PART I
Item 1.
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Identity of Directors, Senior Management and Advisors
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Item 1 details are not required to be disclosed
as part of the Annual Report.
Item 2.
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Offer Statistics and Expected Timetable
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Item 2 details are not required to be disclosed as part of the
Annual Report.
A. Selected financial data
The selected financial data at June 30, 2017 and 2016 and for the years ended June 30, 2017, 2016 and 2015 have been derived from the consolidated
financial statements of the Company included in this Annual Report and should be read in conjunction with, and are qualified in their entirety by, reference to those statements and the notes thereto.
This financial report complies with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board
(IASB).
The consolidated financial statements have been audited in accordance with the Public Company Accounting Oversight Board
(PCAOB) auditing standards in the United States by the Companys independent registered public accounting firm.
The Companys
fiscal year ends on June 30. As used throughout this Annual Report, the word fiscal followed by a year refers to the
12-month
period ended on June 30 of that year. For example, the term
fiscal 2017 refers to the 12 months ended June 30, 2017. Except as otherwise indicated, all dollar amounts referred to in this Annual Report are at the consolidated level and exclude inter-company amounts.
2
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Summary of consolidated profit or loss and other
comprehensive income (IFRS)
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2013
A$000
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2014
A$000
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2015
A$000
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2016
A$000
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2017
A$000
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2017
US$000
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Revenue and other income
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1,730
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429
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2,842
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4,071
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8,812
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6,764
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Loss before income tax expense from continuing operations
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(1,508
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(7,569
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(7,306
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(12,155
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(10,869
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(8,343
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Profit after income tax expense from discontinued operations
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723
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Loss after income tax expense for the year
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(785
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(7,569
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(7,306
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(12,155
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(10,670
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(8,191
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Net profit/(loss) attributable to members of Novogen Limited
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(1,031
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(7,468
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(7,139
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(12,062
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(10,670
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(8,191
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Earnings per share for loss from continuing operations attributable to the owners of Novogen
Limited
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Basic earnings /(loss) per share (cents per share)
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(1.32
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(4.76
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(2.99
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(2.82
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(2.28
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(1.75
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)
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Diluted earnings/(loss) per share (cents per share)
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(1.32
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(4.76
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(2.99
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(2.82
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)
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(2.28
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(1.75
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)
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Earnings per share for profit/(loss) from discontinued operations attributable to the owners of
Novogen Limited
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Basic earnings/(loss) per share (cents per share)
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0.42
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Diluted earnings/(loss) per share (cents per share)
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0.42
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Earnings per share for profit/(loss) attributable to the owners of Novogen Limited
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Basic earnings/(loss) per share (cents per share)
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(0.90
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(4.76
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(2.99
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(2.82
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(2.28
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(1.75
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Diluted earnings/(loss) per share (cents per share)
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(0.90
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)
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(4.76
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)
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(2.99
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(2.82
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(2.28
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(1.75
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Weighted average number of ordinary share shares used to calculate earnings per share
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114,690,737
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156,725,363
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238,418,048
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427,431,910
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467,833,849
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467,833,849
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Number of outstanding ordinary shares at year end
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138,276,033
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168,557,834
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423,116,465
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429,733,982
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483,287,914
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483,287,914
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Summary of consolidated financial position (IFRS)
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2013
A$000
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2014
A$000
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2015
A$000
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2016
A$000
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2017
A$000
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2017
US$000
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Cash and cash equivalents
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2,738
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2,502
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44,371
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33,453
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14,455
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11,095
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Total assets
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5,749
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4,660
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46,140
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35,517
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35,910
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27,565
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Net assets/Equity
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4,041
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1,413
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44,362
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33,931
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25,338
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19,449
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Debt
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1,416
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2,707
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Capital Stock
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137,663
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142,586
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190,404
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191,301
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193,769
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148,737
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3
The Company publishes its consolidated financial statements expressed in Australian dollars. In this Annual
Report, references to U.S. dollars or US$ are to the currency of the United States of America (U.S.) and references to Australian dollars or A$ are to the currency of Australia. For the
convenience of the reader, this Annual Report contains translations of certain Australian dollar amounts into U.S. dollars at specified rates. These translations should not be construed as representations that the Australian dollar amounts actually
represent such U.S. dollar amounts or could be converted into U.S. dollars at the rate indicated. Unless otherwise stated, the translations of Australian dollars into U.S. dollars have been made at the rate of US$0.7676 = A$1.00, the foreign
exchange rate as issued weekly by the Board of Governors of the Federal Reserve System (
www.federalreserve.gov/releases
) on June 30, 2017.
Exchange rates for the six months to September 2017 A$1.00 per US$
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Month
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High
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Low
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April
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$
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0.7604
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$
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0.7452
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May
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$
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0.7534
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$
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0.7352
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June
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$
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0.7680
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$
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0.7387
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July
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$
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0.7991
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$
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0.7584
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August
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$
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0.7983
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$
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0.7584
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September
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$
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0.8071
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$
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0.7831
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Exchange rates for the last five fiscal years A$1.00 per US$
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Fiscal year ended June 30
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Average Rate*
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2013
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$
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1.0272
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2014
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$
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0.9186
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2015
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$
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0.8365
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2016
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$
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0.7289
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2017
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$
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0.7542
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*
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Determined by calculating the average rate of the exchange rates on the last trading day of each month during the period.
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B. Capitalization and Indebtedness.
Not
applicable.
C. Reasons for the Offer and Use of Proceeds.
Not applicable.
4
D. Risk factors
Investment in our securities involves a high degree of risk. You should consider carefully the risks described below, together with other information in
this Annual Report on
Form 20-F
and our other public filings, before making investment decisions regarding our securities. If any of the following events actually occur, our business, operating results,
prospects or financial condition could be materially and adversely affected. This could cause the trading price of our common stock to decline and you may lose all or part of your investment. Moreover, the risks described below are not the only ones
that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition.
We have incurred significant net losses. We anticipate that we will continue to incur significant net losses for the foreseeable future and we may never
achieve or maintain profitability.
We are a biotechnology company and have not yet generated significant revenue. We have incurred losses of
A$7.3 million, A$12.2 million and A$10.7 million for the fiscal years ended June 30, 2015, 2016 and 2017, respectively. We have not generated any revenues from sales of any of our product candidates.
As of June 30, 2017, we had accumulated losses of A$171 million. We have devoted most of our financial resources to research and development,
including our clinical and preclinical development activities. To date, we have financed our operations primarily through the issuance of equity securities, research and development grants from the Australian government and payments from our
collaboration partners. We have not generated, and do not expect to generate, any significant revenue for the foreseeable future, and we expect to continue to incur significant operating losses for the foreseeable future due to the cost of research
and development, preclinical studies and clinical trials and the regulatory approval process for product candidates. The amount of our future net losses is uncertain and will depend, in part, on the rate of our future expenditures. Our ability to
continue operations will depend on, among other things, our ability to obtain funding through equity or debt financings, strategic collaborations or additional grants.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase
substantially if and as we:
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continue our research and preclinical development of our product candidates;
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expand the scope of our current preclinical studies for our product candidates or initiate clinical, additional preclinical or other studies for product candidates;
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seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;
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further develop the manufacturing process for our product candidates;
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change or add additional manufacturers or suppliers;
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seek to identify and validate additional product candidates;
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acquire or
in-license
other product candidates and technologies;
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maintain, protect and expand our intellectual property portfolio;
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create additional infrastructure to support our operations as a public company in the United States and our product development and future commercialization efforts; and
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experience any delays or encounter issues with any of the above.
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The net losses we incur may fluctuate
significantly from quarter to quarter and year to year, such that a
period-to-period
comparison of our results of operations may not be a good indication of our future
performance. In any particular quarter or quarters, our operating results could be below the expectations of securities analysts or investors, which could cause the price of the ADSs to decline.
5
We have never generated any revenue from product sales and may never be profitable.
Our ability to generate significant revenue and achieve profitability depends on our ability to, alone or with strategic collaboration partners, successfully
complete the development of and obtain the regulatory approvals for our product candidates, to manufacture sufficient supply of our product candidates, to establish a sales and marketing organization or suitable third-party alternative for the
marketing of any approved products and to successfully commercialize any approved products on commercially reasonable terms. All of these activities will require us to raise sufficient funds to finance business activities. We do not expect any
milestone payments from our collaborative partners to be significant in the foreseeable future. In addition, we do not anticipate generating revenue from commercializing product candidates for the foreseeable future, if ever. Our ability to generate
future revenues from commercializing product candidates depends heavily on our success in:
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establishing proof of concept in preclinical studies and clinical trials for our product candidates;
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successfully initiating and completing clinical trials of our product candidates;
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obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials;
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maintaining, protecting and expanding our intellectual property portfolio, and avoiding infringing on intellectual property of third parties;
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establishing and maintaining successful licenses, collaborations and alliances with third parties;
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developing a sustainable, scalable, reproducible and transferable manufacturing process for our product candidates;
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establishing and maintaining supply and manufacturing relationships with third parties that can provide products and services adequate, in amount and quality, to support clinical development and commercialization of our
product candidates, if approved;
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launching and commercializing any product candidates for which we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing a sales, marketing and
distribution infrastructure;
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obtaining market acceptance of any product candidates that receive regulatory approval as viable treatment options;
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obtaining favorable coverage and reimbursement rates for our products from third-party payers;
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addressing any competing technological and market developments;
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identifying and validating new product candidates; and
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negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter.
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Even if one or more of our product candidates is approved for commercial sale, we may incur significant costs associated with commercializing any approved
product candidate. As one example, our expenses could increase beyond expectations if we are required by the Food and Drug Administration, or FDA, or other regulatory agencies, domestic or foreign, to perform clinical and other studies in addition
to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations, which could have an adverse effect
on our business, financial condition, results of operations and prospects.
The Company is currently conducting clinical trials of two experimental
therapies. Failure of one or both of these therapies to show benefit to patients could materially affect the continuity of our business and our financial condition.
The Companys lead programs include
GDC-0084,
a small molecule inhibitor of the PI3K/Akt/mTor pathway, and
Cantrixil
(TRX-E-002-1),
a small molecule agent with activity against tumor-initiating cells. The PI3K/Akt/mTor pathway has been
clinically validated as a target for oncology therapies, but some clinical trials have nevertheless failed to meet expectations. Cantrixil has an uncertain mechanism of action, and so the likelihood of success cannot easily be assessed in reference
to other drug development candidates. It is possible that either or both agents may fail to show sufficient benefit as a treatment for cancer to become commercially-viable products.
6
The Company has ongoing clinical trials in which experimental therapies are administered to human subjects.
If profound and unexpected safety concerns are encountered in clinical trials, it may materially affect the continuity of our business and our financial condition.
Despite all applicable efforts to characterise the safety profile of our drug development candidates through animal studies and other mechanisms, the
possibility of unexpected safety concerns remains. If one or both of our clinical stage candidates were found to be associated with profound and unexpected toxicity, Novogen may be required to cease development, and may additionally incur other
impairments to the business including reputational damage.
The Companys ability to continue as a going concern is dependent on its ability to
raise capital to support its R&D programs.
The Company has limited cash resources and will periodically need additional funds to maintain the
planned level of R&D activity. We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates. The impact on cash resources and results from operations will vary
with the extent and timing of future clinical trial programs. While it is not possible to make accurate predictions of future operating results, we expect existing cash and cash equivalents will be sufficient to enable us to continue our research
and development activities until approximately second quarter 2018.
As at 30 June 2017 the consolidated entity had cash in hand and at bank of
$14,454,784. The financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business. As is often the case with
drug development companies, the ability of the consolidated entity to continue its development activities as a going concern is dependent upon it deriving sufficient cash from investors, from licensing and partnering activities and from other
sources of revenue such as grant funding. The directors have considered the cash flow forecasts and the funding requirements of the business and are confident that the strategies in place are appropriate to generate sufficient funding to allow the
consolidated entity to continue as a going concern. Accordingly the directors have prepared the financial statements on a going concern basis. Should the above assumptions not prove to be appropriate, there is material uncertainty whether the
consolidated entity will continue as a going concern and therefore whether it will realise its assets and extinguish its liabilities in the normal course of business and at the amounts stated in these financial statements.
If the Company is unable to obtain additional funds on favorable terms or at all, it may be required to cease or reduce its operations. Also, if the Company
raises more funds by selling additional securities, the ownership interests of holders of its securities will be diluted.
We receive Australian
government research and development grants. If we lose funding from these research and development grants, we may encounter difficulties in the funding of future research and development projects, which could harm our operating results.
We have historically received, and expect to continue to receive, grants through the Australian federal governments Research and Development Tax
Incentive program (R&D tax rebate), under which the government provides a cash refund for a percentage of eligible research and development expenditures by small Australian entities, which are defined as Australian entities with less
than A$20 million in revenue, having a tax loss. The R&D tax rebate rate changed from 45% to 43.5% in July 2016. The R&D tax rebate is made by the Australian federal government for eligible research and development purposes based on the
filing of an annual application. We received R&D tax rebates in fiscal 2016 and 2017 of A$2.9 million and A$4.4 million, respectively. In fiscal 2017, the group has estimated the rebate which will be received in early 2018 and has
accrued that amount of A$4 million as income in the statement of profit or loss and other comprehensive income. This rebate is available for our research and development activities in Australia, as well as activities in the United States to the
extent such U.S. based expenses relate to our activities in Australia, do not exceed 50% of the expenses for the relevant activities and are approved by the Australian government. To the extent our research and development expenditures are deemed to
be ineligible, then our rebates would decrease. In addition, the Australian government may in the future decide to modify the requirements of, reduce the amounts of the rebates available under, or discontinue the R&D tax rebate
program. For instance, the Australian government is considering a recommendation from a review panel for a cap in the amount of the rebate available to small entities such as Novogen at a maximum of A$2 million per annum. Any such change in the
R&D tax rebate could have a material adverse effect on our future cash flows and financial position.
7
The Company is at an early stage of drug development and is in the process of applying for patents over
composition and matter and use for both of its drug technology platforms. There is no certainty that patent protection will be granted, or maintained in the event of challenge by an external party.
The Company has an extensive patent portfolio to protect its key assets. The patent strategy is adapted for each technology platform and the
sub-sections
of each platform. The over-arching strategy in the IP portfolio is to cover the three critical corner stones of pharmaceutical patent: composition of matter (the breadth structures covered in the
patent), method of manufacture (the chemical processes used to manufacture the compounds disclosed in the patent) and method of use. Our key patents covering lead assets have been granted in Australia and are at different stages of entering national
phase in jurisdictions covering ~95% of the global market as measured by sales. Consequently, the risk to our patent coverage for our lead assets has been substantially reduced. While the Companys patent strategy is closely supervised by
experienced patent attorneys and every effort made to ensure the likely success of achieving approval of patent claims in all major territories, there is no guarantee that any or all territories will grant such claims.
Negative global economic conditions may pose challenges to the Companys business strategy, which relies on access to capital from the markets or
collaborators. Failure to obtain sufficient funding on acceptable terms could have a material adverse effect on our business, results of operations and financial condition.
Negative conditions in the global economy, including credit markets and the financial services industry, have generally made equity and debt financing more
difficult to obtain, and may negatively impact the Companys ability to complete financing transactions. The duration and severity of these conditions is uncertain, as is the extent to which they may adversely affect the Companys business
and the business of current and prospective vendors and collaborators. If negative global economic conditions persist or worsen, the Company may be unable to secure additional funding to sustain its operations or to find suitable collaborators to
advance its internal programs, even if positive results are achieved from research and development efforts.
If we are unable to raise sufficient funding
on acceptable terms, we may be unable to continue to operate. There is no assurance that we will be successful in obtaining sufficient financing on acceptable terms and conditions to fund continuing operations, if at all. Our failure to obtain
sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations and financial condition.
Final approval by regulatory authorities of the Companys drug candidates for commercial use may be delayed, limited or prevented, any of which
would adversely affect its ability to generate operating revenues.
The Company will not generate any operating revenue until it, or its
subsidiaries, successfully commercializes one of its drug candidates. Currently, the Companys drug candidates are at an early stage of development, and each will need to successfully proceed through a number of steps in order to obtain
regulatory approval before potential commercialization.
8
Even if the Company receives regulatory approval to commercialize its drug candidates, the ability to
generate revenues from any resulting products will be subject to a variety of risks, many of which are out of the Companys control.
Regardless of regulatory approval, products arising from the development process may not gain market acceptance among physicians, patients, healthcare payers
or the medical community. The Company believes that the degree of market acceptance and its ability to generate revenues from such products will depend on a number of factors, including, but not limited to:
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advancements in the treatment of cancer that make our treatments obsolete;
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market exclusivity and competitor products;
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timing of market introduction of the Companys drugs and competitive drugs;
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actual and perceived efficacy and safety of the Companys drug candidates;
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prevalence and severity of any side effects;
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potential or perceived advantages or disadvantages over alternative treatments;
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strength of sales, marketing and distribution support;
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price of future products, both in absolute terms and relative to alternative treatments;
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the effect of current and future healthcare laws on the Companys drug candidates; and
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availability of coverage and reimbursement from government and other third-party payers.
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If any of the
Companys drugs are approved and fail to achieve market acceptance, the Company may not be able to generate significant revenue to achieve or sustain profitability.
The Company may not be able to establish the contractual arrangements necessary to develop, market and distribute the product candidates. Our failure to
do so may adversely affect our business, results of operations and financial condition.
The Company has been successful in executing contractual
agreements with strategic partners. This remains a key part of the Companys business plan and the Company must continue to partner with third parties to manufacture clinical grade drug product, and conduct key
pre-clinical
and clinical investigations. Strategic agreements around packaging, branding, market access and distribution for its drug products will also eventually be required.
Potential partners could be discouraged by the Companys limited operating history.
There is no assurance that the Company will be able to negotiate commercially acceptable licensing or other agreements for the future exploitation of its drug
product candidates including continued clinical development, manufacture or marketing. If the Company is unable to successfully contract for these services, or if arrangements for these services are terminated, the Company may have to delay the
commercialization program which will adversely affect its ability to generate operating revenues.
The Companys commercial opportunity will be
reduced or eliminated if competitors develop and market products that are more effective, have fewer side effects or are less expensive than its drug candidates.
The development of drug candidates is highly competitive and is high risk. A number of other companies have products or drug candidates in various stages of
pre-clinical
or clinical development that are intended for the same therapeutic indications for which the Companys drug candidates are being developed. Some of these potential competing drugs are further
advanced in development than the Companys drug candidates and may be commercialized sooner. Even if the Company is successful in developing effective drugs, its compounds may not compete successfully with products produced by its competitors.
9
The Companys competitors include pharmaceutical companies and biotechnology companies, as well as
universities and public and private research institutions. In addition, companies active in different but related fields represent substantial competition. Many of the Companys competitors developing oncology drugs have significantly greater
capital resources, larger R&D staff and facilities and greater experience in drug development, regulation, manufacturing and marketing. These organizations also compete with the Company and its service providers, to recruit qualified personnel,
and to attract partners for joint ventures and to license technologies. As a result, the Companys competitors may be able to more easily develop technologies and products that would render the Companys technologies or its drug candidates
obsolete or
non-competitive.
The Company relies on third parties to conduct its
pre-clinical
studies. If those parties do not successfully carry out their contractual duties or meet expected deadlines, the Companys drug candidates may not advance in a timely manner or at all.
In the course of discovery,
pre-clinical
testing and clinical trials, the Company relies on third parties, including
laboratories, investigators, clinical contract research organizations (CROs), and manufacturers, to perform critical services. For example, the Company relies on third parties to conduct all of its
pre-clinical
and clinical studies. These third parties may not be available when the Company needs them or, if they are available, may not comply with all regulatory and contractual requirements or may not
otherwise perform their services in a timely or acceptable manner, and the Company may need to enter into new arrangements with alternative third parties and the studies may be extended, delayed or terminated. These independent third parties may
also have relationships with other commercial entities, some of which may compete with the Company. As a result of the Companys dependence on third parties, it may face delays or failures outside of its direct control. These risks also apply
to the development activities of collaborators, and the Company does not control their research and development, clinical trial or regulatory activities.
The Company has no direct control over the cost of manufacturing its drug candidates. Increases in the cost of manufacturing the Companys drug
candidates would increase the costs of conducting clinical trials and could adversely affect future profitability.
The Company does not intend to
manufacture the drug product candidates
in-house,
and it will rely on third parties for drug supplies both for clinical trials and for commercial quantities in the future. The Company has taken the strategic
decision not to manufacture active pharmaceutical ingredients (API) for the drug candidates, as these can be more economically supplied by third parties with particular expertise in this area. The Company outsources the manufacture of
its drug product and testing of it to FDA requirements. The Company uses contract facilities that are registered with the FDA, have a track record of large scale API manufacture, and have already invested in capital and equipment. The Company has no
direct control over the cost of manufacturing its product candidates. If the cost of manufacturing increases, or if the cost of the materials used increases, these costs may be passed on, making the cost of conducting clinical trials more expensive.
Increases in manufacturing costs could adversely affect the Companys future profitability if it was unable to pass all of the increased costs along to its customers.
The Company may face a risk of product liability claims and may not be able to obtain adequate insurance.
The Companys business exposes it to the risk of product liability claims. This risk is inherent in the manufacturing, testing and marketing of human
therapeutic products. The Company has product liability insurance. The coverage is subject to deductibles and coverage limitations. The Company is in the process of identifying lead candidate compounds. When identified, and INDs are obtained they
will be taken into the clinic. The Company may not be able to obtain or maintain adequate protection against potential liabilities, or claims may exceed the insurance limits. If the Company cannot or does not sufficiently insure against potential
product liability claims, it may be exposed to significant liabilities, which may materially and adversely affect our business, results of operations and financial condition.
10
Enforceability of civil liabilities under the federal securities laws against the Company or the
Companys officers and directors may be difficult.
The Company is a public company limited by shares and is registered and operates under
the Australian Corporations Act 2001. Some of the Companys directors and officers reside outside of the United States. In addition, a substantial portion of the directly owned assets of the Company are located outside of the United States. As
a result, it may be difficult or impossible for investors to effect service of process within the United States against the Company or its directors and officers or to enforce against them any of the judgments, including those obtained in original
actions or in actions to enforce judgments of the U.S. courts, predicated upon the civil liability provisions of the federal or state securities laws of the United States. There is doubt as to the enforceability in the Commonwealth of Australia, in
original actions or in actions for enforcement of judgments of U.S. courts, of civil liabilities predicated solely upon federal or state securities laws of the U.S., especially in the case of enforcement of judgments of U.S. courts where the
defendant has not been properly served in Australia.
The trading price of the Companys ordinary shares and American Depositary Shares
(ADSs) is highly volatile. Your investment could decline in value and the Company may incur significant costs from class action litigation and its securities may be delisted from NASDAQ.
The trading price of the Companys ordinary shares and ADSs is highly volatile in response to various factors, many of which are beyond the
Companys control, including:
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unacceptable toxicity findings in animals and humans;
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lack of efficacy in human trials at Phase II stage or beyond;
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announcements of technological innovations by the Company and its competitors;
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new products introduced or announced by the Company or its competitors;
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changes in financial estimates by securities analysts;
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actual or anticipated variations in operating results;
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expiration or termination of licenses, research contracts or other collaboration agreements;
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conditions or trends in the regulatory climate in the biotechnology, pharmaceutical and genomics industries;
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changes in the market values of similar companies;
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the liquidity of any market for the Companys securities; and
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additional sales by the Company of its shares.
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In addition, equity markets in general and the market for
biotechnology and life sciences companies in particular, have experienced substantial price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the companies traded in those markets. Further
changes in economic conditions in Australia, the U.S., EU, or globally, could impact the Companys ability to grow profitably. Adverse economic changes are outside the Companys control and may result in material adverse effects on the
Companys business or results of operations. These broad market and industry factors may materially affect the market price of the Companys ordinary shares and ADSs regardless of its development and operating performance. In the past,
following periods of volatility in the market price of a companys securities, securities class action litigation has often been instituted against that company. Such litigation, if instituted against the Company, could cause it to incur
substantial costs and divert managements attention and resources.
If the market price of the Companys ADSs remains below US$5.00 per share,
under stock exchange rules, the Companys stockholders will not be able to use such ADSs as collateral for borrowing in margin accounts. This inability to use ADSs as collateral may depress demand as certain institutional investors are
restricted from investing in securities priced below US$5.00 and may lead to sales of such ADSs, creating downward pressure on and increased volatility in the market price of the Companys ordinary shares and ADSs.
11
In addition, under NASDAQ rules, companies listed on the NASDAQ Capital Market are required to maintain a share
price of at least US$1.00 per share and if the share price declines below US$1.00 for a period of 30 consecutive business days, then that listed company would have 180 days to regain compliance with the US$1.00 per share minimum. In the event that
the Companys share price declines below US$1.00, it may be required to take action, such as a reverse stock split, in order to comply with the NASDAQ rules that may be in effect at the time.
You are reliant on the depositary to exercise your voting rights and to receive distributions on ADSs and, as a result, you may be unable to exercise
your voting rights on a timely basis or you may not receive certain distributions.
In certain circumstances, holders of ADSs may have limited
rights relative to holders of ordinary shares. The rights of holders of ADSs with respect to the voting of ordinary shares and the right to receive certain distributions may be limited in certain respects by the deposit agreement entered into by us
and The Bank of New York Mellon. For example, although ADS holders are entitled under the deposit agreement, subject to any applicable provisions of Australian law and of our Constitution, to instruct the depositary as to the exercise of the voting
rights pertaining to the ordinary shares represented by the ADSs, and the depositary has agreed that it will try, as far as practical, to vote the ordinary shares so represented in accordance with such instructions, ADS holders may not receive
notices sent by the depositary in time to ensure that the depositary will vote the ordinary shares. This means that, from a practical point of view, the holders of ADSs may not be able to exercise their right to vote. In addition, under the deposit
agreement, the depositary has the right to restrict distributions to holders of the ADSs in the event that it is unlawful or impractical to make such distributions. We have no obligation to take any action to permit distributions to holders of our
ADSs. As a result, holders of ADSs may not receive distributions.
There is a substantial risk that we are, or will become, a passive foreign
investment company, or PFIC, which will subject our U.S. investors to adverse tax rules
Holders of our ADSs who are U.S. residents face income
tax risks. There is a substantial risk that we are, or will become, a passive foreign investment company, commonly referred to as a PFIC. Our treatment as a PFIC could result in a reduction in the
after-tax
return to the holders of our ADSs and would likely cause a reduction in the value of such ADSs. For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which either (i) 75% or more of our gross income is passive
income, or (ii) at least 50% of the average value of all of our assets for the taxable year produce or are held for the production of passive income. For this purpose, cash is considered to be an asset that produces passive income. We believe
that there is a risk we will be classified as a PFIC for the taxable year ended June 30, 2017. If we are classified as a PFIC for U.S. federal income tax purposes, highly complex rules will apply to U.S. holders owning ADSs. Accordingly, you
are urged to consult your tax advisors regarding the application of such rules. See Item 10 - Additional Information - Taxation, United States Federal Income Tax Consequences for a more complete discussion of the U.S. federal income tax risks
related to owning and disposing of our ADSs.
Item 4.
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Information on the Company
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A. History and development of the Company
Novogen Limited, a public company limited by shares, was incorporated in March 1994 under the laws of New South Wales, Australia. Novogen is registered and
operates under the Australian Corporations Act 2001. Novogen has its registered office at Level 5, 20 George Street, Hornsby, New South Wales NSW 2077, Australia. Its telephone number and other contact details are: Phone
+61-2-9472
4100; Fax
+61-2-9476-0388;
and website,
www.novogen.com
(the information
contained in the website does not form part of the Annual Report). The Companys Ordinary Shares are listed on the Australian Securities Exchange (ASX) under the symbol NRT and its ADSs, each representing one hundred
Ordinary Shares, trade on the NASDAQ Capital Market under the symbol NVGN. The Depositary for the Companys ADSs is The Bank of New York Mellon, 101 Barclay Street 22W New York, N.Y. 10286.
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B. Business overview
Since its inception in 1994, the principal business of the Company has been pharmaceutical drug development. The Company is an emerging oncology-focused
biotechnology company that has a portfolio of development candidates, diversified across several distinct technologies, with the potential to yield
first-in-class
and
best-
in-class
agents in a range of oncology indications. The lead program is
GDC-0084,
a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being
developed to treat glioblastoma multiforme (GBM) the most common malignant and highly aggressive form of primary brain tumor in adults. Cantrixil
(TRX-E-002-1)
is the companys second clinical asset and is being developed as a potential therapy for ovarian cancer. In
addition, the company has several preclinical programs in active development, the largest of which is substantially funded by a
CRC-P
grant from the Australian Federal Government.
Research and Development
The Companys lead
development candidate is
GDC-0084,
a small molecule inhibitor of the PI3K / Akt / mTor pathway that is being developed as a potential therapy for glioblastoma multiforme (GBM), the most common malignant and
highly aggressive form of primary brain tumor in adults.
GDC-0084
was developed by Genentech, Inc (South San Francisco, California) and the Company entered into a worldwide exclusive license for the asset in
October 2016. Prior to this transaction, Genentech had completed an extensive preclinical development program that provided convincing validation for
GDC-0084
as a potential drug for brain cancer. Genentech
also completed a phase I clinical trial in 47 patients with advanced grade III and grade IV glioma. The most common adverse events were oral mucositis and hyperglycemia. Per RANO criteria, 40% of patients exhibited a best observable response of
stable disease, and 26% demonstrated a metabolic partial response on
FDG-PET.
Since completing the license transaction, the Company has transferred all relevant data from Genentech, has assumed responsibility
for prosecuting the intellectual property associated with the asset, and has taken over the open Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA). The Company intends to commence a phase II
clinical trial in GBM during calendar 2017, and has been in consultation with expert neuro-oncologists in the United States to develop an appropriate study design. The Company has also commenced manufacture of capsules for use in the clinical trial,
having received 48.8kg of drug substance as part of the transaction with Genentech.
Cantrixil
(TRX-E-002-1)
is the Companys second clinical asset, and is derived from a proprietary drug discovery program. It is being developed as a potential therapy for
ovarian cancer. Research undertaken by Yale University (New Haven, Connecticut) has provided preclinical evidence that Cantrixil is active against both differentiated cancer cells and tumour-initiating cells (sometimes referred to as cancer
stem cells). The latter are thought to be an important component of chemotherapy resistance and disease recurrence in diseases such as ovarian cancer, and thus Cantrixil has potential to offer benefit to the approximately three-quarters of
ovarian cancer patients who are not adequately managed by conventional chemotherapy treatments. In December 2016, the Company commenced a phase I clinical trial of Cantrixil in patients with ovarian cancer. The study will seek to establish the
safety and tolerability of the development candidate, to determine a Maximum Tolerated Dose (MTD), and to explore indicative signals of clinical efficacy. Five trials sites in the United States and Australia are currently recruiting to the study,
and the Company anticipates being in a position to disclose initial data in late 2017 or early 2018, subject to ongoing progress of the trial. The Company maintains two active preclinical programs. Trilexium
(TRX-E-009-1)
is chemically related to Cantrixil and has shown in vitro and in vivo evidence of activity against a range of cancer cell lines and tumor models. The
Company continues to explore a range of opportunities to realize value from this asset in the context of emerging data from the Cantrixil program.
In
February 2017, the Company announced that it had been successfully awarded a
CRC-P
grant by the Australian Federal Government in the amount of A$3 million over three years to support an additional
preclinical program focused on development of a next-generation anti-tropomyosin agent. Under the conditions of the grant, Novogen has committed to contributing $1 million over the three-year life of the project, and University of
New South Wales (UNSW) will contribute up to $300,000, in addition to the $3 million provided by Department of Industry, Innovation and Science(DIIS) under the terms of the grant. In addition, the
three parties will provide manpower and other
in-kind
resources to the project. A significant body of research has
validated tropomyosin as a potential anti-cancer target, and the Company will devote the grant funds to exploring novel approaches to developing anti-cancer agents based on this mechanism.
13
In April 2017, the Company announced termination of its
pre-IND
development candidate, Anisina
(ATM-3507),
on the basis of unpromising emergent preclinical data.
Patent
Protection
The Company has an aggressive global Intellectual Property (IP) strategy to protect its key assets and we have partnered
with a global patent law firm to lodge patents that offer the best possible protection for our assets. The patent strategy is adapted for each technology platform and the principle mode of protection is through the patenting procedure, seeking to
obtain exclusive licenses for all its key inventions and drug pipeline. The over-arching strategy in the IP portfolio is to cover the three critical corner stones of pharmaceutical patent: composition of matter (the breadth structures covered in the
patent), method of manufacture (the chemical processes used to manufacture the compounds disclosed in the patent) and method of use. Patents are submitted initially as provisional applications and after 12 months progress through to a Patent
Cooperation Treaty (PCT) application.
Drug discovery/development efforts are contributing to our pipeline with our other technology platforms
also delivering hit and lead drug candidates. As the research programs reveal new hit molecules, these are protected through lodging patents. The Company will continue to pursue a broad patent filing strategy based on multiple jurisdictions with a
focus on those member countries offering the most significant market opportunities for future development.
Regulatory requirements
Australian Regulatory Requirements
The
Therapeutic
Goods
Act 1989 (
1989 Act), sets out the legal requirements for the import, export, manufacture and supply of pharmaceutical products in Australia. The 1989 Act requires that all pharmaceutical products to
be imported into, supplied in, manufactured in or exported from Australia be included in the Australian Register of Therapeutic Goods (ARTG), unless specifically exempted under the Act.
Medicines with a higher level of risk (prescription medicines, some
non-prescription
medicines) are evaluated for
quality, safety and efficacy and are registered on the ARTG. Medicines with a lower risk (many over the counter medicines including vitamins) are assessed only for quality and safety. Medicines included in the ARTG can be identified by the AUST R
number (for registered medicines) or an AUST L number (for listed medicines) which appears on the packaging of the medicine.
In order to ensure that a
product can be included in the ARTG, a sponsoring company must make an application to the Therapeutic Goods Administration (TGA). The application usually consists of a form accompanied by data (based on the EU requirements) to support
the quality, safety and efficacy of the product for its intended use and payment of a fee. Application details are available on the TGA website
www.tga.gov.au
.
The first phase of evaluation, known as the Application Entry Process, is usually a short period during which an application is assessed at an administrative
level to ensure that it complies with the basic guidelines. The TGA may request further details from the applicant, and may agree with sponsors that additional data (which while not actually required by the application, could enhance the assessment
outcome) may be submitted later at an agreed time. The TGA must decide within at least 40 working days whether it will accept the application for evaluation.
14
Once an application is accepted for evaluation, aspects of the data provided are allocated to evaluators within
the different relevant sections, who prepare clinical evaluation reports. Following evaluation, the chemistry, quality control bioavailability and pharmacokinetics aspects of a product may be referred to a Pharmaceutical
Sub-Committee
(PSC), which is a
sub-committee
of the TGA prescription medicine expert advisory committee, the Advisory Committee on Prescriptive Medicines
(ACPM) to review the relevant clinical evaluation reports.
The clinical evaluation reports (along with any resolutions of the ACPM
sub-committee)
are then sent to the sponsoring company who then has the opportunity to comment on the views expressed within the evaluation report, provide corrections and to submit supplementary data to address any
issues raised in the evaluation reports.
Once the evaluations are complete, the TGA prepares a summary document on the key issues on which advice will be
sought from either the ACPM (for new medicines) or from the Peer Review Committee (PRC) for extensions to products which are already registered. This summary is sent to the sponsoring company, which is able to submit a response to the
ACPM or PRC dealing with issues raised in the summary and those not previously addressed in the evaluation report. The ACPM/PRC provide independent advice on the quality, risk-benefit, effectiveness and access of the product and conduct medical and
scientific evaluations of the application. The ACPM meets every two months to examine the applications referred by the TGA and its resolutions are provided to the sponsoring company after five working days after the ACPM meeting.
The TGA takes into account the advice of the ACPM or PRC in reaching a decision to approve or reject a product. Any approval for registration on the ARTG may
have conditions associated with it.
From the time that the TGA accepts the initial application for evaluation, the TGA must complete the evaluation and
make a decision on the registration of the product within at least 255 working days. If not completed within 255 working days, the TGA forfeits 25% of the evaluation fee otherwise payable by the sponsor, but any time spent waiting for a response
from the sponsor is not included in the 255 working days. The TGA also has a system of priority evaluation for products that meet certain criteria, including where the product is a new chemical entity that it is not otherwise available on the market
as an approved product, and is for the treatment of a serious, life-threatening illness for which other therapies are either ineffective or not available.
U.S. Regulatory Requirements
The FDA regulates and
imposes substantial requirements upon the research, development,
pre-clinical
and clinical testing, labelling, manufacture, quality control, storage, approval, advertising, promotion, marketing, distribution,
import and export of pharmaceutical products including drugs and biologics, as well as significant reporting and record-keeping obligations. State governments may also impose obligations in these areas.
In the U.S., pharmaceutical products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (FDCA), and other laws in the case of
biologics, the Public Health Service Act and other acts that implement regulations. The Company believes that the FDA will regulate its products as drugs. The process required by the FDA before drugs may be marketed in the U.S. generally involves
the following:
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pre-clinical
laboratory evaluations, including formulation and stability testing, and animal tests performed under the FDAs Good Laboratory Practices regulations to assess
pharmacological activity and toxicity potential;
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submission and approval of an IND Application, including results of
pre-clinical
studies, clinical experience, manufacturing information, and protocols for clinical tests, which
must become effective before clinical trials may begin in the U.S.;
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obtaining approval of Institutional Review Boards (IRBs), to administer the products to human subjects in clinical trials;
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adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for the products intended use;
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development of manufacturing processes which conform to FDA current Good Manufacturing Practices (cGMPs), as confirmed by FDA inspection;
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submission of results for
pre-clinical
and clinical studies, and chemistry, manufacture and control information on the product to the FDA in a New Drug Approval (NDA)
Application; and
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FDA review and approval of an NDA, prior to any commercial sale, promotion or shipment of a product.
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The
testing and approval process requires substantial time, effort, and financial resources, and the Company cannot be certain that any approval will be granted on a timely basis, if at all.
The results of the
pre-clinical
studies, clinical experience together with initial specified manufacturing
information, the proposed clinical trial protocol, and information about the participating investigators are submitted to the FDA as part of an IND, which must become effective before the Company may begin human clinical trials in the U.S.
Additionally, an independent IRB must review and approve each study protocol and oversee conduct of the trial. An IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the
30-day
period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. If the FDA imposes a clinical hold, the IND sponsor must resolve the FDAs concerns before clinical trials can begin.
Pre-clinical
tests and studies can take several years to complete, and there is no guarantee that an IND submitted, based on such tests and studies, will become effective within any specific time period, if at all.
Human clinical trials are typically conducted in three sequential phases that may overlap, which are:
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Phase I:
The drug is initially introduced into healthy human subjects or patients and tested for safety and dosage tolerance. For oncology medicines, patients with the target disease are used rather than healthy
patients. Absorption, metabolism, distribution, and excretion testing, among other tests, are generally performed at this stage. These studies may also provide early evidence of effectiveness. The maximum tolerated dose of the drug may be calculated
from Phase I studies;
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Phase II:
The drug is studied in controlled, exploratory therapeutic trials in a limited number of subjects with the disease or medical condition for which the new drug is intended to be used in order to identify
possible adverse effects and safety risks, to determine the preliminary or potential efficacy of the product for specific targeted diseases or medical conditions, and to determine dosage tolerance and the optimal effective dose; and
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Phase III:
When Phase II studies demonstrate that a specific dosage range of the drug is likely to be effective and the drug has an acceptable safety profile, controlled, large-scale therapeutic Phase III trials
are undertaken at multiple study sites to demonstrate clinical efficacy and to further test for safety in an expanded patient population. These studies are used to evaluate the overall benefit risk relationship of the drug and provide a basis
for physician labelling.
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The Company cannot be certain that it will successfully complete Phase I, Phase II or Phase III testing of its
products within any specific time period, if at all. Furthermore, the FDA, the IRB or the Company may suspend or terminate clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an
unacceptable health risk.
Results of
pre-clinical
studies and clinical trials, as well as detailed information
about the manufacturing process, quality control methods, and product composition, among other things, are submitted to the FDA as part of an NDA seeking approval to market and commercially distribute the product on the basis of a determination that
the product is safe and effective for its intended use. Before approving an NDA, the FDA will inspect the facilities at which the product is manufactured and will not approve the product unless GMP compliance is satisfactory. If applicable
regulatory criteria are not satisfied, the FDA may deny the NDA or require additional testing or information. As a condition of approval, the FDA also may require post-marketing testing or surveillance to monitor the products safety or
efficacy. Even after an NDA is approved, the FDA may impose additional obligations or restrictions (such as labelling changes), or even suspend or withdraw a product approval on the basis of data that arise after the product reaches the market, or
if compliance with regulatory standards is not maintained. The Company cannot be certain that the FDA on a timely basis, if at all will approve any NDA it submits. Also, any such approval may limit the indicated uses for which the product may be
marketed. Any refusal to approve, delay in approval, suspension or withdrawal of approval, or restrictions on indicated uses could have a material adverse impact on the Companys business prospects.
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A user fee, pursuant to the requirements of the Prescription Drug User Fee Act (PDUFA), and its
amendments, must accompany each NDA. According to the FDAs fee schedule, effective on October 1, 2015, for the fiscal year 2017, the user fee for an application requiring clinical data, such as an NDA, is US$2,038,100. The FDA adjusts the
PDUFA user fees on an annual basis. PDUFA also imposes an annual product fee for prescription drugs and biologics (US$97,750), and an annual establishment fee (US$512,200) on facilities used to manufacture prescription drugs and biologics. A written
request can be submitted for a waiver under certain circumstances. Waivers may be possible for the application fee for the first human drug application that is filed by a small business, as defined by the FDCA, but there are no small business
waivers for product or establishment fees. Waivers may also be possible for one or more fees, upon written request, when a waiver or reduction is necessary to protect the public health, the user fees would present a significant barrier to
innovation, or the fees are anticipated to exceed the present or future costs incurred by FDA. The Company is not at the stage of development with its products where it is subject to these fees, but they are significant expenditures that may be
incurred in the future and must be paid at the time of application submissions to FDA.
Satisfaction of FDA requirements typically takes several years.
The actual time required varies substantially, based upon the type, complexity, and novelty of the pharmaceutical product, among other things. Government regulation imposes costly and time-consuming requirements and restrictions throughout the
product life cycle and may delay product marketing for a considerable period of time, limit product marketing, or prevent marketing altogether. Success in
pre-clinical
or early stage clinical trials does not
ensure success in later stage clinical trials. Data obtained from
pre-clinical
and clinical activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit, or
prevent marketing approval. Even if a product receives marketing approval, the approval is limited to specific clinical indications. Further, even after marketing approval is obtained, the discovery of previously unknown problems with a product may
result in restrictions on the product or even complete withdrawal of the product from the market.
After product approval, there are continuing
significant regulatory requirements imposed by the FDA, including record-keeping requirements, obligations to report adverse events in patients using the products, and restrictions on advertising and promotional activities. Quality control and
manufacturing procedures must continue to conform to GMPs, and the FDA periodically inspects facilities to assess GMP compliance. Additionally, post-approval changes in ingredient composition, manufacturing processes or facilities, product
labelling, or other areas may require submission of a NDA Supplement to the FDA for review and approval. New indications will require additional clinical studies and submission of a NDA Supplement. Failure to comply with FDA regulatory requirements
may result in an enforcement action by the FDA, including warning letters, product recalls, suspension or revocation of product approval, seizure of product to prevent distribution, impositions of injunctions prohibiting product manufacture or
distribution, and civil and criminal penalties. Maintaining compliance is costly and time-consuming. The Company cannot be certain that it, or its present or future suppliers or third-party manufacturers, will be able to comply with all FDA
regulatory requirements, and potential consequences of
non-compliance
could have a material adverse impact on its business prospects.
The FDAs policies may change, and additional governmental regulations may be enacted that could delay, limit, or prevent regulatory approval of the
Companys products or affect its ability to manufacture, market, or distribute its products after approval. Moreover, increased attention to the containment of healthcare costs in the U.S. and in foreign markets could result in new government
regulations that could have a material adverse effect on the business. The Companys failure to obtain coverage, an adequate level of reimbursement, or acceptable prices for future products could diminish any revenues the Company may be able to
generate. The Companys ability to commercialize future products will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health
insurers, and other third-party payers. EU member states and U.S. government and other third-party payers increasingly are attempting to contain healthcare costs by consideration of new laws and regulations limiting both coverage and the level of
reimbursement for new drugs. The Company cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.
17
The Companys activities may also be subject to state laws and regulations that affect its ability to
develop and sell products. The Company is also subject to numerous federal, state, and local laws relating to such matters as safe working conditions, clinical, laboratory, and manufacturing practices, environmental protection, fire hazard control,
and disposal of hazardous or potentially hazardous substances. The Company may incur significant costs to comply with such laws and regulations now or in the future, and the failure to comply may have a material adverse impact on the Company.
The FDCA includes provisions designed to facilitate the development and expedite the review of drugs and biological products intended for treatment of serious
or life-threatening conditions that demonstrate the potential to address unmet medical needs for such conditions. These provisions set forth a procedure for designation of a drug as a fast track product. The fast track designation
applies to the combination of the product and specific indication for which it is being studied. A product designated as fast track is ordinarily eligible for additional programs for expediting development and review, but products that are not in
fast-track drug development programs may also be able to take advantage of these programs if they meet the necessary requirements. These programs include priority review of NDAs and accelerated approval. Drug approval under the accelerated approval
regulations may be based on evidence of clinical effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. A post-marketing clinical study will be required to verify clinical benefit, and other restrictions to assure safe
use may be imposed.
Under the Drug Price Competition and Patent Term Restoration Act of 1984, a sponsor may obtain marketing exclusivity for a period of
time following FDA approval of certain drug applications, regardless of patent status, if the drug is a new chemical entity or if new clinical studies were required to support the marketing application for the drug. This marketing exclusivity
prevents a third party from obtaining FDA approval for an identical or nearly identical drug under an Abbreviated New Drug Application or a 505(b)(2) New Drug Application. The statute also allows a patent owner to obtain an extension of
applicable patent terms for a period equal to one-half the period of time elapsed between the filing of an IND and the filing of the corresponding NDA plus the period of time between the filing of the NDA and FDA approval, with reductions taken for
any time an applicant did not act with due diligence. There is a five-year maximum patent extension and a maximum of 14 years protection from product approval. The Company cannot be certain that it will be able to take advantage of either the patent
term extension or marketing exclusivity provisions of these laws.
The Best Pharmaceuticals for Children Act (BPCA), signed into law on
January 4, 2002, was reauthorized and amended by the FDA Amendments Act of 2007 (FDAAA). The reauthorization of BPCA provides an additional six months of exclusivity to NDA applicants that conduct and file acceptable paediatric
studies of new and currently marketed drug products for which paediatric information would be beneficial, as identified by FDA in a Paediatric Written Request. The Paediatric Research Equity Act (PREA), signed into law on
December 3, 2003, also was reauthorized and amended by FDAAA. The reauthorization of PREA requires that most applications for drugs and biologics include a paediatric assessment (unless waived or deferred) to ensure the drugs and
biologics safety and effectiveness in children. Such paediatric assessment must contain data, gathered using appropriate formulations for each age group for which the assessment is required, that are adequate to assess the safety and
effectiveness of the drug or the biological product for the claimed indications in all relevant paediatric subpopulations, and to support dosing and administration for each paediatric subpopulation for which the drug or the biological product is
safe and effective. The paediatric assessments can only be deferred provided there is a timeline for the completion of such studies. The FDA may partially waive or fully waive the paediatric assessment requirement for several reasons, including if
the applicant can demonstrate that necessary studies are impossible or highly impracticable. The FDA Safety and Innovation Act permanently renewed and strengthened BPCA and PREA.
18
European Union Regulatory Requirements
Outside the U.S., the Companys ability to market its products will also be contingent upon receiving marketing authorizations from the appropriate
regulatory authorities and compliance with applicable post-approval regulatory requirements. Although the specific requirements and restrictions vary from country to country, as a general matter, foreign regulatory systems include risks similar to
those associated with FDA regulation, described above. Under EU regulatory systems, marketing authorizations may be submitted either under a centralized or a national procedure. Under the centralized procedure, a single application to the European
Medicines Agency (EMA) leads to an approval granted by the European Commission that permits the marketing of the product throughout the EU. The centralized procedure is mandatory for certain classes of medicinal products, but optional
for others. For example, all medicinal products developed by certain biotechnological means, and those developed for cancer and other specified diseases and disorders, must be authorized via the centralized procedure. The Company assumes that the
centralized procedure will apply to its products that are developed by means of a biotechnology process. The national procedure is used for products not requiring authorization by the centralized procedure. Under the national procedure, an
application for a marketing authorization is submitted to the competent authority of
one-member
state of the EU. The holders of a national marketing authorization may submit further applications to the
competent authorities of the remaining member states via either the decentralized or mutual recognition procedure. The decentralized procedure enables applicants to submit an identical application to the competent authorities of all member states
where approval is sought at the same time as the first application, while under the mutual recognition procedure, products are authorized initially in
one-member
state, and other member states where approval
is sought are then requested to recognize the original authorization based upon an assessment report prepared by the original authorizing competent authority. Both the decentralized and mutual recognition procedures should take no longer than 90
days, but if
one-member
state makes an objection, which under the legislation can only be based on a possible risk to human health, the application will be automatically referred to the Committee for Medicinal
Products for Human Use (CHMP) of the EMA. If a referral for arbitration is made, the procedure is suspended. However, member states that have already approved the application may, at the request of the applicant, authorize the product in
question without waiting for the result of the arbitration. Such authorizations will be without prejudice to the outcome of the arbitration. For all other concerned member states, the opinion of the CHMP, which is binding, could support or reject
the objection or alternatively could reach a compromise position acceptable to all EU countries concerned. The arbitration procedure may take an additional year before a final decision is reached and may require the delivery of additional data.
As with FDA approval, the Company may not be able to secure regulatory approvals in the EU in a timely manner, if at all. Additionally, as in the U.S.,
post-approval regulatory requirements, such as those regarding product manufacture, marketing, or distribution, would apply to any product that is approved in the EU, and failure to comply with such obligations could have a material adverse effect
on the Companys ability to successfully commercialize any product.
The conduct of clinical trials in the EU is governed by the European Clinical
Trials Directive (2001/20/EC), which was implemented in May 2004. This Directive governs how regulatory bodies in member states control clinical trials. No clinical trial may be started without a clinical trial authorization granted by the national
competent authority and favorable ethics approval.
Accordingly, there is a marked degree of change and uncertainty both in the regulation of clinical
trials and in respect of marketing authorizations that face the Company or its products in the EU.
Stock market listing compliance
On November 7, 2014, NASDAQ notified the Company that it did not comply with Listing Rule 5550(b) (Rule), which requires a minimum $2,500,000
stockholders equity, $35,000,000 market value of listed securities, or $500,000 net income from continuing operations. The Company submitted a plan to regain compliance on December 18, 2014 and January 19, 2015
(Submission). Following the Submission, NASDAQ granted on January 26, 2015 an extension to regain compliance with the Rule. On April 28, 2015, NASDAQ advised the Company that it had regained full compliance with the Rule.
19
On May 30, 2017, NASDAQ notified the Company that for the previous 30 business days the bid price of the
Companys common stock closed below the minimum US$1 per share requirement for continued inclusion on the NASDAQ Capital Market under NASDAQ Rule 5450(a)(1). On July 14, 2017 the Company effected a ratio change on the ADS program from 25
Ordinary Shares representing 1 ADS, to 100 Ordinary Shares representing 1 ADS, and as a consequence the traded price of the Companys common stock increased by a factor of 4, bringing the Company back into compliance with NASDAQ Listing Rule
5450(a)(1).
The Company has met the compliance requirements for ASX listings and accordingly has not been in breach of those requirements.
Product and Corporate Developments during Fiscal 2017
Submission and approval of Investigational New Drug application to FDA
In August 2016, the Company announced an Investigational New Drug (IND) application had been lodged to the United States Food and Drug Administration (FDA) for
Cantrixil
(TRX-E-002-1)
in ovarian cancer. The IND application is the key regulatory filing to initiate clinical trials in the
USA. In September 2016, the Company announced it had received confirmation from the FDA that the application had been successfully opened, and the phase 1 study of Cantrixil in patients with ovarian cancer could proceed as planned.
Inlicensing of
GDC-0084
In October 2016, the Company entered into a worldwide licensing agreement with Genentech, a member of the Roche Group, to develop and commercialise
GDC-0084,
a small molecule inhibitor of the
phosphoinositide-3-kinase
(PI3K) pathway. Under the terms of the agreement, the Company
paid Genentech an upfront payment of US$5 million. In addition the terms of the agreement call for performance-related consideration linked to regulatory and commercial outcomes and royalty payments
in-line
with industry benchmarks.
Acquisition of Glioblast Pty Ltd
In October 2016, the Company acquired 100% of the issued shares of Glioblast Pty Ltd, a privately-held, neuro-oncology-focused Australian biotechnology
company. The transaction included an upfront payment of A$2.1 million, comprising A$600,000 in cash and ordinary fully-paid shares valued at A$1.5 million, with the actual number of shares determined on the basis of the volume-weighted
average price of the Companys shares on the ASX in the seven days prior to this announcement. The shareholders of Glioblast will be eligible for further payments in cash or equity on the achievement of performance related milestones. The first
two of these milestones provide for the issue of ordinary fully-paid shares valued at A$1.25 million respectively on commencement and successful completion of a phase II clinical trial
of GDC-0084, with
the actual number of shares determined on the basis of the volume-weighted average price of the Companys shares on the ASX in the seven days prior to satisfaction of the
relevant milestone being announced. A further two milestones may trigger payments in cash or equity at the Companys sole discretion. Any issue of equity in the Company will be subject to a minimum
six-month
escrow period.
Enrolment of First Patient into Phase I Study of Cantrixil
In December 2016, the Company enrolled the first patient into its
first-in-human,
phase I clinical study for Cantrixil
(TRX-E-002-1)
in ovarian cancer. Opening the study represents an important clinical and commercial milestone for the Company.
The Company was awarded a grant of up to $3m for novel drug discovery
In February 2017, the Company was awarded a cash grant of up to $3 million over three years to fund a collaboration led by the Company, the University of
New South Wales and a privately held contract research organisation. The grant has been awarded to fund development of a next-generation anti-tropomyosin program, which is intended to provide potential new therapies for cancer. This research is
distinct from the Companys existing anti-tropomyosin program,
ATM-3507.
20
The Company terminated
ATM-3507
preclinical development program
In April 2017, the Company announced termination of its
pre-IND
development candidate, Anisina
(ATM-3507),
on the basis of unpromising emergent preclinical data.
C. Organizational structure
Novogen Limited is incorporated in Australia and has the following wholly-owned subsidiaries:
|
|
|
Name
|
|
Country of incorporation
|
|
|
Novogen Laboratories Pty Ltd
|
|
Australia
|
Novogen Research Pty Ltd
|
|
Australia
|
Novogen North America Inc.
|
|
United States (Delaware)
|
Glioblast Pty Ltd
|
|
Australia
|
The dissolution of Triaxial Pharmaceuticals Pty Ltd, a wholly-owned subsidiary of the Company, was completed in 2016.
D. Property, plant and equipment
To accommodate
its growth, the Company has entered into a
3-year
lease, starting November 2015. The office lease contains two renewal options, each for a three-year period. These renewal options may be cancelled by the
Company. In order to exercise an option, the Company must inform the lessor no later than 6 months prior to the end of the lease, by which time it must commit to the term of the option.
Item 4A.
|
Unresolved Staff Comments
|
None.
Item 5.
|
Operating and Financial Review and Prospects
|
The following discussion and analysis should be read in
conjunction with Item 18. Financial Statements included below. Operating results are not necessarily indicative of results that may occur in future periods. This discussion and analysis contains forward-looking statements that involve
risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in the forward-looking statements as a result of many factors including, but not limited to, those set forth under Forward-Looking
Statements and Risk Factors in Item 3 Key Information included above in this Annual Report on Form
20-F.
All forward-looking statements included in this document are based on the
information available to the Company on the date of this document and the Company assumes no obligation to update any forward-looking statements contained in this Annual Report on Form
20-F.
Critical accounting policies
We prepare our financial
statements in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). As such, we are required to make certain estimates, judgments, and assumptions that management
believes are reasonable based upon the information available. These estimates, judgments and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses
during the periods presented. The significant accounting policies are summarized in Item 18. Financial Statements - Note 2 - Significant Accounting Policies.
21
Income taxes
The Company has not recognized deferred tax assets relating to carried forward tax losses and taxable temporary differences since the Company is currently in a
loss-making position and unable to generate taxable income to utilize the carried forward tax losses and taxable temporary differences. The utilization of the tax losses also depends on the ability of the entity to satisfy certain tests at the time
the losses are recouped. Significant judgment is required in determining the worldwide provision for income taxes. There are certain transactions and calculations undertaken during the ordinary course of business for which the ultimate tax
determination is uncertain. The Company estimates its tax liabilities based on the Companys understanding of the tax law. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences
will impact the current and deferred income tax assets and liabilities in the period in which such determination is made.
Share-based Payment
Transactions
The Company measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at
the date at which they are granted. The fair value is determined by using the Black-Scholes model taking into account the terms and conditions upon which the instruments were granted. The accounting estimates and assumptions relating to
equity-settled share-based payments would have no impact on the carrying amounts of assets and liabilities within the next Annual Reporting period but may impact profit or loss and equity.
Research and Development
We expense all internal
research and development expenditures as the costs relate to the initial expenditure for research and development of biopharmaceutical products and the generation of future economic benefits is not considered probable given the stage of development.
It was considered appropriate to expense the research and development costs as they did not meet the criteria to be capitalized under IAS 38.
The
Australian Research and Development Tax Incentive is a government run program which helps to offset some of the costs of R&D. Annually, the Company claims a cash rebate and has disclosed this as other income in the statement of profit or loss
and other comprehensive income. The Company currently accounts for R&D Tax Incentive on an accruals basis provided it can make a reasonable estimation as at year end.
Impairment of Assets
We assess impairment of
non-financial
assets at each reporting date by evaluating conditions specific to the Company and parent entity and to the particular asset that may lead to impairment. If an impairment trigger exists, the
recoverable amount of the asset is determined. This involves fair value less costs to sell or
value-in-use
calculations, which incorporate a number of key estimates and
assumptions such as cash flow projections and discount rate.
For additional information on significant accounting policies refer to Item 18.
Financial Statements - Note 2 - Significant Accounting Policies.
Results of Operations
The following discussion relates to our consolidated results of operations, financial condition and capital resources. You should read this discussion in
conjunction with our consolidated financial statements and the notes thereto contained elsewhere in this report.
22
A. Operating results
The following table provides a summary of revenues and income for the past three fiscal years:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
|
For the fiscal year ended June 30,
|
|
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
249
|
|
|
|
406
|
|
|
|
89
|
|
Other income:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net foreign exchange gain
|
|
|
|
|
|
|
781
|
|
|
|
1,116
|
|
Payroll tax rebate
|
|
|
7
|
|
|
|
18
|
|
|
|
8
|
|
Reimbursement of expenses
|
|
|
17
|
|
|
|
|
|
|
|
|
|
Research and development rebate
|
|
|
8,409
|
|
|
|
2,866
|
|
|
|
1,538
|
|
Subsidies and grants
|
|
|
130
|
|
|
|
|
|
|
|
91
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue and other income
|
|
|
A$8,812
|
|
|
|
A$4,071
|
|
|
|
A$2,842
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2017 compared to fiscal 2016
Revenue and other income
The Companys revenue,
which is solely interest income derived from interest bearing bank account, decreased from A$406,000 in 2016 to A$249,000 in 2017 as a result of decreased cash balances.
The net foreign exchange loss is A$0.9 million in fiscal 2017 in comparison of net foreign exchange gain of A$0.8 million in fiscal 2016. The change
is mainly due to the depreciation of AUD against USD.
Research and development rebate increased by 190% from A$2.9 million in fiscal 2016 to
A$8.4 million in fiscal 2017 due to higher level of eligible research and development expense in fiscal 2017, and the fact that the estimate for fiscal 2017 was able to be estimated with a sufficient level of accuracy to allow this amount to be
booked in the fiscal 2017 accounts. Determining the eligible expenses requires an element of judgement. In prior years, we were of the view that, due to the uncertainty around determining which expenses were eligible and uncertainty around the
collectability of the claim that was made, we were unable to make a reliable estimate until the claim was submitted to and approved by the Australian Tax Office. Novogen has been claiming and successfully collecting the R&D tax incentive for a
few years now, and we believe that, given the history of successful claims, we are able to make a reliable estimate in the current year. As such, during the current year, we recognised the FY17 claim as a receivable at
year-end.The
Australian federal governments Research and Development Tax incentive program cash refund rate changed from 45% to 43.5% from July 2016. We note that the Australian government is considering
a recommendation from a review panel for a reduction of the amount of the grants available to small entities such as Novogen to a maximum of A$2 million per annum. Any such change in the Research and Development Tax Incentive program could have
a material adverse effect on the Companys research and development rebate as well as on our future cash flows and financial position.
Expenses
Research and development expenses increased by A$1.2 million (12%) from A$9.9 million in fiscal 2016 to A$11.1 million in fiscal 2017
due to higher research and development activity in fiscal 2017, including the commencement of the Phase I clinical study for the Cantrixil program, as well as the design of the Phase II clinical study for the newly acquired asset, GDC 0084.
General and administrative costs increased by A$2.0 million (34%) from A$5.8 million in fiscal 2016 to A$7.8 million in fiscal 2017 due, in
large part, to a
one-off
increase of salary expense as well as higher legal and consultancy fees. Higher legal costs arose as a result of increased patent activity as well as the costs surrounding the
in-license
of GDC 0084, while increased consultancy costs reflect a move to a more outsourced model where the Company accesses deep expertise through the use of consultants rather than employing staff with a more
general expertise set. It should be noted that the salary expense in fiscal 2017 is confounded to a certain extent by significant change in the Key Management Personnel during the year, and therefore includes several positions that have become
redundant and several overlapping positions, as the Company made the transition from a research based business to one engaged in clinical trials.
23
The finance costs in fiscal 2017 amounted to A$765,000, which relates to the
non-cash
unwinding of the discount on contingent consideration. There were no finance costs in fiscal 2016 as the Company carried no interest bearing debt during fiscal 2017. These changes were consistent with
the change in strategy of the Company over the past 18 months.
Net loss
The Companys loss after income tax decreased by A$1.5 million (12%) from A$12.2 million in fiscal 2016 to A$10.7 million in fiscal 2017.
This was mainly as a result of the accrual of the fiscal 2017 R&D tax rebate, offset somewhat by additional R&D costs.
Fiscal 2016 compared
to fiscal 2015
Revenue and other income
The
Companys revenue, which is solely interest income derived from interest bearing bank account, increased from A$89,000 in 2015 to A$406,000 in 2016 as a result of capital raisings in April and June 2015 that raised aggregate gross proceeds of
A$33.2 million, thus providing for higher interest returns on increased bank account cash balances in fiscal 2016.
Net foreign exchange gain
decreased 30% from A$1.1 million in fiscal 2015 to A$0.8 million in fiscal 2016 due to lower volatility in the exchange rate.
Research and
development tax rebate increased 86% from A$1.5 million in fiscal 2015 to A$2.9 million in fiscal 2016 due to higher level of eligible research and development expense in fiscal 2016. The Australian federal governments Research and
Development Tax incentive program cash refund changed from 45% to 43.5% from July 2016. We note that the Australian government recently received a recommendation from a review panel recommending a reduction of the amount of the grants available to
small entities such as Novogen to a maximum of A$2 million per annum. Any such change in the Research and Development Tax Incentive program could have a material adverse effect on the Companys research and development grant (rebate) as
well as on our future cash flows and financial position.
Expenses
Research and development expenses increased A$4.0 million from A$5.9 million in fiscal 2015 to A$9.9 million in fiscal 2016 due to higher
research and development activity in fiscal 2016, including the completion of necessary Chemistry, Manufacturing and Controls activity in relation to the Cantrixil program, as required by the FDA and finalization of the
first-in-human
Phase I clinical protocol. In relation to Anisina, the Company has manufactured both the active candidate drug substance and candidate drug product. The Company
has also manufactured the candidate drug substance to cGMP in preparation for
first-in-human
clinical trials.
General and administrative costs increased A$2.0 million (53%) from A$3.8 million in fiscal 2015 to A$5.8 million in fiscal 2016 due, in large
part, to a rental increase arising from a relocation of our headquarters in November 2015 as well as higher legal and consultancy fees.
There were no
finance costs in fiscal 2016, representing a decrease of A$370,000 in comparison with fiscal 2015, with the A$370,000 consisting of A$69,000 finance costs and A$301,000 loss in fair value of convertible notes. There was no borrowing during fiscal
2016 as a result of the additional funds raised through the issue of equity securities in fiscal 2015.
24
Net loss
As
a result of the above and particularly the higher research and development expenses, the Companys loss after income tax increased A$4.9 million (67%) from A$7.3 million in fiscal 2015 to A$12.2 million in fiscal 2016.
B. Liquidity and capital resources
We have incurred
cumulative losses and negative cash flows from operations since our inception and, as of June 30, 2017, we had accumulated losses of A$171 million. We anticipate that we will continue to incur losses for at least the next several years. We
expect that our research and development expenditure will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, other third-party funding, and
other collaborations, strategic alliances and licensing arrangements.
We had no borrowings in fiscal 2017 and do not currently have a credit facility.
As of June 30, 2017, we had cash and cash equivalents of A$14.5 million. Cash in excess of immediate requirements is invested in accordance
with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts. Our short-term investments consist of term deposits with maturity within 90 days. At
June 30, 2017, term deposits amounting to A$6.0 million had a weighted average interest rate of 2.40%.
We expect to consume cash and incur
operating losses for the foreseeable future as the Company continues developing its oncology drug candidates. The impact on cash resources and results from operations will vary with the extent and timing of the future clinical trial programs. The
financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and realisation of assets and settlement of liabilities in the normal course of business. As is often the case with drug development
companies, the ability of the consolidated entity to continue its development activities as a going concern is dependent upon it deriving sufficient cash from investors, from licensing and partnering activities and from other sources of revenue such
as grant funding. The directors have considered the cash flow forecasts and the funding requirements of the business and are confident that the strategies in place are appropriate to generate sufficient funding to allow the consolidated entity to
continue as a going concern. Accordingly, the directors have prepared the financial statements on a going concern basis. Should the above assumptions not prove to be appropriate, there is material uncertainty whether the consolidated entity will
continue as a going concern and therefore whether it will realise its assets and extinguish its liabilities in the normal course of business and at the amounts stated in these financial statements.
Cash flows
The following table set forth the
sources and uses of cash for the past three fiscal years:
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
A$(11,435)
|
|
|
A$
|
(11,980
|
)
|
|
A$
|
(5,759
|
)
|
Net cash used in investing activities
|
|
|
(7,117
|
)
|
|
|
(522
|
)
|
|
|
(89
|
)
|
Net cash used in provided by financing activities
|
|
|
(18
|
)
|
|
|
782
|
|
|
|
47,415
|
|
25
Operating activities.
Net cash used in operating activities for the three fiscal years primarily
represents net outflows for the cost of the R&D programs and the general and administrative costs of running the business.
Investing activities.
Net cash used in investing activities in fiscal 2017 represents the purchase of a business and the
out-licensing
of a clinical stage asset, GDC 0084 during the year. The cash outflow in fiscal 2016
primarily represented the cost of an office move and associated fit out.
Financing activities.
Net cash provided by financing activities of
A$782,000 in fiscal 2016 related to the exercise of options, A$47.4 million in fiscal 2015 related to the issuance of ordinary shares in private placements and a rights issue. No such financing was received in fiscal 2017.
At June 30, 2017, the Company did not hold any derivative financial instruments for managing its foreign currency; however, the Company may from time to
time enter into hedging arrangements where circumstances are deemed appropriate.
The Company believes that its future ability to fund its operations will
be dependent on deriving sufficient cash from investors through successful capital raising, from licensing and partnering activities and return from government grants as well as continuing to qualify for the Research and Development Tax Incentive
Program available in Australia. The R&D Tax Incentive is an Australian government run program which helps to offset some of the costs of R&D. Annually, the Company claims a refundable tax offset and has disclosed this as other income in the
statement of profit or loss and other comprehensive income. The Company currently accounts for R&D Tax Incentive on an accruals basis providing a reasonable estimation can be made at year end.
The Company had no commitments for capital expenditure at the end of fiscal 2017.
The Company continuously pursues opportunities for
non-dilutive
funding, such as grant applications.
The Company cannot provide assurance that it or its subsidiaries will be able to raise the funds necessary to complete the planned clinical trial programs, or
find appropriate collaboration or licensing opportunities.
Financing activities
The Company has historically financed its operations primarily from issuing equity capital.
Private Equity Placement April 2015
In April
2015, the Company issued to institutional investors in a private placement 51,750,000 ordinary shares at a purchase price of A$0.30 and, following shareholders approval received on June 24, 2015:
|
|
51,750,000 options, exercisable at A$0.30 by December 30, 2015; and
|
|
|
25,875,000 options, exercisable at A$0.40 by June 30, 2020.
|
The Company received gross proceeds of
approximately $15.5 million from the placement.
Rights Issue June 2015
In June 2015, the Company issued as part of a rights offer to eligible shareholders 58,971,151 ordinary shares at a purchase price of A$0.30 and:
|
|
58,971,151 options, exercisable at A$0.30 by December 4, 2015; and
|
|
|
29,485,999 options, exercisable at A$0.40 by June 4, 2020.
|
The Company received gross proceeds of
approximately A$17.7 million from the rights offer.
During fiscal 2016, the Company issued 6,617,517 ordinary shares, all following the exercise of
options. The details of these options are as follows:
|
|
1,000 options expiring June 4, 2020, at an exercise price of A$0.40 per option;
|
|
|
1,000,000 options expiring on December 18, 2019, at an exercise price of A$0.15 per option;
|
26
|
|
5,614,224 options expiring on November 18, 2015, at an exercise price of A$0.125 per option; and
|
|
|
2,293 options expiring December 4, 2015, at an exercise price of A$0.30 per option.
|
During fiscal 2017,
the Company issued 53,553,932 ordinary shares. The details of these ordinary shares issuing are as follows:
|
|
In September 2016, 400,000 shares were issued to the Companys Scientific Advisory Board for no consideration in respect of share based payments;
|
|
|
In September 2016, 20,000,000 shares were issued in relation to the conversion of part of the Triaxial convertible note;
|
|
|
In October 2016, 17,153,932 shares were issued in relation to the acquisition of Glioblast Pty Ltd to support the development of
GDC-0084;
and
|
|
|
In November 2016, 16,000,000 shares were issued in relation to the conversion of part of the Triaxial convertible note.
|
Foreign currency fluctuations were not material for the Company in fiscal 2017. See Item 18. Financial Statements - Note 29 - Financial
Instruments for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk.
Convertible
note (Triaxial) carrying value of A$1,500,000
During the year ended June 30, 2013 the Company issued Convertible Notes
with a face value of A$1,500,000 to Triaxial in consideration of the acquisition of patents and intellectual property assets. The terms of these Convertible Notes was amended on December 4, 2014. During fiscal 2017, Novogen reached two
milestones that triggered the conversion of a portion of its Convertible Notes. On September 14, 2016 the directors approved the issue of 20,000,000 ordinary shares as a consequence of a conversion of a portion of the Convertible Notes, and on
November 1, 2016 a further 16,000,000 ordinary shares were issued as a result of the conversion of a further portion of the Convertible Notes.
C.
Research and development, Patents and Licences, etc.
Expenditure during the research phase of a project is recognized as an expense when incurred.
Development costs are capitalized only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.
Research and development expenses consist primarily of costs incurred for the development of our product candidates, which include:
|
|
|
expenses incurred under agreements with academic research centres, clinical research organizations and investigative sites that conduct our clinical trials; and
|
|
|
|
the cost of acquiring, developing, and manufacturing clinical trial materials.
|
We cannot determine with
certainty the duration and completion costs of the current or future product development, preclinical studies or clinical trials of our product candidates. The duration, costs, and timing of clinical trials and development of our product candidates
will depend on a variety of factors, including:
|
|
|
the scope, rate of progress, and expense of our ongoing as well as any additional clinical trials and other research and development activities;
|
|
|
|
the countries in which trials are conducted;
|
|
|
|
future clinical trial results;
|
|
|
|
uncertainties in clinical trial enrolment rates or
drop-out
or discontinuation rates of patients;
|
27
|
|
|
potential additional safety monitoring or other studies requested by regulatory agencies;
|
|
|
|
significant and changing government regulation; and
|
|
|
|
the timing and receipt of any regulatory approvals.
|
A change in the outcome of any of these variables with
respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA, or another regulatory authority were to require us to
conduct clinical trials beyond those that we anticipate will be required to complete clinical development of a product candidate or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend
significant additional financial resources and time on the completion of clinical development.
We plan to increase our research and development expenses
for the foreseeable future as we continue the development of product candidates and explore further potential applications of our technology.
D. Trend
Information
The key milestone for fiscal 2018 will be commencement of the phase II clinical study of
GDC-0084,
which is expected to begin in the fourth quarter of calendar 2017. Given the high mortality associated with glioblastoma, and dependent on the performance of
GDC-0084
relative to current
standard-of-care,
there is a possibility the FDA may consider the drug for accelerated approval a mechanism whereby the FDA may sometimes approve drugs for
high-need diseases prior to completion of a formal phase III clinical study. The Company also expects to report initial data from the phase I clinical study of Cantrixil in the first quarter of calendar 2018. It is anticipated that exploratory
efficacy data from additional patients will be available later in calendar 2018. In parallel, the Company continues to actively explore licensing and partnering opportunities with other companies that have the potential to effect further stepwise
transformations in the scope of the Companys business.
E.
Off-balance
sheet arrangements
The Company does not have any
off-balance
sheet arrangements.
F. Tabular disclosure of contractual obligations
The
following table sets forth the Companys contractual obligations for the periods as at June 30, 2017:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
A$000
|
|
|
less than 1
year
A$000
|
|
|
1 - 3 years
A$000
|
|
|
3 - 5 years
A$000
|
|
|
more than
5 years
A$000
|
|
Operating Leases
|
|
|
328
|
|
|
|
250
|
|
|
|
78
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
328
|
|
|
|
250
|
|
|
|
78
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease commitments include contracted amounts for leases of premises and plant and equipment under
non-cancellable
operating leases expiring within three years. Leases for premises include an annual review for CPI increases.
The office lease contains two renewal options, each for a three-year period. These renewal options are not included in the commitments as they may be
cancelled by the Company. In order to exercise an option, the Company must inform the lessor no later than 6 months prior to the end of the lease, by which time it must commit to the term of the option.
28
Item 6.
|
Directors, Senior Management and Employees
|
A. Directors and Senior Management
The names and details of the Companys Directors and senior management at the date of this report are as follows:
|
|
|
Bryce Carmine
|
|
Non-Executive
Director
|
Steven Coffey
|
|
Non-Executive
Director
|
James Garner
|
|
Managing Director, CEO
|
Iain Ross-Note 1
|
|
Chairman
|
Dr Gordon Hirsch
|
|
Chief Medical Officer
|
Dr Peng Leong
|
|
Chief Business Officer
|
Kate Hill
|
|
Company Secretary
|
Gabrielle Heaton
|
|
Director of Finance and Administration
|
Note
1-
Iain Ross was appointed as a
Non-Executive
Director on 22 July 2015 and acted in an executive capacity until the appointment of James Garner on 1 February 2016. He was appointed as Chairman on 8 June 2017.
Former directors who served during fiscal 2017:
|
|
John OConnor, former Chairman (resigned 8 June 2017)
|
|
|
Ian Phillips,
Non-Executive
Director (resigned 8 June 2017)
|
|
|
Peter Gunning, former
Non-Executive
Director (resigned 5 September 2016)
|
Directors were in office for the entire period unless otherwise stated.
Names, titles, experience and expertise
|
|
|
Name:
|
|
Bryce Carmine
|
Title:
|
|
Non-Executive
Director
|
Experience and expertise:
|
|
Bryce Carmine spent 36 years working for Eli Lilly & Co. and retired as Executive Vice President for Eli Lilly & Co, and President, Lilly
Bio-Medicines.
Prior to this he led
the Global Pharmaceutical Sales and Marketing and was a member of the Companys Executive Committee. Mr Carmine previously held a series of product development portfolio leadership roles culminating when he was named President, Global
Pharmaceutical Product Development, with responsibility for the entire late-phase pipeline development across all therapeutic areas for Eli Lilly. During his career with Lilly, Bryce held several country leadership positions including President Eli
Lilly Japan, Managing Dir. Australia/NZ & General Manager of a JV for Lilly in Seoul, Korea.
|
Other current directorships:
|
|
None
|
Special responsibilities:
|
|
Chair of Remuneration and Nomination Committee, Chair of Scientific Committee, member of Audit, Risk and Governance Committee
|
29
|
|
|
|
|
Name:
|
|
Steven Coffey
|
Title:
|
|
Non-Executive
Director
|
Experience and expertise:
|
|
Steven Coffey is a chartered accountant, having spent his career in public practice since graduating from University of New South Wales, Australia in 1983. He has been a partner in the chartered accounting firm Watkins Coffey Martin
since 1993. He is a registered company auditor and audits a number of large private companies as well as a number of
not-for-profit
entities. Steven has previously
served on the board of an Australian listed public company. He is currently a board member of private family foundation.
|
Other current directorships:
|
|
None
|
Special responsibilities:
|
|
Chair of Audit, Risk and Governance Committee, member of Remuneration and Nomination Committee
|
|
|
Name:
|
|
Dr James Garner
|
Title:
|
|
Executive Director and Chief Executive Officer
|
Experience and expertise:
|
|
Dr Garner is an internationally experienced life sciences executive who has previously worked with companies ranging from small biotechs to multinational pharmaceutical companies such as Biogen and Takeda. His career has focused on
regional and global development of new medicines from preclinical to commercialisation.
|
|
|
Dr Garner is a physician by training and holds an MBA from the University of Queensland. He began his career in hospital medicine and worked for a number of years as a corporate strategy consultant with Bain & Company
before entering the pharmaceutical industry. Prior to joining Novogen in 2016, he led R&D strategy for Sanofi in Asia-Pacific and was based in Singapore. from 2013 to 2016. Prior to that, he was regional Vice President of R&D for Takeda,
from 2009-2013, where he had responsibility for a multinational team of approximately 60 people, and oversight of all development activities in the Asia-Pacific region.
|
Other current directorships:
|
|
None
|
Special responsibilities:
|
|
Member of Scientific Committee, Member of Strategy and Innovation Committee
|
|
|
Name:
|
|
Iain Ross
|
Title:
|
|
Chairman (appointed on June 8, 2017),
Non-Executive
Director
|
Experience and expertise:
|
|
Iain, based in the UK, is an experienced Director on a number of Australian company boards. He is Chairman of
e-Therapeutics
plc (LSE:ETX), Redx Pharma plc (LON:REDX) and Biomer Technology
Limited. In his career he has held senior positions in Sandoz AG, Fisons Plc,
Hoffmann-La
Roche AG and Celltech Group Plc and also undertaken a number of
start-ups
and
turnarounds on behalf of banks and private equity groups. His track record includes multiple financing transactions having raised in excess of £300 million, both publicly and privately, as well as extensive experience of divestments and
strategic restructurings and has over 20 years in cross-border management as a Chairman and CEO. He has led and participated in four London Stock Exchange (LSE) Initial Public Offerings, and has direct experience of mergers and
acquisitions transactions in Europe, USA and the Pacific Rim.
|
Other current directorships:
|
|
Anatara Lifesciences Limited,
e-Therapeutics
plc (LSE: ETX), Redx Pharma plc (LON:REDX
|
Special responsibilities:
|
|
Member of Remuneration and Nomination Committee, Member of Scientific Committee and Member of the Audit, Risk and Governance Committee, Member of Strategy and Innovation
Committee.
|
30
|
|
|
|
|
Name:
|
|
Dr Gordon Hirsch
|
Title:
|
|
Chief Medical Officer
|
Experience and expertise:
|
|
Dr Hirsch is a scientist, specialist physician and pharmaceutical executive with more than 20 years experience in the pharmaceutical industry. He has held various scientific, medical and operational roles at country, regional and
global levels with a range of responsibilities from development to commercialisation in companies including Eli Lilly, Pfizer, Sanofi and Takeda. He has held appointments in South Africa, Australia, France, Japan and the United States. He holds BSc
Hons and MBBCh degrees from the University of the Witwatersrand, South Africa and an MBA from Henley Business School, UK. Dr Hirsch is also a Fellow of the South African College of Physicians.
|
|
|
Name:
|
|
Dr Peng Leong
|
Title:
|
|
Chief Business Officer
|
Experience and expertise:
|
|
Dr Leong has spent eighteen years in the pharmaceutical industry, beginning as a scientist, and followed by eight years in healthcare investment banking and private equity, and eight years in business development. Dr Leong started
his career at Chiron Corporation, a pioneering biotechnology company based in California that was subsequently acquired by Novartis International AG (NYSE: NVS). While working in healthcare investment banking at CIBC World Markets and Piper Jaffray,
he was involved in raising more than US$1.4 billion for over 20 biotechnology companies. In his various roles, including his most recent position at Merck Serono (FWB: MRK), Dr Leong has had a leadership role in the acquisition or sale of over
US$1 billion in pharmaceutical product rights. He holds a PhD in Biochemistry from the University of Toronto, Canada and an MBA from the University of California, Berkeley.
|
|
|
Name:
|
|
Kate Hill
|
Title:
|
|
Company Secretary
|
Experience and expertise:
|
|
Kate has over 20 years experience as an audit partner with Deloitte Touche Tohmatsu, working with ASX listed and privately owned clients. She has worked extensively in regulated environments including assisting with Initial Public
Offerings, capital raising and general compliance, as well as operating in an audit environment. She is also a
Non-Executive
Director of CountPlus Limited, an ASX listed company, as well as a
Non-Executive
Director of a small
not-for-profit
organisation. She is a member of the Audit and Risk Committees of both
organisations. Kate is a member of the Institute of Chartered Accountants in Australia and New Zealand, and a graduate of the Australian Institute of Company Directors.
|
|
|
Name:
|
|
Gabrielle Heaton
|
Title:
|
|
Director of Finance and Administration
|
Experience and expertise:
|
|
Gabrielle Heaton has over 30 years of commercial experience in media, property services and healthcare for multinational, ASX listed and overseas companies. She has held a number of senior Finance positions including CFO, Quality
Auditor and been responsible for Human Resources and IT. Gabrielle has a Bachelor of Business from the University of Technology and is a member of CPA Australia.
|
31
Appointment of Scientific Advisory Board (SAB)
In September 2016, the Company announced the appointment of a Scientific Advisory Board (the
SAB
), a consultative advisory body, providing
input and guidance to scientific programs but with no formal governance role. Reporting to the CEO, members of the SAB are appointed for
two-year
terms, with appointments renewable by mutual agreement. The SAB
initially includes four newly-appointed members, including Professor Peter Gunning, who stepped down as a Non Executive Director of the Company at this time. The inaugural membership of the SAB includes:
|
|
|
Professor Sir Murray Brennan, GNZM Chairman Emeritus of the Department of Surgery, Benno C Schmidt Chair in Clinical Oncology, and Vice President of International Programs, at Memorial Sloan Kettering Cancer
Centre, New York.
|
|
|
|
Dr Karen Ferrante former Chief Medical Officer at Millennium Pharmaceuticals and former Head of Oncology Development at Pfizer Inc (NYSE: PFE).
|
|
|
|
Professor Alex Matter, Chairman and Chief Executive Officer of the Experimental Therapeutics Centre, and also Chief Executive Officer of the D3 Platform, both part of A*STAR, the Agency for Science, Technology, and
Research, in Singapore. Emeritus Professor of the Medical Faculty of the University of Basel, and an Honorary Adjunct Professor of the Department of Pharmacology in the Yong Loo Lin School of Medicine at the National University of Singapore.
|
|
|
|
Professor Peter Gunning, Head of the School of Medical Sciences at the University of New South Wales.
|
B. Compensation
Principles used to determine
the nature and amount of remuneration
Remuneration philosophy
Remuneration for Directors and Senior Executives is based on the overall objective of attracting and retaining people of high quality who will make a
worthwhile contribution to the consolidated entity in the short, medium and long term, and thereby contribute to long term shareholder value. The Board and its Remuneration and Nomination Committee take a balanced position between the need to pay
market rates to attract talent, and the financial resources of the consolidated entity, in determining remuneration. In particular, during the year ended June 30, 2017, the Board and the Remuneration and Nomination Committee have focused on
hiring Senior Executives with appropriate global experience in the pharmaceutical industry so that the entity is best placed to deliver on the revised strategy. The Board and the Remuneration and Nomination Committee note that there is a level of
overlap of key management personnel (KMP) during the financial year, with certain executives leaving the Company and other new executives joining the team. Such overlap is not anticipated to exist in future years.
The Board and the Remuneration and Nomination Committee have put in place both short term (cash bonus) and long term (employee share options) incentives for
its employees.
Non-executive
directors fees
The Constitution of the Company and the ASX listing rules specify that the aggregate remuneration of
non-executive
directors shall be determined from time to time by General Meeting. The last determination for the Company was at the Annual General Meeting held on October 28, 2005 when the shareholders approved an aggregate remuneration of A$560,000.
Non-Executive
Directors fees are reviewed periodically by the Board and are regularly compared with those of
companies of comparable market capitalisation and stage of development. The Chairman and Deputy Chairmans fees are determined independently to the fees of other
non-executive
Directors based on
comparative roles in the external market. The
Non-Executive
Directors fee structure is a fixed fee model (inclusive of superannuation). Since the end of the financial year the
Non-Executive
fee structure has been further reviewed and simplified, with an overall reduction in the number of
Non-Executive
Directors and their individual fee
arrangements.
Non-Executive
Directors fees for the year ending June 30, 2018 are anticipated to amount to less than $300,000.
32
Executive directors and other KMP remuneration
The Board, the Remuneration and Nomination Committee in consultation with the Managing Director have put in place a performance based short-term incentive, in
addition to the fixed remuneration, and long-term incentive based on tenure via the ESOP. The Board determines an appropriate level of fixed remuneration for the CEO and Group Executives, as well as the proportion of performance based remuneration.
Fixed remuneration, consisting of base salary and superannuation, is reviewed annually at the end of each calendar year.
The executive remuneration and
reward framework has three components:
|
|
short-term performance incentives
|
Fixed remuneration is reviewed annually by the Remuneration and Nomination Committee
based on individual performance, the overall performance of the consolidated entity and comparable market remunerations.
The short-term incentives
program is designed to align the targets of the consolidated entity with the performance hurdles of executives. Short-term incentive payments are granted to executives based on specific annual performance objectives, metrics and performance
appraisals. Annual performance reviews are conducted at the end of each calendar year and bonuses are paid shortly after the performance reviews are completed.
The Board or the Remuneration and Nomination Committee may, at its discretion, award bonuses for exceptional performance.
The long-term incentive comprises equity-based payments. The consolidated entity aims to attract and retain high calibre executives, and align their interests
with those of the shareholders, by granting equity-based payments based on tenure. The share-options issued to executives are governed by the ESOP.
Employee share option plan
The Employee Share Option
Plan (ESOP) was approved by shareholders on March 4, 2015.
The ESOP provides for the issue of options to eligible individuals, being
employees or Officers of the consolidated entity, however it excludes
Non-Executive
Directors.
Each option issued
under the ESOP entitles its holder to acquire one fully paid ordinary share and is exercisable at a price based on a formula, which includes the weighted average price of such shares at the close of trading on the Australian Securities Exchange for
the seven days prior to the date of issue. The number of options offered, the amount payable, the vesting period, the option period, the conditions of exercise or any other factors are at the discretion of the Board of Directors.
The consolidated entity issued 5,120,000 share options under the ESOP during the financial year that ended June 30, 2017.
Any change to the ESOP will require approval by shareholders.
Use of remuneration consultants
During fiscal 2017, the
Company did not engage remuneration consultants.
33
Details of remuneration
Details of the remuneration of the directors and other KMP of the Company are set out in the following tables.
The KMP of the consolidated entity consisted of the following directors of Novogen Limited:
|
|
|
Bryce Carmine
|
|
-
Non-Executive
Director, Deputy Chairman
|
Steven Coffey
|
|
-
Non-Executive
Director
|
Dr James Garner
|
|
- Managing Director, CEO
|
Prof Peter Gunning
|
|
-
Non-Executive
Director (resigned 5 September 2016)
|
John OConnor
|
|
-
Non-Executive
Director, Chairman (resigned 8 June 2017)
|
Ian Phillips
|
|
-
Non-Executive
Director (resigned 8 June 2017)
|
Iain Ross
|
|
-
Non-Executive
Director, Chairman (appointed 8 June 2017)
|
|
|
And the following persons:
|
|
|
Dr David Brown
|
|
- Chief Scientific Officer (resigned March 10, 2017)
|
Dr Andrew Heaton
|
|
- CEO and President of Novogen North America, Inc. (resigned March 10, 2017)
|
Gabrielle Heaton
|
|
- Director of Finance and Administration (appointed March 13, 2017)
|
Kate Hill
|
|
- Interim Company Secretary (appointed September 9, 2016), Company Secretary (appointed March 6, 2017)
|
Dr Gordon Hirsch
|
|
- Chief Medical Officer (appointed November 21, 2016)
|
Cristyn Humphreys
|
|
- Chief Financial Officer (resigned March 15, 2017)
|
Dr Peng Leong
|
|
- Chief Business Officer (appointed September 1, 2016)
|
Lionel Mateo
|
|
- Company Secretary (resigned September 9, 2016)
|
34
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term benefits
|
|
|
Post-
employment
benefits
|
|
|
Share-
based
payments
|
|
|
|
|
|
|
|
|
|
|
|
|
Movements
in accrued
leave
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash salary
|
|
|
Cash
|
|
|
Non-
|
|
|
|
|
|
|
|
|
Super-
|
|
|
Equity-
|
|
|
|
|
|
|
and fees
|
|
|
bonus
|
|
|
monetary
|
|
|
Health Insurance
|
|
|
Termination
|
|
|
annuation
|
|
|
settled
|
|
|
Total
|
|
2017
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
Non-Executive
Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
B Carmine
|
|
|
117,123
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,127
|
|
|
|
|
|
|
|
128,250
|
|
S Coffey
|
|
|
46,338
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,000
|
|
|
|
|
|
|
|
81,338
|
|
P Gunning*
|
|
|
12,639
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,201
|
|
|
|
|
|
|
|
13,840
|
|
J OConnor*,***
|
|
|
145,685
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,403
|
|
|
|
|
|
|
|
163,088
|
|
I Phillips*,***
|
|
|
79,713
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
79,713
|
|
I Ross
|
|
|
84,822
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
84,822
|
|
|
|
|
|
|
|
|
|
|
Executive Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
J Garner
|
|
|
410,412
|
|
|
|
90,000
|
|
|
|
25,755
|
|
|
|
3,758
|
|
|
|
|
|
|
|
35,283
|
|
|
|
259,454
|
|
|
|
824,662
|
|
|
|
|
|
|
|
|
|
|
Other Key Management Personnel:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A Heaton*,**,****
|
|
|
238,241
|
|
|
|
37,883
|
|
|
|
(34,442
|
)
|
|
|
6,146
|
|
|
|
174,592
|
|
|
|
|
|
|
|
|
|
|
|
422,420
|
|
C Humphreys*
|
|
|
141,191
|
|
|
|
23,760
|
|
|
|
(4,934
|
)
|
|
|
|
|
|
|
|
|
|
|
14,470
|
|
|
|
11,884
|
|
|
|
186,371
|
|
D Brown*, ****
|
|
|
203,754
|
|
|
|
32,588
|
|
|
|
(21,096
|
)
|
|
|
|
|
|
|
140,780
|
|
|
|
13,797
|
|
|
|
|
|
|
|
369,823
|
|
G Heaton*
|
|
|
52,308
|
|
|
|
|
|
|
|
4,024
|
|
|
|
|
|
|
|
|
|
|
|
4,969
|
|
|
|
|
|
|
|
61,301
|
|
G Hirsch*
|
|
|
215,857
|
|
|
|
6,904
|
|
|
|
16,621
|
|
|
|
|
|
|
|
|
|
|
|
18,861
|
|
|
|
46,055
|
|
|
|
304,298
|
|
K Hill*
|
|
|
113,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
113,200
|
|
L Mateo*
|
|
|
25,192
|
|
|
|
|
|
|
|
1,095
|
|
|
|
|
|
|
|
|
|
|
|
2,364
|
|
|
|
|
|
|
|
28,651
|
|
P Leong*, **
|
|
|
394,811
|
|
|
|
|
|
|
|
15,001
|
|
|
|
28,717
|
|
|
|
|
|
|
|
|
|
|
|
85,864
|
|
|
|
524,393
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,281,286
|
|
|
|
191,135
|
|
|
|
2,024
|
|
|
|
38,621
|
|
|
|
315,372
|
|
|
|
154,475
|
|
|
|
403,257
|
|
|
|
3,386,170
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
Remuneration for the duration of appointment as KMP
|
**
|
Salary paid in US dollars, but disclosed in Australian dollars using a conversion rate of .7545.
|
***
|
In addition to the above amounts, consultancy fees of A$20,531 were paid to Kumara Inc, a corporation in which Ian Phillips is a Director and has a beneficial interest, and consultancy fees of A$37,500 were paid to John
OConnor. These fees were incurred in respect of executive duties performed during the year and, in accordance with the Companys Constitution, fall outside of the cap on
Non-Executive
Directors
fees.
|
****
|
Consistent with their contractual terms, amounts of A$140,780 and A$174,592 were paid to D Brown and A Heaton respectively, in lieu of notice.
|
The table above does not include long service leave as no KMP have been employed by the consolidated entity for more than 5 years.
35
Employment agreements
It is the Remuneration and Nomination Committee policy that employment contracts are entered into with each of the executives who are considered to be KMP.
Under the terms of the contracts, remuneration is reviewed at least annually (or more often at the discretion of the Remuneration and Nomination Committee). The employment contracts of KMPs include a termination clause whereby a party can terminate
the agreement on notice. Such notice may vary between 4 weeks and 6 months. Under the terms of each contract, payment in lieu can be made by the Company to substitute the notice period. In the event of the Company terminating without cause, under
the terms of some contracts, the amount payable on termination is equal to six months remuneration, in addition to any amount payable in lieu of notice. The Company may terminate the contracts at any time without cause if serious misconduct
has occurred. In the event that employment is terminated for cause, no severance pay or other benefits are payable by the Company.
Remuneration and other
terms of employment for key management personnel are formalised in service agreements. Details of these agreements are as follows:
|
|
|
Name:
|
|
James Garner
|
Title:
|
|
Chief Executive Officer, Managing Director
|
Agreement commenced:
|
|
February 1, 2016
|
Term of agreement:
|
|
Full-time employment
|
Details:
|
|
Base salary from February 1, 2017 of $425,000 (previously $400,000), to be reviewed annually by the Remuneration and Nomination Committee. Jamess appointment with the consolidated entity may be terminated with the
consolidated entity giving 6 months notice or by James giving 6 months notice. The consolidated entity may elect to pay James equal amount to that proportion of his salary equivalent 6 months pay in lieu of notice, together with
any outstanding entitlements due to him.
|
|
|
Name:
|
|
Gabrielle Heaton
|
Title:
|
|
Director of Finance and Administration
|
Agreement commenced:
|
|
March 13, 2017
|
Term of agreement:
|
|
Full time employment
|
Details:
|
|
Base salary for fiscal 2017 of $170,000, to be reviewed annually by the Remuneration and Nomination Committee. Gabrielles appointment with the consolidated entity may be terminated with the consolidated entity giving 4
weeks notice or by Gabrielle giving 4 weeks notice. The consolidated entity may elect to pay Gabrielle equal amount to that proportion of her salary equivalent 4 weeks pay in lieu of notice, together with any outstanding
entitlements due to her.
|
|
|
Name:
|
|
Gordon Hirsch
|
Title:
|
|
Chief Medical Officer
|
Agreement commenced:
|
|
November 21, 2016
|
Term of agreement:
|
|
Full-time employment
|
Details:
|
|
Base salary for fiscal 2017 of $351,841, to be reviewed annually by the Remuneration and Nomination Committee. Gordons appointment with the consolidated entity may be terminated with the consolidated entity giving 12
weeks notice or by Gordon giving 4 weeks notice. The consolidated entity may elect to pay Gordon equal amount to that proportion of his salary equivalent 12 weeks pay in lieu of notice, together with any outstanding entitlements
due to him.
|
36
|
|
|
|
|
Name:
|
|
Kate Hill
|
Title:
|
|
Company Secretary
|
Agreement commenced:
|
|
September 9, 2016
|
Term of agreement:
|
|
Part-time contractor
|
Details:
|
|
Base remuneration for fiscal 2017 of $113,200, to be reviewed annually by the Remuneration and Nomination Committee. The contract is open ended. Kates appointment with the consolidated entity may be terminated with the
consolidated entity giving 60 days notice or by Kate giving 60 days notice.
|
|
|
Name:
|
|
Peng Leong
|
Title:
|
|
Chief Business Officer
|
Agreement commenced:
|
|
September 1, 2016
|
Term of agreement:
|
|
Full-time employment
|
Details:
|
|
Base salary for fiscal 2017 of US$300,000 to be reviewed annually by the Remuneration and Nomination Committee. Peng also receives an annual stipend of USD 26,000 to provide health cover. Pengs appointment with the
consolidated entity may be terminated with the consolidated entity giving 90 days notice or by Peng giving 90 days notice. The consolidated entity may elect to pay Peng equal amount to that proportion of his salary equivalent 90
days pay in lieu of notice, together with any outstanding entitlements due to him.
|
Key management personnel have no entitlement to termination payments in the event of removal for misconduct.
Share-based compensation
Issue of shares
There were no shares issued to Directors and other KMP as part of remuneration during the fiscal 2017.
37
Options
The
terms and conditions of each grant of options over ordinary shares affecting remuneration of Directors and other Key Management Personnel in this financial year or future reporting years are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant date
|
|
Number
Of options
|
|
|
Vesting Date
|
|
Exercisable
Date
|
|
Expiry date
|
|
Exercise Price
|
|
|
Fair value per option
at grant date
|
|
|
|
|
|
|
|
|
15-October-2015
|
|
|
266,667
|
|
|
16-11-16
|
|
16-11-17
|
|
16-November-2020
|
|
$
|
0.220
|
|
|
$
|
0.128
|
|
01-February-2016
|
|
|
750,000
|
|
|
01-08-16
|
|
01-08-16
|
|
01-February-2021
|
|
$
|
0.198
|
|
|
$
|
0.081
|
|
01-February-2016
|
|
|
750,000
|
|
|
01-02-17
|
|
01-02-17
|
|
01-February-2021
|
|
$
|
0.198
|
|
|
$
|
0.081
|
|
01-February-2016
|
|
|
750,000
|
|
|
01-08-17
|
|
01-08-17
|
|
01-February-2021
|
|
$
|
0.198
|
|
|
$
|
0.081
|
|
01-February-2016
|
|
|
750,000
|
|
|
01-02-18
|
|
01-02-18
|
|
01-February-2021
|
|
$
|
0.198
|
|
|
$
|
0.081
|
|
01-February-2016
|
|
|
2,000,000
|
|
|
01-02-19
|
|
01-02-19
|
|
01-February-2021
|
|
$
|
0.198
|
|
|
$
|
0.086
|
|
01-February-2016
|
|
|
2,500,000
|
|
|
01-02-20
|
|
01-02-20
|
|
01-February-2021
|
|
$
|
0.260
|
|
|
$
|
0.087
|
|
05-September-2016
|
|
|
500,000
|
|
|
05-09-17
|
|
05-09-17
|
|
05-September-2021
|
|
$
|
0.163
|
|
|
$
|
0.051
|
|
05-September-2016
|
|
|
500,000
|
|
|
05-09-18
|
|
05-09-18
|
|
05-September-2021
|
|
$
|
0.163
|
|
|
$
|
0.051
|
|
05-September-2016
|
|
|
500,000
|
|
|
05-09-19
|
|
05-09-19
|
|
05-September-2021
|
|
$
|
0.163
|
|
|
$
|
0.051
|
|
05-September-2016
|
|
|
500,000
|
|
|
05-09-20
|
|
05-09-20
|
|
05-September-2021
|
|
$
|
0.163
|
|
|
$
|
0.051
|
|
31-October-2016
|
|
|
166,667
|
|
|
01-11-17
|
|
01-11-17
|
|
05-September-2021
|
|
$
|
0.138
|
|
|
$
|
0.044
|
|
31-October-2016
|
|
|
166,667
|
|
|
01-11-18
|
|
01-11-18
|
|
05-September-2021
|
|
$
|
0.138
|
|
|
$
|
0.044
|
|
31-October-2016
|
|
|
166,666
|
|
|
01-11-19
|
|
01-11-19
|
|
05-September-2021
|
|
$
|
0.138
|
|
|
$
|
0.044
|
|
21-November-2016
|
|
|
500,000
|
|
|
23-11-17
|
|
23-11-17
|
|
23-November-2021
|
|
$
|
0.138
|
|
|
$
|
0.046
|
|
21-November-2016
|
|
|
500,000
|
|
|
23-11-18
|
|
23-11-18
|
|
23-November-2021
|
|
$
|
0.138
|
|
|
$
|
0.046
|
|
21-November-2016
|
|
|
500,000
|
|
|
23-11-19
|
|
23-11-19
|
|
23-November-2021
|
|
$
|
0.138
|
|
|
$
|
0.046
|
|
21-November-2016
|
|
|
500,000
|
|
|
23-11-20
|
|
23-11-20
|
|
23-November-2021
|
|
$
|
0.138
|
|
|
$
|
0.046
|
|
None of the options listed in the table above were exercised during the year ended June 30, 2017.
Options granted carry no dividend or voting rights. Each option is convertible to one ordinary share upon exercise.
Remuneration options: granted and vested during the year
There were 4,500,000 options over ordinary shares issued to directors and other KMP as part of remuneration that were outstanding as at June 30, 2017.
There were 266,667 options over ordinary shares vested in fiscal 2017.
There is no Board policy in relation to staff members limiting their exposure to risk as options vest subject to service criteria, not performance criteria.
Remuneration options: expired during the year
During fiscal 2017, 1,033,333 options had lapsed.
38
Pension benefits
The Company paid A$288,000 during fiscal 2017 for employee superannuation benefits and pension benefits.
C. Board Practices
The role of the Board is as follows:
|
|
|
representing and serving the interests of shareholders by overseeing and appraising the strategies, policies and performance of the Company. This includes overviewing the financial and human resources the Company has in
place to meet its objectives and the review of management performance;
|
|
|
|
protecting and optimising Company performance and building sustainable value for shareholders in accordance with any duties and obligations imposed on the Board by law and the Companys Constitution and within a
framework of prudent and effective controls that enable risk to be assessed and managed;
|
|
|
|
responsible for the overall Corporate Governance of Novogen Limited and its subsidiaries, including monitoring the strategic direction of the Company and those entities, formulating goals for management and monitoring
the achievement of those goals;
|
|
|
|
setting, reviewing and ensuring compliance with the Companys values (including the establishment and observance of high ethical standards); and
|
|
|
|
ensuring shareholders are kept informed of the Companys performance and major developments affecting its state of affairs.
|
Responsibilities/functions of the Board include:
|
|
|
selecting, appointing and evaluating from time to time the performance of, determining the remuneration of, and planning for the successor of, the CEO;
|
|
|
|
reviewing procedures in place for appointment of senior management and monitoring of its performance, and for succession planning. This includes ratifying the appointment and the removal of the Company Secretary;
|
|
|
|
overseeing the Company, including its control and accountability systems;
|
|
|
|
input into and final approval of management development of corporate strategy, including setting performance objectives and approving operating budgets;
|
|
|
|
reviewing and guiding systems of risk management and internal control and ethical and legal compliance. This includes reviewing procedures in place to identify the main risks associated with the Companys
businesses and the implementation of appropriate systems to manage these risks;
|
|
|
|
overseeing and monitoring compliance with the Code of Conduct and other corporate governance policies;
|
|
|
|
monitoring corporate performance and implementation of strategy and policy;
|
|
|
|
approving major capital expenditure, acquisitions and divestitures, and monitoring capital management;
|
|
|
|
monitoring and reviewing management processes in place aimed at ensuring the integrity of financial and other reporting;
|
|
|
|
monitoring and reviewing policies and processes in place relating to occupational health and safety, compliance with laws, and the maintenance of high ethical standards; and
|
|
|
|
performing such other functions as are prescribed by law or are assigned to the Board.
|
In carrying out its
responsibilities and functions, the Board may delegate any of its powers to a Board committee, a director, employee or other person subject to ultimate responsibility of the directors under the Australian Corporations Act 2001.
Matters which are specifically reserved for the Board or its committees include the following:
|
|
|
appointment of a Chair;
|
|
|
|
appointment and removal of the CEO;
|
|
|
|
appointment of directors to fill a vacancy or as additional directors;
|
39
|
|
|
establishment of Board committees, their membership and delegated authorities;
|
|
|
|
development and review of corporate governance principles and policies;
|
|
|
|
approval of major capital expenditure, acquisitions and divestitures in excess of authority levels delegated to management;
|
|
|
|
calling of meetings of shareholders; and
|
|
|
|
any other specific matters nominated by the Board from time to time.
|
Structure of the Board
The Companys Constitution governs the regulation of meetings and proceedings of the Board. The Board determines its size and composition, subject to the
terms of the Constitution. The Board does not believe that it should establish a limit on tenure other than stipulated in the Company Constitution (refer to Term of Directors below).
While tenure limits can help to ensure that there are fresh ideas and viewpoints available to the Board, they hold the disadvantage of losing the contribution
of directors who have been able to develop, over a period of time, increasing insight in the Company and its operation and, therefore, an increasing contribution to the Board as a whole. It is intended that the Board should comprise a majority of
independent
non-executive
directors and comprise directors with a broad range of skills, expertise and experience from a diverse range of backgrounds, including compliance with the Diversity Policy. The Board
regularly reviews the independence of each director in light of the interests disclosed to the Board.
The Board only considers directors to be
independent where they are independent of management and free of any business or other relationship that could materially interfere with, or could reasonably be perceived to interfere with, the exercise of their unfettered and independent judgment.
The Board has adopted a definition of independence based on that set out in Principle 2.3 of the ASX Corporate Governance Principles and Recommendations (3
rd
edition). The Board will review the
independence of each director in light of interests disclosed to the Board from time to time. In accordance with the definition of independence above, and the materiality thresholds set, the Board considers Bryce Carmine, Iain Ross and Steven Coffey
to be independent directors.
There are procedures in place, agreed by the Board, to enable directors in furtherance of their duties to seek independent
professional advice at the Companys expense.
40
The appointment and expiration dates of each director in office at the date of this report is as follows:
|
|
|
|
|
|
|
Name
|
|
Position
|
|
Year first appointed
|
|
Current term expires
|
|
|
|
|
Bryce Carmine
|
|
Non-Executive
|
|
2015
|
|
November 2017
|
|
|
|
|
Iain Ross
|
|
Non-Executive
Director
|
|
2014
(resigned November 22, 2014
Re-appointed
July 22, 2015)
|
|
November 2018
|
|
|
|
|
Steven Coffey
|
|
Non-Executive
Director
|
|
2012
|
|
November 2019
|
|
|
|
|
James Garner
|
|
Managing Director, CEO
|
|
2016
|
|
N/A (managing director exempt from election under constitution and Australian corporation law)
|
Further details on each director can be found in Names, titles, experience and expertise above.
Term of Directors
The Companys Constitution
requires that at each Annual General Meeting of the Company, one third (or the number nearest to but not exceeding one third) of the directors, (excluding a director who is the Managing Director, and a director appointed to fill a casual vacancy)
must retire from office provided that no director may retain office for more than three years without offering himself/herself for
re-election
even though such submission results in more than one third of the
directors retiring from office.
The Board of Directors has the power to appoint any person to be a director either to fill a casual vacancy or as an
additional director (up to a maximum of 10). Any director so appointed may hold office only until the next Annual General Meeting when he or she shall be eligible for election by the Company shareholders.
Board of Directors
The Board of Novogen Limited is
elected by and accountable to shareholders. The Board monitors and directs the business and is responsible for the corporate governance of the Company. As at June 30, 2017, the Board comprised of four directors, three of whom were
non-executive
directors.
Committees
The Board has established an Audit, Risk and Governance Committee, a Remuneration and Nomination Committee, and a Scientific Committee.
Audit, Risk and Governance Committee
The Board has
established an Audit, Risk and Governance Committee which operates under a Charter approved by the Board, which is available on the Companys website. It is the Boards responsibility to ensure that an effective internal control framework
exists within the entity. This includes internal controls to deal with both the effectiveness and efficiency of significant business processes, the safeguarding of assets, the maintenance of proper accounting records, and the reliability of
financial information as well as
non-financial
considerations such as the benchmarking of operational key performance indicators. The Board has delegated responsibility for establishing and maintaining a
framework of internal control and ethical standards to the Audit, Risk and Governance Committee.
41
The Committee also provides the Board with additional assurance regarding the reliability of financial
information for inclusion in the financial reports.
Members of the Audit, Risk and Governance Committee are Steven Coffey (Chairman), Bryce Carmine and
Iain Ross, each of whom is an independent director.
Remuneration and Nomination Committee
The purpose of the Remuneration and Nomination Committee is to assist and advise the Board to develop, implement and, from time to time, update policies in
relation to:
|
|
|
the selection, nomination and appointment processes for directors; and
|
|
|
|
the remuneration of key management personnel and directors.
|
This committee is accountable to the Board for
its performance and is subject to an annual review by the Board. Members of the Remuneration and Nomination Committee are Bryce Carmine (Chairman), Steven Coffey and Iain Ross.
Scientific Committee
The purpose of the Committee is to
assist and advise the Board in overseeing the strategic direction and investment in research and development and other scientific initiatives of Novogen Limited and its subsidiaries.
The Committee is empowered by the Board to review and recommend scientific strategies to the Board.
Performance
The performance of the Board and key
executives is reviewed regularly using both measurable and qualitative indicators.
On an annual basis, directors will provide written feedback in
relation to the performance of the Board and its Committees against a set of agreed criteria:
|
|
|
each Committee of the Board will also be required to provide feedback in terms of a review of its own performance;
|
|
|
|
feedback will be collected by the chair of the Board, or an external facilitator, and discussed by the Board, with consideration being given as to whether any steps should be taken to improve performance of the Board or
its Committees;
|
|
|
|
the Chief Executive Officer will also provide feedback from senior management in connection with any issues that may be relevant in the context of Board performance review; and
|
|
|
|
where appropriate to facilitate the review process, assistance may be obtained from third party advisers.
|
Remuneration
It is the Companys objective to
provide maximum shareholder benefit from the retention of a high quality Board and executive team by remunerating directors and key executives fairly and appropriately with reference to relevant employment market conditions. To assist in achieving
this objective, the Board, in assuming the responsibilities of assessing remuneration to employees, links the nature and amount of executive directors and officers remuneration to the Company and Companys financial and operational
performance.
42
The expected outcomes of the remuneration structure are:
|
|
|
retention and motivation of key executives;
|
|
|
|
attraction of high quality management to the Company and Company; and
|
|
|
|
performance incentives that allow executives to share in the success of Novogen Limited.
|
For a more
comprehensive explanation of the Companys remuneration framework and the remuneration received by directors and key executives in the current period, please refer to the section Compensation above.
There is no plan to provide retirement benefits to executive or
non-executive
directors, except for the Australian
Government Superannuation Guarantee.
The Remuneration and Nomination Committee is responsible for determining and reviewing compensation arrangements for
the directors themselves and the Chief Executive Officer and executive team.
D. Employees
As of the end of each of the last three fiscal years, the Company employed the following number of people:
|
|
|
|
|
|
|
|
|
|
|
|
|
Category of Activity
|
|
Number of People
|
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
Research and Development
|
|
|
10
|
|
|
|
9
|
|
|
|
7
|
|
Finance and Administration
|
|
|
6
|
|
|
|
7
|
|
|
|
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
16
|
|
|
|
16
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Geographic Location
|
|
Number of People
|
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
Australia
|
|
|
15
|
|
|
|
15
|
|
|
|
13
|
|
United States
|
|
|
1
|
|
|
|
1
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
16
|
|
|
|
16
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43
E. Share Ownership
Directors and KMP interests in the shares and options of the Company for fiscal 2017:
Shareholding
The number of shares in the Company held
during fiscal 2017 by each Director and other members of Key Management Personnel of the Company, including their personally related parties, is set out below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the
start of the year
|
|
|
Received as part
of remuneration
|
|
|
Additions
|
|
|
Disposals/
other
|
|
|
Balance at
the end of
the year
|
|
Ordinary shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
B Carmine
|
|
|
318,181
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
318,181
|
|
S Coffey
|
|
|
822,460
|
|
|
|
|
|
|
|
597,540
|
|
|
|
|
|
|
|
1,420,000
|
|
J OConnor (resigned June 8, 2017)*
|
|
|
325,035
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
325,035
|
|
J Garner
|
|
|
150,000
|
|
|
|
|
|
|
|
350,000
|
|
|
|
|
|
|
|
500,000
|
|
I Ross
|
|
|
750,000
|
|
|
|
|
|
|
|
1,450,000
|
|
|
|
|
|
|
|
2,200,000
|
|
I Phillips (resigned June 8, 2017)*
|
|
|
70,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70,000
|
|
A Heaton (resigned March 10, 2017)*
|
|
|
5,165,098
|
|
|
|
|
|
|
|
17,298,662
|
|
|
|
(2,842,633
|
)
|
|
|
19,621,127
|
|
C Humphreys (resigned March 15, 2017)*
|
|
|
183,683
|
|
|
|
|
|
|
|
|
|
|
|
(183,683
|
)
|
|
|
|
|
D Brown (resigned March 10, 2017 )*
|
|
|
3,497,795
|
|
|
|
|
|
|
|
8,166,651
|
|
|
|
|
|
|
|
11,664,446
|
|
K Hill (appointed September 9, 2016)*
|
|
|
|
|
|
|
|
|
|
|
300,000
|
|
|
|
|
|
|
|
300,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,282,252
|
|
|
|
|
|
|
|
28,162,853
|
|
|
|
(3,026,316
|
)
|
|
|
36,418,789
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
Number of shares as at last day of employment with Novogen
|
Option holding
The number of options over ordinary shares in the Company held during fiscal 2017 by each Director and other members of Key Management Personnel of the
Company, including their personally related parties, is set out below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
the start of
the year
|
|
|
Granted
|
|
|
Exercised
|
|
|
Expired/
forfeited/
other
|
|
|
Balance at
the end of
the year
|
|
Options over ordinary shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
J OConnor*
|
|
|
23,218
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,218
|
|
S Coffey*
|
|
|
58,747
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58,747
|
|
J Garner***
|
|
|
7,500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,500,000
|
|
C Humphreys*
|
|
|
7,592
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,592
|
|
C Humphreys**
|
|
|
800,000
|
|
|
|
|
|
|
|
|
|
|
|
(533,333
|
)
|
|
|
266,667
|
|
L Mateo**
|
|
|
500,000
|
|
|
|
|
|
|
|
|
|
|
|
(500,000
|
)
|
|
|
|
|
G Hirsch***
|
|
|
|
|
|
|
2,000,000
|
|
|
|
|
|
|
|
|
|
|
|
2,000,000
|
|
P Leong***
|
|
|
|
|
|
|
2,500,000
|
|
|
|
|
|
|
|
|
|
|
|
2,500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,889,557
|
|
|
|
4,500,000
|
|
|
|
|
|
|
|
(1,033,333
|
)
|
|
|
12,356,224
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
44
*
|
The above listed options were not issued as part of remuneration.
|
**
|
Options issued under the Employee Share Option Plan. Unvested options are forfeited upon cessation of employment with the consolidated entity.
|
***
|
Options issued under the Employee Share Option Plan.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and
exercisable
|
|
|
Vested and
unexercisable
|
|
|
Balance at
the end of
the year
|
|
Options over ordinary shares
|
|
|
|
|
|
|
|
|
|
|
|
|
J OConnor*
|
|
|
23,218
|
|
|
|
|
|
|
|
23,218
|
|
S Coffey*
|
|
|
58,747
|
|
|
|
|
|
|
|
58,747
|
|
C Humphreys*
|
|
|
7,592
|
|
|
|
|
|
|
|
7,592
|
|
C Humphreys
|
|
|
|
|
|
|
266,667
|
|
|
|
266,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89,557
|
|
|
|
266,667
|
|
|
|
356,224
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
The above listed options were not issued as part of remuneration.
|
For all other KMPs, no options were vested
at year end.
In addition to Directors fees, Consultancy fees of $20,531 were paid to Kumara Inc for executive duties. Kumara Inc is a corporation
in which Ian Phillips is a Director and has a beneficial interest.
In addition to Directors fees, Consultancy fees of $37,500 were paid to John
OConnor for executive duties.
Share-based compensation
There were no shares issued to Directors or other KMP as part of compensation during fiscal 2017
Item 7.
|
Major Shareholders and Related Party Transactions
|
A. Major shareholders
As of June 30, 2017, Hishenk Pty Limited beneficially owned 26,900,000 or 5.57% of the total outstanding ordinary shares on issue.
At August 24, 2017 there were 1,739,030 of the Companys ADSs outstanding, representing 173,903,059 ordinary shares (or 35.98% of the then
outstanding ordinary shares). At August 24, 2017 there were 52 registered holders of the Companys ADSs.
There have been no other significant
shareholders in the last three fiscal years.
B. Related party transactions
Other than as disclosed below, during fiscal 2017, we did not enter into any transactions or loans with any: (i) enterprises that directly or indirectly,
through one or more intermediaries, control, are controlled by or are under common control with us; (ii) associates; (iii) individuals owning, directly or indirectly, an interest in our voting power that gives them significant influence over
us, and close members of any such individuals family; (iv) executive officers and close members of such individuals families; or (v) enterprises in which a substantial interest in our voting power is owned, directly or
indirectly, by any person described in (iii) or (iv) or over which such person is able to exercise significant influence.
In addition to
Directors fees, Consultancy fees of $20,531 were paid to Kumara Inc for executive duties. Kumara Inc is a corporation in which Ian Phillips is a Director and has a beneficial interest.
45
In addition to Directors fees, Consultancy fees of $37,500 were paid to John OConnor for executive
duties.
Transactions between related parties are on normal commercial terms and the conditions no more favorable than those available to other
non-related
parties.
C. Interests of Experts and Counsel
Not applicable
Item 8.
|
Financial Information
|
A. Consolidated Statements and Other Financial Information
Consolidated financial statements are included in Item 18. Financial Statements commencing on page
F-1.
Legal proceedings
There are no pending legal
proceedings which either individually or in the aggregate will have a significant effect on the Companys financial position or loss, nor have any such proceedings had any impact in the recent past.
Dividends
There were no dividends paid, recommended or
declared during fiscal years 2017, 2016 or 2015.
B. Significant Changes
No significant change has occurred since the date of the annual financial statements included in this Annual Report on Form
20-F.
Item 9.
|
The Offer and Listing
|
A. Offer and listing details
The following table sets forth, for the calendar periods indicated, the high and low market quotations for Novogens ordinary shares, as quoted on the
ASX, and Novogens ADSs, as quoted on the NASDAQ Capital Market.
46
Novogen Limited share price history
The Companys ordinary shares are traded on the ASX. The following table
sets forth, for the periods indicated, the high and low market quotations for our ordinary shares, as quoted on the ASX.
|
|
|
|
|
|
|
|
|
|
|
Per Ordinary Share (A$)
|
|
|
|
High
|
|
|
Low
|
|
Fiscal Year Ended June 30,
|
|
|
|
|
|
|
|
|
2013
|
|
|
0.47
|
|
|
|
0.06
|
|
2014
|
|
|
0.40
|
|
|
|
0.15
|
|
2015
|
|
|
0.45
|
|
|
|
0.08
|
|
2016
|
|
|
0.30
|
|
|
|
0.10
|
|
2017
|
|
|
0.12
|
|
|
|
0.04
|
|
|
|
|
Quarter Ended:
|
|
|
|
|
|
|
|
|
September 2015
|
|
|
0.30
|
|
|
|
0.14
|
|
December 2015
|
|
|
0.18
|
|
|
|
0.11
|
|
March 2016
|
|
|
0.15
|
|
|
|
0.10
|
|
June 2016
|
|
|
0.14
|
|
|
|
0.10
|
|
September 2016
|
|
|
0.12
|
|
|
|
0.08
|
|
December 2016
|
|
|
0.11
|
|
|
|
0.08
|
|
March 2017
|
|
|
0.11
|
|
|
|
0.05
|
|
June 2017
|
|
|
0.05
|
|
|
|
0.04
|
|
September 2017
|
|
|
0.04
|
|
|
|
0.04
|
|
|
|
|
Month Ended:
|
|
|
|
|
|
|
|
|
April 2017
|
|
|
0.06
|
|
|
|
0.05
|
|
May 2017
|
|
|
0.06
|
|
|
|
0.04
|
|
June 2017
|
|
|
0.05
|
|
|
|
0.04
|
|
July 2017
|
|
|
0.05
|
|
|
|
0.04
|
|
August 2017
|
|
|
0.04
|
|
|
|
0.04
|
|
September 2017
|
|
|
0.04
|
|
|
|
0.04
|
|
47
The ADSs are traded on the NASDAQ Capital Market under the symbol
NVGN. The following table sets forth, for the periods indicated, the high ask and low bid prices of the ADSs on the NASDAQ Capital Market:
|
|
|
|
|
|
|
|
|
|
|
Per ADS (US$)*
|
|
|
|
High
|
|
|
Low
|
|
Fiscal Year Ended June 30
|
|
|
|
|
|
|
|
|
2013
|
|
|
10.49
|
|
|
|
0.76
|
|
2014
|
|
|
6.84
|
|
|
|
3.42
|
|
2015
|
|
|
9.50
|
|
|
|
1.51
|
|
2016
|
|
|
5.35
|
|
|
|
1.79
|
|
2017
|
|
|
3.82
|
|
|
|
0.70
|
|
|
|
|
Quarter Ended:
|
|
|
|
|
|
|
|
|
September 2015
|
|
|
5.35
|
|
|
|
2.32
|
|
December 2015
|
|
|
3.09
|
|
|
|
1.98
|
|
March 2016
|
|
|
2.85
|
|
|
|
1.79
|
|
June 2016
|
|
|
2.67
|
|
|
|
1.81
|
|
September 2016
|
|
|
2.44
|
|
|
|
1.72
|
|
December 2016
|
|
|
1.96
|
|
|
|
1.39
|
|
March 2017
|
|
|
1.90
|
|
|
|
1.27
|
|
June 2017
|
|
|
1.45
|
|
|
|
0.70
|
|
September 2017
|
|
|
3.82
|
|
|
|
0.80
|
|
|
|
|
Month Ended:
|
|
|
|
|
|
|
|
|
April 2017
|
|
|
1.45
|
|
|
|
0.85
|
|
May 2017
|
|
|
1.12
|
|
|
|
0.85
|
|
June 2017
|
|
|
1.00
|
|
|
|
0.70
|
|
July 2017
|
|
|
3.82
|
|
|
|
0.80
|
|
August 2017
|
|
|
3.57
|
|
|
|
3.00
|
|
September 2017
|
|
|
3.24
|
|
|
|
3.00
|
|
*
|
Note the Company effected a change to the ADS ratio on January 3, 2012. The ratio changed from each ADS representing 5 ordinary shares to now representing 25 ordinary shares. On July 14, 2017 this ratio was
changed such that from that date each ADS represents one hundred ordinary Novogen shares. All of the ADS prices presented above have been adjusted to be comparative to the current ratio.
|
B. Plan of Distribution
Not applicable
C. Markets
Novogens principal listing
exchange and the exchange upon which its ordinary shares are quoted is the Australian Securities Exchange (ASX). The trading symbol on ASX is NRT.
Novogens ordinary shares trade in the U.S. in the form of ADSs on the NASDAQ Capital Market. Each ADS represents 100 ordinary shares of Novogen. The
trading symbol on the NASDAQ Capital Market is NVGN. Novogen has entered into a Deposit Agreement with The Bank of New York Mellon under which the Bank of New York, acting as depositary, issues the ADSs.
48
D. Selling Shareholders
Not applicable
E. Dilution
Not applicable
F. Expenses of the issue
Not applicable
Item 10.
|
Additional Information
|
A. Share Capital
Not applicable
B. Memorandum and Articles of Association
Our Constitution is similar in nature to the bylaws of a U.S. corporation. It does not provide for or prescribe any specific objectives or
purposes of Novogen. Our Constitution is subject to the terms of the ASX Listing Rules and the Corporations Act. It may be amended or repealed and replaced by special resolution of shareholders, passed by at least 75% of the votes cast by
shareholders entitled to vote on the resolution.
Under Australian law, a company has the legal capacity and powers of an individual both within and
outside Australia. The material provisions of our Constitution are summarized below. This summary is not intended to be complete nor to constitute a definitive statement of the rights and liabilities of our shareholders, and is qualified in its
entirety by reference to the complete text of our Constitution, a copy of which is filed as Exhibit 1.1 to this Annual Report.
Interested Directors
A director may not vote in respect of any contract or arrangement in which the director has, directly or indirectly, any material interest according
to our Constitution. However, that director may execute or otherwise act in respect of that contract or arrangement notwithstanding any material personal interest. Unless a relevant exception applies, the Corporations Act requires our directors to
provide disclosure of certain interests or conflicts of interests and prohibits directors from voting on matters in which they have a material personal interest. In addition, the Corporations Act and the ASX Listing Rules require shareholder
approval of any provision of related party benefits to our directors.
Directors compensation
Our directors are paid remuneration for their services as directors (but excluding any remuneration payable to a director under any executive services contract
with us or one of our related bodies corporate) which is determined in a general meeting of shareholders. The aggregate, fixed sum for directors remuneration is to be divided among the directors in such proportion as the directors themselves
agree and in accordance with our Constitution. The fixed sum remuneration for directors may not be increased except at a general meeting of shareholders and the particulars of the proposed increase are required to have been provided to shareholders
in the notice convening the meeting. In addition, executive directors may be paid remuneration as employees of Novogen.
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Fees payable to our
non-executive
directors must be by way of a fixed sum
and not by way of a commission on or a percentage of profits or operating revenue. Remuneration paid to our executive directors must also not include a commission or percentage of operating revenue.
Pursuant to our Constitution, any director who performs services that in the opinion of our board of directors, are outside the scope of the ordinary duties
of a director may be paid extra remuneration, which is determined by our board of directors.
In addition to other remuneration provided in our
Constitution, all of our directors are entitled to be paid by us for reasonable travel accommodation and other expenses incurred by the directors in attending general meetings, board meetings, committee meetings or otherwise in connection with our
business.
Borrowing powers exercisable by Directors
Pursuant to our Constitution, the management and control of our business affairs are vested in our board of directors. Our board of directors has the power to
raise or borrow money, and charge any of our property or business or any uncalled capital, and may issue debentures or give any other security for any of our debts, liabilities or obligations or of any other person, in each case, in the manner and
on terms it deems fit.
Retirement of Directors
Pursuant to our Constitution and the ASX Listing Rules, at least one director, other than the managing director, must retire from office at every annual
general meeting. The director who retires in this manner is required to be the director longest in office since last being elected. A director, other than the director who is the Chief Executive Officer, must retire from office at the conclusion of
the third annual general meeting after which the director was elected. Retired directors are eligible for a
re-election
to the board of directors unless disqualified from acting as a director under the
Corporations Act or our Constitution.
Rights and restrictions on classes of shares
The rights attaching to our ordinary shares are detailed in our Constitution. Our Constitution provides that our directors may issue shares with preferred,
deferred or other special rights, whether in relation to dividends, voting, return of share capital or otherwise as our board of directors may determine. Subject to any approval which is required from our shareholders under the Corporations Act and
the ASX Listing Rules, we may issue further shares on such terms and conditions as our board of directors resolve.
Dividend rights
Our board of directors may from time to time determine to pay dividends to shareholders. All dividends unclaimed for one year after having been declared may be
invested or otherwise made use of by our board of directors for our benefit until claimed or otherwise disposed of in accordance with our Constitution.
Voting rights
Under our Constitution, and subject to any
voting exclusions imposed under the ASX Listing Rules (which typically exclude parties from voting on resolutions in which they have an interest), the rights and restrictions attaching to a class of shares, each shareholder has one vote on a show of
hands at a meeting of the shareholders unless a poll is demanded under the Constitution or the Corporations Act. On a poll vote, each shareholder shall have one vote for each fully paid share and a fractional vote for each share held by that
shareholder that is not fully paid, such fraction being equivalent to the proportion of the amount that has been paid to such date on that share. Shareholders may vote in person or by proxy, attorney or representative. Under Australian law,
shareholders of a public company are not permitted to approve corporate matters by written consent. Our Constitution does not provide for cumulative voting. Note that ADS holders may not directly vote at a meeting of the shareholders but may
instruct the depositary to vote the number of deposited ordinary shares their ADSs represent.
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Right to share in our profits
Pursuant to our Constitution, our shareholders are entitled to participate in our profits only by payment of dividends. Our board of directors may from time to
time determine to pay dividends to the shareholders; however, no dividend is payable except in accordance with the thresholds set out in the Corporations Act.
Rights to share in the surplus in the event of liquidation
Our Constitution provides for the right of shareholders to participate in a surplus in the event of our liquidation, subject to the rights attaching to a class
of shares.
No redemption provision for ordinary shares
There are no redemption provisions in our Constitution in relation to ordinary shares. Under our Constitution, any preference shares may be issued on the terms
that they are, or may at our option be, liable to be redeemed.
Variation or cancellation of share rights
Subject to the terms of issue of shares of that class, the rights attached to shares in a class of shares may only be varied or cancelled by either:
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a special resolution passed by members holding shares in the class; or
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the written consent of members with at least 75% of the shares in the class.
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Directors may make calls
Our Constitution provides that subject to the terms on which the shares have been issued directors may make calls on a shareholder for amounts unpaid
on shares held by that shareholder, other than monies payable at fixed times under the conditions of allotment.
General Meetings of Shareholders
General meetings of shareholders may be called by our board of directors. Except as permitted under the Corporations Act, shareholders may not convene
a meeting. The Corporations Act requires the directors to call and arrange to hold a general meeting on the request of shareholders with at least 5% of the votes that may be cast at a general meeting or at least 100 shareholders who are entitled to
vote at the general meeting. Notice of the proposed meeting of our shareholders is required at least 28 days prior to such meeting under the Corporations Act.
Foreign Ownership Regulation
There are no limitations on
the rights to own securities imposed by our Constitution. However, acquisitions and proposed acquisitions of securities in Australian companies may be subject to review and approval by the Australian Federal Treasurer under the Foreign Acquisitions
and Takeovers Act 1975, or the FATA, which generally applies to acquisitions or proposed acquisitions:
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by a foreign person (as defined in the FATA) or associated foreign persons that would result in such persons having an interest in 20% or more of the issued shares of, or control of 20% or more of the voting power in,
an Australian public company; and
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by
non-associated
foreign persons that would result in such foreign persons having an aggregate interest in 40% or more of the issued shares of, or control of 40% or more of the
voting power in, an Australian public company, where the Australian company is valued above the monetary threshold prescribed by FATA.
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However, no such review or approval under the FATA is required if the foreign acquirer is a U.S. entity or an entity from certain other countries and the
value of the target is less than A$1,094 million.
The Australian Federal Treasurer may prevent a proposed acquisition in the above categories or
impose conditions on such acquisition if the Treasurer is satisfied that the acquisition would be contrary to the national interest. If a foreign person acquires shares or an interest in shares in an Australian company in contravention of the FATA,
the Australian Federal Treasurer may order the divestiture of such persons shares or interest in shares in that Australian company.
Ownership
Threshold
There are no provisions in our Constitution that require a shareholder to disclose ownership above a certain threshold. The Corporations
Act, however, requires a shareholder to notify us and the ASX once it, together with its associates, acquires a 5% interest in our ordinary shares, at which point the shareholder will be considered to be a substantial shareholder.
Further, once a shareholder owns a 5% interest in us, such shareholder must notify us and the ASX of any increase or decrease of 1% or more in its holding of our ordinary shares, and must also notify us and the ASX on its ceasing to be a
substantial shareholder. As we are now a U.S. public company, our shareholders are also subject to disclosure requirements under U.S. securities laws.
Issues of Shares and Change in Capital
Subject to our
Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, we may at any time issue shares and grant options or warrants on any terms, with preferred, deferred or other special rights and restrictions and for the
consideration and other terms that the directors determine. Subject to the requirements of our Constitution, the Corporations Act, the ASX Listing Rules and any other applicable law, including relevant shareholder approvals, we may consolidate or
divide our share capital into a larger or smaller number by resolution, reduce our share capital (provided that the reduction is fair and reasonable to our shareholders as a whole and does not materially prejudice our ability to pay creditors) or
buy back our ordinary shares whether under an equal access
buy-back
or on a selective basis.
Change of Control
Takeovers of listed Australian public companies, such as Novogen, are regulated by the Corporations Act, which prohibits the acquisition of a
relevant interest in issued voting shares in a listed company if the acquisition will lead to that persons or someone elses voting power in Novogen increasing from 20% or below to more than 20% or increasing from a starting
point that is above 20% and below 90%, subject to a range of exceptions.
Generally, a person will have a relevant interest in securities if the person:
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is the holder of the securities;
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has power to exercise, or control the exercise of, a right to vote attached to the securities; or
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has the power to dispose of, or control the exercise of a power to dispose of, the securities, including any indirect or direct power or control.
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If, at a particular time, a person has a relevant interest in issued securities and the person:
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has entered or enters into an agreement with another person with respect to the securities;
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has given or gives another person an enforceable right, or has been or is given an enforceable right by another person, in relation to the securities (whether the right is enforceable presently or in the future and
whether or not on the fulfillment of a condition);
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has granted or grants an option to, or has been or is granted an option by, another person with respect to the securities; or
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the other person would have a relevant interest in the securities if the agreement were performed, the right enforced or the option exercised;
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the other person is taken to already have a relevant interest in the securities.
There are a number of exceptions to the above prohibition on acquiring a relevant interest in issued voting shares above 20%. In general terms, some of the
more significant exceptions include:
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when the acquisition results from the acceptance of an offer under a formal takeover bid;
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when the acquisition is conducted on market by or on behalf of the bidder under a takeover bid, the acquisition occurs during the bid period, the bid is for all the voting shares in a bid class and the bid is
unconditional or only conditioned on prescribed matters set out in the Corporations Act;
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when shareholders of Novogen approve the takeover by resolution passed at general meeting;
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an acquisition by a person if, throughout the six months before the acquisition, that person or any other person has had voting power in Novogen of at least 19% and, as a result of the acquisition, none of the relevant
persons would have voting power in Novogen more than three percentage points higher than they had six months before the acquisition;
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when the acquisition results from the issue of securities under a rights issue;
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when the acquisition results from the issue of securities under dividend reinvestment schemes;
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when the acquisition results from the issue of securities under underwriting arrangements;
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when the acquisition results from the issue of securities through operation of law;
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an acquisition that arises through the acquisition of a relevant interest in another listed company which is listed on a prescribed financial market or a financial market approved by ASIC;
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an acquisition arising from an auction of forfeited shares conducted
on-market;
or
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an acquisition arising through a compromise, arrangement, liquidation or
buy-back.
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Breaches of the takeovers provisions of the Corporations Act are criminal offenses. ASIC and the Australian Takeover Panel have a wide range of powers
relating to breaches of takeover provisions, including the ability to make orders canceling contracts, freezing transfers of, and rights attached to, securities, and forcing a party to dispose of securities. There are certain defenses to breaches of
the takeover provisions provided in the Corporations Act.
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Access to and Inspection of Documents
Inspection of our records is governed by the Corporations Act. Any member of the public has the right to inspect or obtain copies of our registers on the
payment of a prescribed fee. Shareholders are not required to pay a fee for inspection of our registers or minute books of the meetings of shareholders. Other corporate records, including minutes of directors meetings, financial records and
other documents, are not open for inspection by shareholders. Where a shareholder is acting in good faith and an inspection is deemed to be made for a proper purpose, a shareholder may apply to the court to make an order for inspection of our books.
C. Material contracts
Convertible Note
Deed Poll and Amendment
On December 4, 2014, the consolidated entity and the convertible note holder (Triaxial) signed a Convertible
Note Deed Poll (Deed) which superseded the precedent Loan Agreement between Triaxial shareholders and the consolidated entity. The Deed extinguishes the liability created by the Loan Agreement, which previously allowed for a cash
settlement and now allows Triaxial to convert their debt into ordinary shares during the current financial year, providing that the Company achieves defined milestones established in the schedule of the Deed. Accordingly the convertible note has
been reclassified as an equity instrument rather than debt instrument.
During the Financial year ended June 30, 2017, the Company reached two
milestones triggering the conversion of a portion of its convertible note as follows;
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on August 11, 2016 the Company announced the submission of an IND application. On September 10, 2016, the Company received a letter from the FDA advising the study may proceed triggering conversion of
20,000,000 ordinary shares.
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on October 31, 2016, the Company announced it had licensed a Phase II ready molecule triggering the conversion of 16,000,000 ordinary shares.
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The remaining portion of the convertible note may be exercised at the holders discretion on completion of Phase II clinical trial or achieving
Breakthrough Designation. Completion will be deemed to occur upon the receipt by the consolidated entity of a signed study report or notification of the designation resulting in the option for the holder to convert A$600,000 face value of
convertible notes into 24,000,000 ordinary shares in the consolidated entity.
There is a possibility for an early conversion of the convertible notes if
a third party acquires more than 50% of the issued capital of the consolidated entity.
D. Exchange controls
Australia has largely abolished exchange controls on investment transactions. The Australian dollar is freely convertible into U.S. dollars. In addition,
(other than as specified under taxation below and certain restrictions imposed under Australian law in relation to dealings with the assets of and transactions with, designated countries, entities and persons specified by the Reserve
Bank of Australia from time to time, including, persons connected with terrorism) there are currently no specific rules or limitations regarding the export from Australia of profits, dividends, capital, or similar funds belonging to foreign
investors, except that certain payments to
non-residents
must be reported to the Australian Transaction Reports and Analysis Centre, which monitors such transactions. However, as mentioned above, the Reserve
Bank of Australia does retain discretion to prevent foreign exchange dealings in certain circumstances under the Australian Banking (Foreign Exchange) Regulations 1959.
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Under Australian law, foreign persons are prohibited from acquiring more than a limited percentage of the
interests in an Australian company without approval from the Australian Treasurer or in certain other limited circumstances. These limitations are set forth in the Australian Foreign Acquisitions and Takeovers Act 1975 (the Foreign Takeovers
Act).
Under the Foreign Takeovers Act, as currently in effect, any foreign person, together with associates, is prohibited from acquiring, without
prior approval from the Australian Treasurer, 15% or more of the voting power (including potential voting power) or issued shares (including rights to issued shares) (Substantial Interest) of an entity such as Novogen, whose total share
value or gross assets (whichever is higher) exceed A$231 million. If the person is a U.S. investor, the A$231 million threshold applies only for investments in prescribed sensitive sectors, otherwise a threshold of A$1,004 million
rather than A$231 million applies. All direct investment by foreign governments and their related entities regardless of the value of the investment, including proposals to establish new businesses, must be notified to the Australian Treasurer.
Where an acquisition is made in breach of these requirements, the Australian Treasurer may make an order requiring the acquirer to dispose of its Substantial Interest within a specified period of time. In addition, if a foreign person acquires a
Substantial Interest in Novogen in circumstances where the above thresholds would be exceeded and as a result the total holdings of all foreign persons and their associates exceeds 40% in aggregate without the approval of the Australian Treasurer,
then the Australian Treasurer may make an order requiring the acquirer to dispose of its Substantial Interest within a specified period of time. The same rule applies if the total holdings of all foreign persons and their associates already exceeds
40% and a foreign person (or its associate) acquires any further interests, including in the course of trading in the secondary market of the ADSs.
Under
the current Australian foreign investment policy, it is unlikely that the Australian Treasurer would make such an order in relation to an acquisition that contravenes the Foreign Takeovers Act where the level of foreign ownership exceeds 40% in the
ordinary course of trading, unless the Australian Treasurer is satisfied that the acquisition is contrary to the national interest. The Foreign Takeovers Act allows foreign persons to seek prior approval of acquisitions of Novogen interests which
could otherwise result in the Australian Treasurer making an order requiring the foreign person to dispose of any Substantial Interest.
If a foreign
person holds more than 15% of the interests of Novogen or if the level of aggregate foreign ownership of Novogen exceeds 40% at any time, Novogen would be considered a foreign person under the Foreign Takeovers Act. In such event, Novogen would be
required to obtain the approval of the Australian Treasurer for Novogen, together with its associates, to acquire: (i) more than 15% of an Australian company or business with a share value or gross assets (whichever is higher) totaling over
A$231 million; or (ii) any direct or indirect ownership interest in Australian urban land. However, as mentioned above, proposals by U.S. investors for investment in
non-sensitive
sectors do not
require notification to the Australian Treasurer or the Australian Treasurers approval unless the amount to be invested or the value of the target Australian company or business exceeds A$1,004 million.
The percentage of foreign ownership of Novogen would also be included in determining the foreign ownership of any Australian company or business in which it
may choose to invest. Novogen has no current plans for any such acquisitions. The Companys Constitution does not contain any additional limitations on a
non-residents
right to hold or vote the
Companys securities.
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E. Taxation
U.S. Taxation
This section describes the material U.S.
federal income tax consequences to a U.S. holder of owning ordinary shares or ADSs. It applies only to ordinary shares or ADSs that are held as capital assets for tax purposes. This section does not apply to a holder of ordinary shares or ADSs that
is a member of a special class of holders subject to special rules, including a dealer in securities, a trader in securities who elects to use a
mark-to-market
method of
accounting for its securities holdings, a
tax-exempt
organization, a life insurance company, a person liable for alternative minimum tax, a person who actually or constructively owns 10 per cent or more
of the voting stock of the company, a person that holds ordinary shares or ADSs as part of a straddle or a hedging or conversion transaction, a person that purchases or sells ordinary shares or ADSs as part of a wash sale for tax purposes, or a
person whose functional currency is not the U.S. dollar.
If a partnership holds the ordinary shares or ADSs, the U.S. federal income tax treatment of a
partner generally will depend on the status of the partner and the tax treatment of the partnership. A partner in a partnership holding the ordinary shares or ADSs should consult its tax adviser with regard to the U.S. federal income tax treatment
of an investment in the ordinary shares or ADSs. This section is in part based on the representations of the Depositary and the assumption that each obligation in the deposit agreement and any related agreement will be performed in accordance with
its terms.
In general, for U.S. federal income tax purposes, a holder of ADSs will be treated as the owner of the ordinary shares represented by those
ADSs. Exchanges of ordinary shares for ADSs, and ADSs for ordinary shares generally will not be subject to U.S. federal income tax.
Distributions
Subject to the passive foreign investment company rules discussed below, U.S. holders generally will include as dividend income the U.S. dollar value
of the gross amount of any distributions of cash or property (without deduction for any withholding tax), other than certain pro rata distributions of ordinary shares, with respect to ordinary shares to the extent the distributions are made from our
current or accumulated earnings and profits, as determined for U.S. federal income tax purposes. A U.S. holder will include the dividend income on the day actually or constructively received by the holder, in the case of ordinary shares, or by the
depositary, in the case of ADSs. We do not intend to maintain calculations of earnings and profits, as determined for U.S. federal income tax purposes. Consequently, any distributions generally will be reported as dividend income.
Dividends paid to a
non-corporate
U.S. holder on shares or ADSs will generally be taxable at the preferential rates
applicable to long-term capital gains provided (a) that certain holding period requirements are satisfied, (b) the U.S.-Australia income tax treaty is a qualified treaty and we are eligible for benefits under the treaty or our ordinary
shares or ADSs are readily tradable on a U.S. securities market, and (c) provided that we were not, in the taxable year prior to the year in which the dividend was paid, and are not, in the taxable year in which the dividend is paid, a PFIC.
The Treaty has been approved for the purposes of the qualified dividend rules and the ADSs are listed on NASDAQ. If, as is likely, the Company is currently a PFIC, any dividends paid to a
non-corporate
U.S.
holder will not qualify for the preferential tax rates ordinarily applicable to qualified dividends. In the case of a corporate U.S. holder, dividends on shares and ADSs are taxed as ordinary income and will not be eligible for the
dividends received deduction generally allowed to U.S. corporations in respect of dividends received from other U.S. corporations.
The amount of any cash
distribution paid in any foreign currency will be equal to the U.S. dollar value of such currency, calculated by reference to the spot rate in effect on the date such distribution is received by the U.S. holder or, in the case of ADSs, by the
Depositary, regardless of whether and when the foreign currency is in fact converted into U.S. dollars. If the foreign currency is converted into U.S. dollars on the date received, the U.S. holder generally should not recognize foreign currency gain
or loss on such conversion. If the foreign currency is not converted into U.S. dollars on the date received, the U.S. holder will have a basis in the foreign currency equal to its U.S. dollar value on the date received, and generally will recognize
foreign currency gain or loss on a subsequent conversion or other disposal of such currency. Such foreign currency gain or loss generally will be treated as U.S. source ordinary income or loss for foreign tax credit limitation purposes.
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Dividends will be income from sources outside the United States, and generally will be passive
category income or, for certain taxpayers, general category income, which are treated separately from each other for the purpose of computing the foreign tax credit allowable to a U.S. holder. In general, a taxpayers ability
to use foreign tax credits may be limited and is dependent on the particular circumstances. U.S. holders should consult their own tax advisers with respect to these matters.
Sale, Exchange or other Disposition of Ordinary Shares or ADSs
Subject to the PFIC rules discussed below, a U.S. holder who sells or otherwise disposes of ordinary shares or ADSs will recognize a capital gain or loss for
U.S. federal income tax purposes equal to the difference between the U.S. dollar value of the amount realized and the holders tax basis, determined in U.S. dollars, in those ordinary shares or ADSs. The gain or loss will generally be income or
loss from sources within the United States for foreign tax credit limitation purposes. The capital gain of a
non-corporate
U.S. holder is generally taxed at preferential rates where the holder has a holding
period greater than 12 months in the shares or ADSs sold. There are limitations on the deductibility of capital losses.
The U.S. dollar value of any
foreign currency received upon a sale or other disposition of ordinary shares or ADSs will be calculated by reference to the spot rate in effect on the date of sale or other disposal (or, in the case of a cash basis or electing accrual basis
taxpayer, at the spot rate of exchange on the settlement date). A U.S. holder will have a tax basis in the foreign currency received equal to that U.S. dollar amount, and generally will recognize foreign currency gain or loss on a subsequent
conversion or other disposal of the foreign currency. This foreign currency gain or loss generally will be treated as U.S. source ordinary income or loss for foreign tax credit limitation purposes. However, if such foreign currency is converted into
U.S. dollars on the date received by the U.S. holder, a cash basis or electing accrual basis U.S. holder should not recognize any gain or loss on such conversion.
Passive Foreign Investment Company
A
non-U.S.
corporation will be a PFIC for U.S. federal income tax purposes for any taxable year if either:
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75 per cent or more of its gross income for such year is passive income which for this purpose generally includes dividends, interest, royalties, rents and gains from commodities and securities
transactions and gains from assets that produce passive income (the Income Test); or
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50 per cent or more of the value of its gross assets (based on an average of the quarterly values of the gross assets) during such year is attributable to assets that produce passive income or are held for the
production of passive income (the Asset Test).
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We believe it is likely the Company qualified as a PFIC for fiscal 2017 and
fiscal 2016. This arose because of the decline in the Companys stock price coupled with the fact that the applicable PFIC rules treat working capital as passive assets for purposes of the PFIC Asset Test. As a consequence, any gain realized on
the sale or other disposition of ordinary shares or ADSs would in general not be treated as a capital gain. Instead, a U.S. holder would be treated as if it had realized such gain and certain excess distributions ratably over its holding
period for the ordinary shares or ADSs and would be taxed at the highest tax rate in effect for each such year to which the gain was allocated, together with an interest charge in respect of the tax attributable to each such year. In addition,
dividends received with respect to ordinary shares or ADSs would not be eligible for the special tax rates applicable to qualified dividend income if the company were a PFIC either in the taxable year of the distribution or the preceding taxable
year, but instead would be taxable under the tax rules described above. Assuming the shares or ADSs are marketable stock, a U.S. holder may mitigate the adverse tax consequences described above by timely electing to be taxed annually on
a
mark-to-market
basis with respect to such shares or ADSs.
Holders of
PFIC stock are subject to additional U.S. information reporting rules. If a U.S. holder owns ordinary shares or ADSs during any year in which we are a PFIC, the U.S. holder generally will be required to file an IRS Form 8621 (Information
Return by a Shareholder of a PFIC or Qualified Electing Fund) with respect to the Company, generally with the U.S. holders federal income tax return for that year.
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U.S. holders should consult their tax advisors with respect to the Companys status as a PFIC, the
availability and desirability of a
mark-to-market
election, and such U.S. holders information reporting obligations.
Australian Tax Considerations
In this section, we
discuss the material Australian income tax, stamp duty and goods and services tax considerations related to the acquisition, ownership and disposal by the absolute beneficial owners of the ordinary shares or ADSs.
It is based upon existing Australian tax law as of the date of this registration statement, which is subject to change, possibly retrospectively. This
discussion does not address all aspects of Australian tax law which may be important to particular investors in light of their individual investment circumstances, such as shares held by investors subject to special tax rules (for example, financial
institutions, insurance companies or tax exempt organizations). In addition, this summary does not discuss any foreign or state tax considerations, other than stamp duty and goods and services tax.
Prospective investors are urged to consult their tax advisors regarding the Australian and foreign income and other tax considerations of the acquisition,
ownership and disposition of the shares. This summary is based upon the premise that the holder is not an Australian tax resident and is not carrying on business in Australia through a permanent establishment (referred to as a
Non-Australian
Shareholder in this summary).
Australian Income Tax
Nature of ADSs for Australian Taxation Purposes
Ordinary
shares represented by ADSs held by a U.S. holder will be treated for Australian taxation purposes as held under a bare trust for such holder. Consequently, the underlying ordinary shares will be regarded as owned by the ADS holder for
Australian income tax and capital gains tax purposes. Dividends paid on the underlying ordinary shares will also be treated as dividends paid to the ADS holder, as the person beneficially entitled to those dividends. Therefore, in the following
analysis we discuss the tax consequences to
Non-Australian
Shareholders which, for Australian taxation purposes, will be the same as to U.S. holders of ADSs.
Taxation of Dividends
Australia operates a dividend
imputation system under which dividends may be declared to be franked to the extent of tax paid on company profits. Fully franked dividends are not subject to dividend withholding tax. Dividends payable to
Non-Australian
Shareholders will be subject to dividend withholding tax, to the extent the dividends are not foreign (i.e.,
non-Australian)
sourced and declared to be
conduit foreign income, or CFI, and are unfranked. Dividend withholding tax will be imposed at 30%, unless a shareholder is a resident of a country with which Australia has a double taxation agreement and qualifies for the benefits of the treaty.
Under the provisions of the current Double Taxation Convention between Australia and the United States, the Australian tax withheld on unfranked dividends that are not CFI paid by us to whom a resident of the United States is beneficially entitled
is limited to 15%.
If a company that is a
Non-Australian
Shareholder directly owns a 10% or more interest, the
Australian tax withheld on unfranked dividends (that are not CFI) paid by us to whom a resident of the United States is beneficially entitled is limited to 5%. In limited circumstances, the rate of withholding can be reduced to zero.
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Tax on Sales or other Dispositions of SharesCapital Gains Tax
Non-Australian
Shareholders will not be subject to Australian capital gains tax on the gain made on a sale or other
disposal of ordinary shares, unless they, together with associates, hold 10% or more of our issued capital, at the time of disposal or for 12 months of the last two years prior to disposal.
Non-Australian
Shareholders who own a 10% or more interest would be subject to Australian capital gains tax if more
than 50% of our assets held directly or indirectly, determined by reference to market value, consists of Australian real property (which includes land and leasehold interests) or Australian mining, quarrying or prospecting rights. The Double
Taxation Convention between the United States and Australia is unlikely to limit the amount of this taxable gain. Australian capital gains tax applies to net capital gains of Foreign Shareholders at the Australian tax rates for
non-Australian
residents, which start at a marginal rate of 32.5%. Net capital gains are calculated after reduction for capital losses, which may only be offset against capital gains.
The 50% capital gains tax discount is not available to
Non-Australian
Shareholders on gains accrued after May 8,
2012. Companies are not entitled to a capital gains tax discount.
Broadly, where there is a disposal of certain taxable Australian property, the
purchaser will be required to withhold and remit to the Australian Taxation Office (ATO) 12.5% of the proceeds from the sale. A transaction is excluded from the withholding requirements in certain circumstances, including where the value
of the taxable Australian property is less than A$750,000, the transaction is an
on-market
transaction conducted on an approved stock exchange, a securities lending, or the transaction is conducted using a
broker operated crossing system. There is also an exception to the requirement to withhold where the ATO Commissioner issues a clearance certificate which broadly certifies that the vendor is not a foreign person. The
Non-Australian
Shareholder may be entitled to receive a tax credit for the tax withheld by the purchaser which they may claim in their Australian income tax return.
Tax on Sales or other Dispositions of SharesShareholders Holding Shares on Revenue Account
Some
Non-Australian
Shareholders may hold ordinary shares on revenue rather than on capital account for example, share
traders. These shareholders may have the gains made on the sale or other disposal of the ordinary shares and/or warrants included in their assessable income under the ordinary income provisions of the income tax law, if the gains are sourced in
Australia.
Non-Australian
Shareholders assessable under these ordinary income provisions in respect of gains made
on ordinary shares held on revenue account would be assessed for such gains at the Australian tax rates for
non-Australian
residents, which start at a marginal rate of 32.5%. Some relief from Australian income
tax may be available to
Non-Australian
Shareholders under the Double Taxation Convention between the United States and Australia.
To the extent an amount would be included in a
Non-Australian
Shareholders assessable income under both the
capital gains tax provisions and the ordinary income provisions, the capital gain amount would generally be reduced, so that the shareholder would not be subject to double tax on any part of the income gain or capital gain.
The comments above in Tax on Sales or Other Dispositions of SharesCapital Gains Tax regarding a purchaser being required to withhold 12.5%
tax on the acquisition of certain taxable Australian property equally applies where the disposal of the Australian real property asset by a foreign resident is likely to generate gains on revenue account, rather than a capital gain.
Dual Residency
If a shareholder is a resident of both
Australia and the United States under those countries domestic taxation laws, that shareholder may be subject to tax as an Australian resident. If, however, the shareholder is determined to be a U.S. resident for the purposes of the Double
Taxation Convention between the United States and Australia, the Australian tax would be subject to limitation by the Double Taxation Convention. Shareholders should obtain specialist taxation advice in these circumstances.
59
Stamp Duty
No Australian stamp duty is payable by Australian residents or
non-Australian
residents on the issue, transfer and/or
surrender of the ADSs or the ordinary shares in Novogen, provided that the shares issued, transferred and/or surrendered do not represent 90% or more of the issued shares in Novogen.
Australian Death Duty
Australia does not have estate or
death duties. As a general rule, no capital gains tax liability is realized upon the inheritance of a deceased persons shares. The disposal of inherited shares by beneficiaries may, however, give rise to a capital gains tax liability if the
gain falls within the scope of Australias jurisdiction to tax.
Goods and Services Tax
The supply of ADSs or ordinary shares in Novogen will not be subject to Australian goods and services tax.
D. Dividends and paying agents
Not applicable
E. Statement by experts
Not applicable
F. Documents on Display
The Company is subject to
the reporting requirements of the Exchange Act that are applicable to a foreign private issuer. Under the Exchange Act, the Company is required to file periodic reports and other information with the SEC. These materials, including this Annual
Report and the exhibits hereto, may be inspected without charge and copied at established rates at the public reference facilities maintained by the SEC at 100 F Street, N.E., Washington, D.C., 20549. Please call the SEC at
1-800-SEC-0330
to obtain information on the operation of the public reference room. Such materials can also be obtained at the
SECs website at
www.sec.gov
.
E. Subsidiary Information
Not applicable
Item 11.
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Quantitative and Qualitative Disclosures about Market Risk
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Interest rate risk
The Companys exposure to market interest rates relate primarily to the investments of cash balances.
The Company has cash reserves held primarily in Australian dollars and places funds on deposit with financial institutions for periods generally not exceeding
three months.
The Company places its deposits with high credit quality financial institutions, and, by policy, limits the amount of credit exposure to
any single counter-party. The Company is averse to principal loss and ensures the safety and preservation of its invested funds by limiting default risk, market risk and reinvestment risk.
60
The Company mitigates default risk by depositing funds with only the safest and highest credit quality financial
institutions and by constantly positioning its portfolio to respond appropriately to a significant reduction in a credit rating of any financial institution.
The Company has no interest rate exposure due to rate changes for long-term debt obligations. The Company primarily enters into debt obligations to support
general corporate purposes, including capital expenditures and working capital needs.
The Company does not consider the effects of interest rate
movements to be a material risk to its financial condition.
For additional disclosure regarding interest rate risk see Item 18. Financial
Statements Note 29 Financial Instruments.
Foreign currency risk
The Company operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the U.S.
dollar. Foreign exchange risk arises from future transactions and recognised assets and liabilities denominated in a currency that is not the entitys functional currency and net investments in foreign operations.
As of June 30, 2017, the Company did not hold derivative financial instruments in managing its foreign currency, however, the Company may from time to
time enter into hedging arrangements where circumstances are deemed appropriate. The Company used natural hedging to reduce the foreign currency risk, which involved processing USD payments from cash held in USD. Foreign subsidiaries with a
functional currency of Australian Dollar (AUD) have exposure to the local currency of these subsidiaries and any other currency these subsidiaries trade in.
For additional disclosure regarding market risk see Item 18. Financial Statements Note 29 Financial Instruments.
Item 12.
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Description of Securities Other than Equity Securities
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A. Debt Securities
Not applicable
B. Warrants and Rights
Not applicable
C. Other Securities
Not applicable
D. American Depositary Shares
The depositary collects its fees for delivery and surrender of American Depositary Shares (ADSs) directly from investors depositing shares or
surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable
property to pay the fees. The depositary may collect its annual fee for depositary services by deductions from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The
depositary may generally refuse to provide
fee-attracting
services until its fees for those services are paid. The depositary may collect any of its fees by deduction from any cash distribution payable to you
that are obligated to pay those fees.
61
From time to time, the depositary may make payments to us to reimburse or share revenue from the fees collected
from you, or waive fees and expenses for services provided, generally relating to costs and expenses arising out of establishment and maintenance of the ADS program. In performing its duties under the deposit agreement, the depositary may use
brokers, dealers or other service providers that are affiliates of the depositary and that may earn or share fees or commissions.
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Persons depositing or withdrawing shares must pay:
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For:
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US$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)
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Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property
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Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates
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US$.02 (or less) per ADS
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Any cash distribution to ADS registered holders
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A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs
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Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS registered holders
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US$.02 (or less) per ADSs per calendar year
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Depositary services
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Registration or transfer fees
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Transfer and registration of shares on the Companys share register to or from the name of the depositary or its agent when you deposit or withdraw shares
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Expenses of the depositary
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Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement)
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Converting foreign currency to U.S. dollars
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Taxes and other governmental charges the depositary or the custodian have to pay on any ADS or share underlying an ADS, for example, stock transfer taxes, stamp duty or withholding taxes
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As necessary
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Any charges incurred by the depositary or its agents for servicing the deposited securities
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As necessary
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62
Note 1. General information
The
financial statements cover the consolidated entity consisting of Novogen Limited and its subsidiaries controlled during the year. The financial statements are presented in Australian dollars, which is Novogen Limiteds functional and
presentation currency.
Novogen Limited is a listed public company limited by shares, incorporated and domiciled in Australia. Its registered
office and principal place of business is:
Level 5
20 George Street
Hornsby NSW 2077
The principal business of Novogen Limited is that of a pharmaceutical drug development business.
The financial statements were authorised for issue, in accordance with a resolution of directors, on 25 October 2017. The directors have the power
to amend and reissue the financial statements.
Note 2. Significant accounting policies
The principal accounting policies adopted in the preparation of the financial statements are set out below. These policies have been consistently applied
to all the years presented, unless otherwise stated
New, revised or amending Accounting Standards and Interpretations adopted
The consolidated entity has adopted all of the new, revised or amending Accounting Standards and Interpretations as issued by the
International Accounting Standards Board that are mandatory in Australia for the current reporting period.
Any new, revised or amending
Accounting Standards or Interpretations that are not yet mandatory have not been early adopted.
F-10
Note 2. Significant accounting policies (continued)
Any significant impact on the accounting policies of the consolidated entity from the adoption of these
Accounting Standards and Interpretations are disclosed below. The adoption of these Accounting Standards and Interpretations did not have any significant impact on the financial performance or position of the consolidated entity.
Going concern
The consolidated entity
incurred a loss after income tax of $10,670,377 (2016: $12,154,527), was in a net current asset position of $14,096,234 (2016: net current asset position of $32,657,767) and had net cash outflows from operating activities of $11,434,698 (2016:
$11,978,329) for the year ended 30 June 2017.
As at 30 June 2017 the consolidated entity had cash in hand and at bank of
$14,454,784.
The financial statements have been prepared on a going concern basis, which contemplates continuity of normal activities and
realisation of assets and settlement of liabilities in the normal course of business. As is often the case with drug development companies, the ability of the consolidated entity to continue its development activities as a going concern is dependent
upon it deriving sufficient cash from investors, from licensing and partnering activities and from other sources of revenue such as grant funding.
The directors have considered the cash flow forecasts and the funding requirements of the business and are confident that the strategies in place are appropriate to generate sufficient funding to allow
the consolidated entity to continue as a going concern. Accordingly the directors have prepared the financial statements on a going concern basis.
Should the above assumptions not prove to be appropriate, there is material uncertainty whether the consolidated entity will continue as a going concern and therefore whether it will realise its assets
and extinguish its liabilities in the normal course of business and at the amounts stated in these financial statements.
Basis of
preparation
These financial statements comply with International Financial Reporting Standards as issued by the International Accounting
Standards Board (IASB).
Historical cost convention
The financial statements have been prepared under the historical cost convention, except for derivative financial instruments and
available-for-sale
financial assets, which are at fair value.
Critical accounting estimates
The
preparation of the financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the consolidated entitys accounting policies. The areas
involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements, are disclosed in note 3.
Principles of consolidation
The consolidated financial statements incorporate the assets
and liabilities of all subsidiaries of Novogen Limited (Company or parent entity) as at 30 June 2017 and the results of all subsidiaries for the year then ended. Novogen Limited and its subsidiaries together are referred
to in these financial statements as the consolidated entity.
Subsidiaries are all those entities over which the consolidated
entity has control. The consolidated entity controls an entity when the consolidated entity is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power to
direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the consolidated entity. They are
de-consolidated
from the date that control ceases.
F-11
Note 2. Significant accounting policies (continued)
Intercompany transactions, balances and unrealised gains on transactions between entities in the
consolidated entity are eliminated. Unrealised losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure
consistency with the policies adopted by the consolidated entity.
The acquisition of subsidiaries is accounted for using the acquisition
method of accounting. A change in ownership interest, without the loss of control, is accounted for as an equity transaction, where the difference between the consideration transferred and the book value of the share of the
non-controlling
interest acquired is recognised directly in equity attributable to the parent.
Non-controlling
interest in the results and equity of subsidiaries are shown separately in the statement of profit or loss and other comprehensive income, statement of financial position and statement of changes in
equity of the consolidated entity. Losses incurred by the consolidated entity are attributed to the
non-controlling
interest in full, even if that results in a deficit balance.
Where the consolidated entity loses control over a subsidiary, it derecognises the assets including goodwill, liabilities and
non-controlling
interest in the subsidiary together with any cumulative translation differences recognised in equity. The consolidated entity recognises the fair value of the consideration received and the fair
value of any investment retained together with any gain or loss in profit or loss.
F-12
Note 2. Significant accounting policies (continued)
Operating segments
Operating segments are presented using the management approach, where the information presented is on the same basis as the internal reports provided to the Chief Operating Decision Makers
(CODM). The CODM is responsible for the allocation of resources to operating segments and assessing their performance.
Foreign
currency translation
The financial statements are presented in Australian dollars, which is Novogen Limiteds functional and
presentation currency.
Foreign currency transactions
Foreign currency transactions are translated into Australian dollars using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement
of such transactions and from the translation at financial
year-end
exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in profit or loss.
Foreign operations
The assets and
liabilities of foreign operations are translated into Australian dollars using the exchange rates at the reporting date. The revenues and expenses of foreign operations are translated into Australian dollars using the average exchange rates, which
approximate the rate at the date of the transaction, for the period. All resulting foreign exchange differences are recognised in other comprehensive income through the foreign currency reserve in equity.
The foreign currency reserve is recognised in profit or loss when the foreign operation or net investment is disposed of.
Exchange differences arising on a monetary item that forms part of a reporting entitys net investment in a foreign operation shall be recognised
initially in other comprehensive income and reclassified from equity to profit or loss on disposal of the
net investment.
Revenue recognition
Revenue is
recognised when it is probable that the economic benefit will flow to the consolidated entity and the revenue can be reliably measured. In determining the economic benefits, provisions are made for certain trade discounts and returned goods. The
following specific recognition criteria must also be met:
Interest
Interest revenue is recognised as interest accrues using the effective interest method. This is a method of calculating the amortised cost of a financial asset and allocating the interest income over the
relevant period using the effective interest rate, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to the net carrying amount of the financial asset.
Other revenue
Other revenue is
recognised when it is received or when the right to receive payment is established.
Income tax
The income tax expense or benefit for the period is the tax payable on that periods taxable income based on the applicable income tax rate for each
jurisdiction, adjusted by changes in deferred tax assets and liabilities attributable to temporary differences, unused tax losses and the adjustment recognised for prior periods, where applicable.
Deferred tax assets and liabilities are recognised for temporary differences at the tax rates expected to apply when the assets are recovered or
liabilities are settled, based on those tax rates that are enacted or substantively enacted, except for:
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When the deferred income tax asset or liability arises from the initial recognition of goodwill or an asset or liability in a transaction that is not a
business combination and that, at the time of the transaction, affects neither the accounting nor taxable profits; or
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When the taxable temporary difference is associated with interests in subsidiaries, associates or joint ventures, and the timing of the reversal can be
controlled and it is probable that the temporary difference will not reverse in the foreseeable future.
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F-13
Note 2. Significant accounting policies (continued)
Deferred tax assets are recognised for deductible temporary differences and unused tax losses only if it
is probable that future taxable amounts will be available to utilise those temporary differences and losses.
Deferred tax assets and
liabilities are offset only where there is a legally enforceable right to offset current tax assets against current tax liabilities and deferred tax assets against deferred tax liabilities; and they relate to the same taxable authority on either the
same taxable entity or different taxable entities which intend to settle simultaneously.
The R&D Tax Incentive is an Australian
government run program which helps to offset some of the costs of R&D. Annually, the consolidated entity claims a refundable tax offset and has disclosed this as other income in the statement of profit or loss and other comprehensive income. The
group currently accounts for R&D Tax Incentive on a cash basis due to the difficulty of making reasonable estimation as at year end.
Novogen Limited (the head entity) and its wholly-owned Australian controlled entities have formed an income tax consolidated group under the
Australian tax consolidation regime. Novogen Limited as the head entity discloses all of the deferred tax assets of the tax consolidated group in relation to tax losses carried forward (after elimination of inter-group transactions). The tax
consolidated group has applied the separate taxpayer in the group allocation approach in determining the appropriate amount of taxes to allocate to members of the tax consolidated group.
As the tax consolidation group continues to generate tax losses there has been no reason for the Company to enter a tax funding agreement with members of
the tax consolidation group.
Current and
non-current
classification
Assets and liabilities are presented in the statement of financial position based on current and
non-current
classification.
An asset is current when: it is expected to be realised or intended to be sold or consumed in normal operating cycle; it is
held primarily for the purpose of trading; it is expected to be realised within 12 months after the reporting period; or the asset is cash or cash equivalent unless restricted from being exchanged or used to settle a liability for at least 12 months
after the reporting period. All other assets are classified as
non-current.
A liability is current
when: it is expected to be settled in normal operating cycle; it is held primarily for the purpose of trading; it is due to be settled within 12 months after the reporting period; or there is no unconditional right to defer the settlement of the
liability for at least 12 months after the reporting period. All other liabilities are classified as
non-current.
Deferred tax assets and liabilities are always classified as
non-current.
Cash and cash equivalents
Cash and cash equivalents includes cash on hand, deposits held
at call with financial institutions, other short-term, highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in
value.
Trade and other receivables
Trade receivables are initially recognised at fair value and subsequently measured at amortised cost using the effective interest method, less any provision for impairment. Trade receivables are generally
due for settlement within 30 to 60 days.
Collectability of trade receivables is reviewed on an ongoing basis. Debts which are known to be
uncollectable are written off by reducing the carrying amount directly. A provision for impairment of trade receivables is raised when there is objective evidence that the consolidated entity will not be able to collect all amounts due according to
the original terms of the receivables. Significant financial difficulties of the debtor, probability that the debtor will enter bankruptcy or financial reorganisation and default or delinquency in payments (more than 120 days overdue) are considered
indicators that the trade receivable may be impaired. The amount of the impairment allowance is the difference between the assets carrying amount and the present value of estimated future cash flows, discounted at the original effective
interest rate. Cash flows relating to short-term receivables are not discounted if the effect of discounting is immaterial.
Other
receivables are recognised at amortised cost, less any provision for impairment.
F-14
Note 2. Significant accounting policies (continued)
Investments and other financial assets
Investments and other financial assets are initially measured at fair value. Transaction costs are included as part of the initial measurement, except for financial assets at fair value through profit or
loss. They are subsequently measured at either amortised cost or fair value depending on their classification. Classification is determined based on the purpose of the acquisition and subsequent reclassification to other categories is restricted.
Financial assets are derecognised when the rights to receive cash flows from the financial assets have expired or have been transferred and
the consolidated entity has transferred substantially all the risks and rewards of ownership.
Loans and receivables
Loans and receivables are
non-derivative
financial assets with fixed or determinable payments that are not quoted
in an active market. They are carried at amortised cost using the effective interest rate method. Gains and losses are recognised in profit or loss when the asset is derecognised or impaired.
Available-for-sale
financial assets
Available-for-sale
financial assets are
non-derivative
financial assets, principally
equity securities, that are either designated as
available-for-sale
or not classified as any other category. After initial recognition, fair value movements are
recognised in other comprehensive income through the
available-for-sale
reserve in equity. Cumulative gain or loss previously reported in the
available-for-sale
reserve is recognised in profit or loss when the asset is derecognised or impaired.
Impairment of financial assets
The consolidated entity assesses at the end of each
reporting period whether there is any objective evidence that a financial asset or group of financial assets is impaired. Objective evidence includes significant financial difficulty of the issuer or obligor; a breach of contract such as default or
delinquency in payments; the lender granting to a borrower concessions due to economic or legal reasons that the lender would not otherwise do; it becomes probable that the borrower will enter bankruptcy or other financial reorganisation; the
disappearance of an active market for the financial asset; or observable data indicating that there is a measurable decrease in estimated future cash flows.
The amount of the impairment allowance for loans and receivables carried at amortised cost is the difference between the assets carrying amount and the present value of estimated future cash flows,
discounted at the original effective interest rate. If there is a reversal of impairment, the reversal cannot exceed the amortised cost that would have been recognised had the impairment not been made and is reversed to profit or loss.
Available-for-sale
financial assets are considered impaired when there
has been a significant or prolonged decline in value below initial cost. Subsequent increments in value are recognised in other comprehensive income through the
available-for-sale
reserve.
Property, plant and equipment
Plant and equipment is stated at historical cost less accumulated depreciation and impairment. Historical cost includes expenditure that
is directly attributable to the acquisition of the items.
Depreciation is calculated on a straight-line basis to write off the net cost of
each item of plant and equipment over their expected useful lives from 2.5 to 10 years.
Leasehold improvements and plant and equipment under
lease are depreciated over the
9-year
period of the lease (including options to extend) or the estimated useful life of the assets, whichever is shorter.
The residual values, useful lives and depreciation methods are reviewed, and adjusted if appropriate, at each reporting date.
An item of property, plant and equipment is derecognised upon disposal or when there is no future economic benefit to the consolidated entity. Gains and
losses between the carrying amount and the disposal proceeds are taken to profit or loss.
F-15
Note 2. Significant accounting policies (continued)
Research and development
Expenditure during the research phase of a project is recognised as an expense when incurred. Development costs are capitalised only when technical feasibility studies identify that the project will
deliver future economic benefits and these benefits can be measured reliably.
Leases
The determination of whether an arrangement is or contains a lease is based on the substance of the arrangement and requires an assessment of whether the
fulfilment of the arrangement is dependent on the use of a specific asset or assets and the arrangement conveys a right to use the asset.
A
distinction is made between finance leases, which effectively transfer from the lessor to the lessee substantially all the risks and benefits incidental to ownership of leased assets, and operating leases, under which the lessor effectively retains
substantially all such risks and benefits.
Finance leases are capitalised. A lease asset and liability are established at the fair value of
the leased assets, or if lower, the present value of minimum lease payments. Lease payments are allocated between the principal component of the lease liability and the finance costs, so as to achieve a constant rate of interest on the remaining
balance of the liability.
Leased assets acquired under a finance lease are depreciated over the assets useful life or over the shorter
of the assets useful life and the lease term if there is no reasonable certainty that the consolidated entity will obtain ownership at the end of the lease term.
Operating lease payments, net of any incentives received from the lessor, are charged to profit or loss on a straight-line basis over the term of the lease.
Intangible assets
Intangible assets
acquired as part of a business combination, other than goodwill, are initially measured at their fair value at the date of the acquisition. Intangible assets acquired separately are initially recognised at cost. Indefinite life intangible assets are
not amortised and are subsequently measured at cost less any impairment. Finite life intangible assets are subsequently measured at cost less amortisation and any impairment. The gains or losses recognised in profit or loss arising from the
derecognition of intangible assets are measured as the difference between net disposal proceeds and the carrying amount of the intangible asset. The method and useful lives of finite life intangible assets are reviewed annually. Changes in the
expected pattern of consumption or useful life are accounted for prospectively by changing the amortisation method or period.
Patents and
intellectual property
Significant costs associated with patents and intellectual property are deferred and amortised on a straight-line
basis over the period of their expected benefit, being their finite useful life of five years.
Software
Amortisation is calculated on a straight-line basis to write off the net cost of each item of software over their expected useful lives from 2.5 to 10
years.
Impairment of
non-financial
assets
Non-financial
assets with finite useful lives are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognised for the amount by which the assets carrying amount exceeds its recoverable amount.
Recoverable amount is the higher of an assets fair value less costs of disposal and
value-in-use.
The
value-in-use
is the present value of the estimated future cash flows
relating to the asset using a
pre-tax
discount rate specific to the asset or cash-generating unit to which the asset belongs. Assets that do not have independent cash flows are grouped together to form a
cash-generating unit.
F-16
Note 2. Significant accounting policies (continued)
Trade and other payables
These amounts represent liabilities for goods and services provided to the consolidated entity prior to the end of the financial year and which are unpaid. Due to their short-term nature they are measured
at amortised cost and are not discounted. The amounts are unsecured and are usually paid within 30 days of recognition.
Compound financial
instruments
Compound financial instruments issued by the consolidated entity comprise convertible notes that can be converted to share
capital at the option of the holder, and the number of shares does not vary with changes in fair value. The liability component of a financial liability is recognised at the fair value of a similar liability that does not have an equity conversion
option. The equity component is recognised initially at the difference between the fair value of the compound financial instrument as a whole and the fair value of the liability component. Any directly attributable transaction costs are allocated to
the liability and equity components in proportion to their initial carrying amounts.
Subsequent to initial recognition, the liability
component of a compound financial instrument is measured at amortised cost using the effective interest rate method, whereas the equity component is not remeasured. Interest, gains and losses relating to the financial liability are recognised in
profit or loss. On conversion, the financial liability is reclassified to equity; no gain or loss is recognised on conversion.
Finance
costs
Finance costs attributable to qualifying assets are capitalised as part of the asset. All other finance costs are expensed in the
period in which they are incurred, including interest on short-term and long-term borrowings.
Provisions
Provisions are recognised when the consolidated entity has a present (legal or constructive) obligation as a result of a past event, it is probable the
consolidated entity will be required to settle the obligation, and a reliable estimate can be made of the amount of the obligation. The amount recognised as a provision is the best estimate of the consideration required to settle the present
obligation at the reporting date, taking into account the risks and uncertainties surrounding the obligation. If the time value of money is material, provisions are discounted using a current
pre-tax
rate
specific to the liability. The increase in the provision resulting from the passage of time is recognised as a finance cost.
Employee
benefits
Short-term employee benefits
Liabilities for wages and salaries, including
non-monetary
benefits, annual leave and long service leave expected to be settled within 12 months of the reporting
date are measured at the amounts expected to be paid when the liabilities are settled.
Other long-term employee benefits
The liability for annual leave and long service leave not expected to be settled within 12 months of the reporting date is measured as the present value
of expected future payments to be made in respect of services provided by employees up to the reporting date using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures
and periods of service. Expected future payments are discounted using market yields at the reporting date on national government bonds with terms to maturity and currency that match, as closely as possible, the estimated future cash outflows.
Defined contribution superannuation expense
Contributions to defined contribution superannuation plans are expensed in the period in which they are incurred.
Share-based payments
Equity-settled share-based compensation benefits are provided to
employees under the terms of the Employee Share Option Plan (ESOP) and consultants as compensation for services performed.
Equity-settled transactions are awards of shares, or options over shares, that are provided to employees in exchange for the rendering of services.
F-17
Note 2. Significant accounting policies (continued)
The cost of equity-settled transactions are measured at fair value on grant date. Fair value is
independently determined using the Binomial option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the
expected dividend yield and the risk free interest rate for the term of the option, together with
non-vesting
conditions that do not determine whether the consolidated entity receives the services that entitle
the employees to receive payment. No account is taken of any other vesting conditions.
The cost of equity-settled transactions are recognised
as an expense with a corresponding increase in equity over the vesting period. The cumulative charge to profit or loss is calculated based on the grant date fair value of the award, the best estimate of the number of awards that are likely to vest
and the expired portion of the vesting period. The amount recognised in profit or loss for the period is the cumulative amount calculated at each reporting date less amounts already recognised in previous periods.
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during the vesting period, the liability at each reporting date is the fair value of the award at that date multiplied by the expired portion of the
vesting period.
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|
|
from the end of the vesting period until settlement of the award, the liability is the full fair value of the liability at the reporting date.
|
Market conditions are taken into consideration in determining fair value. Therefore, any awards subject to market
conditions are considered to vest irrespective of whether or not that market condition has been met, provided all other conditions are satisfied.
If equity-settled awards are modified, as a minimum an expense is recognised as if the modification has not been made. An additional expense is recognised, over the remaining vesting period, for any
modification that increases the total fair value of the share-based compensation benefit as at the date of modification.
If the
non-vesting
condition is within the control of the consolidated entity or employee, the failure to satisfy the condition is treated as a cancellation. If the condition is not within the control of the consolidated
entity or employee and is not satisfied during the vesting period, any remaining expense for the award is recognised over the remaining vesting period, unless the award is forfeited.
If equity-settled awards are cancelled, it is treated as if it has vested on the date of cancellation, and any remaining expense is recognised immediately. If a new replacement award is substituted for
the cancelled award, the cancelled and new award is treated as if they were a modification.
Fair value measurement
When an asset or liability, financial or
non-financial,
is measured at fair value for recognition or disclosure
purposes, the fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date; and assumes that the transaction will take place
either: in the principal market; or in the absence of a principal market, in the most advantageous market.
Fair value is measured using the
assumptions that market participants would use when pricing the asset or liability, assuming they act in their economic best interest. For
non-financial
assets, the fair value measurement is based on its
highest and best use. Valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, are used, maximising the use of relevant observable inputs and minimising the use of unobservable
inputs.
Assets and liabilities measured at fair value are classified, into three levels, using a fair value hierarchy that reflects the
significance of the inputs used in making the measurements. Classifications are reviewed each reporting date and transfers between levels are determined based on a reassessment of the lowest level input that is significant to the fair value
measurement.
F-18
Note 2. Significant accounting policies (continued)
For recurring and
non-recurring
fair value measurements,
external valuers may be used when internal expertise is either not available or when the valuation is deemed to be significant. External valuers are selected based on market knowledge and reputation. Where there is a significant change in fair value
of an asset or liability from one period to another, an analysis is undertaken, which includes a verification of the major inputs applied in the latest valuation and a comparison, where applicable, with external sources of data.
Issued capital
Ordinary shares are
classified as equity.
Incremental costs directly attributable to the issue of new shares or options are shown in equity as a deduction, net
of tax, from the proceeds.
Earnings per share
Basic earnings per share
Basic earnings per share is calculated by dividing the profit
attributable to the owners of Novogen Limited, excluding any costs of servicing equity other than ordinary shares, by the weighted average number of ordinary shares outstanding during the financial year, adjusted for bonus elements in ordinary
shares issued during the financial year.
Diluted earnings per share
Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account the after income tax effect of interest and other financing costs associated with
dilutive potential ordinary shares and the weighted average number of shares assumed to have been issued for no consideration in relation to dilutive potential ordinary shares.
Goods and Services Tax (GST) and other similar taxes
Revenues, expenses and
assets are recognised net of the amount of associated GST, unless the GST incurred is not recoverable from the tax authority. In this case it is recognised as part of the cost of the acquisition of the asset or as part of the expense.
Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the tax
authority is included in other receivables or other payables in the statement of financial position.
Cash flows are presented on a gross
basis. The GST components of cash flows arising from investing or financing activities which are recoverable from, or payable to the tax authority, are presented as operating cash flows.
Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the tax authority.
Rounding of amounts
Amounts in these financial statements have been rounded to the nearest
thousand dollars, or in certain cases, the nearest dollar.
F-19
Note 2. Significant accounting policies (continued)
New Accounting Standards and Interpretations not yet mandatory or early adopted
Accounting Standards and Interpretations that have recently been issued or amended but are not yet mandatory, have not been early adopted by the
consolidated entity for the annual reporting period ended 30 June 2017. The consolidated entitys assessment of the impact of these new or amended Accounting Standards and Interpretations, most relevant to the consolidated entity, are set
out below.
IFRS 9 Financial Instruments and its consequential amendments
This standard and its consequential amendments are applicable to annual reporting periods beginning on or after 1 January 2018 and completes phases I
and III of the IASBs project to replace IAS 39 Financial Instruments:Recognition and Measurement. This standard introduces new classification and measurement models for financial assets, using a single approach to determine whether
a financial asset is measured at amortised cost or fair value. The accounting for financial liabilities continues to be classified and measured in accordance with IAS 139, with one exception, being that the portion of a change of fair value relating
to the entitys own credit risk is to be presented in other comprehensive income unless it would create an accounting mismatch. Chapter 6 Hedge Accounting supersedes the general hedge accounting requirements in IAS 139 and provides
a new simpler approach to hedge accounting that is intended to more closely align with risk management activities undertaken by entities when hedging financial and
non-financial
risks.
The consolidated entity will adopt this standard and the amendments from 1 July 2018. The entity is yet to undertake a detailed assessment of the
impact of IFRS 9. However, based on the entitys preliminary assessment, the Standard is not expected to have a material impact on the transactions and balances recognised in the financial statements when it is first adopted for the year ending
30 June 2019.
IFRS 15 Revenue from Contracts with Customers
This standard is expected to be applicable to annual reporting periods beginning on or after 1 January 2018. The standard provides a single standard for revenue recognition. The core principle of the
standard is that an entity will recognise revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The
standard will require: contracts (either written, verbal or implied) to be identified, together with the separate performance obligations within the contract; determine the transaction price, adjusted for the time value of money excluding credit
risk; allocation of the transaction price to the separate performance obligations on a basis of relative stand-alone selling price of each distinct good or service, or estimation approach if no distinct observable prices exist; and recognition of
revenue when each performance obligation is satisfied. Credit risk will be presented separately as an expense rather than adjusted to revenue. For goods, the performance obligation would be satisfied when the customer obtains control of the goods.
For services, the performance obligation is satisfied when the service has been provided, typically for promises to transfer services to customers. For performance obligations satisfied over time, an entity would select an appropriate measure of
progress to determine how much revenue should be recognised as the performance obligation is satisfied. Contracts with customers will be presented in an entitys statement of financial position as a contract liability, a contract asset, or a
receivable, depending on the relationship between the entitys performance and the customers payment. Sufficient quantitative and qualitative disclosure is required to enable users to understand the contracts with customers; the
significant judgments made in applying the guidance to those contracts; and any assets recognised from the costs to obtain or fulfil a contract with a customer.
The consolidated entity will adopt this standard and the amendments from 1 July 2018. Based on the entitys assessment, when this Standard is first adopted for the year ending 30 June 2019,
there will be no material impact on the transactions and balances recognised in the financial statements. This is because the entity is still in the R&D stage of its development and is not anticipating generating material revenue streams during
the year ending 30 June 2019.
F-20
Note 2. Significant accounting policies (continued)
IFRS 16 Leases
This standard is applicable to annual reporting periods beginning on or after 1 January 2019. The standard replaces IAS 17 Leases and for lessees will eliminate the classifications of
operating leases and finance leases. Subject to exceptions, a
right-of-use
asset will be capitalised in the statement of financial position, measured as the
present value of the unavoidable future lease payments to be made over the lease term. The exceptions relate to short-term leases of 12 months or less and leases of
low-value
assets (such as personal computers
and small office furniture) where an accounting policy choice exists whereby either a
right-of-use
asset is recognised or lease payments are expensed to
profit or loss as incurred. A liability corresponding to the capitalised lease will also be recognised, adjusted for lease prepayments, lease incentives received, initial direct costs incurred and an estimate of any future restoration, removal or
dismantling costs. Straight-line operating lease expense recognition will be replaced with a depreciation charge for the leased asset (included in operating costs) and an interest expense on the recognised lease liability (included in finance
costs). In the earlier periods of the lease, the expenses associated with the lease under IFRS 16 will be higher when compared to lease expenses under IAS 17. However, EBITDA (Earnings Before Interest, Tax, Depreciation and Amortisation) results
will be improved as the operating expense is replaced by interest expense and depreciation in profit or loss under IFRS 16. For classification within the statement of cash flows, the lease payments will be separated into both a principal (financing
activities) and interest (either operating or financing activities) component. For lessor accounting, the standard does not substantially change how a lessor accounts for leases. The entity is yet to undertake a detailed assessment of the impact of
IFRS 16. However, based on the entitys preliminary assessment,
taking into account the leases in place, the Standard is not expected to have a material impact on the transactions and balances recognised in the financial statements when
it is first adopted for the year ending 30 June 2020.
Note 3. Critical accounting judgements, estimates and assumptions
The preparation of the financial statements requires management to make judgements, estimates and assumptions that affect the reported
amounts in the financial statements. Management continually evaluates its judgements and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgements, estimates and assumptions on
historical experience and on other various factors, including expectations of future events, management believes to be reasonable under the circumstances. The resulting accounting judgements and estimates will seldom equal the related actual
results. The judgements, estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities (refer to the respective notes) within the next financial year are discussed below.
Research and development expenses
The directors do not consider the development programs to be sufficiently advanced to reliably determine the economic benefits and technical feasibility to justify capitalisation of development costs.
These costs have been recognised as an expense when incurred.
Research and development expenses relate primarily to the cost of conducting
human clinical and
pre-clinical
trials. Clinical development costs are a significant component of research and development expenses. Estimates have been used in determining the expense liability under certain
clinical trial contracts where services have been performed but not yet invoiced. Generally, the costs, and therefore estimates, associated with clinical trial contracts are based on the number of patients, drug administration cycles, the type of
treatment and the outcome being measured. The length of time before actual amounts can be determined will vary depending on length of the patient cycles and the timing of the invoices by the clinical trial partners.
Clinical trial expenses
Estimates have
been used in determining the expense liability under certain clinical trial contracts performed but not yet invoiced.
F-21
Note 3. Critical accounting judgements, estimates and assumptions (continued)
Share-based payment transactions
The consolidated entity measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is
determined by using the Binomial model taking into account the terms and conditions upon which the instruments were granted. The accounting estimates and assumptions relating to equity-settled share-based payments would have no impact on the
carrying amounts of assets and liabilities within the next annual reporting period but may impact profit or loss and equity.
Fair value
measurement hierarchy
The consolidated entity is required to classify all assets and liabilities, measured at fair value, using a three
level hierarchy, based on the lowest level of input that is significant to the entire fair value measurement, being: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the
measurement date; Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly; and Level 3: Unobservable inputs for the asset or liability.
Considerable judgement is required to determine what is significant to fair value and therefore which category the asset or liability is placed in can be subjective.
Research and development tax rebate
The R&D Tax Incentive is recognised when a
reliable estimate of the amounts receivable can be made. For the year ended 30 June 2017 the group has estimated the rebate which will be received in early 2018 and has accrued that amount as income in the statement of profit or loss and other
comprehensive income.
Recovery of deferred tax assets
Deferred tax assets are recognised for deductible temporary differences only if the consolidated entity considers it is probable that future taxable amounts will be available to utilise those temporary
differences and losses.
Net investment in foreign operations
In managements view, repayment of the Novogen, Inc. intercompany loan, which has been merged into Novogen North America, Inc., is neither planned nor likely to occur in the foreseeable future, thus
it has been treated as a net investment in foreign operations. Exchange differences arising on a monetary item that forms part of the net investment in a foreign operation is recognised initially in other comprehensive income and reclassified from
equity to profit or loss on disposal of the net investment.
Contingent consideration
Management uses valuation techniques in determining the fair values of the various elements of a business combination (see Note 36). Particularly, the
fair value of contingent consideration is dependent on the key assumptions including probability of milestones occurring, timing of settlement and discount rates.
Note 4. Operating segments
Identification of reportable operating segments
The consolidated entitys operating segment is based on the internal reports that are reviewed and used by the Board of Directors
(being the Chief Operating Decision Makers (CODM)) in assessing performance and in determining the allocation of resources.
The
consolidated entity operates in the pharmaceutical research and development business. There are no operating segments for which discrete financial information exists.
The information reported to the CODM, on at least a monthly basis, is the consolidated results as shown in the statement of profit or loss and other comprehensive income and statement of financial
position.
Major customers
During the years ended 30 June 2017, 30 June 2016 and 30 June 2015 there were no major customers.
F-22
Note 5. Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
From continuing operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
Bank interest
|
|
|
249
|
|
|
|
406
|
|
|
|
89
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
249
|
|
|
|
406
|
|
|
|
89
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from continuing operations
|
|
|
249
|
|
|
|
406
|
|
|
|
89
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 6. Other income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
Net foreign exchange gain
|
|
|
|
|
|
|
781
|
|
|
|
1,116
|
|
Payroll tax rebate
|
|
|
7
|
|
|
|
18
|
|
|
|
8
|
|
Research and development rebate
|
|
|
8,409
|
|
|
|
2,866
|
|
|
|
1,538
|
|
Reimbursement of expenses
|
|
|
17
|
|
|
|
|
|
|
|
|
|
Subsidies and grants
|
|
|
130
|
|
|
|
|
|
|
|
91
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
|
|
|
8,563
|
|
|
|
3,665
|
|
|
|
2,753
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 7. Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
Loss before income tax from continuing operations includes the following specific expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
|
|
|
|
|
|
|
|
|
|
Leasehold improvements
|
|
|
52
|
|
|
|
30
|
|
|
|
|
|
Property, plant and equipment
|
|
|
47
|
|
|
|
43
|
|
|
|
5
|
|
|
|
|
|
Total depreciation
|
|
|
99
|
|
|
|
73
|
|
|
|
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortisation
|
|
|
|
|
|
|
|
|
|
|
|
|
Patents and intellectual property
|
|
|
570
|
|
|
|
570
|
|
|
|
570
|
|
Software
|
|
|
5
|
|
|
|
|
|
|
|
|
|
GDC licensing agreement
|
|
|
745
|
|
|
|
|
|
|
|
|
|
Total amortisation
|
|
|
1,320
|
|
|
|
570
|
|
|
|
570
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total depreciation and amortisation
|
|
|
1,419
|
|
|
|
643
|
|
|
|
575
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance costs
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and finance charges paid/payable
|
|
|
1
|
|
|
|
|
|
|
|
1
|
|
Unwinding of the discount on contingent consideration
|
|
|
764
|
|
|
|
|
|
|
|
|
|
Imputed interest on convertible note
|
|
|
|
|
|
|
|
|
|
|
68
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance costs expensed
|
|
|
765
|
|
|
|
|
|
|
|
69
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rental expense relating to operating leases
|
|
|
|
|
|
|
|
|
|
|
|
|
Minimum lease payments
|
|
|
335
|
|
|
|
280
|
|
|
|
98
|
|
Superannuation expense
|
|
|
|
|
|
|
|
|
|
|
|
|
Defined contribution superannuation expense
|
|
|
288
|
|
|
|
209
|
|
|
|
147
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee benefits expense excluding superannuation
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee benefits expense excluding superannuation
|
|
|
4,078
|
|
|
|
2,828
|
|
|
|
2,105
|
|
F-23
Note 8. Income tax expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
Numerical reconciliation of income tax expense and tax at the statutory rate
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income tax expense from continuing operations
|
|
|
(10,869
|
)
|
|
|
(12,155
|
)
|
|
|
(7,306
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,869
|
)
|
|
|
(12,155
|
)
|
|
|
(7,306
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax at the statutory tax rate of 27.5% (2016:30%, 2015: 30%)
|
|
|
(2,989
|
)
|
|
|
(3,646
|
)
|
|
|
(2,192
|
)
|
|
|
|
|
Tax effect amounts which are not deductible/(taxable) in calculating taxable income:
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-deductible
expenses
|
|
|
1,651
|
|
|
|
1,353
|
|
|
|
772
|
|
Derecognition of foreign currency reserve
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
1,651
|
|
|
|
44
|
|
|
|
60
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,338
|
)
|
|
|
(2,249
|
)
|
|
|
(1,360
|
)
|
Difference in overseas tax rates
|
|
|
|
|
|
|
|
|
|
|
|
|
Prior year tax losses not recognised now recouped
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
|
Tax losses and timing differences not recognised
|
|
|
(1,140
|
)
|
|
|
2,249
|
|
|
|
1,360
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit
|
|
|
(199
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax losses not recognised
|
|
|
|
|
|
|
|
|
|
|
|
|
Unused tax losses for which no deferred tax asset has been recognised-Australia
|
|
|
60,633
|
|
|
|
59,909
|
|
|
|
53,995
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Potential tax benefit @ 27.5% (2016:30%, 2015: 30%)-Australia
|
|
|
16,674
|
|
|
|
17,973
|
|
|
|
16,199
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unused tax losses for which no deferred tax asset has been
recognised-US
|
|
|
2,090
|
|
|
|
2,100
|
|
|
|
1,401
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Potential tax benefit @
34%-US
|
|
|
711
|
|
|
|
714
|
|
|
|
476
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-24
Note 9. Current assets - cash and cash equivalents
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Cash at bank and on hand
|
|
|
8,455
|
|
|
|
20,437
|
|
Short-term deposits
|
|
|
6,000
|
|
|
|
13,016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,455
|
|
|
|
33,453
|
|
|
|
|
|
|
|
|
|
|
Note 10. Current assets - trade and other receivables
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
Trade receivables
|
|
|
231
|
|
|
|
235
|
|
|
|
228
|
|
Less: Provision for impairment of receivables
|
|
|
(226
|
)
|
|
|
(226
|
)
|
|
|
(226
|
)
|
R&D tax rebate receivable
|
|
|
3,973
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,978
|
|
|
|
9
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other receivables
|
|
|
77
|
|
|
|
78
|
|
|
|
99
|
|
Deposits held
|
|
|
578
|
|
|
|
485
|
|
|
|
414
|
|
Less: Provision for impairment of deposits held
|
|
|
(371
|
)
|
|
|
(373
|
)
|
|
|
(364
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,262
|
|
|
|
199
|
|
|
|
151
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deposit held included a guarantee to the value of 250,000 (A$371,000) for the APO Trend case. Please
refer to Note 33 for further information on deposits held.
Impairment of receivables
The consolidated entity has recognised a loss of nil (2016: loss of nil ) in profit or loss in respect of impairment of receivables (excluding
deposits held) for the year ended 30 June 2017.
The ageing of the impaired receivables provided for above are as follows:
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Over 6 months overdue
|
|
|
226
|
|
|
|
226
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
226
|
|
|
|
226
|
|
|
|
|
|
|
|
|
|
|
Note 11. Current assets - income tax refund due
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Income tax refund due
|
|
|
5
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
F-25
Note 12. Current assets - other
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Prepayments
|
|
|
758
|
|
|
|
434
|
|
|
|
|
|
|
|
|
|
|
Note 13.
Non-current
assets -
available-for-sale
financial assets
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Listed ordinary shares
|
|
|
22
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
Refer to Note 30 for further information on fair value measurement.
Note 14.
Non-current
assets - property, plant and equipment
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Leasehold improvements - at cost
|
|
|
466
|
|
|
|
464
|
|
Less: Accumulated depreciation
|
|
|
(82
|
)
|
|
|
(30
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
384
|
|
|
|
434
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plant and equipment - at cost
|
|
|
201
|
|
|
|
217
|
|
Less: Accumulated depreciation
|
|
|
(95
|
)
|
|
|
(59
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
106
|
|
|
|
158
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
490
|
|
|
|
592
|
|
|
|
|
|
|
|
|
|
|
Reconciliations
Reconciliations of the written down values at the beginning and end of the current and previous financial year are set out below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leasehold
|
|
|
Plant and
|
|
|
|
|
|
|
improvement
|
|
|
Equipment
|
|
|
Total
|
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
Balance at 30 June 2015
|
|
|
|
|
|
|
85
|
|
|
|
85
|
|
Additions
|
|
|
465
|
|
|
|
120
|
|
|
|
585
|
|
Disposals
|
|
|
|
|
|
|
(5
|
)
|
|
|
(5
|
)
|
Depreciation expense
|
|
|
(30
|
)
|
|
|
(43
|
)
|
|
|
(73
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 30 June 2016
|
|
|
435
|
|
|
|
157
|
|
|
|
592
|
|
Additions
|
|
|
7
|
|
|
|
6
|
|
|
|
13
|
|
Disposals
|
|
|
(6
|
)
|
|
|
(10
|
)
|
|
|
(16
|
)
|
Depreciation expense
|
|
|
(52
|
)
|
|
|
(47
|
)
|
|
|
(99
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 30 June 2017
|
|
|
384
|
|
|
|
106
|
|
|
|
490
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-26
Note 15.
Non-current
assets
intangibles
|
|
|
|
|
|
|
|
|
|
|
2017
A$000
|
|
|
2016
A$000
|
|
|
|
|
Patents and intellectual property - at cost
|
|
|
2,851
|
|
|
|
2,851
|
|
Less: Accumulated amortisation
|
|
|
(2,601
|
)
|
|
|
(2,031
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
250
|
|
|
|
820
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Software at cost
|
|
|
11
|
|
|
|
2
|
|
Less: Accumulated amortisation
|
|
|
(6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing agreement - at acquired fair value (Note 37)*
|
|
|
16,408
|
|
|
|
|
|
Less: Accumulated amortisation
|
|
|
(745
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,663
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,918
|
|
|
|
822
|
|
|
|
|
|
|
|
|
|
|
*
|
Remaining amortisation period is 14.47 years as at 30 June 2017
|
Reconciliations
Reconciliations of the written down values at the beginning and end of the
current and previous financial year are set out below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Software
|
|
|
Patents and
intellectual
property
|
|
|
GDC
licensing
agreement
|
|
|
Total
|
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
|
Balance at 30 June 2015
|
|
|
|
|
|
|
1,390
|
|
|
|
|
|
|
|
1,390
|
|
Additions
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
Amortisation expense
|
|
|
|
|
|
|
(570
|
)
|
|
|
|
|
|
|
(570
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 30 June 2016
|
|
|
2
|
|
|
|
820
|
|
|
|
|
|
|
|
822
|
|
Additions
|
|
|
8
|
|
|
|
|
|
|
|
|
|
|
|
8
|
|
Additions through business combinations (note 37)
|
|
|
|
|
|
|
|
|
|
|
16,408
|
|
|
|
16,408
|
|
Amortisation expense
|
|
|
(5
|
)
|
|
|
(570
|
)
|
|
|
(745
|
)
|
|
|
(1,320
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 30 June 2017
|
|
|
5
|
|
|
|
250
|
|
|
|
15,663
|
|
|
|
15,918
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 16. Current liabilities - trade and other payables
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Trade payables
|
|
|
1,249
|
|
|
|
512
|
|
Accrued payables
|
|
|
614
|
|
|
|
778
|
|
Lease incentive liability
|
|
|
10
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,873
|
|
|
|
1,300
|
|
|
|
|
|
|
|
|
|
|
Refer to Note 29 for further information on financial instruments.
F-27
Note 17. Current liabilities - provisions
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Employee benefits
|
|
|
155
|
|
|
|
132
|
|
|
|
|
|
|
|
|
|
|
Note 18. Current liabilities - Unearned revenue
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Unearned revenue
|
|
|
41
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 19. Current liabilities - Contingent consideration
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Contingent consideration
|
|
|
3,315
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 20.
Non-current
liabilities - deferred tax
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Deferred tax liability associated with Licensing Agreement
|
|
|
4,314
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 21.
Non-current
liabilities - provisions
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Lease make good
|
|
|
64
|
|
|
|
62
|
|
|
|
|
|
|
|
|
|
|
F-28
Note 22.
Non-current
liabilities - Trade and other payables
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Liability for straight-lining
|
|
|
44
|
|
|
|
19
|
|
Lease incentive liability
|
|
|
62
|
|
|
|
73
|
|
|
|
|
|
|
|
|
|
|
|
|
|
106
|
|
|
|
92
|
|
|
|
|
|
|
|
|
|
|
Note 23.
Non-current
liabilities - Contingent consideration
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Contingent consideration
|
|
|
704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration is payable on the achievement of certain
pre-determined
milestones. Certain of the contingent payments are contracted to be satisfied by issue of shares, and other such payments may be settled by the issue of shares or the payment of cash, at the discretion of the consolidated entity.
F-29
Note 24. Equity - contributed equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
|
|
Shares
|
|
|
Shares
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
|
Ordinary shares - fully paid
|
|
|
483,287,914
|
|
|
|
429,733,982
|
|
|
|
193,769
|
|
|
|
191,301
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Movements in ordinary share capital
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Details
|
|
Date
|
|
Shares
|
|
|
Issue price
A$
|
|
|
A$000
|
|
|
|
|
|
|
Balance
|
|
1 July 2015
|
|
|
423,116,465
|
|
|
|
|
|
|
|
190,404
|
|
Issue of shares on exercise of options
|
|
24 July 2015
|
|
|
1,000
|
|
|
|
0.400
|
|
|
|
|
|
Issue of shares on exercise of options
|
|
24 July 2015
|
|
|
1,000,000
|
|
|
|
0.150
|
|
|
|
150
|
|
Issue of shares on exercise of options
|
|
8 October 2015
|
|
|
109,309
|
|
|
|
0.125
|
|
|
|
14
|
|
Issue of shares on exercise of options
|
|
23 November 2015
|
|
|
1,990,545
|
|
|
|
0.125
|
|
|
|
249
|
|
Issue of shares on exercise of options
|
|
24 November 2015
|
|
|
3,514,370
|
|
|
|
0.125
|
|
|
|
439
|
|
Issue of shares on exercise of options
|
|
09 December 2015
|
|
|
2,293
|
|
|
|
0.300
|
|
|
|
1
|
|
Share issue transaction costs (including share-based payments)
|
|
|
|
|
|
|
|
|
0.000
|
|
|
|
(71
|
)
|
Share based payment fair value movement
|
|
|
|
|
|
|
|
|
0.000
|
|
|
|
115
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
|
|
30 June 2016
|
|
|
429,733,982
|
|
|
|
|
|
|
|
191,301
|
|
|
|
|
|
|
Issue of shares - Note 1
|
|
05 September 2016
|
|
|
400,000
|
|
|
$
|
0.105
|
|
|
|
42
|
|
Issue of shares - Note 2
|
|
14 September 2016
|
|
|
20,000,000
|
|
|
$
|
0.025
|
|
|
|
500
|
|
Issue of shares - Note 3
|
|
31 October 2016
|
|
|
17,153,932
|
|
|
$
|
0.090
|
|
|
|
1,544
|
|
Issue of shares - Note 4
|
|
01 November 2016
|
|
|
16,000,000
|
|
|
$
|
0.025
|
|
|
|
400
|
|
Share issue transaction costs
|
|
|
|
|
|
|
|
$
|
0.000
|
|
|
|
(18
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
|
|
30 June 2017
|
|
|
483,287,914
|
|
|
|
|
|
|
|
193,769
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares
Note 1 - Shares issued to the Companys Scientific Advisory Board for no consideration in respect of share based payments
Note 2 - Issue of shares in relation to the conversion of part of the Triaxial convertible note
Note 3 - Issue of shares in relation to the acquisition of Glioblast Pty Ltd to support the development of
GDC-0084
Note 4 - Issue of shares in relation to the conversion of part of the Triaxial convertible
note
Ordinary shares
Ordinary shares entitle the holder to participate in dividends and the proceeds on the winding up of the Company in proportion to the number of and
amounts paid on the shares held. The fully paid ordinary shares have no par value and the Company does not have a limited amount of authorised capital.
On a show of hands every member present at a meeting in person or by proxy shall have one vote and upon a poll each share shall have one vote.
F-30
Note 24. Equity - contributed equity (continued)
Share
buy-back
There is no current
on-market
share
buy-back.
Capital risk management
The
consolidated entitys objectives when managing capital are to safeguard its ability to continue as a going concern, so
that it can
provide returns for shareholders and benefits for other stakeholders and to maintain an optimum capital structure
to reduce the cost of
capital.
The capital structure of the consolidated entity consists of cash and cash equivalents and equity attributable to equity
holders. Operating globally, the consolidated entity develops specialty pharmaceutical products. The overall strategy of the
consolidated entity is to continue its drug development programs, which depends on raising additional equity.
The capital risk management policy remains unchanged from the prior year
.
Note 25. Equity - Other contributed equity
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Convertible loan note - Triaxial
|
|
|
600
|
|
|
|
1,716
|
|
|
|
|
|
|
|
|
|
|
On 4 December 2014, the consolidated entity and the convertible note holder (Triaxial) signed a
Convertible Note Deed Poll (Deed) which superseded the precedent Loan Agreement between Triaxial shareholders and the consolidated entity. The Deed extinguishes the liability created by the Loan Agreement, which previously allowed for a
cash settlement and now allows Triaxial to convert their debt into ordinary shares during the current financial year, providing that the company achieves defined milestones established in the schedule of the Deed. Accordingly the convertible note
has been reclassified as an equity instrument rather than debt instrument.
During the Financial year ended 30 June 2017, the Company
reached two milestones triggering the conversion of a portion of its convertible note as follows;
|
|
|
on 11 August 2016 the Company announced the submission of an IND application. On 10 September 2016, the Company received a letter from the
FDA advising the study may proceed triggering conversion of 20,000,000 ordinary shares.
|
|
|
|
on 31 October 2016, the Company announced it had licensed a Phase II ready molecule triggering the conversion of 16,000,000 ordinary shares.
|
The remaining portion of the convertible note may be exercised at the holders discretion as follows;
|
|
|
on completion of Phase II clinical trial or achieving Breakthrough Designation. Completion will be deemed to occur upon the receipt by the consolidated
entity of a signed study report or notification of the designation: $600,000 converted into 24,000,000 ordinary shares in the consolidated entity.
|
There is a possibility for an early conversion of the convertible notes if a third party acquires more than 50% of the issued capital of the consolidated entity.
F-31
Note 26. Equity - reserves
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
Available-for-sale
reserve
|
|
|
(37
|
)
|
|
|
(45
|
)
|
Foreign currency reserve
|
|
|
(111
|
)
|
|
|
(136
|
)
|
Share-based payments reserve
|
|
|
2,078
|
|
|
|
1,602
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,930
|
|
|
|
1,421
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale
reserve
The reserve is used to recognise increments and decrements in the fair value of
available-for-sale
financial assets.
Foreign currency reserve
The reserve is used to recognise exchange differences arising from translation of the financial statements of foreign operations to Australian dollars.
Share-based payments reserve
The reserve is used to recognise the value of equity benefits provided to employees and Directors as part of their remuneration, and other parties as part
of their compensation for services.
Movements in reserves
Movements in each class of reserve during the current and previous financial year are set out below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
payment
reserve
|
|
|
Available-
for-sale
|
|
|
Foreign
currency
|
|
|
Convertible
note
|
|
|
Total
|
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
|
|
Balance at 30 June 2015
|
|
|
1,345
|
|
|
|
(43
|
)
|
|
|
(312
|
)
|
|
|
|
|
|
|
990
|
|
Transfer to equity on exercise of options
|
|
|
(115
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(115
|
)
|
Other comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation
|
|
|
|
|
|
|
|
|
|
|
(1
|
)
|
|
|
|
|
|
|
(1
|
)
|
Loss on the revaluation of available
for-sale
financial assets
|
|
|
|
|
|
|
(3
|
)
|
|
|
|
|
|
|
|
|
|
|
(3
|
)
|
|
|
|
|
|
|
Total other comprehensive income
|
|
|
|
|
|
|
(3
|
)
|
|
|
(1
|
)
|
|
|
|
|
|
|
(4
|
)
|
|
|
|
|
|
|
Share based payment expense
|
|
|
372
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
372
|
|
Derecognition of FCTR of CanTx, Inc.
|
|
|
|
|
|
|
|
|
|
|
178
|
|
|
|
|
|
|
|
178
|
|
Balance at 30 June 2016
|
|
|
1,602
|
|
|
|
(46
|
)
|
|
|
(135
|
)
|
|
|
|
|
|
|
1,421
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation
|
|
|
|
|
|
|
|
|
|
|
24
|
|
|
|
|
|
|
|
24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain/(Loss) on the revaluation of available
for-sale
financial assets
|
|
|
|
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share based payment expense
|
|
|
476
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
476
|
|
Balance at 30 June 2017
|
|
|
2,078
|
|
|
|
(37
|
)
|
|
|
(111
|
)
|
|
|
|
|
|
|
1,930
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-32
Note 27. Equity - accumulated losses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
2015
|
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
Accumulated losses at the beginning of the financial year
|
|
|
(160,507
|
)
|
|
|
(148,445
|
)
|
|
|
(141,306
|
)
|
Loss after income tax expense for the year
|
|
|
(10,670
|
)
|
|
|
(12,062
|
)
|
|
|
(7,139
|
)
|
Transfer from other contributed equity
|
|
|
216
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated losses at the end of the financial year
|
|
|
(170,961
|
)
|
|
|
(160,507
|
)
|
|
|
(148,445
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 28. Equity - dividends
Dividends
There were no dividends paid, recommended or declared during the current or
previous financial year.
Franking credits
There were no franking credits available at the reporting date.
Note 29. Financial
instruments
Financial risk management objectives
The consolidated entitys activities expose it to a variety of financial risks: market risk, credit risk and liquidity risk. The consolidated entity uses different methods to measure and manage the
different types of risks to which it is exposed. These methods include monitoring the levels of exposure to interest rates and foreign exchange, ageing analysis and monitoring of specific credit allowances to manage credit risk, and, rolling cash
flow forecasts to manage liquidity risk.
Market risk
Foreign currency risk
The consolidated entity operates internationally and is exposed to
foreign exchange risk arising from various currency exposures, primarily with respect to the US dollar (USD). Foreign exchange risk arises from future transactions and recognised assets and liabilities denominated in a currency that is
not the entitys functional currency and net investments in foreign operations.
As of 30 June 2017, the consolidated entity
did not hold derivative financial instruments in managing its foreign currency, however, the consolidated entity may from time to time enter into hedging arrangements where circumstances are deemed appropriate. Foreign subsidiaries with a functional
currency of Australian Dollar (AUD) have exposure to the local currency of these subsidiaries and any other currency these subsidiaries trade in.
The carrying amount of the consolidated entitys foreign currency denominated financial assets and financial liabilities at the reporting date was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
Liabilities
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
|
US dollars
|
|
|
5,797
|
|
|
|
15,314
|
|
|
|
1,010
|
|
|
|
702
|
|
Euros
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5
|
|
Pound Sterling
|
|
|
|
|
|
|
20
|
|
|
|
84
|
|
|
|
59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,797
|
|
|
|
15,334
|
|
|
|
1,094
|
|
|
|
766
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-33
Note 29. Financial instruments (continued)
The consolidated entity had net assets denominated in foreign currencies of A$4,703,000 as at
30 June 2017 (2016: net assets A$14,568,000).
If the AUD had strengthened against the USD by 10% (2016: 10%) , Euro by 10% (2016: 10%),
GBP by 10% (2016: 10%) respectively then this would have had the following impact:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUD strengthened
|
|
|
AUD weakened
|
|
Consolidated - 2017
|
|
% change
|
|
|
Effect on
profit before
tax
|
|
|
Effect on
equity
|
|
|
% change
|
|
|
Effect on
profit before
tax
|
|
|
Effect on
equity
|
|
|
|
|
|
|
|
|
US dollars
|
|
|
10
|
%
|
|
|
(478
|
)
|
|
|
(478
|
)
|
|
|
(10
|
%)
|
|
|
478
|
|
|
|
478
|
|
Euros
|
|
|
10
|
%
|
|
|
|
|
|
|
|
|
|
|
(10
|
%)
|
|
|
|
|
|
|
|
|
Pound Sterling
|
|
|
10
|
%
|
|
|
8
|
|
|
|
8
|
|
|
|
(10
|
%)
|
|
|
(8
|
)
|
|
|
(8
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(470
|
)
|
|
|
(470
|
)
|
|
|
|
|
|
|
470
|
|
|
|
470
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUD strengthened
|
|
|
AUD weakened
|
|
Consolidated - 2016
|
|
% change
|
|
|
Effect on
profit before
tax
|
|
|
Effect on
equity
|
|
|
% change
|
|
|
Effect on
profit before
tax
|
|
|
Effect on
equity
|
|
|
|
|
|
|
|
|
US dollars
|
|
|
10
|
%
|
|
|
(1,461
|
)
|
|
|
(1,461
|
)
|
|
|
(10
|
%)
|
|
|
1,461
|
|
|
|
1,461
|
|
Euros
|
|
|
10
|
%
|
|
|
|
|
|
|
|
|
|
|
(10
|
%)
|
|
|
|
|
|
|
|
|
Pound Sterling
|
|
|
10
|
%
|
|
|
4
|
|
|
|
4
|
|
|
|
(10
|
%)
|
|
|
(4
|
)
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,457
|
)
|
|
|
(1,457
|
)
|
|
|
|
|
|
|
1,457
|
|
|
|
1,465
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Price risk
The consolidated entity is not exposed to any significant price risk.
Interest rate risk
The consolidated entitys exposure to market interest rates relate primarily to the investments of cash balances.
The consolidated entity has cash reserves held primarily in Australian dollars and United States dollars and places funds on deposit with financial
institutions for periods generally not exceeding three months.
As at the reporting date, the consolidated entity had the following variable
interest rate balances:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
Weighted
average
interest rate
|
|
|
Balance
|
|
|
Weighted
average
interest rate
|
|
|
Balance
|
|
|
|
%
|
|
|
A$000
|
|
|
%
|
|
|
A$000
|
|
|
|
|
|
|
Cash at bank and in hand
|
|
|
0.10
|
%
|
|
|
8,455
|
|
|
|
0.31
|
%
|
|
|
20,437
|
|
Short term deposits
|
|
|
2.40
|
%
|
|
|
6,000
|
|
|
|
2.60
|
%
|
|
|
13,016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net exposure to cash flow interest rate risk
|
|
|
|
|
|
|
14,455
|
|
|
|
|
|
|
|
33,453
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-34
Note 29. Financial instruments (continued)
The consolidated entity has cash and cash equivalents totalling A$14,455,000 (2016: A$33,453,000). An
official increase/decrease in interest rates of 100 basis points (2016: 100 basis points) would have a favourable/adverse effect on profit before tax and equity of A$144,000 (2016: A$335,000) per annum. The percentage change is based on the expected
volatility of interest rates using market data and analysts forecasts.
Credit risk
Credit risk refers to the risk that a counterparty will default on its contractual obligations resulting in financial loss to the consolidated entity. The
entity is not exposed to significant credit risk on receivables.
The consolidated entity places its cash deposits with high credit quality
financial institutions and by policy, limits the amount of credit exposure to any single counter-party. The consolidated entity is averse to principal loss and ensures the safety and preservation of its invested funds by limiting default risk,
market risk, and reinvestment risk. The consolidated entity mitigates default risk by constantly positioning its portfolio to respond appropriately to a significant reduction in a credit rating of any financial institution.
The consolidated entitys maximum exposures to credit risk at the end of the reporting period in relation to each class of recognised financial
assets is the carrying amount of those assets as indicated in the statement of financial position, the significant majority in Australia.
There are no significant concentrations of credit risk within the consolidated entity. The credit risk on liquid funds is limited as the counter parties
are banks with high credit ratings.
Credit risk is managed by limiting the amount of credit exposure to any single counter-party for cash
deposits.
Liquidity risk
The consolidated entity manages liquidity risk by maintaining adequate cash reserves and available borrowing facilities by continuously monitoring actual and forecast cash flows and matching the maturity
profiles of financial assets and liabilities.
Remaining contractual maturities
The following tables detail the consolidated entitys remaining contractual maturity for its financial instrument liabilities. The tables have been
drawn up based on the undiscounted cash flows of financial liabilities based on the earliest date on which the financial liabilities are required to be paid. The tables include both interest and principal cash flows disclosed as remaining
contractual maturities and therefore these totals may differ from their carrying amount in the statement of financial position.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
interest rate
|
|
|
1 year or less
|
|
|
Between 1
and 2 years
|
|
|
Between 2
and 5 years
|
|
|
Over 5
years
|
|
|
Remaining
contractual
maturities
|
|
2017
|
|
%
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
A$000
|
|
|
|
|
|
|
|
|
Non-derivatives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-interest
bearing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade payables
|
|
|
|
|
|
|
1,249
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,249
|
|
Accrued payables
|
|
|
|
|
|
|
614
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
614
|
|
Contingent consideration
|
|
|
|
|
|
|
4,250
|
|
|
|
|
|
|
|
4,650
|
|
|
|
1,394
|
|
|
|
10,294
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
non-derivatives
|
|
|
|
|
|
|
6,113
|
|
|
|
|
|
|
|
4,650
|
|
|
|
1,394
|
|
|
|
12,157
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-35
Note 29. Financial instruments (continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2016
|
|
Weighted average
interest rate
%
|
|
|
1 year or less
A$000
|
|
|
Between 1
and 2 years
A$000
|
|
|
Between 2 and
5 years
A$000
|
|
|
Over 5
years
A$000
|
|
|
Remaining
contractual
maturities
A$000
|
|
|
|
|
|
|
|
|
Non-derivatives
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-interest
bearing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade payables
|
|
|
|
|
|
|
513
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
513
|
|
Accrued payables
|
|
|
|
|
|
|
778
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
778
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
non-derivatives
|
|
|
|
|
|
|
1,291
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,291
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The cash flows in the maturity analysis above are not expected to occur significantly earlier than contractually
disclosed above.
Note 30. Fair value measurement
Fair value hierarchy
The following tables detail the consolidated entitys assets and
liabilities, measured or disclosed at fair value, using a three level hierarchy, based on the lowest level of input that is significant to the entire fair value measurement, being:
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date
Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly
Level 3: Unobservable inputs for the asset or liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
Level 1
A$000
|
|
|
Level 2
A$000
|
|
|
Level 3
A$000
|
|
|
Total
A$000
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares
|
|
|
22
|
|
|
|
|
|
|
|
|
|
|
|
22
|
|
Contingent Consideration
|
|
|
|
|
|
|
|
|
|
|
4,019
|
|
|
|
4,019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
22
|
|
|
|
|
|
|
|
4,019
|
|
|
|
4,041
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2016
|
|
Level 1
A$000
|
|
|
Level 2
A$000
|
|
|
Level 3
A$000
|
|
|
Total
A$000
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no transfers between levels during the financial year.
The fair value of contingent consideration related to the acquisition of Glioblast Pty Ltd (see Note 36) is estimated using a present value technique.
The fair value is estimated by probability-weighting the estimated future cash outflows, adjusting for risk and discounting.
The effects on the fair value of risk and uncertainty in the future cash flows are dealt with by adjusting the estimated cash flows rather than adjusting the discount rate.
F-36
|
Note 31. Key management personnel disclosures
Compensation
The aggregate compensation made to directors and other members
of key management personnel (KMP) of the consolidated entity is set out below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
A$000
|
|
|
2016
A$000
|
|
|
2015
A$000
|
|
|
|
|
|
Short-term employee benefits
|
|
|
2,513
|
|
|
|
1,586
|
|
|
|
1,328
|
|
Post-employment benefits
|
|
|
155
|
|
|
|
130
|
|
|
|
101
|
|
Long-term benefits
|
|
|
|
|
|
|
200
|
|
|
|
38
|
|
Termination benefits
|
|
|
315
|
|
|
|
|
|
|
|
|
|
Share-based payments
|
|
|
403
|
|
|
|
183
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,386
|
|
|
|
2,099
|
|
|
|
1,467
|
|
Please refer to Note 35 for other transactions with key management personnel and their related parties.
Note 32. Remuneration of auditors
During the financial year the following fees were paid or payable for services provided by Grant Thornton Audit Pty Ltd, the auditor of the consolidated entity:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
|
|
|
|
2017
A$000
|
|
|
2016
A$000
|
|
|
2015
A$000
|
|
|
|
|
|
Audit services - Grant Thornton Audit Pty Ltd
|
|
|
|
|
|
|
|
|
|
|
|
|
Audit or review of the financial statements
|
|
|
132
|
|
|
|
140
|
|
|
|
114
|
|
F3 consent
|
|
|
|
|
|
|
1
|
|
|
|
21
|
|
|
|
|
|
Other services - Grant Thornton Audit Pty Ltd
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax compliance services
|
|
|
8
|
|
|
|
12
|
|
|
|
20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
140
|
|
|
|
153
|
|
|
|
155
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 33. Contingent liabilities
The consolidated entity is continuing to prosecute its Intellectual Property (IP) rights and in June 2007 announced that the Vienna Commercial Court had upheld a provisional injunction against
an Austrian company, APOtrend. The consolidated entity has provided a guarantee to the value of 250,000 ($371,000) with the court to confirm its commitment to the ongoing enforcement process. As at 30 June 2017, the receivable balance
continues to be fully impaired on the basis that it is unlikely to be recovered. The receivable balance and the corresponding provision for impairment is classified as deposits held. Refer to note 10. Due to the lengthy procedure,
further delayed by the appointment of technical experts, the case did not progress and the status remained unchanged during the period.
F-37
Note 34. Commitments
|
|
|
|
|
|
|
|
|
|
|
2017
A$000
|
|
|
2016
A$000
|
|
|
|
|
Lease commitments - operating
|
|
|
|
|
|
|
|
|
Committed at the reporting date but not recognised as liabilities, payable:
|
|
|
|
|
|
|
|
|
Within one year
|
|
|
250
|
|
|
|
204
|
|
One to five years
|
|
|
78
|
|
|
|
290
|
|
|
|
|
|
|
|
|
|
|
|
|
|
328
|
|
|
|
494
|
|
|
|
|
|
|
|
|
|
|
Operating lease commitments includes contracted amounts for leases of premises and plant and equipment under
non-cancellable
operating leases expiring within three years. On renewal, the terms of the leases are renegotiated. Leases for premises include an annual review for CPI increases.
The office lease contains two renewal options, each for a three-year period. These renewal options are not included in the commitments as they may be
cancelled by the consolidated entity. The consolidated entity at this stage intends to exercise the two remaining options. In order to exercise an option, the consolidated entity must inform the lessor no later than 6 months prior to the end of the
lease, by which time it must commit to the term of the option.
F-38
Note 35. Related party transactions
Parent entity
Novogen Limited is the parent entity.
Subsidiaries
Interests in subsidiaries
are set out in note 37.
Key management personnel
Disclosures relating to key management personnel are set out in note 31.
Transactions with
related parties
The following transactions occurred with related parties:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
A$000
|
|
|
2016
A$000
|
|
|
2015
A$000
|
|
|
|
|
|
Payment for other expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounting fees paid to Watkins Coffey Martin, an entity (partnership) in which Steven Coffey is a partner
|
|
|
|
|
|
|
7
|
|
|
|
12
|
|
|
|
|
|
Salary paid to Prue Kelly, the partner of Graham Kelly, a former director
|
|
|
|
|
|
|
47
|
|
|
|
77
|
|
|
|
|
|
In addition to Directors fees, Consultancy fees for executive duties while Mr Iain Ross was Acting CEO were paid to
Gladstone Consultancy Partnership, a UK based consulting partnership in which he has a beneficial interest.
|
|
|
|
|
|
|
266
|
|
|
|
|
|
|
|
|
|
In addition to Directors fees, Consultancy fees for executive duties were paid to Kumara Inc, a corporation in which Mr Ian
Phillips is a Director and has a beneficial interest.
|
|
|
21
|
|
|
|
120
|
|
|
|
|
|
|
|
|
|
In addition to Directors fees, Consultancy fees for executive duties were paid to John OConnor.
|
|
|
38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salary paid to Michael Kelly, the brother of Graham Kelly, a former director
|
|
|
|
|
|
|
|
|
|
|
6
|
|
|
|
|
|
Salary paid to Kathryn Stoddart, the daughter of Graham Kelly, a former director
|
|
|
|
|
|
|
|
|
|
|
4
|
|
Other transactions:
There were no other transactions with KMP and their related parties.
Receivable from and
payable to related parties
There were no trade receivables from or trade payables to related parties at the current and previous reporting
date.
Loans to/from related parties
There were no loans to or from related parties at the current and previous reporting date.
Terms and conditions
All transactions
were made on normal commercial terms and conditions and at market rates.
F-39
Note 36. Business combinations
Glioblast Pty Ltd
On 31 October 2016, Novogen announced it acquired 100% of the
issued shares in Glioblast Pty Ltd, a privately-held, neuro-oncology-focused Australian biotechnology company. On the same day, Novogen entered into a worldwide licensing agreement with Genentech to develop and commercialise
GDC-0084
(the Molecule). These events have been considered a business combination in accordance with IFRS 3.
Details of the acquisition are as follows:
|
|
|
|
|
|
|
Fair
value
A$000
|
|
|
|
Intellectual property
|
|
|
16,408
|
|
Deferred tax liability
|
|
|
(4,512
|
)
|
|
|
|
|
|
Net assets acquired
|
|
|
11,896
|
|
Goodwill
|
|
|
|
|
|
|
|
|
|
Acquisition-date fair value of the total consideration transferred
|
|
|
11,896
|
|
|
|
|
|
|
Representing:
|
|
|
|
|
Cash paid or payable to vendor
|
|
|
7,097
|
|
Novogen Limited shares issued to vendor
|
|
|
1,544
|
|
Contingent consideration
|
|
|
3,255
|
|
|
|
|
|
|
|
|
11,896
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
|
|
|
|
2017
$
|
|
|
2016
$
|
|
|
|
|
Cash used to acquire business, net of cash acquired:
|
|
|
|
|
|
|
|
|
Acquisition-date fair value of the total consideration transferred
|
|
|
16,408
|
|
|
|
|
|
Less: contingent consideration
|
|
|
(3,255
|
)
|
|
|
|
|
Less: shares issued by company as part of consideration
|
|
|
(1,544
|
)
|
|
|
|
|
Less: Deferred Tax Liability
|
|
|
(4,512
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used
|
|
|
7,097
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36.1 Consideration transferred
Acquisition-related costs amounting to $345,000 are not included as part of consideration transferred and have been recognised as an expense in the consolidated statement of profit or loss and other
comprehensive income, as part of other expenses.
36.2 Goodwill
There is no goodwill arising from this business combination.
36.3 Glioblasts contribution
to the Groups results
Glioblast contributed $nil to the Groups revenues and profits, respectively from the date of the acquisition
to 30 June 2017. Had the acquisition occurred on 1 July 2016, the Groups revenue for the financial year ended 30 June 2017 would be unchanged.
F-40
Note 36. Business combinations (continued)
36.4 Contingent consideration
The Glioblast acquisition contains four contingent milestone payments, the first two milestone payments are to be settled with Novogen shares, and the third and fourth milestone payments are to be settled
with either cash or Novogen shares at the discretion of Novogen.
The Genentech Agreement comprises of one milestone payment payable on the
first commercial licensed product sale.
The range of outcomes of contingent consideration are summarised below.
|
|
|
|
|
|
|
|
|
Milestone
|
|
Contingent consideration-Low
|
|
|
Contingent consideration-High
|
|
|
|
|
|
|
|
A$000
|
|
|
|
A$000
|
|
1
|
|
|
1,250
|
|
|
|
1,250
|
|
2
|
|
|
1,250
|
|
|
|
1,250
|
|
3
|
|
|
3,000
|
|
|
|
3,705
|
|
4
|
|
|
3,400
|
|
|
|
4,199
|
|
5
|
|
|
1,394
|
|
|
|
1,394
|
|
Total
|
|
|
10,294
|
|
|
|
11,798
|
|
The contingent considerations listed above are undiscounted.
Each milestone payment is probability weighted for valuation purposes. The milestone payments are discounted to present value, using a discount rate of 35% per annum, if they are expected to be achieved
more than 12 months after the valuation date.
Novogen is also required to pay royalties to Genentech in relation to net sales. These payments
are related to future financial performance, and are not considered as part of the consideration in relation to the Genentech Agreement.
Note 37. Interests in subsidiaries
The
consolidated financial statements incorporate the assets, liabilities and results of the following subsidiaries in accordance with the accounting policy described in note 2:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ownership interest
|
|
Name
|
|
Principal place of business /
Country of incorporation
|
|
2017
%
|
|
|
2016
%
|
|
|
|
|
|
Novogen Laboratories Pty Ltd
|
|
Australia
|
|
|
100.00%
|
|
|
|
100.00%
|
|
Novogen Research Pty Ltd
|
|
Australia
|
|
|
100.00%
|
|
|
|
100.00%
|
|
Novogen North America Inc.
|
|
United States of America
|
|
|
100.00%
|
|
|
|
100.00%
|
|
Glioblast Pty Ltd
|
|
Australia
|
|
|
100.00%
|
|
|
|
|
|
Triaxial Pharmaceuticals Pty Ltd
|
|
Australia
|
|
|
|
|
|
|
100.00%
|
|
The consolidated entity approved the dissolution of Triaxial Pharmaceuticals Pty Ltd., which is wholly owned by the
consolidated entity. The dissolution of Triaxial Pharmaceuticals Pty Ltd was completed on 20 December 2016.
F-41
Note 38. Events after the reporting period
Novogen issued 2,240,000 unlisted Options with exercise price of $0.0668 on 7 August 2017. Options vest in four equal tranches on the anniversary of the issue date and will be fully vested on
7 August 2021. The Options expire on 7 August 2022. Upon exercise, Options convert into Ordinary Shares.
No other matter or
circumstance has arisen since 30 June 2017 that has significantly affected, or may significantly affect, the consolidated entitys operations, the results of those operations, or the consolidated entitys state of affairs in future
financial years.
Note 39. Earnings per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
A$000
|
|
|
2016
A$000
|
|
|
2015
A$000
|
|
|
|
|
|
Earnings per share for loss from continuing operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss after income tax
|
|
|
(10,670
|
)
|
|
|
(12,155
|
)
|
|
|
(7,306
|
)
|
Non-controlling
interest
|
|
|
|
|
|
|
93
|
|
|
|
167
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss after income tax attributable to the owners of Novogen Limited
|
|
|
(10,670
|
)
|
|
|
(12,062
|
)
|
|
|
(7,139
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
|
|
|
Number
|
|
|
Number
|
|
|
|
|
|
Weighted average number of ordinary shares used in calculating basic earnings per share
|
|
|
467,833,849
|
|
|
|
427,431,910
|
|
|
|
238,418,048
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of ordinary shares used in calculating diluted earnings per share
|
|
|
467,833,849
|
|
|
|
427,431,910
|
|
|
|
238,418,048
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cents
|
|
|
Cents
|
|
|
Cents
|
|
|
|
|
|
Basic earnings per share
|
|
|
(2.28
|
)
|
|
|
(2.82
|
)
|
|
|
(2.99
|
)
|
Diluted earnings per share
|
|
|
(2.28
|
)
|
|
|
(2.82
|
)
|
|
|
(2.99
|
)
|
24,000,000 unlisted convertible notes with a face value of $600,000, 45,984,325 unlisted options and 31,484,002 listed
options have been excluded from the above calculations as they were antidilutive.
Note 40. Share-based payments
The options in tranches 1 - 3 in the table below have been issued as consideration for services rendered in relation to capital raising conducted during
the previous year by the consolidated entity.
The options in tranches 4 - 11 in the table below have been issued to employees under the ESOP.
In total, $475,189 (2016: $372,208) of employee remuneration expense (all of which related to equity-settled share-based payment transactions) has been included in profit or loss and credited to share-based payment reserve.
F-42
Note 40. Share-based payments (continued)
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tranche
|
|
Grant date
|
|
|
Expiry date
|
|
|
Exercise
price
|
|
|
Balance at
the start of
the year
|
|
|
Granted
|
|
|
Exercised
|
|
|
Forfeited
|
|
|
Balance at
the end of
the year
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
04-03-2015
|
|
|
|
16-12-2019
|
|
|
$
|
0.150
|
|
|
|
466,470
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
466,470
|
|
2
|
|
|
04-03-2015
|
|
|
|
18-12-2019
|
|
|
$
|
0.150
|
|
|
|
199,521
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
199,521
|
|
3
|
|
|
24-06-2015
|
|
|
|
30-06-2020
|
|
|
$
|
0.400
|
|
|
|
5,190,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,190,000
|
|
4
|
|
|
15-10-2015
|
|
|
|
16-11-2020
|
|
|
$
|
0.220
|
|
|
|
5,200,008
|
|
|
|
|
|
|
|
|
|
|
|
(1,566,674)
|
|
|
|
3,633,334
|
|
5
|
|
|
18-03-2016
|
|
|
|
01-02-2021
|
|
|
$
|
0.199
|
|
|
|
3,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,000,000
|
|
6
|
|
|
18-03-2016
|
|
|
|
01-02-2021
|
|
|
$
|
0.199
|
|
|
|
2,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,000,000
|
|
7
|
|
|
18-03-2016
|
|
|
|
01-02-2021
|
|
|
$
|
0.261
|
|
|
|
2,500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,500,000
|
|
8
|
|
|
05-09-2016
|
|
|
|
05-09-2021
|
|
|
$
|
0.163
|
|
|
|
|
|
|
|
2,000,000
|
|
|
|
|
|
|
|
|
|
|
|
2,000,000
|
|
9
|
|
|
12-10-2016
|
|
|
|
17-10-2021
|
|
|
$
|
0.156
|
|
|
|
|
|
|
|
620,000
|
|
|
|
|
|
|
|
|
|
|
|
620,000
|
|
10
|
|
|
31-10-2016
|
|
|
|
01-11-2021
|
|
|
$
|
0.138
|
|
|
|
|
|
|
|
500,000
|
|
|
|
|
|
|
|
|
|
|
|
500,000
|
|
11
|
|
|
21-11-2016
|
|
|
|
23-11-2021
|
|
|
$
|
0.138
|
|
|
|
|
|
|
|
2,000,000
|
|
|
|
|
|
|
|
|
|
|
|
2,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,555,999
|
|
|
|
5,120,000
|
|
|
|
|
|
|
|
(1,566,674)
|
|
|
|
22,109,325
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average exercise price
|
|
|
$
|
0.2680
|
|
|
$
|
0.1500
|
|
|
$
|
0.0000
|
|
|
$
|
0.2200
|
|
|
$
|
0.2440
|
|
*
|
Options from Tranche 1 to Tranche 3 listed above were vested and exercisable at the end of the period.
|
Options from Tranche 4 listed above include 1/3 vested options at the end of the period.
Options from Tranche 5 listed above include 1/4 vested and exercisable options at the end of the period.
All remaining options are expected to vest in future periods.
The weighted average remaining contractual life of options outstanding at the 30 June 2017 is 3.55 years.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant date
|
|
|
Expiry date
|
|
|
Exercise
price
|
|
|
Balance at
the start of
the year
|
|
|
Granted
|
|
|
Exercised
|
|
|
Expired/
forfeited/
other
|
|
|
Balance at
the end of
the year
|
|
|
|
|
|
|
|
|
|
|
04-03-2015
|
|
|
|
16-12-2019
|
|
|
$
|
0.150
|
|
|
|
466,470
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
466,470
|
|
|
04-03-2015
|
|
|
|
18-12-2019
|
|
|
$
|
0.150
|
|
|
|
199,521
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
199,521
|
|
|
24-06-2015
|
|
|
|
30-12-2015
|
|
|
$
|
0.300
|
|
|
|
1,380,000
|
|
|
|
|
|
|
|
|
|
|
|
(1,380,000
|
)
|
|
|
|
|
|
24-06-2015
|
|
|
|
30-06-2020
|
|
|
$
|
0.400
|
|
|
|
5,190,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,190,000
|
|
|
15-10-2015
|
|
|
|
16-11-2020
|
|
|
$
|
0.220
|
|
|
|
|
|
|
|
5,500,008
|
|
|
|
|
|
|
|
(300,000
|
)
|
|
|
5,200,008
|
|
|
18-03-2016
|
|
|
|
01-02-2021
|
|
|
$
|
0.199
|
|
|
|
|
|
|
|
3,000,000
|
|
|
|
|
|
|
|
|
|
|
|
3,000,000
|
|
|
18-03-2016
|
|
|
|
01-02-2021
|
|
|
$
|
0.199
|
|
|
|
|
|
|
|
2,000,000
|
|
|
|
|
|
|
|
|
|
|
|
2,000,000
|
|
|
18-03-2016
|
|
|
|
01-02-2021
|
|
|
$
|
0.261
|
|
|
|
|
|
|
|
2,500,000
|
|
|
|
|
|
|
|
|
|
|
|
2,500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,235,991
|
|
|
|
13,000,008
|
|
|
|
|
|
|
|
(1,680,000
|
)
|
|
|
18,555,999
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average exercise price
|
|
|
$
|
0.358
|
|
|
$
|
0.220
|
|
|
$
|
0.000
|
|
|
$
|
0.286
|
|
|
$
|
0.268
|
|
The weighted average remaining contractual life of options outstanding at the 30 Jun 2016 is 4.33 years.
F-43
Note 40. Share-based payments (continued)
Employee share options
During the year ended 30 June 2017, 5,120,000 options have been issued to the employees during the year by the consolidated entity pursuant to the Companys Employee Share Option Plan.
|
|
Tranche 8 of 2,000,000 options vesting equally over 4 years
|
|
|
Tranche 9 of 620,000 options vesting equally over 4 years
|
|
|
Tranche 10 of 500,000 options vesting equally over 3 years
|
|
|
Tranche 11 of 2,000,000 options vesting equally over 4 years.
|
An option will only vest if the option holder continues to be a full-time employee with the Company or an Associated Company during the vesting period relating to the option.
Conditions for an option to be exercised:
|
|
The option must have vested and a period of 1 years from the date the option was issued must have expired;
|
|
|
Option holder must have provided the Company with an Exercise Notice and have paid the Exercise Price for the option.
|
|
|
The Exercise Notice must be for the exercise of at least the Minimum Number of Options;
|
|
|
The Exercise Notice must have been provided to the Company and Exercise Price paid before the expiry of 5 years from the date the Option is issued.
|
Options Valuation
In order to obtain a fair valuation of these options, the following assumptions have been made:
The Black Scholes option valuation methodology has been used with the expectation that the majority of these options would be exercised towards the end
of the term of these options. Inputs into the Black Scholes model includes the share price at grant date, exercise price, volatility, and the risk free rate of a five year Australian Government Bond on grant date.
The exercise prices and expiry dates of these options are disclosed in the table above.
Risk-free rate and grant date
For all tranches, the risk-free rate of a five-year Australian
Government bond on grant date was used. Please refer to the table below for details.
The Tranche 8 to Tranches 11 options have various
vesting periods and exercising conditions. These options are unlisted as at 30/06/2017.
No dividends are expected to be declared or paid by
the consolidated entity during the terms of the options.
The underlying expected volatility was determined by reference to historical data of
the Companys shares over a period of time. No special features inherent to the options granted were incorporated into measurement of fair value.
F-44
Note 40. Share-based payments (continued)
Based on the above assumptions, the table below sets out the valuation for each tranche of options:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tranche
|
|
Grant date
|
|
|
Expiry date
|
|
|
Share price
at
Grant Date
|
|
|
Exercise
price
|
|
|
Volatility
(%)
|
|
|
Remaining
Option
Life
|
|
|
Fair value
per option
|
|
|
Risk free
Rate
|
|
1
|
|
|
04/03/2015
|
|
|
|
16/12/2019
|
|
|
$
|
0.180
|
|
|
$
|
0.150
|
|
|
|
120.00
|
%
|
|
|
2.46
|
|
|
$
|
0.150
|
|
|
|
2.07
|
%
|
2
|
|
|
04/03/2015
|
|
|
|
18/12/2019
|
|
|
$
|
0.180
|
|
|
$
|
0.150
|
|
|
|
120.00
|
%
|
|
|
2.47
|
|
|
$
|
0.150
|
|
|
|
2.07
|
%
|
3
|
|
|
24/06/2015
|
|
|
|
30/06/2020
|
|
|
$
|
0.245
|
|
|
$
|
0.400
|
|
|
|
150.00
|
%
|
|
|
3.00
|
|
|
$
|
0.217
|
|
|
|
2.02
|
%
|
4
|
|
|
15/10/2015
|
|
|
|
16/11/2020
|
|
|
$
|
0.140
|
|
|
$
|
0.220
|
|
|
|
158.11
|
%
|
|
|
3.38
|
|
|
$
|
0.128
|
|
|
|
2.04
|
%
|
5
|
|
|
18/03/2016
|
|
|
|
01/02/2021
|
|
|
$
|
0.115
|
|
|
$
|
0.199
|
|
|
|
130.00
|
%
|
|
|
3.59
|
|
|
$
|
0.081
|
|
|
|
2.00
|
%
|
6
|
|
|
18/03/2016
|
|
|
|
01/02/2021
|
|
|
$
|
0.115
|
|
|
$
|
0.199
|
|
|
|
130.00
|
%
|
|
|
3.59
|
|
|
$
|
0.086
|
|
|
|
2.00
|
%
|
7
|
|
|
18/03/2016
|
|
|
|
01/02/2021
|
|
|
$
|
0.115
|
|
|
$
|
0.261
|
|
|
|
130.00
|
%
|
|
|
3.59
|
|
|
$
|
0.087
|
|
|
|
2.00
|
%
|
8
|
|
|
05/09/2016
|
|
|
|
05/09/2021
|
|
|
$
|
0.105
|
|
|
$
|
0.163
|
|
|
|
122.00
|
%
|
|
|
4.19
|
|
|
$
|
0.084
|
|
|
|
1.60
|
%
|
9
|
|
|
12/10/2016
|
|
|
|
17/10/2021
|
|
|
$
|
0.098
|
|
|
$
|
0.156
|
|
|
|
122.00
|
%
|
|
|
4.30
|
|
|
$
|
0.078
|
|
|
|
1.89
|
%
|
10
|
|
|
31/10/2016
|
|
|
|
01/11/2021
|
|
|
$
|
0.090
|
|
|
$
|
0.138
|
|
|
|
122.00
|
%
|
|
|
4.34
|
|
|
$
|
0.072
|
|
|
|
1.87
|
%
|
11
|
|
|
21/11/2016
|
|
|
|
23/11/2021
|
|
|
$
|
0.092
|
|
|
$
|
0.138
|
|
|
|
122.00
|
%
|
|
|
4.40
|
|
|
$
|
0.073
|
|
|
|
2.10
|
%
|
F-45