ANZ BREAST CANCER TRIALS GROUP LIMITED ABN FINANCIAL REPORT FOR THE YEAR ENDED 31 MARCH 2009

Transcription

1 ANZ BREAST CANCER TRIALS GROUP LIMITED FINANCIAL REPORT

2 CONTENTS Directors Report 1 Income Statement 15 Balance Sheet 16 Changes in Equity 17 Cash Flow Statement 18 Notes to and Forming Part of the Financial Statements 19 Directors Declaration 30 Auditor s Independence Declaration 31 Independent Auditor s Report 33 Auditor s Disclaimer 34 Statement of Income and Expenditure 35 Directors Declaration in Respect of Fundraising Activities 39 Breast Cancer Institute of Australia (BCIA) 40 Statements of BCIA Income and Expenditure 41

3 DIRECTORS REPORT The directors of ANZ Breast Cancer Trials Group Limited present their report for the year ended 31 March DIRECTORS Elections were held in July The names of directors in office at any time during or since the end of the last financial year are: S Ackland, MBBS, FRACP S Ackland is Conjoint Professor at the University Newcastle and Senior Staff Specialist at Calvary Mater Newcastle (Newcastle, NSW, AUSTRALIA). F Boyle, MBBS, PhD, FRACP F Boyle is Associate Professor of Medical Oncology at the University of Sydney and Director, Patricia Richie Centre for Cancer Care & Research, The Mater Hospital (Sydney, NSW, AUSTRALIA). I D Campbell, BHB (Human Biology), MBChB, Dip Obst., FRACS I D Campbell is Clinical Director of the Breast Care Centre, and a Surgeon at Waikato Hospital (Hamilton, NEW ZEALAND). J H Chirgwin (Chair) MA(Oxon), MBBS, FRCP(UK),FRACP J H Chirgwin is a Medical Oncologist at Box Hill Hospital and Maroondah Hospital (Melbourne, VIC, AUSTRALIA). A S Coates (Vice Chair) A S Coates is Clinical Professor at the MBBS, MD, MRACP FRACP University of Sydney (Sydney, NSW, AUSTRALIA). J F Forbes, MBBS, B.Med.Sci, MS, FRACS, FRCS J F Forbes is Professor of Surgical Oncology at the University of Newcastle and Director, Department of Surgical Oncology, Calvary Mater Newcastle (Waratah, NSW, AUSTRALIA). RETIRED 7 JULY 2008 A Hamilton, MBBS, DES, FRACP A Hamilton is a Medical Oncologist at Sydney Cancer Centre, Royal Prince Alfred Hospital (Sydney, NSW, AUSTRALIA). G Lindeman, B Sc (Med), MBBS (Hons), PhD G Lindeman is a Medical Oncologist and Basic 3

4 DIRECTORS REPORT FRACP Research Scientist. He is head of the Familial Cancer Centre, Royal Melbourne Hospital, and co-head of the Victorian Breast Cancer Research Consortium Breast Cancer Laboratory, The Walter and Eliza Hall Institute (Melbourne, VIC, AUSTRALIA). R J Simes, MBBS, SM, FRACP, MD R J Simes is Professor of Clinical Epidemiology and Director of the NHMRC Clinical Trials Centre (University of Sydney, NSW). 2. PRINCIPAL ACTIVITIES The principal activities of the company during the year were the design, conduct, analysis and publication of clinical trials in breast cancer, the development and furtherance of the scientific basis of trials and the collaboration with people, groups and bodies as appropriate to pursue these activities. These activities involve laboratory and clinical research, treatment and prevention research, and fundraising and education. 3. OPERATING RESULTS The net amount of the surplus of the company for the year ended 31 March 2009 was $2,708,284 (for the year ended 31 March 2008 surplus of $2,310,601). 4

5 DIRECTORS REPORT 4. REVIEW OF OPERATIONS 4.1 ANZ BCTG National and International Clinical Trials Program The ANZ BCTG conducts investigator initiated, academic clinical trials for the treatment of all stages of breast cancer and for the prevention of breast cancer. The ANZ BCTG s clinical trials program rigorously and scientifically tests the efficacy of new breast cancer treatments and prevention interventions through the conduct of multi-centre clinical trials. The Group collaborates extensively with institutions and researchers in every Australian State and New Zealand, and also with other national and international Cancer Clinical Trials Research Groups Current (Open & Closed) Clinical Trials The ANZ BCTG Clinical Trials Program continues to expand, and new research grants and contracts have been secured. ANZ BCTG breast cancer protocols are conducted in collaboration with a number of international research groups, including: The International Breast Cancer Study Group (IBCSG), which involves collaboration with over 15 countries internationally. Many peer reviewed publications have resulted from this collaboration, including important publications of trials evaluating the timing and dose of chemotherapy, the quality of life of patients, and the biology of breast cancer. The IBSCG has an Operations Office in Bern, Switzerland and a statistical centre at Harvard University in Boston, US. The Early Breast Cancer Trials Collaborative Group (EBCTCG), which undertakes overviews of all randomised treatment trials for early breast cancer. This Group is located at the CTSU, University of Oxford, UK. The Breast International Group (BIG), located in Brussels, Belgium. The Cancer International Research Group (CIRG), located in Paris, France. Cancer Research UK (CRUK), located in London, UK. The following trials are relevant to this Financial Report: Breast Cancer Prevention Open Trials (i) ANZ 02P2/IBIS II (International Breast cancer Intervention Study) The IBIS II trial is designed to determine if anastrozole (Arimidex) is effective in preventing breast cancer in postmenopausal women at increased risk of the disease. It is an international study conducted in collaboration with CRUK. The recruitment phase of this trial is partially funded, in Australia, by a National Health and Medical Research Council (NHMRC) Project Grant ( ). 5

6 DIRECTORS REPORT Closed (Active) Trials (i) ANZ 92P1/IBIS I (International Breast cancer Intervention Study) Pre-Surgical Open Trials The IBIS I trial is designed to determine whether women at high risk of developing breast cancer can avoid breast cancer if they use tamoxifen. It is an international study conducted in collaboration with CRUK. The study completed its Australian target accrual of 2,674 during in March 2001 and Australia achieved the highest per capita accrual worldwide. The follow-up phase of this trial is funded, in Australia, by a NHMRC Project Grant ( ). (i) Protocol ANZ 0502 Closed Trials A phase II trial evaluating the efficacy and safety of epirubicin and cyclophosphamide followed by docetaxel with gemcitabine (+ trastuzumab if HER2 Positive) as neoadjuvant chemotherapy for women with large operable or locally advanced breast carcinoma excluding inflammatory breast cancer. This trial is being coordinated by the ANZ BCTG and receives support from Eli Lilly Australia, Roche Products Pty Ltd and Sanofi-Aventis. The study is also partially funded, in Australia, by a NHMRC Project Grant ( ). (i) Protocol ANZ 0301/BCIRG 103 A pre-surgical study to evaluate molecular alterations which occur in human breast cancer tissue and normal skin after short term exposure to ZD1839 (IRESSA ) and to correlate these alterations with pharmacokinetic parameters. It is an international trial conducted in collaboration with the CIRG. Accrual closed in December Early Breast Cancer Open Trials (i) Protocol IBCSG 22 This trial evaluates Anti-angiogenesis Treatment following adjuvant induction chemotherapy for patients with ER-negative and PgR-negative breast cancer. It is an international trial conducted in collaboration with the IBCSG. (ii) Protocol IBCSG 23 A randomised trial to determine axillary dissection vs. no further axillary surgery, for patients with micrometastasis in the sentinel lymph node. It is an international trial conducted in collaboration with the IBCSG. 6

7 DIRECTORS REPORT (iii) Protocol IBSCG 24/BIG 2-02 (SOFT) Part of a suite of trials investigating the optimum endocrine treatment of breast cancer in young premenopausal women with endocrine responsive disease. The trial is conducted in collaboration with the IBCSG, BIG and North American Breast Intergroup. It is supported in Australia by a NHMRC Project Grant ( ), and internationally by Pfizer Inc. (iv) Protocol ANZ 0701 (Co-SOFT) A sub-study which is investigating cognitive function in patients participating in the SOFT trial. This sub-study is coordinated by the ANZ BCTG and conducted in collaboration with the IBCSG and North American Breast Intergroup. The trial is supported by a NHMRC Project Grant ( ). (v) Protocol IBCSG 27 A randomized clinical trial of adjuvant chemotherapy versus observation for radically resected loco-regional breast cancer recurrence. It is an international trial conducted in collaboration with the IBCSG. (vi) Protocol IBCSG 34/SWOG 0230 A phase III trial of LHRH analogue administration during chemotherapy to reduce ovarian failure following standard adjuvant chemotherapy in early stage, hormone receptor negative breast cancer. It is an international trial conducted in collaboration with the IBCSG and South Western Oncology Group (SWOG). (vii) Protocol BIG 2-06 (ALTTO) A phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer. This is an international study conducted in collaboration with BIG, and funded internationally by Glaxo Smith Kline. (viii) Protocol ANZ 0501 (LATER) A phase III randomised trial evaluating late adjuvant aromatase inhibitor therapy with letrozole for postmenopausal women with endocrine responsive tumours. The trial is coordinated by the ANZ BCTG and receives support from Novartis Pharmaceuticals Australia Pty Ltd and the NHMRC (Project Grant ). (ix) Protocol IBCSG 35/BIG 2-07 (SOLE) A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer. This is an international study conducted in collaboration with IBCSG and BIG. 7

8 DIRECTORS REPORT Closed (Active) Trials (i) Protocol IBCSG 16/BIG 2-97 (Intergroup Exemestane Study, IES) A phase III trial for postmenopausal women with primary breast cancer who have received adjuvant tamoxifen for two - three years, compared with subsequent treatment for two - three years with either further tamoxifen or exemestane. It is an international trial conducted in collaboration with the IBCSG and BIG, and receives funding support from Pfizer Australia Pty Ltd. Accrual closed in February 2003, follow-up of patients continues. (ii) Protocol IBCSG 18/BIG 1-98 (Adjuvant Letrozole) A phase III trial testing letrozole (Femara) against tamoxifen in postmenopausal women with operable breast cancers which are sensitive to oestrogen. It is an international trial conducted in collaboration with the IBCSG and BIG and, internationally, receives funding support from Novartis Pharmaceuticals. Accrual closed in May 2003, follow-up of patients continues. (iii) Protocol IBCSG 20/BIG 2-98 (Taxotere) A phase III trial testing docetaxol (Taxotere) for the treatment of women with operable breast cancer and involved lymph glands. It is an international trial conducted in collaboration with the IBCSG and BIG. The trial is supported internationally, by Sanofi-Aventis. Accrual closed in June 2001, follow-up of patients continues. (iv) Protocol ANZ 9602 ATLAS (Adjuvant Tamoxifen Longer Against Shorter) A phase III trial for women with early breast cancer comparing different durations of adjuvant tamoxifen therapy to determine the optimum period of tamoxifen use. It is an international study conducted in collaboration with the CTSU at the University of Oxford, UK. Accrual closed in March 2005, follow-up of patients continues. (v) Protocol IBCSG 25/BIG 3-02 (TEXT) Part of a suite of trials investigating the optimum endocrine treatment of breast cancer in young premenopausal women with endocrine responsive disease. The trial is conducted in collaboration with the IBCSG, BIG and North American Breast Intergroup, It is supported in Australia by a NHMRC Project Grant ( ), and internationally by Pfizer Inc. Accrual closed in October 2007, follow-up of patients continues. (x) Protocol IBCSG 30/MA 27 A phase III trial of exemestane vs anastrozole in postmenopausal women with hormone receptor positive primary breast cancer. It is an international study conducted in collaboration with the National Cancer Institute of Canada, the BIG and the IBCSG and supported by Pfizer Inc. Accrual closed in December 2006, follow-up of patients continues. 8

9 DIRECTORS REPORT Advanced Breast Cancer Closed (Active) Trials (i) Protocol ANZ 0601/CIRG TORI 010 A phase II trial of double-blind, placebo controlled AMG 706 in combination with paclitaxel, or open-label bevacizumab in combination with paclitaxel, as first line therapy in women with HER2 negative locally recurrent or metastatic breast cancer. It is an international trial conducted in collaboration with CIRG, and supported internationally by Amgen Pty Ltd. Accrual closed in July 2008, follow-up of patients continues. (ii) Protocol ANZ 0001 (Capecitabine) A phase III trial evaluating whether simple daily oral chemotherapy with capecitabine is preferable to standard intermittent bolus chemotherapy with CMF. The trial receives support from Roche Products Pty Ltd (Australia). Accrual closed in July 2005, follow-up of patients continues. (iii) Protocol ANZ 0102/BCIRG 007 A phase II trial comparing docetaxel and trastuzumab with trastuzumab, docetaxel and platinum salt, as a first line chemotherapy for patients with advanced breast cancer containing the HER2 gene amplification. It is an international trial conducted in collaboration with CIRG. Accrual closed in March 2004, follow-up of patients continues. (iv) Patterns of Recurrence Survey The ANZ BCTG conducted a "Patterns of Recurrence Survey" during this financial year. It is hoped that by identifying the characteristics of consecutive relapsing patients the survey results will: Permit the design of relevant ANZ BCTG clinical trials in the metastatic disease setting; Identify markers of high risk of recurrence despite appropriate use of all current adjuvant therapies that will help the ANZ BCTG to design clinical trials in the adjuvant setting that address the needs of women at greater risk. Survey responses were completed in February and data analysis is underway New Clinical Trials Early Breast Cancer (i) Protocol TAILORx A phase III trial to determine which patients with early breast cancer would be more likely to benefit from chemotherapy and reduce the use of chemotherapy in those 9

10 DIRECTORS REPORT who are unlikely to benefit from it. This will be an international trial conducted in collaboration with the NSABP. Advanced Breast Cancer (ii) Protocol ANZ 0802/CIRG TRIO 012 A phase III trial of IMC-1121B plus docetaxel versus placebo plus docetaxel in previously untreated patients with HER2-Negative, unresectable, locally-recurrent or metastatic breast cancer. This will be an international trial conducted in collaboration with CIRG ANZ BCTG Quality of Life and Cost Effectiveness Research Quality of Life research and cost effectiveness research continued to be a major activity ANZ BCTG Committees and Director of Research Doctor Jacquie Chirgwin continued as Chair of the Group s Board of Directors and Professor Alan Coates, continues as Vice-Chair of the Group s Board of Directors. Associate Professor Frances Boyle continued as Chair of the Group s Scientific Advisory Committee (SAC), and Doctor Nicholas Wilcken has recently been appointed as Deputy- Chair. Clinical Associate Professor Anne Hamilton continued as Chair of the Group s Finance and Audit sub-committee (FAC). This committee continued its important oversight of the Group s financial and risk management practices. Professor Linda Reaby continued as Chair of the Consumer Advisory Panel (CAP). The CAP continued its role of community education and developing strategies to improve recruitment to breast cancer clinical trials. Professor John F Forbes continued as Director of Research and a member of the Group s Scientific Advisory Committee. Many ANZ BCTG committee members are also representatives on many national and international clinical trial steering committees, scientific committees, editorial boards, advisory boards and societies. 4.2 ANZ BCTG Education Activities In July 2009, the Group held its 30 th Annual Scientific Meeting in Wellington, New Zealand. The ASM was attended by 200 delegates and focused on new research developments and discussion of interpretable, scientific data from breast cancer clinical trials for prevention, diagnosis and treatment. 10

11 DIRECTORS REPORT In December 2009, the ANZ BCTG appointed a Medical Fellow, Dr James Bull. The Fellow position aims to provide educational, research and career development opportunities for young clinical researchers in the field of breast cancer through participation in the development, implementation and conduct of the clinical and translational components of trials conducted by the ANZ BCTG. The position is funded by the Cancer Institute NSW. Members of the Group continued their extensive education activities, nationally and internationally, with presentations of scientific papers, guest lectures, and contributions to workshops. The ANZ BCTG remains Australia's major national source of important up to date research data and new breast cancer clinical trials protocols. The ANZ BCTG also continued the IMPACT (IMproving Participation and Advocacy for Clinical Trials) Program. This initiative acknowledges women who have participated in ANZ BCTG studies. IMPACT aims to encourage these women to increase awareness and understanding about breast cancer clinical trials, in their communities, by providing them with information about breast cancer research e.g. via regular IMPACT Newsletters. The IMPACT Program is supported by Avon. 4.3 ANZ BCTG Publications Members of the Group have contributed numerous publications to scientific journals over the past 12 months, and the total number of published papers now exceeds Highlights Operational Achievements To highlight some of the Group s operational achievements in 2008/2009: (i) The ANZ BCTG Board of Directors completed its strategic planning activities and produced a five year plan covering 2009/ /2014. Business planning for each twelve month period of the Strategic Plan is now underway. (ii) The ANZ BCTG reviewed its operational Policies and Procedures (PnPs) which were first rolled out in ANZ BCTG PnP s consist of eight chapters 1. Governance, 2. Committees and Committee Management, 3. Operating Principles, 4. Operational Management, 5. Public Relations/Education/Communication, 6. Information Systems, 7. Research Projects and Trials Coordination, 8. Fundraising each chapter contains numerous individual PnP s. The PnP review involved; a needs analysis, staff consultation, updating of existing PnP s development of new PnP s, creation of an improved search facility and uploading of the final PnP s and associated attachments onto the ANZ BCTG staff member intranet. The review process took five months and was a resounding success. (iii) The Group commenced using character recognition software in its data collection processes. The new software reduces the amount of manual data entry required and improves the Group s data query and resolution timelines. (iv) The development of the ANZ BCTG Clinical Trials Management Database (TMD) continued. This utility will enable staff to track the status of all regulatory documentation and monitoring 11

12 DIRECTORS REPORT activities across trials, in a centralised and standardised manner. The TMD will eliminate administrative tasks associated with ascertaining regulatory documentation which is common across all trials coordinated by the ANZ BCTG. Research Achievements As new trials begin, other trials reach their accrual targets, progress into follow-up phase and become ready for analysis. To highlight some of the Group s research achievements in 2008/2009: (i) Ten clinical trials (and two sub-studies) were open for recruitment during the reporting period. One recently opened phase III study, ALTTO, evaluates adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer. The principal objective of the study is to compare disease free survival in patients receiving sequential treatment with those receiving combined treatment. (ii) Publication: (A) The ten year update of trial IBCSG 11 was published (Breast Cancer Res Treat 2009; 113: ). This phase III trial involved premenopausal women who after surgery for their breast cancer were found to have tumours which are hormone receptor positive and positive axillary lymph nodes. For these women it was not known whether hormonal treatment alone is sufficient, or whether the addition of chemotherapy may be beneficial in reducing the incidence of disease recurrence and improving survival. Internationally, 174 women were recruited to this study and thirteen ANZ BCTG institutions participated (B) The 100 month follow-up analysis of the ATAC (Arimidex of Tamoxifen Alone or in Combination) trial was published in The Lancet (Lancet Oncology: 9: ). These results showed that anastrozole, compared to tamoxifen, can significantly reduce the risk of recurrence and minimize life-threatening side effects. The data also showed that the protective effect of anastrozole lasts well beyond the standard treatment period of five years. Internationally, 9306 women were recruited to this study and eleven ANZ BCTG institutions participated. 4.5 Breast Cancer Institute of Australia (BCIA) The Group's operating division for increasing awareness and support for breast cancer research is the Breast Cancer Institute of Australia (BCIA). This is a very important Group activity as total medical research funding remains substantially below the minimum levels required. The BCIA enables industry and the community to share in the Group's research activities and is an essential source of funding for our high priority research. The BCIA conducted a number of mail campaigns to existing donors and two acquisition campaigns during the 2008/2009 financial year and The Australian Women s Weekly again produced the Australian Women s Health Diary on behalf of the BCIA. Other annual events continue to raise much needed funding and enhance the profile of our research program. For more information on the activities of the BCIA please refer to the BCIA section of these financial statements. 12

13 DIRECTORS REPORT 5. SIGNIFICANT CHANGES In the opinion of the directors there were no significant changes in the state of affairs of the company that occurred during the financial year. 6. MATTERS SUBSEQUENT TO THE END OF THE FINANCIAL YEAR No other matter or circumstance has arisen since 31 March 2009 that has significantly affected or may significantly affect: the operations of the company; the results of those operations; or the company s state of affairs. 7. DIRECTORS' BENEFITS During or since the end of the financial year no director of the company has received or become entitled to receive a benefit because of a contract made by the company with the Director, or with a firm of which the Director is a member, or with an entity in which the Director has a substantial financial interest. 8. MEETINGS OF DIRECTORS During the financial year, 3 full meetings, 1 executive meeting and 1 extraordinary meeting of directors were held. Attendances were: Director No. Eligible to Attend No. Attended Prof Stephen Ackland (appointed Jul07) 4 4 A/Prof Frances Boyle 4 3 Dr Ian D Campbell 4 2 Dr Jacquie H Chirgwin (Chair) 5 4 Prof Alan S Coates (Vice Chair) 5 5 Prof John F Forbes (Director of 3 3 Research) RETIRED 7 JULY 2008 Clin A/Prof Anne Hamilton 5 4 Dr Geoffrey Lindeman 4 3 Prof R John Simes INDEMNIFYING OFFICERS OR AUDITOR The company has paid insurance premiums to insure each of the directors against liabilities for the costs and expenses incurred by them in defending any legal proceedings arising out of their conduct while acting in the capacity of director of the company, other than conduct resulting in a willful breach of duty in relation to the company. Disclosure of the amount of the premium is prohibited by the insurance contract. 13

14 10. ENVIRONMENTAL REGULATIONS DIRECTOR S REPORT The company s operations are not regulated by any significant environmental regulation under a law of the Commonwealth or of a State or Territory. 11. AUDITOR S INDEPENDENCE DECLARATION The auditor s independence declaration for the year ended 31 March 2009 has been received and can be found on page 31 of the financial report. 12. DIVIDENDS As the company is limited by guarantee, it is prohibited from paying dividends. 13. FUTURE DEVELOPMENTS The directors consider that there are no likely developments, which will significantly affect the operations of the company. Signed in accordance with a resolution of the directors. Director Date: 22 May 2009 Director Date: 22 May

15 INCOME STATEMENT Notes $ $ Revenues from ordinary activities 2 9,346,985 7,430,185 Scientific and Administrative meetings expenses 544, ,036 IMPACT education program 79,216 96,475 BCIA expenses 1,653,822 1,344,724 Clinical trials protocol and per-patient expenses 1,799,161 1,557,214 Clinical trials program expenses 2,427,042 1,583,643 Other expenditure 135,221 46,492 6,638,701 5,119,584 Net surplus from ordinary activities 3 2,708,284 2,310,601 Total changes in equity 2,708,284 2,310,601 The accompanying notes form part of these financial statements 15

16 BALANCE SHEET AS AT 31 MARCH 2009 CURRENT ASSETS Notes $ $ Cash assets 4 11,353,150 9,366,530 Receivables 5 2,017,814 1,051,052 Other financial assets 6 240, ,146 Total Current Assets 13,611,664 10,750,728 NON-CURRENT ASSETS Other financial assets 6 113,166 64,203 Property, plant and equipment 7 462, ,285 Total Non-Current Assets 575, ,488 TOTAL ASSETS 14,187,598 10,944,216 CURRENT LIABILITIES Payables 8 2,544,837 2,009,739 Total Current Liabilities 2,544,837 2,009,739 TOTAL LIABILITIES 2,544,837 2,009,739 NET ASSETS 11,642,761 8,934,477 ACCUMULATED FUNDS Accumulated funds 11,642,761 8,934,477 TOTAL ACCUMULATED FUNDS 11,642,761 8,934,477 The accompanying notes form part of these financial statements 16

17 STATEMENT OF CHANGES IN EQUITY Accumulated Funds Total $ $ BALANCE AT 1 APRIL ,623,876 6,623,876 Surplus attributable to the organisation 2,310,601 2,310,601 BALANCE AT 31 MARCH ,934,477 8,934,477 Surplus attributable to the organisation 2,708,284 2,708,284 BALANCE AT 31 MARCH ,642,761 11,642,761 The accompanying notes form part of these financial statements 17

18 CASHFLOW STATEMENT $ $ Inflow/ Inflow/ Notes (Outflow) (Outflow) CASH FLOWS FROM OPERATING ACTIVITIES Receipts from customers, donors and external funding 8,128,497 7,430,751 Interest received 565, ,546 Payments to suppliers and employees (6,253,714) (5,083,980) Net cash provided by (used in) operating activities 12 2,439,876 2,824,317 CASH FLOWS FROM INVESTING ACTIVITIES Purchase of property, plant and equipment (453,256) (62,700) Net cash provided by (used in) investing activities (453,256) (62,700) Net increase/(decrease) in cash held 1,986,620 2,761,617 Cash at the beginning of the year 9,366,530 6,604,913 Cash at the end of the year 4 11,353,150 9,366,530 The accompanying notes form part of these financial statements 18

19 NOTES TO AND FORMING PART OF THE FINANCIAL REPORT 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The financial report is a general purpose financial report that has been prepared in accordance with Accounting Standards, including Australian Accounting Interpretations, other authoritative pronouncements of the Australian Accounting Standards Board and the Corporations Act ANZ Breast Cancer Trials Group Limited is a company limited by guarantee and, incorporated and domiciled in Australia. The following is a summary of the material accounting policies adopted by the Company in the preparation of the financial report. The accounting policies have been consistently applied, unless otherwise stated. Basis of Preparation Reporting Basis and Conventions The financial report has been prepared on an accruals basis and is based on historical costs modified by the revaluation of selected non-current assets, and financial assets and financial liabilities for which the fair value basis of accounting has been applied. Accounting Policies (a) Cash and cash equivalents Cash and cash equivalents include cash on hand, deposits at call, deposits held at call with banks, other short-term highly liquid investments with original maturities of twelve months or less. (b) Property, Plant and Equipment Plant and equipment are measured on the cost basis less depreciation and impairment losses. The carrying amount of plant and equipment is reviewed annually by directors to ensure it is not in excess of the recoverable amount from these assets. The recoverable amount is assessed on the basis of the expected net cash flows, which will be received from the assets employment and subsequent disposal. The expected net cash flows have not been discounted to their net present values in determining recoverable amounts. The cost of fixed assets constructed within the economic entity includes the cost of materials, direct labour, borrowing costs and an appropriate proportion of fixed and variable overheads. 19

20 NOTES TO AND FORMING PART OF THE FINANCIAL REPORT 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont) Depreciation The depreciable amount of all fixed assets including building and capitalised lease assets, but excluding freehold land, is depreciated on a straight line basis over their useful lives to the economic entity commencing from the time that the asset is held ready for use. Leasehold improvements are depreciated over the shorter of either the unexpired period of the lease or the estimated useful lives of the improvements. The depreciation rates used for each class of depreciable assets are: Class of Fixed Asset Depreciation Rate Equipment 13-27% Professional Library 20% (c) Revenue Revenue from the sale of goods is recognised on the delivery of the goods to the customer. Interest revenue is recognised on a proportional basis taking into account the interest rates applicable to the financial assets. Revenue from the rendering of a service is recognised upon the delivery of the service to the customers. All revenue is stated net of the amount of goods and services tax (GST). Grant Income Grant income is recognised at fair value when there is a reasonable assurance that the grant will be received and the entity will comply with the attached conditions. (d) Receivables Trade debtors are carried at nominal amounts due at the time of invoicing less any provision for doubtful debts as the amounts are due for settlement upon the issue of the invoice. The collectability of receivables is assessed periodically with provision being made for impairment. (e) Income Tax An application for exemption from income tax under Section 50 of the Income Tax Assessment Act, 1997 has been granted. Therefore, no amounts have been provided for income tax. 20

21 NOTES TO AND FORMING PART OF THE FINANCIAL REPORT 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont) (f) Goods and Services Tax (GST) Revenues, expenses and assets are recognised net of the amount of GST, except where the amount of GST incurred is not recoverable from the Australian Tax Office (ATO). In these circumstances, the GST is recognised as part of the cost of acquisition of the asset or as part of an item of the expense. Receivables and Payables in the statement of financial position are shown inclusive of GST. (g) Impairment of Assets At each reporting date, the Company reviews the carrying values of its tangible and intangible assets to determine whether there is any indication that those assets have been impaired. If such an indication exists, the recoverable amount of the asset, being the higher of the asset s fair value less costs to sell, and its value in use (being the depreciated replacement cost of the asset), is compared to the assets carrying value. Any excess of the assets carrying value over its recoverable amount is expensed to the income statement. Impairment testing is performed annually for intangible assets with indefinite lives. (h) Financial Instruments Recognition Financial instruments are initially measured at cost on trade date, which includes transaction costs, when the related contractual rights or obligations exist. Subsequent to initial recognition these instruments are measured as set out below. Available-for-sale financial assets Available-for-sale financial assets include any financial assets not included in the above categories. Available-for-sale financial assets are reflected at fair value. Unrealised gains and losses arising from changes in fair value are taken directly to equity. Financial liabilities Non-derivative financial liabilities are recognised at amortised cost, comprising original debt less principal payments and amortisation. Fair Value Fair value is determined based on current bid prices for all quoted investments. Valuation techniques are applied to determine the fair value for all unlisted securities, including recent arms length transactions, reference to similar instruments and option pricing models. Where fair value for financial assets cannot be reliably measured, such assets have been reflected at cost. 21

22 NOTES TO AND FORMING PART OF THE FINANCIAL REPORT 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (cont) (h) Financial Instruments (con t) Impairment At each reporting date, the company assesses whether there is objective evidence that a financial instrument has been impaired. Impairment losses are recognised in the income statement. (i) Critical Accounting Estimates and Judgments The directors evaluate estimates and judgments incorporated into the financial report based on historical knowledge and best available current information. Estimates assume a reasonable expectation of future events and are based on current trends and economic data, obtained both externally and within the company. (j) New Australian Accounting Standards As at the date of this report there are a number of new Australian Accounting Standards that have been issued but are not yet effective. The company has assessed the impact of these new Australian Accounting Standards and has concluded that any changes are only minimal and related to disclosure, or would have no material impact upon the financial statements. (k) Comparative Figures When required by accounting standards, comparative figures have been adjusted to conform to changes in presentation for the current financial year. 22

23 NOTES TO AND FORMING PART OF THE FINANCIAL STATEMENTS 2 REVENUE Operating activities: $ $ Scientific Meetings 287, ,532 Donations and Fundraising 4,856,949 4,379,037 Trial and Pharmaceutical income 2,176,358 1,471,922 Infrastructure Grant 342, ,705 Other income 1,118, ,443 Interest received 565, ,546 Total revenue 9,346,985 7,430,185 3 SURPLUS/(DEFICIT) FROM ORDINARY ACTIVITIES Surplus/(deficit) from ordinary activities has been determined after the following expenses: Depreciation Other Assets 30,116 40,828 Printers 2,421 4,203 Computers 80,783 33, ,320 78,076 23

24 NOTES TO AND FORMING PART OF THE FINANCIAL STATEMENTS $ $ 4 CASH ANZ Cheque Account 71,109 16,580 BCIA Term Deposit 1,163, ,010 BCIA Accelerator Account 8,916,616 5,869,699 BCIA Chip In Account 70, ,635 BCIA Foundation Account 707,063 2,141,142 BCIA Race for Research Chq Acc 65, ,709 BCIA Term Deposit 358, ,505 Petty Cash ,353,150 9,366,530 5 RECEIVABLES CURRENT Trade debtors 2,047,403 1,001,891 GST Receivable (29,589) 49,161 2,017,814 1,051,052 6 OTHER FINANCIAL ASSETS CURRENT Prepayments 240, ,146 NON-CURRENT Prepayments 113,166 64,203 24

25 NOTES TO AND FORMING PART OF THE FINANCIAL STATEMENTS 7 PROPERTY, PLANT AND EQUIPMENT $ $ Equipment - at cost 1,055, ,432 Less: Accumulated depreciation (592,754) (479,147) 462, ,285 Professional Library - at cost 4,806 4,806 Less: Accumulated depreciation (4,806) (4,806) - - Total plant and equipment 462, ,285 (a) Movements in Carrying Amounts Movement in the carrying amounts for each class of property, plant and equipment between the beginning and the end of the current financial year Professional Equipment Library At Cost At Cost Total $ $ $ Balance at the beginning of the year 129, ,285 Additions 453, ,256 Disposals (6,543) - (6,453) Depreciation Expense (113,320) - (113,320) Carrying amount at the end of the year 462, ,768 25

26 NOTES TO AND FORMING PART OF THE FINANCIAL STATEMENTS 8 PAYABLES $ $ CURRENT Trade creditors 677, ,645 Income in advance 1,742,170 1,259,094 Non interest bearing liability 125, ,000 2,544,837 2,009,739 9 RELATED PARTY DISCLOSURES There were no related party transactions during the period. 10 REMUNERATION AND RETIREMENT BENEFITS During or since the end of the financial year, no Director of the company has received, or become entitled to receive, a benefit because of a contract made by the company with the Director, or with a firm of which the Director is a member, or with an entity in which the Director has a substantial financial interest. 11 LIMITATION OF MEMBER'S LIABILITY The company is limited by guarantee and in accordance with Memorandum of Association, the liability of members, in the event of the company being wound up, would not exceed $10 per member. 26

27 NOTES TO AND FORMING PART OF THE FINANCIAL STATEMENTS 12 STATEMENT OF CASH FLOWS Reconciliation of cash flows from Operations with surplus/(deficit) from ordinary activities: $ $ Surplus/(deficit) from ordinary activities 2,708,284 2,310,601 Non-Cash flows in surplus from ordinary activities: Depreciation 113,320 78,076 Disposals 6,453 - Changes in assets and liabilities: Decrease (Increase) in receivables (966,762) (92,797) Decrease (Increase) in other financial assets 43,483 (116,368) Increase (Decrease) in payables 535, ,805 2,439,876 2,824, REMUNERATION OF AUDITORS Amounts received by the auditor for the audit of ANZ Breast Cancer Trials Group Limited Auditing or reviewing the financial report 10,800 10, EVENTS SUBSEQUENT TO BALANCE DATE There were no events subsequent to reporting date that would have a material impact on the financial report. 15 CAPITAL AND OTHER COMMITTED FUNDS The Company does not have any expenditure commitments which have not been recognised in the financial statements as liabilities. 27

28 NOTES TO AND FORMING PART OF THE FINANCIAL STATEMENTS 16 FINANCIAL INSTRUMENTS The company's activities expose it to a variety of financial risks: market risk, credit risk and liquidity risk. (a) Market Risk The company's exposure to interest rate risk, which is the risk that a financial instrument's value will fluctuate as a result of changes in market interest rates and the effective weighted average interest rates on classes of financial assets and financial liabilities, is as follows Interest Rate Interest Rate + 10% - 10% Interest Rate Risk + 10% - 10% Carrying Amount Profit Equity Profit Equity Financial Assets Cash at Bank 4.5% 5.0% 4.1% 11,353,150 51,554 - (51,554) - Financial Liabilities Payables 0.0% 0.0% 0.0% 677, (b) Credit Risk The maximum exposure to credit risk, excluding the value of any collateral or other security, at balance date to recognised financial assets is the carrying amount, net of any provisions for doubtful debts, as disclosed in the balance sheet and notes to the financial statements. The company does not have any material credit risk exposure to any single debtor or group of debtors under financial instruments entered into by the company. 28

29 NOTES TO AND FORMING PART OF THE FINANCIAL STATEMENTS 16 FINANCIAL INSTRUMENTS (cont) (c) Liquidity Risk Prudent liquidity risk management implies maintaining sufficient cash or credit facilities to meet the operating requirements of the company. This is managed through prudent cash flow management. (d) Fair Values The carrying amounts and estimated fair values of financial assets and financial liabilities held at balance date are the same. 17 KEY MANAGEMENT PERSONNEL COMPENSATION No remuneration was paid or payable to any Key Management Personnel during the 2009, or 2008 financial year by the entity. Any Remuneration paid to Key Management Personnel was administrated and paid by the University of Newcastle. Key Management Personnel The names of Company directors who have held office during the financial year are: Director S Ackland (Appointed July 2007) J H Chirgwin (Chair) A S Coates (Vice Chair) J F Forbes (Retired July 2008) F Boyle I D Campbell G Lindeman R J Simes A Hamilton Management Wendy Carmichael (Chief Operating Officer, Company Secretary) J F Forbes (Director of Research) 29

30 DIRECTORS DECLARATION The directors of the company declare that:- 1. The financial statements and notes, as set out on pages 15 to 29 are in accordance with the Corporations Act 2001: (a) (b) comply with Accounting Standards and the Corporations Regulations 2001; and give a true and fair view of the financial position as at 31 March 2009 and of the performance for the year ended on that date of the company. 2. In the opinion of the directors there are reasonable grounds to believe that the company will be able to pay its debts as and when they fall due. This declaration is made in accordance with a resolution of the Board of Directors. Director Date: 22 May 2009 Director Date: 22 May

31 AUDITOR S INDEPENDENCE DECLARATION UNDER SECTION 307C OF THE CORPORATIONS ACT 2001 TO THE DIRECTORS OF I declare that, to the best of my knowledge and belief, during the year ended 31 March 2009 there have been: (i) (ii) no contraventions of the auditor independence requirements as set out in the Corporations Act 2001 in relation to the audit; and no contraventions of any applicable code of professional conduct in relation to the audit. SNEDDON McKEOWN PAUL HORNE Partner 18 May 2009 Newcastle 31

32 INDEPENDENT AUDITOR S REPORT TO THE MEMBERS OF Report on the Financial Report We have audited the accompanying financial report of ANZ Breast Cancer Trials Group Limited (the company), which comprises the balance sheet as at 31 March 2009, and the income statement, statement of changes in equity and cash flow statement for the year ended on that date, a summary of significant accounting policies and other explanatory notes and the directors declaration of the company at the year s end. Directors Responsibility for the Financial Report The directors of the company are responsible for the preparation and fair presentation of the financial report in accordance with Australian Accounting Standards (including the Australian Accounting Interpretations) and the Corporations Act This responsibility includes establishing and maintaining internal control relevant to the preparation and fair presentation of the financial report that is free from material misstatement, whether due to fraud or error; selecting and applying appropriate accounting policies; and making accounting estimates that are reasonable in the circumstances. Auditor s Responsibility Our responsibility is to express an opinion on the financial report based on our audit. We conducted our audit in accordance with Australian Auditing Standards. These Auditing Standards require that we comply with relevant ethical requirements relating to audit engagements and plan and perform the audit to obtain reasonable assurance whether the financial report is free from material misstatement. An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial report. The procedures selected depend on the auditor s judgment, including the assessment of the risks of material misstatement of the financial report, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entity s preparation and fair presentation of the financial report in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity s internal control. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of accounting estimates made by the directors, as well as evaluating the overall presentation of the financial report. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion. 32 Chartered Accountants 2 nd floor, hunter mall chambers 175 scott street newcastle nsw 2300 phone: fax: Chartered Accountants Liability limited by a Scheme approved under the Professional Standards Legislation.

33 INDEPENDENT AUDITOR S REPORT TO THE MEMBERS OF Independence In conducting our audit, we have complied with the independence requirements of the Corporations Act We confirm that the independence declaration required by the Corporations Act 2001, provided to the directors of ANZ Breast Cancer Trials Group Limited on 18 May 2009, would be in the same terms if provided to the directors as at the date of this auditor s report. Qualification As is common for an organisation of this type, it is not practicable for ANZ Breast Cancer Trials Limited to maintain an effective system of control over donations and other fundraising activities until their initial entry in the accounting records. Accordingly, our audit in relation to fundraising was limited to the amounts recorded. Qualified Auditor s Opinion In our opinion, except for the effect on the financial statements of the matter referred to in the preceding paragraph, the financial report of ANZ Breast Cancer Trials Group Limited is in accordance with the Corporations Act 2001, including: (i) (ii) giving a true and fair view of the company s financial position as at 31 March 2009 and of their performance for the year ended on that date; and complying with Australian Accounting Standards (including the Australian Accounting Interpretations) and the Corporations Regulations SNEDDON McKEOWN PAUL HORNE Partner 11 June 2009 Newcastle Chartered 33 Accountants 2 nd floor, hunter mall chambers 175 scott street newcastle nsw 2300 phone: fax: Chartered Accountants Liability limited by a Scheme approved under the Professional Standards Legislation.

34 AUDITOR S DISCLAIMER To the members of ANZ Breast Cancer Trials Group Limited: The additional financial data presented in the following pages is in accordance with the books and records of the company which have been subject to the auditing procedures applied in our statutory audit of the Company for the year ended 31 March It will be appreciated that our statutory audit did not cover all details of the additional financial data. Accordingly, we do not express an opinion on such financial data and no warranty of accuracy or reliability is given. Neither the firm nor any member or employee of the firm undertakes responsibility in any way whatsoever to any person in respect of such data, including any errors or omissions therein however caused. SNEDDON McKEOWN PAUL HORNE Partner 11 June 2009 Newcastle 34

35 STATEMENT OF INCOME AND EXPENDITURE $ $ INCOME Annual Scientific Meeting (ASM) ASM Event Fees - 1,130 ASM Meal Fees 6,806 7,803 Other 5,397 3,205 Registration 31,490 31,800 Sponsors and Trade Displays 243, ,594 Total Annual Scientific Meeting (ASM) 287, ,532 Donations & Fundraising (see page 39 for details) 4,856,949 4,379,037 Other Income University of Newcastle 873, ,761 Sundry Income 154, ,682 Bequests 55,000 1,000 COSA 36,000 18,000 1,118, ,443 Bank Interest 565, ,546 Commonwealth of Australia 342, ,705 Total Other Income 2,026,135 1,383,694 Trial Income Astra Zeneca 47,148 45,308 Aventis 8,592 10,975 Atlas Funding 41,795 - BCIRG Income 214, ,619 BIG 469,592 - CRUK Income 267,627 65,428 Eli Lilly 96, ,000 Glaxo Smith Kline 436, ,116 IBCSG Income 370, ,572 Novartis 88, ,318 Pharmacia/Pfizer 15,745 12,778 Roche Products 112, ,517 Other Trial Income 6,907 5,291 Total Income 2,176,358 1,471,922 TOTAL INCOME 9,346,985 7,430,185 35

36 STATEMENT OF INCOME AND EXPENDITURE $ $ EXPENSE Advertising and Promotion 50,718 36,805 Annual Report Printing 30,435 29,456 Bank Charges 20,242 17,765 BCIA Tee-Off Expenses 10,604 2,607 BCIA Diary Production and Writing 242, ,530 BCIA Mailing House 80, ,681 BCIA Merchandising BCIA Race for Research Expenses 31,282 18,294 Cab Charge 9,314 10,365 Computer Expenses - Hardware 13,930 5,300 Computer Expenses - Software 25,266 12,329 Data Management Reimbursements DMR IBCSG 22 1,200 6,000 DMR CIRG TORI ,632 55,872 DMR (ANZ0502) 138,732 74,000 DMR ATLAS 12,293 - DMR (IBIS II) 72,130 21,494 DMR (ATAC) DMR (ALTO) 329,000 - DMR (BCIRG 007) - 22,750 DMR (STP) 70,160 71,490 DMR (IBIS) 146, ,991 DMR (Letrozole) 82, ,245 DMR (Taxotere) 6,000 - DMR (SWOG) 66,600 22,000 DMR (IBCSG Pathology) 625 7,625 DMR IBCSG (MA27) 6,400 - DMR IBCSG ,000 10,000 DMR (LATER) 171,600 55,200 Total Data Management Reimbursements 1,244,035 1,019,017 36

37 STATEMENT OF INCOME AND EXPENDITURE $ $ Depreciation 113,320 78,076 Employee Salaries (TUNRA) 1,991,058 1,203,012 Employee Salaries (University) 162,810 32,967 Equipment - Non Asset 89,558 14,744 Freight 5,588 7,486 Grants and Awards 27,175 - Impact Education Program 79,216 96,475 Institutional Audits 8,174 8,804 Insurance 45, ,427 IT Consultant Fees 405, ,510 Labour Hire 39,078 46,582 Meetings & Meetings Admin ASM External Event Expenses 6,190 2,932 ASM Guest Speaker Expense 90, ,538 ASM Travel & Accommodation 75,041 20,049 ASM Banqueting/ Venue 95, ,420 ANZ BCTG Committees 42,972 38,579 Board of Directors 11,006 29,131 Business/Admin/Fundraising 13,386 1,198 Consumer Advisory Panel 17,972 21,990 Scientific Meetings 194, ,282 Total Meetings & Meetings Admin 546, ,119 Photocopying 2,805 2,555 Postage 308, ,049 Premises Management 3,718 3,047 Premises Rental 101,448 79,177 Printing & Stationery 253, ,639 Professional Fees - Accounting 3,115 3,515 Professional Fees - Audit 9,000 9,350 Professional Fees - ASIC 1, Professional Fees - Legal Fees 43,139 74,733 37