of this report a total of $650,000 has been advanced by these directors. These loans are subject to repayment upon the repatriation of funds from China and may be converted, subject to shareholder approval, to equity. In addition Nicholas Weston agreed to convert monies due to him on resignation to an unsecured loan to be paid once the repatriation of funds from China is completed. The timing of the repatriation of funds is dependent upon obtaining all necessary approvals from various Chinese authorities and as such the exact timing is beyond the control of the Group. The Group continues to have as a backstop a Continuous Investment Agreement with Baycrest Capital LLC entered into on 31 January 2013 for the provision of up to $3 million over three years. Subject to its conditions, Agenix has full control over the timing, price and number of securities Baycrest purchases. Since entering into the agreement and to the date of this report no draw down under this facility has occurred. Operations During the period, sustained and substantial efforts were undertaken to explore strategic business alternatives. The Company has conducted initial due diligence and assessed numerous paths to enhance value and accelerate the route to revenue. As part of this due diligence process, the Company became aware of a writ that was lodged with the Supreme Court of Victoria naming the Company as defendant. The writ has not been served on the Company but its issue in March 2014 sought to preserve rights otherwise arguably statute barred since then. The writ concerned claims arising from a share subscription agreement entered into between Agenix and OKS AGX Inc. (OKS) in March 2008. It made no claims concerning the conduct of any current Agenix board member or personnel. The Company immediately entered into discussions with OKS to resolve the matter resulting in a settlement agreement being reached in March 2015. Under the terms of the settlement agreement, shareholder approval was obtained at an Extraordinary General Meeting held in May 2015 to: (a) immediately allot 13,240,000 Ordinary Securities to OKS and to provide and maintain OKS with a 10% shareholding in the total issued capital of Agenix for a period of 2 years or until a point immediately preceding a merger or acquisition transaction by Agenix, whichever occurs first in time; and (b) assign all rights, title and interest in the Thromboview project. The assignment of the Thromboview project was subject to acceptance by OKS. In July 2015 the Company received formal notification from OKS, that it has exercised its discretion under the Settlement Deed not to proceed with the assignment of Thromboview.

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As a result the intellectual property in relation to Thromboview remains the property of the Group. The Settlement Deed terms and conditions remain in force which removed a significant legacy barrier to allowing the company to move to pursue strategic alternatives with a view to achieving an increase in shareholder value and near term revenues. Financial result The Group’s loss for the year ended 30 June 2015 was $1,083,446 compared to a profit of $786,160 in the previous financial year. The loss is primarily attributed to: • one off costs associated with the finalisation of the divestment of AGX-1009 and termination of employees in China $117,902; • costs incurred in respect of the settlement with OKS $105,200; and • a charge to the statement of profit and loss and other comprehensive income amounting to $198,600, being the non cash fair value of the securities issued to OKS AGX Inc. in accordance with accounting standards. Total income for the year ended 30 June 2015 was $7,657 down from $28,190 in the previous financial year due to reduction in licence fees on the Group’s intellectual property. Operating expenses (excluding OKS charge) for the year totalled $581,684 compared with the previous financial year of $832,769 the Group has continued to reduce costs and cash burn wherever possible whilst it reviews strategic alternatives. Current assets at 30 June 2015 were $1,694,819 (2014: $2,085,169). Total liabilities at 30 June 2015 were $846,100 (2013: $705,220). Current assets reduced due to the use of cash to settle all outstanding liabilities in respect of its China operations. The increase in current liabilities is mainly due to the loans being advanced by directors to enable the Company to meet its obligations whilst the process of repatriation of funds from China is completed. Capital Baycrest Capital LLC Funding Facility On 31 January 2013, the Company entered into a Continuous Investment Agreement with Baycrest Capital LLC for the provision of up to $3 million over three years. Baycrest Capital is a specialist fund that invests in high growth Australian public companies. Agenix has full control over the timing, price and number of securities Baycrest purchases. Since entering into the agreement and to the date of this report no draw down under this facility has occurred. http://www.agenix.com/wp-content/uploads/2015/08/Agenix-Limited-Annual-Report-2015-Final.pdf

Avexa Limited (ASX: AVX) Melbourne, Australia, Friday 31st July 2015: Avexa Limited (ASX: AVX) lodges the attached Appendix 4C Quarterly Consolidated Statement of Cash Flows for the period ending 30 June 2015. Commentary is provided as follows: • The Company held cash reserves of $1.0 million at 30 June 2015. • Net operating cash outflows for the June quarter were $0.4 million. • The Company has invested USD$4.1million in Coal Holdings USA, LLC and through a loan facility, invested another USD$4.5million in Coal Holdings USA, LLC as at 30 June 2015. • The Company expects to receive proceeds from the R&D Incentive in the second half of calendar year 2015.

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• The Company continues to develop the ATC Named Patient Scheme program by providing product related information to patient advocate groups and physicians on request and expects revenue in the next half of the calendar year. COMPANY UPDATE Key points: 1. North Pratt coal mine – coal shipments amounted to 19,294 short tons since production commenced to 30 June 2015; sales revenue were US$1.3 million (net). Production in Q3 (2015) is expected to ramp up towards 22,000 short tons per month as demand increases. 2. Named Patient Supply (NPS) – momentum is growing as awareness of ATC’s availability widens. North Pratt coal mine The demand for coal since the North Pratt mine commenced production earlier this year has been anaemic. The severity and duration of the commodity downturn is not what was modelled a couple of years ago – arguably the ‘perfect storm’ scenario. So the resultant lack of any returns from North Pratt means we have had to defer plans based on receiving our share of the surplus cash flows and putting them to work on progressing ATC clinical trials. Our strategy in North Pratt has been to fight hard to keep everything ‘open’ and moving in an environment where many producers have reacted to the downturn by choosing to close/mothball operations or slash costs and production. In the current month of July we have become increasingly confident that this strategy appears to be paying off. We are sensing increasing demand for our coal from the local industrial market. This reflects the fact that (i) coal inventories have been run very low (a result of buyers’ working capital management) and (ii) many players have shut down or gone out of business. Demand is picking up, albeit from a very low base, and we have a number of local buyers who are looking to North Pratt for its coal which would see production increase to approximately 22,000 short tons per month. As a consequence, local management are now hiring additional workers to ramp up production to meet these orders. Further, there is increasing confidence that in September/October 2015 we will be able to engage with local buyers to negotiate contracts for 2016 supply. Obviously it has been a very challenging and difficult period to steer through but the securing of meaningful contracts for 2016 would be a significant and positive step forward to meeting the board’s original investment strategy. Apricitabine (ATC) – Named Patient Supply (NPS) The Special Access or NPS scheme has been slower to gain traction than we had originally envisaged even taking into account the fact that active promotion is not permitted. The board can assure shareholders that management from both Avexa and our partners LINK have been actively working on multiple fronts to spread knowledge about ATC, its availability and increase uptake of ATC. This will include ATC related information being:• Published in the HIV+ newsletter (circulation +3million) • Published in an additional seven patient advocate newsletters over coming weeks • Published in a number of widely read patient advocate blogs LINK recently attended the Pathogenesis Conference held in Vancouver, Canada earlier this month and will be attending the US Conference on AIDS to be held in Washington DC (10-13 September) to continue to drive these initiatives. About Avexa Limited

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Avexa Limited is a Melbourne-based biotechnology company with a focus on discovery, development and commercialization of small molecules for the treatment of infectious diseases. Avexa’s key projects include apricitabine (ATC) for the treatment of drug-resistant HIV, an HIV integrase program and an antibiotic program for antibiotic-resistant bacterial infections. http://www.avexa.com.au/sites/default/files/asx/Appendix%204C%20%20Quarterly%20Cash%20Flow%20Report%20-%20June%202015.pdf

Benitec Biopharma Limited (ASE: BLT) Sydney, 30 July 2015: Benitec Biopharma Limited (ASX: BLT; OTCPK: BTEBY) today lodged, with ASX, the attached Appendix 4C quarterly cash flow report for period ended 30 June 2015. Benitec held $22.2 million in cash at 30 June 2015, compared to $26.7 million at 31 March 2015. Net operating cash flow for the quarter was ($3.8) million, and included scientific and business development expenditure of $2.2 million. Total research and development spending for the year to 30 June 2015 was $6.1 million. The company received a research and development grant of $2.3 million from the Australian Government in the March quarter under the research and development tax incentive scheme. About Benitec Biopharma Limited: Benitec Biopharma Limited is a biotechnology company (ASX: BLT; OTCPK: BTEBY), which has developed a patented gene silencing technology delivered by gene therapy, called DNA directed RNA interference (ddRNAi) that has the potential to produce 'one-shot' cures for a range of diseases. The company is developing ddRNAi-based therapeutics for chronic and life-threatening human conditions including hepatitis C and B, drug resistant lung cancer and wet age-related macular degeneration. Benitec has also licensed ddRNAi to other biopharmaceutical companies for applications including HIV/AIDS, Huntington’s disease, chronic neuropathic pain and retinitis pigmentosa. For more information visit www.benitec.com http://blt.live.irmau.com/IRM/Company/ShowPage.aspx/PDFs/1579-10000000/Appendix4Cquarterly

Circadian Technologies Limited (ASX: CIR) 31 December 2014 half-year financial report Review of operations Financial performance For the half year ended 31 December 2014, the Company’s net loss attributable to members is $3,018,683 (31 December 2013: $1,587,808). The increased loss is mainly due to the increase in research and development spending by the Group as it progresses development of OPT-302 through pre-clinical testing to support IND filing to the US FDA to allow initiation of clinical trials in the US. Set out below are a number of other factors affecting financial performance: • Revenue was $366,215 (31 December 2013: $396,901). The lower revenue is largely attributable to reduced cash balances and lower prevailing interest rates impacting interest income. • Other income includes grant income $18,515 (31 December 2013: $5,000) • The total investment in R&D was $3,891,303 (31 December 2013: $2,577,973). Direct R&D spending (excluding personnel and R&D support costs) was $3,211,561 (31 December 2013: $1,725,111). Further R&D project commentary is included under the operational update heading. • Patent and intellectual property costs of $142,936 (31 December 2013: $340,712).

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• The net income tax benefit for the half year is $1,272,989 and includes an income tax benefit of $1,751,087 based on the research and development spend for this half year. In the previous corresponding period the R&D income tax benefit recognised in relation to the 2014 financial year was $1,160,088. Financial position The cash position as at 31 December 2014 was $18,988,424 (30 June 2014: $7,162,020). Other points to note on the Company’s financial position are: • The 2014 Research and Development (R&D) tax incentive claim of $2,170,911, included in current tax assets at 31 December 2014, was received from the Australian Tax Office during January 2015. A benefit of $1,751,087 (31 December 2013: $1,160,088) has been recognised in relation to the R&D tax incentive spend in the current period and included in current tax assets. • The value of the investment portfolio (Available for sale financial assets) decreased by a net $509,448 to $1,765,973 during the half year. This was mainly due to fair value decreases to the value of Antisense Therapeutics Limited (ASX:ANP) in which the Group has a 8.89% holding. • As at 31 December 2014, the estimated tax losses available to the Group are $12,558,385. As the ability to realise this benefit and other timing differences is not beyond reasonable doubt, a deferred tax asset has only been recognised to the extent an offsetting deferred tax liability has been recognised. No other tax losses have been recognised. • During the half year the company issued 99,453,313 new shares through a placement to professional and institutional investors and a rights issue. Proceeds from the issue were $17,405,458. The company also issued options to purchase 49,726,672 shares with an exercise price of $0.27 expiring on 25 November 2018. • As at 31 December 2014, the Net Tangible Asset backing per share was 16 cents; down 27% from 22 cents as at 30 June 2014. The company’s share price commenced the half year at $0.19 and ended the half year at $0.16 with $0.21 being the highest share price recorded during the half year. As at 31 December 2014, the company had 2,394 shareholders with the top 20 accounting for 79% of issued shares. Opthea Pty Ltd OPT-302: A potent inhibitor of VEGF-C and VEGF-D for the treatment of wet AMD Since our announcement in February 2014 to focus Circadian’s cash and resources on the opportunity represented in the OPT-302 program for the treatment of eye diseases, Circadian has continued to execute on this strategy and advance the development program through its 100% owned subsidiary Opthea Pty Ltd. OPT-302 is Circadian’s lead molecule, a soluble form of VEGFR-3 that acts as a VEGF-C/VEGF-D ‘trap’. Blockade of VEGF-C and VEGF-D by OPT-302 inhibits blood and lymphatic vessel development, as well as vessel leakage, which are characteristic hallmarks of several eye diseases, including neovascular (‘wet’) age-related macular degeneration. Wet AMD is a disease characterised by loss of vision in the middle of the visual field caused by degeneration of the central portion of the retina (the macula). Abnormal growth of blood vessels below the retina, and the leakage of fluid and protein from the vessels, cause retinal degeneration and lead to severe and rapid loss of vision if left untreated. Approved therapies for the disease include Eylea® and Lucentis® which block the activity of VEGF-A, a signal that causes blood vessels to grow and leak. The approved therapies target VEGF-A but not VEGF-C or VEGF-D which are alternate members of the same family of molecules. VEGF-C and VEGF-D can stimulate blood vessel growth and leakage through the same pathway as VEGF-A, as well as through pathways that are independent of VEGF-A. Our strategy is to address the unmet medical need that remains for wet AMD patients. Approximately half of the people receiving the existing therapies exhibit a sub-response and do not experience a significant gain in vision and/or have persistent fluid at the back of the eye. As the leading cause of blindness in the developed world, and one which is increasing in prevalence as the population ages, wet AMD represents a multi-billion dollar market opportunity.

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OPT-302 has the potential to be used as a single-agent (monotherapy), or in combination with existing approved inhibitors of VEGF-A (Lucentis®/Eylea®) in order to achieve a more complete blockade of the VEGF pathway. http://www.circadian.com.au/sites/default/files/Circadian%20Half%20Year%20Report%20and%20Accounts.pdf

Clinuvel Pharmaceuticals Ltd (ASX: CUV) Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-­‐DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified patient populations with a clinical need for photoprotection and another population with a need for repigmentation. These patient groups range in size from 5,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide 16mg), a first-­‐in-­‐class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been approved by the European Commission for treating adults with EPP. Since 2006, Clinuvel’s focus has been to develop and commercialise SCENESSE® (INN: afamelanotide 16mg) as a medicinal photoprotective solution for patients who are most severely affected by ambient light exposure and UV. Erythropoietic protoporphyria (EPP) was identified as a most severe disorder affecting adult and juvenile patients. Following positive results from Phase II and III trials of the drug in EPP, SCENESSE® was approved by the European Commission for treating adults with EPP in late 2014. Orphan Drug Designations Clinuvel has obtained Orphan Drug Designations (ODDs) for afamelanotide for the indications porphyria (EPP) and solar urticaria (SU) in Europe and the USA. ODD status entitles Clinuvel to market exclusivity in the USA and European Union’s 28 member states (plus Iceland, Lichtenstein and Norway) for seven and ten years respectively. Together with its extensive data on afamelanotide and clinical trials, Clinuvel is in a strong position to retain the exclusive rights to afamelanotide and its analogues. Quarter ended 30 June 2015 Intellectual Property Clinuvel Pharmaceuticals has the worldwide rights to the licence of analogues of alpha-MSH invented by scientists at the University of Arizona. In total there are 34 patents in the licence's patent family. The patents contain within their scope the use of numerous analogues of alpha-MSH for the induction of melanogenesis A period of marketing exclusivity is established in the major marketing jurisdictions globally. This basically affords protection for a period of 7 years in the US and Australia/New Zealand and 6-10 years (plus a further 1 to 3 years for the generic registration process) in Europe. http://www.clinuvel.com/index.php?option=com_k2&Itemid=8&id=490_620fc470f4123d2a394cefcd92499570&lang=e n&task=download&view=item http://www.clinuvel.com/en/investors/investing-in-clinuvel/financial-overview

CSL Limited (ASE: CSL) Strong Full Year Result Double digit growth in albumin and specialty products

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CSL becomes No.2 global influenza vaccines manufacturer New Privigen® facility completed Board to consider further share buyback Melbourne, Australia — 12/08/2015 CSL Limited (ASX:CSL; USOTC:CSLLY) today announced a net profit after tax (NPAT) of US$1,379 million for the full year ended 30 June 2015, up 6% on a reported basis when compared to the prior comparable period (PCP). NPAT grew 10% on a constant currency1 basis, after adjusting for the one-off costs2 associated with the acquisition of the Novartis influenza vaccine business. HIGHLIGHTS Financial • Sales US$5,459 million, up 2% on PCP o Up 7% at constant currency1 • EBIT US$1,758 million, up 7% on PCP o Up 12% at constant currency & after adjusting for acquisition costs2 • NPAT US$1,379 million, up 6% on PCP o Up 10% at constant currency & after adjusting for acquisition costs • Earnings per share US$2.92, up 8% on PCP o Up 13% at constant currency & after adjusting for acquisition costs • Research and development investment was US$463 million • Final dividend3 increased 10% to US$0.66 per share, unfranked for Australian tax purposes, payable on 2 October 2015 o Converted to Australian currency, the final dividend increased to approximately A$0.90 per share, up 39% on PCP. Operational • Acquisition of Novartis‘ global influenza vaccine business • bioCSL business turnaround • Hizentra® (subcutaneous immunoglobulin) - European Medical Agency & U.S. Food and Drug Administration (FDA) approved flexible dosing • CSL 654 (rIX-FP) - license application submitted to U.S. and European regulators • CSL 627 (rFVIII-SingleChain) – license application submitted to U.S. FDA • CSL 112 (rHDL) – global phase IIb clinical trial recruiting rapidly • Major capital projects completed Capital Management • A$950 million share buyback completed • New buyback4 foreshadowed • New private placement foreshadowed 27 October 2015

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“CSL’s solid 2015 results demonstrate our track record of delivering strong shareholder returns,” said CSL Chief Executive Officer and Managing Director, Paul Perreault. “Robust demand for our differentiated biotherapies continued, with albumin and specialty products growing at double digit rates. bioCSL is growing again with influenza vaccine sales increasing particularly well.” “We fast tracked the acquisition of the Novartis influenza vaccines business, which lets us get on with integration much earlier,” Mr. Perreault said. “CSL is now the second largest influenza vaccine manufacturer in the world - a sector we understand deeply. The combined business has an extensive product portfolio, broad global sales reach, specialized R&D and scaled manufacturing, positioning the business very well to compete globally.” “We also invested to support our future growth, completing a number of key projects and advancing our major multisite facilities expansion program,” said Mr Perreault. “We recently ‘broke ground’ on our new recombinant coagulation manufacturing plant in Lengnau, Switzerland. We’ve completed validation runs in our new Privigen® facility in Broadmeadows, Australia and obtained U.S. FDA approval to commence operations in our recently completed base fractionation and albumin facility at Kankakee, in the U.S.,” Mr. Perreault added. OUTLOOK (at FY15 exchange rates) CSL expects strong underlying demand for its products to continue in FY16, with sales growth similar to gains achieved FY15. The Company said the market place will remain competitive, particularly as new manufacturers and products emerge. “FY16 will be a critical year in investing in our sustainable growth,” Mr Perreault said. “We continue to invest substantially in our research and development pipeline. A major investment in our commercial capabilities will be made ahead of our anticipated launch of new recombinant coagulation products in 2017. Our significant capacity expansion coming on line in FY16 will trigger a lift in fixed asset depreciation. Notwithstanding these additional costs, we anticipate net profit after tax to grow by around 5%, with earnings per share growth to exceed profit growth. “Given the accelerated close of the Novartis deal, we are not yet in a position to provide guidance on this business beyond what was announced in October 2014. Consequently the gain on acquisition, integration costs and operational contribution are excluded from our guidance. We expect to provide an update on the outlook for this business in the coming months,” Mr. Perreault said. OPERATING REVIEW CSL Behring sales of US$5,029 million increased 7% in constant currency terms when compared to the prior comparable period. Immunoglobulin product sales of US$2,326 million grew 5% in constant currency terms, with ‘normal’ immunoglobulin volumes growing 8%. Demand for intravenous immunoglobulin (IVIG) was led by Privigen®, with growth in Europe being particularly strong. Privigen’s expanded indication in Europe to include its use in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) has underpinned this growth. This dynamic has contributed to the average IVIG sales price being adversely affected as a greater proportion of sales were made into lower priced markets. The U.S. market remains competitive. Demand for subcutaneous immunoglobulin (SCIG) was strong in both North American and European markets. CSL’s SCIG product, Hizentra®, offers patients the convenience of self-administration at home. In the U.S. the approval of flexible dosing has driven an increased penetration of the product into the Primary Immune Deficiency (PID) patient market. Albumin sales of US$754 million rose 12% in constant currency terms, driven by ongoing global demand. China continued to drive albumin performance boosted by improved penetration into Tier 2 and Tier 3 cities. CSL’s uniquely broad suite of albumin presentations provides an attractive portfolio of choice to customers. Haemophilia product sales of US$1,026 million grew 3% in constant currency terms. Plasma derived haemophilia sales increased 4%, notwithstanding an ongoing transition towards recombinant therapies. Growth was largely driven

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by demand for Beriate® in Brazil, Poland and Germany. Haemate® and Humate® sales grew in Eastern Europe, the Middle East, Africa and North America. Helixate®, CSL’s recombinant factor VIII, delivered modest growth following the successful introduction of a patient retention program. New entrants continue to make this market competitive. Specialty products sales of US$923 million grew 15% in constant currency terms, tempered by a sales decline of wound healing products in Japan. The remaining group of specialty products grew 18%, driven largely by strong sales of Kcentra®, Berinert® and Zemaira®. Kcentra® (4 factor pro-thrombin complex concentrate) continued to grow strongly following the launch of the surgical indication approved by the U.S. FDA. In December the U.S. Centres for Medicare and Medicaid Services approved an extension to the new technology add-on payment for Kcentra® through to September 2015, recognising its significant clinical advancement in reversing the effects of warfarin in patients who experience acute major bleeding. Strong demand for Berinert® continued. Berinert® (C1-esterase inhibitor concentrate) is used for the treatment of acute attacks in patients with hereditary angioedema. In 2012, the U.S. FDA approved a label expansion to include self-administration and now in excess of 75% of patients are self-administering Berinert®. Zemaira®, which is used to treat Alpha-1 associated emphysema, grew strongly. CSL’s new DNA test kits have been invaluable for patient identification. More than 9,000 kits were processed during the year. bioCSL sales of A$480 million grew 11% in constant currency terms. Influenza vaccine sales increased 18% to A$145 million. Contributing to this growth was the re-establishment of our in-house commercial capability. bioCSL’s influenza vaccines were first to market in the U.S., U.K., and Germany – an important competitive advantage. CSL Intellectual Property revenue of US$137 million declined 5% in constant currency terms. This was driven by a reduction in royalties received on intellectual property associated with human papillomavirus vaccines, which contributed US$106 million to revenue. CAPITAL MANAGEMENT Share Buyback During October 2014, CSL announced its intention to conduct an on-market share buyback of up to A$950 million. This program is now complete, with the repurchase of approximately 10.6 million shares representing approximately 2.2% of CSL’s shares on issue. CSL’s balance sheet remains sound and modestly geared and the Company continues to deliver strong free cashflow. Cash and cash equivalents were US$557 million as at 30 June 2015, with interest bearing liabilities of US$2,281 million and undrawn debt facilities of $141 million. Capital management foreshadowed during FY16 In the interests of improving shareholder returns, CSL aims to maintain an efficient balance sheet. CSL has been pursuing an objective of increasing its gearing to approximately one times net debt to EBITDA. At 30 June 2015, this gearing ratio stood at 0.9x. The Board of Directors is considering a further on market share buyback program of a similar amount to the most recent program. During the first half of FY16, CSL intends to approach the U.S. private placement market to raise the equivalent of ~US$500 million as part of CSL’s overall debt management program. http://www.csl.com.au/docs/491/480/FY15%20ASX%20release%20-%20FINAL.pdf

Cynata Therapeutics Limited (ASX: CYP) Annual report for the financial year ended 30 June 2015 Operating and financial review

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Principal activities

The Group’s principal activities in the course of the financial year were the development and commercialisation of a proprietary mesenchymal stem cell (MSC) technology for potential human therapeutic use, which the Company has branded Cymerus™. Cynata’s Cymerus™ technology represents an important breakthrough in stem cell product research that facilitates large-scale manufacture of MSCs from a single donor and a single donation, comparing favourably to most other MSC technologies that require multiple donors and multiple donations. This has the potential to revolutionise commercial manufacture of MSC based therapeutic products. Operating results The consolidated loss of the Group for the financial year, after providing for income tax expense, amounted to $3,712,077 (2014: $3,039,663). Further discussion on the Group’s operations is provided below: Review of operations Overview During the year, the Company continued to develop its proprietary, scalable mesenchymal stem cell (MSC) manufacturing technology, Cymerus™. This technology enables essentially limitless production of therapeutic MSCs and thus will provide a vital key to the commercialisation of MSC-based medicines. The field of MSC-based medicines is developing at a fast pace with clinical trials underway around the world in a range of medically challenging diseases and Cynata is positioned at the forefront of MSC manufacturing with its unique Cymerus™ technology. The Company achieved a key milestone during the year with the successful transfer of the proprietary Cymerus™ MSC manufacturing technology from the laboratory to a Good Manufacturing Practice (GMP) production environment. The work was undertaken at our US manufacturing and process validation contractor, Waisman Biomanufacturing and involved extensive process engineering, product validation and manufacturing process documentation. This achievement was an important breakthrough, distinguishing Cymerus™ from all existing methods of MSC production, which require a continuous supply of new tissue donations (such as bone marrow or adipose tissue). It facilitated the successful completion of manufacture, testing and release of a clinical-grade induced pluripotent stem cell (iPSC) Master Cell Bank (MCB) which provides Cynata with an effectively limitless starting material for production of the Company’s first therapeutic, off-the-shelf MSC product, CYP-001. Ongoing testing has shown that Cymerus™ MSCs produced at Waisman Biomanufacturing consistently meet expectations and attain standards appropriate for their intended clinical use. This provides a high level of confidence that Cynata’s proprietary manufacturing process is robust and reproducible: absolute requirements for the manufacture of a therapeutic product. In addition to providing GMP-grade Cymerus™ MSC product for Cynata’s partners and for the Company’s own clinical trial programs, the manufacturing transfer and scale-up enables the production of material for the pre-clinical safety program, a pre-condition to commencing clinical trials, and this progressed well during the year through engagements with several service providers including WuXi Apptec (NYSE:WX). The iPS cell line described above was sourced, along with a broad portfolio of associated intellectual property, from the US company, Cellular Dynamics International (CDI) through a transaction completed in September 2014. This arrangement was the first of its kind where a commercial enterprise has secured a clinical grade iPSC line for use in human allogeneic MSC therapy. As such, it places Cynata in a unique and highly competitive position. More recently, CDI was acquired by Fujifilm Holdings Corporation of Japan in a US$307m takeover. Cynata continues to have good relations with CDI under that company’s new ownership Cynata also continues to enjoy good relations with the University of Wisconsin – Madison where the Cymerus™ technology was discovered. A program is presently underway at this eminent institution to seek to optimise the process of storage of Cymerus™ MSC product to provide such enhanced characteristics as improved cryopreservation, more convenient preparation steps for clinical use and greater stability. This program is being led by Professor Igor Slukvin, one of the founders of Cynata Therapeutics Ltd and inventors of its technology.

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In a further academic relationship, the Company partnered with one of the world’s leading centers for studies of fibrotic lung disease and regenerative medicine, The University of Western Australia’s Centre for Cell Therapy and Regenerative Medicine (CCTRM). This program, under the direction of Professor Geoff Laurent, a world authority in extracellular matrix regulation and lung fibrosis, is testing the potential therapeutic efficacy of Cynata’s Cymerus™ MSCs in an animal model of this disease. To date, no treatment has been shown to be effective for the idiopathic form of lung fibrosis, and on average, patients survive for only 3-5 years after diagnosis with this extremely debilitating condition. During the year there were exciting developments among researchers in the stem cell field that pointed to the potential utility of MSCs in treating cancer. In many cases these developments involved “engineering” the MSCs to enhance their properties to make them more effective in this particular therapeutic application. The Cymerus™ technology offers some very important advantages in the manufacture of such engineered MSCs and as such the Company is actively investigating how best to participate in this important new potential clinical use of MSCs. The Company’s plan to undertake a Phase 1 clinical trial in graft-versus-host disease (GvHD) remains a focus of product development activity and to this end discussions with regulatory authorities progressed during the year, including a formal Scientific Advice meeting with the European Medicines Agency (EMA). The information obtained from this meeting has facilitated further scheduled meetings with individual national regulatory bodies as the Company seeks to clarify the path for a Phase 1 clinical trial in the EU. In parallel, dialogue has commenced with the US FDA with a similar goal. Due to the unique nature of the manufacturing process and the novelty of MSC-based therapeutics, this interaction is a lengthy and continuing process. Satisfactory completion of these discussions will facilitate a decision on the location and finalising a schedule for commencement and completion of the trial. Meanwhile, Cynata has progressed arrangements with several leading hospitals of international standing to conduct the planned Phase 1 clinical study to ensure readiness upon approval to commence the trial. Following the publication of favourable equity research reports published by BBY and by Baillieu Holst and the important advances made with the Cymerus™ technology during the year, the Company undertook vigorous and ongoing engagement with global life science investors and potential partners. This included appointing the US-based PCG Advisory Group to drive the Company’s IR activities and to increase exposure to the vast U.S. life sciences investment community. It also involved the Company presenting at several international conferences including the World Stem Cell Summit in December 2014. These activities are all with a view to ensuring that the value of Cynata’s unique and valuable stem cell technologies are shared with investors and potential partners. The Company’s strategy for commercializing potential specific Cymerus™ therapeutic products is through the formation of development and strategic partnerships. In parallel with the product development and regulatory activities described above, the Company continually assesses the optimal approach to commercialisation with the goal to maximise value and potential return to all stakeholders. This involves ongoing evaluation and assessment of strategic issues, such as the costs and risks associated with development of Cymerus™ products, at what development stage partnering might occur, the resources and market access capabilities provided by potential partners and in which markets partnering could be appropriate. Discussions are presently underway with potential partners to fulfil the Company’s goal of completing at least one strategic partnership during calendar year 2015. The addition to the Board of Dr John Chiplin as a non-executive director brought new experience and skills to the Company’s Board of Directors. Dr Chiplin has a successful international reputation in the life science and technology sectors and has been directly involved in several major M&A transactions in recent years. Mr Howard Digby stepped down from his role as a non-executive Director and the Company extends its gratitude to him for his significant contributions to Cynata. The exercise of the Company’s December 2014 options provided the Company with additional funds to continue its planned operations. The field of stem cell-based medicine continues to grow apace and we look forward to a productive and exciting year for Cynata Therapeutics in 2015-16. Financial position

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The net assets of the Group have decreased by $1,104,673 from 30 June 2014 to $8,749,959 in 2015 (2014: $9,854,632). This decrease is mainly due to the following factors: - amortisation of intangibles as a result of an allocation of the carrying value of the patents to the different categories of research based on their estimates (refer note 11 for further information); - substantial increase in costs incurred in product research and development; increase in trade and other payables and provisions for annual leave; and - reduction in cash and cash equivalents resulting from funding operations. Notwithstanding this, the Company received total proceeds of $2,222,450 from the exercise of listed options during the financial year. The directors believe the Group is in a strong and stable financial position to expand and grow its current operations. Significant changes in state of affairs The following significant changes in the state of affairs of the Group occurred during the financial year: - During the months of September 2014 and January 2015, a total of 11,112,250 ordinary shares were issued at $0.20 as a result of the exercise of the remaining 11,112,250 listed 31 December 2014 options. - On 3 February 2015, the Company announced it has commenced a study to test the potential therapeutic efficacy of its Cymerus mesenchymal stem cells (MSCs) in an animal model of lung fibrosis. This study is being performed within the University of Western Australia’s Centre for Cell Therapy and Regenerative Medicine (CCTRM). - On 19 February 2015, the Company announced that it has achieved a world first breakthrough in the manufacture of stem cells and is now set to scale up manufacturing of its mesenchymal stem cells (MSCs) for therapeutic use. Subsequent events On 17 July 2015, the Company issued 6,666,672 fully paid ordinary shares plus one attaching 13-month option for every 2 ordinary shares issued and one attaching 5-year option for every 2 ordinary shares issued, to institutional investors in the United States of America in a private placement for gross proceeds of A$5,000,004 (before costs). The Company also issued 333,333 5-year options to the placement agent. Other than the above, there has not been any matter or circumstance occurring subsequent to the end of the financial year that has significantly affected, or may significantly affect, the operations of the Group, the results of those operations, or state of affairs of the Group in future financial years. http://cynata.com/uploads/default/source/2015/10/d026f.15.10.06.AnnualReportto.pdf Dorsavi Limited (AU: DVL) Continued momentum for dorsaVi sales globally Quarterly Cashflow for Period Ended 30 September 2015 Key points: • Cash receipts from customers of A$564,000 up from A$319,000 (77%) in the June 30, 2015 quarter • Total cash receipts – including interest and grant income - of A$1.23M • Recognised revenue (customer revenue) exceeded A$608,000; doraVi’s highest revenue quarter to date, representing quarter-on-quarter growth of 24% (A$492,000) • Quarterly cash outflow A$1.7M, down 19% on previous quarter ($2.1M) • Cash at hand A$10.79M Melbourne, Australia: 22 October 2015. Wearable sensor medical device company dorsaVi Ltd (ASX: DVL) has today released its Appendix 4C – Quarterly Cashflow report for the period ended September 30, 2015.

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Cash receipts for the period were A$1.23M including receipts from customers of $564,000, up 77% on the previous quarter (A$319,000), R&D tax refund of A$649,000 and A$18,000 in interest income. dorsaVi is experiencing continued momentum across its three key geographies (US, UK and Australia). Recognised revenue for the quarter, which reflects the dollar amount invoiced to customers, was A$608,000, representing the best performing quarter to date, and up 24% on the previous best quarter (A$492,000). The most significant customer contract signed during the period was with UK physiotherapy network YourPhysioPlan to market and sell ViMove in the United Kingdom and Ireland. The three year deal includes minimum sales targets of 100, 300 and 600 ViMove units to be purchased or leased consecutively each year over this period. If minimum sales targets are achieved, the deal has the potential to generate more than A$9M over the three years. The first order exceeding A$120,000 was invoiced during the quarter. Other new customer contracts include Sodexo Australia Pty Ltd, Design Inc, Silver Chain, New England Patriots (NFL), Washington Wizards (NBA), Ohio State University, Marquette University and Heathrow Airport. dorsaVi now has more than 230 active customers across its three priority geographies, the UK, US and Australia. Net operating cash outflow for the quarter was A$1.7 million, and down 19% from the previous quarter of A$2.1. Cash at hand is A$10.79M and includes the receipt of A$4 million in a successful Placement to sophisticated investors and an underwritten Rights Issue, which raised an additional A$3.2 million. About dorsaVi dorsaVi (ASX:DVL) is an ASX company focused on developing innovative motion analysis device technologies for use in elite sports, occupational health and safety, and clinical applications. dorsaVi believes its wearable sensor technology enables – for the first time – many aspects of detailed human movement and position to be accurately captured, quantified and assessed outside a biomechanics lab, in both real-time and real situations for up to 24 hours. Our technology has applications across three sectors: • Clinical: ViMove is transforming the management of patients by providing objective assessment, monitoring outside the clinic and immediate biofeedback. ViMove is currently used by medical and physiotherapy practices in Australia and the United Kingdom and is now available in the United States following FDA 510K clearance. • Elite Sports: ViPerform is allowing coaches and medical teams managing elite athletes and teams to screen athletes and provide objective evidence for decisions on return to play, measure biomechanics and provide immediate biofeedback out on the field, tailor and track training programs and optimise technique and peak performance. ViPerform is being used by AFL and NRL clubs in Australia, clubs in the Barclays Premier League, Australian and Victorian Institutes of Sport, various Olympic teams and athletes internationally, and Cricket Australia. • OH&S: We combine innovation, measurement and quality to reduce workplace incidents, costs, meet compliance and improve brand reputation. ViSafe enables employers to assess risk of injury for employees as well as test the effectiveness of proposed changes to workplace design, equipment or methods based on objective evidence. ViSafe has been used by major corporations including Coles, Woolworths, Toll, Toyota, Orora (formerly Amcor), Crown and BHP Billiton. Australian Workplace Compliance delivers risk mitigation through compliance to OHS, Quality Management Systems, Company Policy and Process. http://dorsavi.com/wp-content/sharelink/20151022-appendix-4c---quarterly-77584134669885223.pdf Genera Biosystems Limited (ASX: GBI)

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Genera Biosystems Limited (‘Genera’) is pleased to provide an update to accompany the attached Appendix 4C Quarterly Cash Flow report for the period ended 31 March 2015. The company held cash at end of quarter of $1,992k representing a net increase of $313k after the company issued an additional tranche of Series B Convertible Notes to raise approximately $500k during the period. During the period the Company also received partial proceeds from the initial $2.0m tranche of Series B Notes undertaken in late December 2014 and also $504k from its 2014 ATO R&D tax incentive rebate. During the quarter Genera incurred $329k of cash outflows in aggregate relating to Series B Convertible Notes capital raising costs and the repayment of shareholder loans provided in the latter part of 2014. Business Updated Cash receipts from customers for the period amounted to $67k an increase of 294% versus the previous corresponding period. Cash receipts were largely derived from sales of RTI-plexTM Genera’s upper respiratory tract multiplex MDx test. Genera Chief Executive Officer Richard Hannebery commented, “While these figures are coming off a very small base the growth curve is encouraging with most recent calendar year to date figures to end of April showing a 114.3% increase in RTIplexTM kit sales volumes versus the prior 2014 period. Further with our recent regulatory approvals, Genera is now entitled to a 30% price increase with its major pathology customer for RTIplexTM.” “Our most recent order kit volumes for RTI-plexTM suggest a more robust start to the domestic 2015 flu-season. With the test now IVD-approved, we are confident that 2015 kit sales will substantially exceed last year’s volumes, delivering record revenues for our RTI-plexTM assay in 2015.” Outside of the Australian market with recent CE mark for RTI-plexTM , Genera is currently exploring non-exclusive supply of RTI-plexTM into the Indian market with selected potential pathology customers in both New Delhi and Mumbai. CE mark status makes the reimbursement pathway for potential pathology customers in the Indian market substantially more transparent. These potential Indian pathology customers have also expressed strong interest in Genera’s next MDx assay, STIplexTM, a 5-plex sexually transmitted infection assay that is well advanced in development. Genera is also exploring opportunities in the North American market for our STI-plexTM assay with a substantial prospective pathology customer currently undertaking significant testing volumes utilizing a competitor’s MDx assay via the ASR/LDT (Analyte Specific Reagents/Laboratory Developed Test) regime. Timing of any new supply arrangements may be in the 4th quarter of calendar 2015 after the Company has in place an appropriately structured partnership with a leading global IVD company to support this prospective customer. Sales of Genera’s PapTypeTM HPV assay have been subdued and are expected to remain so for the bulk of the remainder of the 2015 calendar year. Richard Hannebery added, “The domestic growth opportunity for our PapTypeTM HPV test remains very much a focus for us in 2016 when the new national cervical screening program in Australia is implemented and selected HPV tests are included under the Medicare Benefits Schedule. Inclusion on the MBS can provide broad access to all women in Australia under the age of 30 and remains a priority for our team.” Volumes of HPV testing in the Australian market are expected to grow to 1.3m tests per annum with the introduction of the new cervical cancer screening regime. The global market opportunity for HPV testing is expected to exceed US$2 billion per annum as numerous countries follow Australia’s lead in replacing the traditional pap smear with HPV testing as the front line screening tool in the fight against cervical cancer in women. PREDICTORS 3 CLINICAL STUDY Genera’s PapTypeTM HPV test is currently being evaluated in the Predictors 3, 6,000 patient screening study at the Wolfson Institute London - a comprehensive head-to-head trial against all other major commercially available HPV tests by a global key opinion leader in cervical cancer screening. The Predictors 3 clinical study is currently anticipated to complete in late May with data available to Genera on a confidential basis during the month of June.

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Richard Hannebery commented, “Given the sound performance of PapTypeTM in the Predictors 2 study which focussed on establishing relative sensitivity performance, primarily in a referral population, and what we know about the superior specificity of PapTypeTM versus most other DNA and RNA based HPV tests, we hold a high degree of confidence for the Predictors 3 study which is aimed at establishing relative specificity performance in a screening population.” PARTNERING AND NEW ASSAY DEVELOPMENT UPDATE The Company continues to progress its integration program with Beckman Coulter’s chosen instrumentation platform. Upon finalisation of the integration Genera intends to also run the Predictors 3 6,000 patient samples with PapTypeTM on this instrumentation platform. The Company has an ongoing focus on working towards a broader arrangement with a leading global IVD company upon successful integration of AmpaSandTM based tests on that partner’s instrumentation platform, which at this stage is due for completion in approximately 9 weeks’ time. “In addition to our three existing high value assays we have identified a number of new attractive MDx assays to develop on AmpaSandTM to substantially broaden our menu thereby positioning Genera to aggressively market its products to pathology customers in concert with a leading global IVD company,” Richard Hannebery added. The first of these new MDx assays that Genera has commenced development of is a BBV-plex (Blood Borne Viral plex) which is a multiplexed HIV1/2, HCV and HBV assay that will be well differentiated in the market with the subsequent prospect of adapting this new assay to a viral load companion MDx test. In the longer term in concert with a well-credentialed global IVD partner Genera intends to roll out a menu of a dozen or more high value multiplexed MDx tests upon its AmpaSandTM technology platform. About Genera Biosystems Genera Biosystems Limited (“GBI”) is an Australian Stock Exchange listed molecular diagnostics company, which develops, manufactures and distributes advanced PCR molecular diagnostics tests. GBI has successfully developed two products to date, PapType™ and RTI-Plex™, with several additional products in the company’s development pipeline. Genera manufactures these products in its Therapeutics Goods Administration (TGA) certified manufacturing facility in Scoresby, Victoria, Australia. http://generabiosystems.com/wp-content/uploads/bsk-pdf-manager/41_ASX_ANNOUNCEMENT__QUARTERLY_CASH_FLOW_&_BUSINESS_UPDATE_(2).PDF

Genetic Technologies (ASX: GTG) Operating and Financial Review Corporate structure Genetic Technologies Limited is a public company limited by shares that is incorporated and domiciled in Australia. The Company has prepared a consolidated financial report incorporating the entities that it controlled during the financial year, which are outlined in the following illustration of the Group’s corporate structure as at the date of this Report: Operating Result The operating result for the year is directly reflective of the repositioning of the business. Non-core business was sold, operations have been appropriately scaled back and equity has been raised to set the Company up for future success. Critical to this was the release of the much improved 2nd generation BREVAGenplus® test in October 2014.

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The Company has purposefully moved focus away from reliance on its past licensing assertion programme as there is now a clear focus on concentrating effort on the Company’s lead product BREVAGenplus® in the U.S. During the 2015 financial year, Genetic Technologies Limited and its subsidiaries generated consolidated gross revenues from continuing operations, excluding other revenue, of approximately $2.0 million compared to $4.6 million in the preceding year. $(2.2) million of this differential is directly attributable to the divested Heritage business with the balance of $(0.4) million due to a decrease in the overall combined sales of the BREVAGenTM and BREVAGenplus® tests. Overheads have decreased by approximately $2.6 million compared with 2014. The combined areas of selling/ marketing, administration (excluding net foreign currency losses), licensing and operations totalled $11.9 million for the year compared with $14.5 million for 2014. The decreased licensing activities accounted for approximately $0.6 million of the decrease with the remaining $2.1 million the result of the divestment of the Heritage business in November 2014, benefits derived from restructure activities and better management with overhead spending. With reference to significant “one-off” items, the loss for the year of approximately $8.8 million includes a $1.4 million pre-tax profit on the sale of the Heritage business and a write-down of $0.8 million against the opening asset value for the Immunaid option. Dividends and distributions No dividends have been paid since the end of the previous financial year, nor have the Directors recommended that any dividend be paid. Capital raising During the year the Company issued 1,100,273,139 ordinary shares increasing contributed equity by approximately $25.2 million after transaction costs. Refer Note 22. Convertible notes During the prior year the Company announced that it had executed documents with Ironridge BioPharma Co., a division of institutional investor Ironridge Global IV, Ltd. (“Ironridge”), in respect of redeemable convertible notes to raise USD 5,000,000 (the “Notes”). During 2014 the Notes were drawn down and the Company received $5,627,462 (being the Australian dollar equivalent of USD 5,000,000) from Ironridge, before the payment of associated costs. During the current year, conversion notices were received from Ironridge in respect of Notes with a face value of USD 1,750,000. These Notes were converted in return for which Ironridge received 164,771,370 ordinary shares (including ordinary shares issued in lieu of interest payment and interest true-up adjustments). As a result of the above conversions, there are no further Notes relating to Ironridge remaining to be converted. The last conversion notice was received by the Company on 27 November 2014. With respect to the unlisted secured (debt) notes that were issued to existing and new Australian institutional and wholesale investors in September 2014, and subsequently became convertible notes, following approval at the Annual General Meeting held on 25 November 2014, $2,125,000 of the convertible notes, together with the capitalised interest, had been converted into 150,961,041 ordinary shares in the Company, as at 30 June 2015. Subsequent to 30 June 2015, the remaining $25,000 of convertible notes plus capitalised interest has been converted into 1,091,093 ordinary shares in the Company. Review of financial condition Capital structure

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As at the date of this Report, the Company had a total of 1,714,191,631 fully paid ordinary shares on issue, all of which were listed on the Australian Securities Exchange, and on the NASDAQ Capital Market in the U.S. via the Company’s ADRs (American Depositary Receipts). Also at that date, there were 24,241,667 unissued ordinary shares in the Company under option. As at the date of this Report, no ordinary shares were subject to escrow. Treasury and related policies The Company has in place a cash management policy which follows industry accepted leading practice by investing the Company’s cash assets in a range of short to medium term interest-bearing deposits with appropriately rated financial institutions. Cash provided by operations During the financial year, the consolidated net cash outflows used in operations was approximately $9.7 million. This is a $1.3 million improvement compared to the prior financial year. Overall, the Group’s consolidated cash assets increased by approximately $15.5 million during the 2015 financial year primarily on the back of proceeds from share issues. Liquidity and funding As at 30 June 2015, the Company also had corporate credit card facilities with National Australia Bank Limited and Bank of America, which had total credit limits of $150,000 and $156,750, respectively. As at that date, a total liability outstanding in respect of these credit card facilities was $25,708. Cash and cash equivalents, as at 30 June 2015, was $18,341,357. Significant changes in the state of affairs During the year the Company’s strategy was to focus on the expansion of its cancer diagnostic franchise whilst divesting of other assets considered to be non-core. Significant changes in the state of affairs of the group during the financial year were as follows: » Contributed equity increased by $25,166,636 to $115,247,128 as the result of a private share placements, a Share Purchase Plan, the issue of shares as part of the conversion of convertible notes and on the exercise of options attached to the convertible notes. Details of the changes in contributed equity are disclosed in note 22 to the financial statements. » The Company issued $2,150,000 of interest bearing convertible notes during the year which are convertible into ordinary shares at the option of the holder. All but $25,000 of these notes were converted during the year. Refer note 20. » The net cash received from the increase in contributed equity and the issue of the convertible notes was used principally to provide the Company with general working capital and to fund the continuing commercialisation and to facilitate the acceptance and growth of the Company’s flagship lead breast cancer risk test BREVAGenplus®. » On 31 July 2014, the Company granted a total of 6,875,000 options over ordinary shares in the Company to its US employees. The options, which were granted at no cost, entitle the holders to acquire one ordinary share at a price of $0.040 at any time up to, and including 31 May 2019, subject to certain vesting conditions. Refer note 26. » On 2 December 2014, the Company granted a total of 143,333,333 fully vested options over ordinary shares in the Company to the holders of convertible notes. The options, which were granted at no cost, entitle the holders to acquire one ordinary share at a price of $0.015 at any time up to, and including 2 December 2018. As at balance date 20,366,667 of these options remain unexercised. Refer note 26.

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There were no other significant changes in the state of affairs that are not described elsewhere in this Report. Significant events after balance date Except for the conversion of $25,000 of convertible notes plus capitalised interest as disclosed above, there have been no significant events which have occurred after balance date. http://gtgcorporate.com/wp-content/uploads/2015/09/2015-Annual-Report-FINAL.pdf Healthlinx Limited (ASX: HTX) HealthLinx® is a Transformational Leadership and Operational Hospital and Nursing Excellence Project Management Firm. We exist to carefully and effectively improve financial performance and help you provide better patient care. Our years of experience and project management improve both the immediate and allow for sustained long-term outcomes through Transitional Leadership, Executive Search and Consulting, Copy and Publication Management for the ANCC Magnet Recognition®. http://www.healthlinx.com/transitional_leadership/about.asp IDT Australia Limited (ASX: IDT) IDT Australia Ltd Annual Results for the financial year ended 30 June 2015 18 August 2015, Melbourne: The Directors of IDT Australia Limited (IDT.AX) announce improved results for the base drug development service business in the financial year ended 30 June 2015, bolstered by a profitable second half result. Year on year revenue growth for the 12 months to June 2015 was 19% to a total of $15.7m. This improvement was driven by a 55% improvement in second half revenues against the first 6 months, from $6.1m in the first half to $9.6m in the second half. This adds to the previously announced creation of substantial growth prospects through the acquisition of a proprietary generic drug portfolio. A renewed focus on business development and customer service has enabled a year on year increase in the Melbourne contract manufacturing business of approximately 60% and in the Adelaide clinical services business of approximately 10%. Containment of operating expenses and no impairment of development assets saw the loss for the full year after income tax reduce by $3.6m to $3.0m, with a small profit after tax generated in the second half. $m

2014

2015

%

Sales Revenue

13.2

15.7

19%

Operating Loss After Tax

6.6

3

55%

Net Assets

39.2

25.6

53%

The Company has customer commitments in place in the form of signed contracts to underpin further anticipated revenue growth in the base business in the coming financial year. IDT also reports material subsequent events with the receipt of US$1 million from ANI Pharmaceuticals Inc. following their appointment as exclusive distributor in the US market for 18 of IDT’s 23 proprietary generic products. The first of these products is expected to be launched during calendar year 2016, with additional milestone payments to be received upon certain product re-launches, further adding to planned base business revenue growth. About IDT Established in 1975, IDT Australia Ltd (ASX:IDT) is a public Australian pharmaceutical manufacturing company. Based in Boronia, Victoria IDT is commercialising a portfolio of specialty generic drugs with aggregate addressable markets of over US$800 million.

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With extensive experience in the development and production of high potency and high containment pharmaceutical products for local and international markets, IDT’s facilities are fully cGMP compliant and are regularly audited by the US FDA and Australian TGA. With an experienced and professional team, operating within world-class facilities, IDT is also committed to providing international pharmaceutical customers services in drug development, scale-up, clinical services and commercial drug manufacture. Through CMAX, its clinical research services business based at the Royal Adelaide Hospital in South Australia, IDT also provides full Phase I clinical trials management and delivery, recruitment in specific disease states for Phase II and Phase III trials as well as being able to offer trial packaging, distribution and pharmacy services from the cGMP Boronia facilities. http://idt.live.irmau.com/IRM/Company/ShowPage.aspx/PDFs/1374-10000000/FY15ResultsAnnouncement Immuron Ltd (AU: IMC) Immuron Ltd is a publicly listed Australian biopharmaceutical company focused on oral immunotherapy using dairyderived antibody products for humans. Immuron has a unique and versatile technology platform that is capable of generating a wide range of products, all with a high safety profile. The versatility of Immuron’s platform technology enables the development of medicines that target a large range of medical needs, including infectious diseases, immune mediated disorders and cancers. The versatility is also a function of the dairy origin of Immuron’s antibodies, which enables Immuron to commercialize its platform derived products through a range of regulatory pathways, including prescription (Rx), medical foods, over-the-counter medicines and also dietary supplements. This high safety profile and all-natural composition of Immuron’s platform derived products confers on Immuron a significant competitive advantage and also allows Immuron to accelerate its product development. For example, Immuron received clearance from the FDA to commence a Phase IIb clinical trial for its NASH product, a potential block buster, in less than 3 years from commencing its NASH research and development program. Immuron has one marketed product and a pipeline of products at various stages of clinical and earlier development. Immuron’s marketed product, Travelan, is for the prevention of travellers’ diarrhoea. It is licensed in Australia, in Canada, South African and Latin America, as well as a number of countries in South East Asia. http://www.immuron.com/index.php/about-immuron/ Imugene Limited (ASX: IMU) For the Year Ended 30 June 2015 Operating and Financial Review Results The Group reported a loss for the full-year ended 30 June 2015 of $2,440,789 (2014: $2,115,964). The loss is after fully expensing all research and development costs, in addition to the full impairment of the Linguet assets (comprising $274,093). Operations HER-Vaxx During the last financial year management have been working towards starting a clinical trial for HER-Vaxx in 2015. This has meant focusing on a number of different elements to ensure the trial can happen on time and within budget.

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These include preclinical work, new formulation work and initiating high quality manufacturing processes to ensure the final product is of sufficient quality to be used in clinical trials and to manufacture for the market thereafter. Following is a report on each of these areas; Manufacture HER-Vaxx consists of three elements: a peptide (which mimics the native HER-2 receptor), a vaccine conjugate (which presents the peptide to a patient’s immune system (the B cells) and an adjuvant which works to “turn on” a patient’s immune system. With three elements to the drug, we have had to ensure each is manufacturable, compatible with the other, and of course not too expensive. Management are pleased to say their efforts throughout the year have been successful; they have not only improved upon an already strong formulation with the new use of CRM197 as a vaccine conjugate in place of the more complicated and costly virosomes, but have finalised the peptide element to be highly immunogenic, and the resulting HER-Vaxx is cheaper, easier to make and above all the most potent combination the Company has ever had. This work has also allowed for the filing of an additional patent, which if granted will refresh the patent life to 2036, which is significantly greater than average and would directly extend the period of time which HER-Vaxx can enjoy a monopoly position in the market. The Company is already manufacturing this final version for use as GMP-quality clinical material and expect it to be produced ready for the trial in late 2015/early 2016. Outlook The Company has completed a lot of unglamorous work in the past year to get it in the position of beginning its clinical trial for HER-Vaxx. Having completed a good deal of this work the Company is looking towards a “data rich” clinical trial and some early pointers of efficacy even from the Phase 1b element of the Phase 1b/2 trial. Combined with news from Professor Weidermann’s formulation work in Vienna, the toxicology work [underway] and the new work on HERVaxx and HER-Vaxx combinations in a model for gastric cancer, it is clear the future holds a good deal of news flow. The Company believes HER-Vaxx will be part of the immune-oncology revolution to dramatically improve survival of cancer patients. Financial Review The Group’s net assets increased by $1M (13%) compared with the previous year to $7.7M. As at 30 June 2015, the Group had cash reserves of $2.0M, an increase of $0.8M on the previous financial year end. The overall increase in receivables for the year reflects the pending receipt of $0.5M research and development tax rebate. The net carrying value of the Group’s intangible assets of $6.6M reduced by $0.3M due to the full impairment of the Company’s Linguet technology, in association the contingent liability of $0.1M was also fully impaired. Other financial liabilities were further reduced from a contractual obligation associated with the Intellectual Property for Biolife of $0.5M. file:///C:/Users/user/Downloads/IMU%20Annual%20Report%202015%20-%20printing%20version.pdf Mayne Pharma Group Limited (ASX: MYX) Mayne Pharma Reports FY15 Result •

Transformational US Doryx™ acquisition completed for US$50m



New business created – US Specialty Brands (SBD) with a 60+ person sales team to promote specialty brands in the US



Brought US distribution in-house for generic Methamphetamine and Oxycodone product family



FDA approval of 50mg Doryx tablets and TGA approval of 12 products



Advanced pipeline of 17 products filed with the FDA, two further products filed in FY15

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Significant first-to-file opportunity for Tikosyn™ generic capsules with settlement reached with Pfizer



2H15 underlying EBITDA performance up 49% on 1H15 with Doryx, directly-distributed US generic products and Metrics Contract Services driving this growth



Balance sheet strengthened with net debt of $2.6m at 30 June 2015, down from $39.7m at 31 December 2014; cash of $59.2m



Significant growth expected in FY16 driven by recent product acquisitions, new product launches, increased market penetration of existing products and accelerated growth in Metrics Contract Services

28 August 2015: Mayne Pharma’s CEO, Mr Scott Richards said, “FY15 was a transformational period for Mayne Pharma with the acquisition of the Doryx brand and distribution rights which diversified the US business platform into an integrated pharmaceutical business with growth platforms in generics, contract services and now specialty brands.” “Following a soft first half, the Company’s performance was substantially stronger in the second half with revenue up 37%, underlying EBITDA up 49% and underlying NPAT up 49% on the first half1. The weaker first half reflected the lack of contribution from sales of Doryx tablets to Actavis as reported in February 2015. Despite this, US Doryx contributed $18m to consolidated revenue (FY14: $22.8m), which represents a combination of direct sales by the SBD team, transition profit and third party revenue. The gross profit contribution from US Doryx for the four months under Mayne Pharma’s ownership was stronger than that recorded for the whole of FY14.” Summary of FY15 financial results $m

FY15

FY14

Revenue Gross profit GM% EBITDA – underlying1 EBITDA – reported NPAT underlying2 NPAT – reported2

141.4 80.0

143.3 75.1 56.6%

Change on pcp (1%) 7% 52.4% (10%)

2H15

1H15

Change 2H/1H 37% 59%

81.9 49.1 59.9% 21.8

59.5 30.9 14.6

49%

52.0%

36.4

40.4

31.3

43.1

(27%)

17.8

13.5

32%

13.4

17.8

(25%)

8.0

5.4

49%

7.8

21.3

(64%)

3.8

4.0

(6%)

Excluding US Doryx revenue and one-off licensing fee income, group revenue was up 7% on the prior corresponding period (pcp) driven by Metrics Contract Services and directly-distributed US generic products. Operating performance US Products The US Products operating segment (USP) performed strongly with sales at $67.7m, up $10.8m or 19% on FY14 and gross profit was $36.2m up 13% on FY14. The key drivers of growth were the part-year contribution from the Doryx acquisition (US$7.9m from re-launch in May 2015) and growth in the key generic product franchises. This was offset by the performance of third party-distributed generic products, several of which were brought in-house late in the second half to improve the contribution of these products.

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In May 2015, the Company brought the distribution of Methamphetamine and Oxycodone products in-house and also acquired full ownership of the Methamphetamine and BAC3 ANDAs during FY15 enabling the Company to control the manufacture, distribution and sales of these products and increase the economic benefit that flows to Mayne Pharma. It is expected these products will be key drivers of growth going forward. In US dollar terms, USP revenue was up 9% to US$56.6m with sales of directly-distributed products (excluding Doryx) up 21% to US$35.1m and third party-distributed products were down 41% to US$13.6m. The Oxycodone franchise was responsible for the majority of the third party decline year on year. Gross profit margin was down from 56% to 53%, which reflects the fact that the margin on the branded Doryx and authorised generic sales in the US is split between USP, which records the distribution margin, and MPI, which records the manufacturing margin. If USP captured all the margin on a vertically integrated segment basis, the gross profit margin would have been 70%. Metrics Contract Services The Metrics Contract Services segment (MCS) outperformed industry growth, with revenue of $33.8m up $5.4m or 19% on FY14 and gross profit was $17.0m up 31% on FY14. Revenue and gross profit margin increases are the result of improved pricing, operational efficiencies and a higher proportion of higher margin formulation development work in FY15. In US dollar terms, MCS sales were US$28.3m up 9% on pcp. Key performance measures continue to improve with the number of quotes signed up 9% on pcp and the amount of signed work in dollar terms up 19% on pcp. The quote conversion rate (the number of quotes signed as a percentage of quotes written) was 66% and MCS has introduced 19 new clients in FY15 up from the 17 added in the prior period. The committed business pipeline also continues to grow strongly. In the last two years, the customer base of MCS has increased 25% to 125 active clients. Mayne Pharma International The Mayne Pharma International (MPI) segment revenue was steady at $60.7m down just 1% on pcp and gross profit improved 9% to $34.2m. This segment captured US Doryx third party revenue to February 2015, as well as the profit that arose during the transition period from Actavis to Mayne Pharma, and the manufacturing margin on in-market and intercompany sales. Excluding US Doryx and one-off licensing fee income, MPI revenue increased 6% driven by increased sales of Erythromycin into the US, Kapanol™/Kadian™ into international markets following the acquisition of rest of world rights in July 2014 from GSK, and Suba™-Itraconazole into Spain. In Australia, the on-market product portfolio increased from 8 to 15 products over the year with the first sales of Lozanoc™ and six injectable products. In Spain, Itragerm™ (the local name for Lozanoc) became the market leader in the Itraconazole market with 17% market share by volume in the 2H15. Cash flow The Company ended the year in a solid financial position with net debt of $2.6m. Cash on hand at 30 June 2015 was $59.2m representing an increase of $44.4m from 30 June 2014. The Company had borrowings of $61.8m which increased $13.7m largely reflecting foreign exchange movements during the period whereby the translation of USD balances at 30 June 2015 was at 0.796 versus the prior period at 0.943. Following the successful debt refinancing programme completed in June, the Company has materially reduced its cost of funds with the margin on the base rate (US Libor) falling from 5.75% to 1.5% on drawn funds and has more flexible and less onerous terms and conditions. The business now has greater financial flexibility to use alternate sources of capital to fund its growth with operating cash, US$75m of undrawn line facility and a A$10m working capital facility.

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Net operating cash flow before interest, tax, SBD set up and transaction costs was $39.1m up $4.8m on pcp and above underlying EBITDA, due to favourable benefits from movements in working capital in the period. Total net cash flows from operating activities was an inflow of $22.4m after including $3.9m of net interest payments, $7.6m of tax payments, $4.5m of SBD set up costs and $0.7m of transaction costs. Notable cash flows during the period included: • • • • •

$16.7m in payments for research and development; $114m of net proceeds from the issue of shares; $4.2m payments for capital expenditure across the Group; $64.3m in payments to acquire Doryx; and $11.9m of earn-out and deferred settlement payments for various other acquisitions.

Pipeline The Company continues to commit substantial resources in terms of people and research and development spend to developing and advancing its pipeline globally. In FY15, the Company invested $16.7m in research and development of which 80% was capitalised over the period to be amortised in the future in accordance with accounting standards. In addition to this, the Company invested US$2.5m in HedgePath Pharmaceuticals Inc. during the year to accelerate the clinical development program using Mayne Pharma’s patented oral formulation of Itraconazole to treat certain cancers. A Phase IIb study in Gorlin’s Syndrome (a rare form of skin cancer) is currently underway with results expected in late FY16. The Company now has more than 30 pipeline products in the US, of which 17 are pending approval at the FDA targeting an addressable market with sales greater than >US$1.8bn4. The Company is now in active dialogue with the FDA on six of these filings including the generic version of Tikosyn (Dofetilide capsules). Mayne Pharma settled the Tikosyn litigation with Pfizer during FY15 and expects to be awarded 180-days of market exclusivity upon approval by the FDA. In Australia, the Company has more than 20 pipeline products of which six have been recently approved by the TGA and expected to launch in 1H16 and a further seven products are pending approval at the TGA. The Company also continues to advance the pipeline of branded products, which are an important part of the strategy to diversify the business across both branded and generic products. Commercialisation of Lozanoc is continuing with the out-licensing of the product in a further nine countries: Argentina, Belgium, China, Chile, Columbia, France, Germany, Mexico and Peru. The next launch of Lozanoc will be in Germany later this calendar year via ISDIN, the Company’s marketing and distribution partner. In the US, the Company is finalising the regulatory filing and expects to lodge the dossier during FY16. Also during FY15, the Company signed an agreement with Flinders University in South Australia to license intellectual property surrounding research relating to the use of Kapanol for the treatment of respiratory dyspnoea (chronic breathlessness). Further clinical studies targeting US registration are planned to start in FY16. Outlook The Company is now set for a period of strong earnings growth driven by recent product acquisitions, new product launches, increased market penetration of key product franchises and accelerated growth of the contract service business. The new SBD division is established and actively promoting Doryx 50mg and 200mg tablets to dermatologists. This segment will capture a full-year contribution of Doryx in FY16. As outlined in the Doryx acquisition presentation on 10 February 2015, the Company expects the monthly EBITDA contribution of the Doryx franchise to approximate US$2.7m on average during FY16.

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MCS has started the year in a solid position with all key performance indicators trending favourably. With an enlarged customer base and a solid pipeline of committed business MCS is positioned well for the future. Growth of the US generic products division is expected to accelerate with Methamphetamine, the Oxycodone franchise, BAC, Hydrocodone/APAP and Erythromycin being the key drivers. Locally, MPI will benefit from growth in the Australian-marketed portfolio including a stronger contribution from the growing injectable product offering, further growth in the OTC portfolio and the launch of oxycodone immediate release tablets, the first Metrics-acquired product approved in Australia. In addition, the Company maintains an active program to identify potential acquisition targets to further expand the product portfolio and will continue to look at opportunities through FY16 to diversify the product portfolio and business. About Mayne Pharma Mayne Pharma is an ASX-listed specialty pharmaceutical company that develops and manufactures branded and generic products, which it distributes globally; either directly or through distribution partners and also provides contract development and manufacturing services. Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems and these technologies have been successfully commercialised in numerous products that have been marketed around the world. Mayne Pharma has two drug development and manufacturing facilities based in Salisbury, SA, Australia and Greenville, NC, USA with expertise in formulation complex oral dose forms including highly potent compounds, controlled substances, modified release products and inherently unstable compounds.  

  http://www.maynepharma.com/download.cfm?downloadfile=C0051714-4D11-11E5908B020054554E01&typename=dmFile&fieldname=filename Medical Developments International Limited (ASX: MVP) Financial Year ended 30 June 2015 Operating Expenses During the year, the Company invested heavily in our regulatory, product development, sales, marketing and research and development teams. The investment in clinical studies, research and development and product development has been capitalised to intangible assets where appropriate. The Company will invest in additional studies in FY16 to support both the European registration and the company plans to pursue opportunities in North America. We received a $0.282 million R&D tax incentive refund during the year and a further $0.133 million is expected in the coming months in relation to FY15. Outlook Our ambition is to make Penthrox® a main stream analgesic of choice around the world and our Respiratory Devices leaders in the field. Penthrox® is a category leading drug in Australia and we expect it can dominate many of the trauma and minor surgical procedure markets around the world. With the completion of our Regulatory Dossier, a number of licensing deals successfully concluded and with the successful completion of our CSIRO manufacturing project, we have the base to make MDI a global pharmaceutical company.

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The growth experienced in asthma device sales in FY15 will be built on in FY16 as a result of growth within existing customer accounts, new product registrations and new overseas market opportunities in the USA and Europe. FY15 has been an improved year in terms of sales and profit. However FY16 and beyond should see the flow through results of new global registrations, licensing deals and recent staff hires, combining to deliver further sales and profit growth. We would like to thank our staff and our trading partners for their efforts and support. http://www.medicaldev.com/wp/wp-content/uploads/2015/08/MVP-FY15-Annual-Report.pdf Mesoblast Limited (ASE: MSB) Mesoblast Reports 2015 Financial Year Result and Provides Update on Phase 3 Chronic Heart Failure Program New York, USA, and Melbourne, Australia; 17 August 2015: Mesoblast Limited (ASX: MSB; USOTC: MBLTY) today reported its 2015 full financial year results, and provided an update on important changes to its Phase 3 chronic heart failure program. At 30 June 2015, the Company had cash reserves of $144.1 million compared with $196.4 million at the end of the previous financial year. Chief Executive Silviu Itescu said: “We have made strong progress during the past year in moving forward our Phase 3, Tier 1 clinical programs, and have appropriately focused our resources on their execution. “In addition, during the year our portfolio targeting inflammatory diseases has emerged with the potential to be a major new opportunity. “We are particularly pleased with the outcome of the recent meeting between our development and commercialization partner Teva Pharmaceutical Industries Ltd (Teva) and the United States Food and Drug Administration (FDA) regarding our Phase 3 chronic heart failure program. The ongoing Phase 3 trial continues to recruit well and, as a result of the FDA meeting, has the potential for early completion based on overwhelming efficacy.” Update On Important Changes To The Phase 3 Chronic Heart Failure Program Following the meeting between Teva and the FDA, important changes to the Phase 3 chronic heart failure program for MPC-150-IM have been agreed. Key outcomes of the FDA meeting were as follows: There will be a reduction in the total number of subjects to be recruited for the ongoing Phase 3 trial, using a time to first event analysis of heart failure-related major adverse cardiovascular events (HF-MACE) as the primary endpoint, from approximately 1,730 to 1,165. An interim analysis will be performed in the ongoing Phase 3 trial when 50% of the HF-MACE have occurred, which will include a test for superiority allowing for the possibility of stopping of the trial early based on overwhelming efficacy. A second, confirmatory study is planned to be conducted in parallel in an identical patient population of approximately 500 subjects using recurrent HF-MACE as the primary endpoint. The use of recurrent HF-MACE as a primary endpoint in the confirmatory study is supported by a new analysis of the completed Phase 2 trial, where patients treated with MPC-150-IM had no HF-MACE over 36 months of follow-up,

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compared with 11 recurrent HF-MACE in the control group (p

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