20-F 1 d464682d20f.htm FORM 20-F Form 20-F
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 20-F

 

 

(Mark One)

REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

 

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended June 30, 2017

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

 

SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report                     

For the transition period from                      to                     

Commission file number 0-29962

 

 

Novogen Limited

ACN 063 259 754

(Exact name of Registrant as specified in its charter)

 

 

Not Applicable

(Translation of Registrant’s name into English)

New South Wales, Australia

(Jurisdiction of incorporation or organization)

Level 5, 20 George Street, Hornsby, New South Wales 2077, Australia

(Address of principal executive offices)

Mrs Gabrielle Heaton

(e)Gabrielle.Heaton@novogen.com (t) +61-2-9472-4111

Level 5, 20 George Street, Hornsby, New South Wales 2077, Australia

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

 

Title of each class

 

Name of each exchange on which registered

American Depositary Shares, each representing twenty-five Ordinary Shares*   The NASDAQ Stock Market

Securities registered or to be registered pursuant to Section 12(g) of the Act.

None

 

 

 

* Not for trading, but only in connection with the registration of American Depositary Shares.

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

Not Applicable

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

The number of outstanding Ordinary Shares of the issuer as at June 30, 2017 was 483,287,914.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes  ☐            No  

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Yes  ☐            No  

Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes  ☒            No  

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes  ☐            No  

Indicate by check mark if the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer                   Accelerated filer                   Non-accelerated filer  ☒                Emerging growth company  ☒

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act.  ☐

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing

 

U.S. GAAP  ☐

    

International Financial Reporting Standards as issued

by the International Accounting Standards Board  ☒

   Other  ☐

If ‘Other’ has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

Item 17          Item 18  

If this is an annual report, indicate by a check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes              No  ☒

 

 

 


Table of Contents

TABLE OF CONTENTS

 

FORWARD-LOOKING STATEMENTS

     1  

PART I

     2  

Item 1.

   Identity of Directors, Senior Management and Advisors      2  

Item 2.

   Offer Statistics and Expected Timetable      2  

Item 3.

   Key Information      2  

Item 4.

   Information on the Company      12  

Item 4A.

   Unresolved Staff Comments      21  

Item 5.

   Operating and Financial Review and Prospects      21  

Item 6.

   Directors, Senior Management and Employees      29  

Item 7.

   Major Shareholders and Related Party Transactions      45  

Item 8.

   Financial Information      46  

Item 9.

   The Offer and Listing      46  

Item 10.

   Additional Information      49  

Item 11.

   Quantitative and Qualitative Disclosures about Market Risk      60  

Item 12.

   Description of Securities Other than Equity Securities      61  

PART II

     63  

Item 13.

   Defaults, Dividend Arrearages and Delinquencies      63  

Item 14.

   Material Modifications to the Rights of Security Holders and the Use of  Proceeds      63  

Item 15.

   Controls and Procedures      63  

Item 16.

   [Reserved]      64  

Item 16A.

   Audit Committee Financial Expert      64  

Item 16B.

   Code of Ethics      64  

Item 16C.

   Principal Accounting Fees and Services      64  

Item 16D.

   Exemptions from the Listing Standards for Audit Committees      65  

Item 16E.

   Purchases of Equity Securities by the Issuer and Affiliated Purchasers      65  

Item 16F.

   Changes in registrant’s Certifying Accountant      65  

Item 16G.

   Corporate Governance      65  

Item 16H.

   Mine Safety Disclosure      67  

PART III

     67  

Item 17.

   Financial Statements      67  

Item 18.

   Financial Statements      67  

Item 19.

   Exhibits      67  


Table of Contents

FORWARD-LOOKING STATEMENTS

This Annual Report on Form 20-F includes forward-looking statements, which involve a number of risks and uncertainties. These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plan,” “believe,” “anticipate,” “expect,” “estimate,” “predict,” “potential,” “continue,” “likely,” or “opportunity,” the negative of these words or other similar words. Similarly, statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects and other statements that are not historical facts are also forward-looking statements. Discussions containing these forward-looking statements may be found, among other places, in “Business Overview” and “Operating and Financial Review and Prospects” in this Annual Report on Form 20-F. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995 and section 27A of the Securities Act and Section 21E of the Exchange Act. Readers of this Annual Report on Form 20-F are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the time this Annual Report on Form 20-F was filed with the Securities and Exchange Commission, or SEC. These forward-looking statements are based largely on our expectations and projections about future events and future trends affecting our business, and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, without limitation, those discussed in “Risk Factors” and in “Operating and Financial Review and Prospects” of this Annual Report on Form 20-F. In addition, past financial or operating performance is not necessarily a reliable indicator of future performance, and you should not use our historical performance to anticipate results or future period trends. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Except as required by law, we undertake no obligation to update publicly or revise our forward-looking statements to reflect events or circumstances that arise after the filing of this Annual Report on Form 20-F.

In this Annual Report on Form 20-F, “Novogen,” “Company,” “we,” “us” and “our” refer to Novogen Limited and its wholly owned subsidiaries on a consolidated basis, unless the context otherwise provides.

 

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PART I

 

Item 1. Identity of Directors, Senior Management and Advisors

Item 1 details are not required to be disclosed as part of the Annual Report.

 

Item 2. Offer Statistics and Expected Timetable

Item 2 details are not required to be disclosed as part of the Annual Report.

 

Item 3. Key Information

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 Company’s independent registered public accounting firm.

The Company’s 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.

 

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Summary of consolidated profit or loss and other
comprehensive income (IFRS)
   2013
A$’000
    2014
A$’000
    2015
A$’000
    2016
A$’000
    2017
A$’000
    2017
US$’000
 

Revenue and other income

     1,730       429       2,842       4,071       8,812       6,764  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax expense from continuing operations

     (1,508     (7,569     (7,306     (12,155     (10,869     (8,343

Profit after income tax expense from discontinued operations

     723       —         —         —         —         —    
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss after income tax expense for the year

     (785     (7,569     (7,306     (12,155     (10,670     (8,191
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net profit/(loss) attributable to members of Novogen Limited

     (1,031     (7,468     (7,139     (12,062     (10,670     (8,191
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Earnings per share for loss from continuing operations attributable to the owners of Novogen Limited

            

Basic earnings /(loss) per share (cents per share)

     (1.32     (4.76     (2.99     (2.82     (2.28     (1.75

Diluted earnings/(loss) per share (cents per share)

     (1.32     (4.76     (2.99     (2.82     (2.28     (1.75

Earnings per share for profit/(loss) from discontinued operations attributable to the owners of Novogen Limited

            

Basic earnings/(loss) per share (cents per share)

     0.42       —         —         —         —         —    

Diluted earnings/(loss) per share (cents per share)

     0.42       —         —         —         —         —    

Earnings per share for profit/(loss) attributable to the owners of Novogen Limited

            

Basic earnings/(loss) per share (cents per share)

     (0.90     (4.76     (2.99     (2.82     (2.28     (1.75

Diluted earnings/(loss) per share (cents per share)

     (0.90     (4.76     (2.99     (2.82     (2.28     (1.75

Weighted average number of ordinary share shares used to calculate earnings per share

     114,690,737       156,725,363       238,418,048       427,431,910       467,833,849       467,833,849  

Number of outstanding ordinary shares at year end

     138,276,033       168,557,834       423,116,465       429,733,982       483,287,914       483,287,914  

 

Summary of consolidated financial position (IFRS)    2013
A$’000
     2014
A$’000
     2015
A$’000
     2016
A$’000
     2017
A$’000
     2017
US$’000
 

Cash and cash equivalents

     2,738        2,502        44,371        33,453        14,455        11,095  

Total assets

     5,749        4,660        46,140        35,517        35,910        27,565  

Net assets/Equity

     4,041        1,413        44,362        33,931        25,338        19,449  

Debt

     1,416        2,707        —          —          —          —    

Capital Stock

     137,663        142,586        190,404        191,301        193,769        148,737  

 

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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$1.00 per US$

 

Month    High      Low  

April

   $ 0.7604      $ 0.7452  

May

   $ 0.7534      $ 0.7352  

June

   $ 0.7680      $ 0.7387  

July

   $ 0.7991      $ 0.7584  

August

   $ 0.7983      $ 0.7584  

September

   $ 0.8071      $ 0.7831  

Exchange rates for the last five fiscal years A$1.00 per US$

 

Fiscal year ended June 30    Average Rate*  

2013

   $ 1.0272  

2014

   $ 0.9186  

2015

   $ 0.8365  

2016

   $ 0.7289  

2017

   $ 0.7542  

 

* Determined by calculating the average rate of the exchange rates on the last trading day of each month during the period.

B. Capitalization and Indebtedness.

Not applicable.

C. Reasons for the Offer and Use of Proceeds.

Not applicable.

 

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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:

 

    continue our research and preclinical development of our product candidates;

 

    expand the scope of our current preclinical studies for our product candidates or initiate clinical, additional preclinical or other studies for product candidates;

 

    seek regulatory and marketing approvals for any of our product candidates that successfully complete clinical trials;

 

    further develop the manufacturing process for our product candidates;

 

    change or add additional manufacturers or suppliers;

 

    seek to identify and validate additional product candidates;

 

    acquire or in-license other product candidates and technologies;

 

    maintain, protect and expand our intellectual property portfolio;

 

    create additional infrastructure to support our operations as a public company in the United States and our product development and future commercialization efforts; and

 

    experience any delays or encounter issues with any of the above.

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.

 

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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:

 

    establishing proof of concept in preclinical studies and clinical trials for our product candidates;

 

    successfully initiating and completing clinical trials of our product candidates;

 

    obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials;

 

    maintaining, protecting and expanding our intellectual property portfolio, and avoiding infringing on intellectual property of third parties;

 

    establishing and maintaining successful licenses, collaborations and alliances with third parties;

 

    developing a sustainable, scalable, reproducible and transferable manufacturing process for our product candidates;

 

    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;

 

    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;

 

    obtaining market acceptance of any product candidates that receive regulatory approval as viable treatment options;

 

    obtaining favorable coverage and reimbursement rates for our products from third-party payers;

 

    addressing any competing technological and market developments;

 

    identifying and validating new product candidates; and

 

    negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter.

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 Company’s 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.

 

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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 Company’s 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 government’s 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.

 

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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 Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s 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.

 

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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 Company’s 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:

 

    advancements in the treatment of cancer that make our treatments obsolete;

 

    market exclusivity and competitor products;

 

    timing of market introduction of the Company’s drugs and competitive drugs;

 

    actual and perceived efficacy and safety of the Company’s drug candidates;

 

    prevalence and severity of any side effects;

 

    potential or perceived advantages or disadvantages over alternative treatments;

 

    strength of sales, marketing and distribution support;

 

    price of future products, both in absolute terms and relative to alternative treatments;

 

    the effect of current and future healthcare laws on the Company’s drug candidates; and

 

    availability of coverage and reimbursement from government and other third-party payers.

If any of the Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s drug candidates are being developed. Some of these potential competing drugs are further advanced in development than the Company’s 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.

 

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The Company’s 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 Company’s 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 Company’s competitors may be able to more easily develop technologies and products that would render the Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s 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.

 

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Enforceability of civil liabilities under the federal securities laws against the Company or the Company’s 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 Company’s 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 Company’s 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 Company’s ordinary shares and ADSs is highly volatile in response to various factors, many of which are beyond the Company’s control, including:

 

    unacceptable toxicity findings in animals and humans;

 

    lack of efficacy in human trials at Phase II stage or beyond;

 

    announcements of technological innovations by the Company and its competitors;

 

    new products introduced or announced by the Company or its competitors;

 

    changes in financial estimates by securities analysts;

 

    actual or anticipated variations in operating results;

 

    expiration or termination of licenses, research contracts or other collaboration agreements;

 

    conditions or trends in the regulatory climate in the biotechnology, pharmaceutical and genomics industries;

 

    changes in the market values of similar companies;

 

    the liquidity of any market for the Company’s securities; and

 

    additional sales by the Company of its shares.

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 Company’s ability to grow profitably. Adverse economic changes are outside the Company’s control and may result in material adverse effects on the Company’s business or results of operations. These broad market and industry factors may materially affect the market price of the Company’s ordinary shares and ADSs regardless of its development and operating performance. In the past, following periods of volatility in the market price of a company’s 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 management’s attention and resources.

If the market price of the Company’s ADSs remains below US$5.00 per share, under stock exchange rules, the Company’s 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 Company’s ordinary shares and ADSs.

 

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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 Company’s 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. Information on the Company

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 Company’s 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 Company’s 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 company’s 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 Company’s 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 Company’s 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.

 

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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.

 

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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:

 

    pre-clinical laboratory evaluations, including formulation and stability testing, and animal tests performed under the FDA’s Good Laboratory Practices regulations to assess pharmacological activity and toxicity potential;

 

    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.;

 

    obtaining approval of Institutional Review Boards (“IRBs”), to administer the products to human subjects in clinical trials;

 

    adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for the product’s intended use;

 

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    development of manufacturing processes which conform to FDA current Good Manufacturing Practices (“cGMPs”), as confirmed by FDA inspection;

 

    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

 

    FDA review and approval of an NDA, prior to any commercial sale, promotion or shipment of a product.

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 FDA’s 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:

 

    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;

 

    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

 

    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.

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 product’s 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 Company’s 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 FDA’s 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 FDA’s policies may change, and additional governmental regulations may be enacted that could delay, limit, or prevent regulatory approval of the Company’s 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 Company’s 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 Company’s 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.

 

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The Company’s 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.

 

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European Union Regulatory Requirements

Outside the U.S., the Company’s 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 Company’s 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.

 

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On May 30, 2017, NASDAQ notified the Company that for the previous 30 business days the bid price of the Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s 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 Company’s existing anti-tropomyosin program, ATM-3507.

 

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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”.

 

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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 Company’s 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.

 

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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 Company’s 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 government’s 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 Company’s 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.

 

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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 Company’s 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 Company’s 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 government’s 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 Company’s 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.

 

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Net loss

As a result of the above and particularly the higher research and development expenses, the Company’s 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  

 

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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;

 

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  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 Company’s 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;

 

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    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 Company’s 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 Company’s 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.

 

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Item 6. Directors, Senior Management and Employees

A. Directors and Senior Management

The names and details of the Company’s 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 O’Connor, 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 Company’s 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

 

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Table of Contents
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.

 

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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.

 

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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 Chairman’s 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.

 

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Table of Contents

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:

 

  fixed remuneration

 

  short-term performance incentives

 

  share-based payments

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.

 

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Table of Contents

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 O’Connor   - 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)

 

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Table of Contents
    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 O’Connor*,***

    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 O’Connor. These fees were incurred in respect of executive duties performed during the year and, in accordance with the Company’s 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.

 

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Table of Contents

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. James’s 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. Gabrielle’s 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. Gordon’s 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.

 

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Table of Contents
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. Kate’s 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. Peng’s 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.

 

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Table of Contents

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.

 

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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 Company’s 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 Company’s values (including the establishment and observance of high ethical standards); and

 

    ensuring shareholders are kept informed of the Company’s 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 Company’s 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;

 

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    establishment of Board committees, their membership and delegated authorities;

 

    approval of dividends;

 

    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 Company’s 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 (3rd 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 Company’s expense.

 

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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 Company’s 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 Company’s website. It is the Board’s 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.

 

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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 Company’s 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 Company’s financial and operational performance.

 

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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 Company’s 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  
  

 

 

    

 

 

    

 

 

 

 

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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 O’Connor (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 O’Connor*

     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  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

 

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* 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 O’Connor*

     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 Director’s 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 Director’s fees, Consultancy fees of $37,500 were paid to John O’Connor 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 Company’s 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 Company’s 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 individual’s 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 Director’s 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.

 

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In addition to Director’s fees, Consultancy fees of $37,500 were paid to John O’Connor 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 Company’s 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 Novogen’s ordinary shares, as quoted on the ASX, and Novogen’s ADSs, as quoted on the NASDAQ Capital Market.

 

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Novogen Limited share price history

 

  ASX

The Company’s 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  

 

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  NASDAQ CAPITAL MARKET

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

Novogen’s 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’.

Novogen’s 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.

 

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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:

 

    a special resolution passed by members holding shares in the class; or

 

    the written consent of members with at least 75% of the shares in the class.

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:

 

    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.

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 person’s 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 person’s or someone else’s 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:

 

    is the holder of the securities;

 

    has power to exercise, or control the exercise of, a right to vote attached to the securities; or

 

    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:

 

    has entered or enters into an agreement with another person with respect to the securities;

 

    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);

 

    has granted or grants an option to, or has been or is granted an option by, another person with respect to the securities; or

 

    the other person would have a relevant interest in the securities if the agreement were performed, the right enforced or the option exercised;

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:

 

    when the acquisition results from the acceptance of an offer under a formal takeover bid;

 

    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;

 

    when shareholders of Novogen approve the takeover by resolution passed at general meeting;

 

    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;

 

    when the acquisition results from the issue of securities under a rights issue;

 

    when the acquisition results from the issue of securities under dividend reinvestment schemes;

 

    when the acquisition results from the issue of securities under underwriting arrangements;

 

    when the acquisition results from the issue of securities through operation of law;

 

    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;

 

    an acquisition arising from an auction of forfeited shares conducted on-market; or

 

    an acquisition arising through a compromise, arrangement, liquidation or buy-back.

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;

 

    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.

 

    on October 31, 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 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 Treasurer’s 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 Company’s Constitution does not contain any additional limitations on a non-resident’s right to hold or vote the Company’s 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 taxpayer’s 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 holder’s 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:

 

    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

 

    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”).

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 Company’s 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. holder’s federal income tax return for that year.

 

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U.S. holders should consult their tax advisors with respect to the Company’s status as a PFIC, the availability and desirability of a mark-to-market election, and such U.S. holder’s 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 Shares—Capital 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 Shares—Shareholders 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 Shareholder’s 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 Shares—Capital 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.

 

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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 person’s 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 Australia’s 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 SEC’s website at www.sec.gov.

E. Subsidiary Information

Not applicable

 

Item 11. Quantitative and Qualitative Disclosures about Market Risk

Interest rate risk

The Company’s 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.

 

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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 entity’s 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. Description of Securities Other than Equity Securities

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.

 

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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.

 

Persons depositing or withdrawing shares must pay:       

For:

US$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)  

   Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property
     Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates
US$.02 (or less) per ADS      Any cash distribution to ADS registered holders
A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs      Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS registered holders
US$.02 (or less) per ADSs per calendar year      Depositary services
Registration or transfer fees      Transfer and registration of shares on the Company’s share register to or from the name of the depositary or its agent when you deposit or withdraw shares
Expenses of the depositary  

   Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement)
     Converting foreign currency to U.S. dollars
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      As necessary
Any charges incurred by the depositary or its agents for servicing the deposited securities      As necessary

 

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PART II

 

Item 13. Defaults, Dividend Arrearages and Delinquencies

This item is not applicable.

 

Item 14. Material Modifications to the Rights of Security Holders and the Use of Proceeds

This item is not applicable.

 

Item 15. Controls and Procedures

(a) Disclosure controls and procedures

At the end of the period covered by this Annual Report, the Company’s management, with the participation of the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on that evaluation, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures are effective as of June 30, 2017.

(b) Management’s annual report on internal controls over financial reporting

The management of Novogen Limited is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief Executive Officer and Director of Finance and Administration, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of June 30, 2017 based on the criteria set forth in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO 2013). Based on our evaluation under the criteria set forth in Internal Control — Integrated Framework, our management concluded that our internal control over financial reporting was effective as of June 30, 2017.

Novogen Limited’s internal control was designed to provide reasonable assurance to the Company’s management and Board of Directors regarding the preparation and fair presentation of published financial statements. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

Management maintains a comprehensive system of controls intended to ensure that transactions are executed in accordance with management’s authorization, assets are safeguarded, and financial records are reliable. Management also takes steps to ensure that information and communication flows are effective and monitor performance, including performance of internal control procedures.

Management assessed the effectiveness of the Company’s internal control over financial reporting as of June 30, 2017. Based on this assessment, management concluded that the Company’s internal control over financial reporting is effective as of June 30, 2017.

(c) Attestation Report of the Registered Public Accounting Firm

Not applicable. As an emerging growth company, we are not required to provide an attestation report of the company’s registered public accounting firm on our internal control over financial reporting.

(d) Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting that occurred during the period covered by this annual report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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Item 16. [Reserved]

 

Item 16A. Audit Committee Financial Expert

The Board of Directors has determined that Steven Coffey, qualifies as an “audit committee financial expert” as that term is defined in Item 16A of Form 20-F. Steven Coffey meets the independence requirements of the NASDAQ Capital Market and SEC’s rules and regulations as he is a qualified Chartered Accountant and has spent over 30 years in public practice. He is also a registered company auditor.

 

Item 16B. Code of Ethics

The Company has adopted a Code of Ethics and Business Conduct (the “Code”). The Code establishes a clear set of values that emphasise a culture encompassing strong corporate governance, sound business practices and good ethical conduct. The Code confirms the Company’s belief in treating all individuals with respect and recognises that different skills and diversity are essential to enrich the Company’s perspective, improve corporate performance, increase shareholder value and maximise the achievement and goals of the Company. The Code applies to all Company employees, including management and Directors. The Code is available on the Company’s website www.novogen.com.

 

Item 16C. Principal Accounting Fees and Services

Grant Thornton Audit Pty Ltd (“GT”) has audited the Company’s annual financial statements acting as the independent registered public accounting firm for the fiscal years ended June 30, 2017, 2016 and 2015.

The table below set forth the total fees for services performed by GT in fiscal years 2017, 2016 and 2015, and summarizes these amounts by the category of service.

 

     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  

SEC Form F-3 consent

        1        21  

Other services - Grant Thornton Audit Pty Ltd

        

Tax compliance services

     8        12        20  
  

 

 

    

 

 

    

 

 

 
     140        153        155  
  

 

 

    

 

 

    

 

 

 

Audit fees

The audit fees include the aggregate fees incurred in fiscal years 2017, 2016 and 2015 for professional services rendered in connection with the audit of the Company’s annual financial statements and for related services that are reasonably related to the performance of the audit or services that are normally provided by the auditor in connection with regulatory filings of engagements for those financial years (including review of the Company’s Annual Report on Form 20-F, consents and other services related to SEC matters).

SEC Form F-3 Consent

Fees paid in respect of filing of SEC Form F-3 consent services, which relates to procedures required by the auditor to issue their consent in the document.

 

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Other services

Tax compliance fees

Tax fees billed in fiscal years 2017 and 2016 were for tax compliance advisory services. Tax fees billed in fiscal year 2015 were for tax compliance services.

Pre-approval policies and procedures

The Audit Committee Charter sets forth the Company’s policy regarding the appointment of independent auditors. The Audit Committee Charter also requires the Audit Committee to review and approve in advance the appointment of the independent auditors for the performance of 100% of all audit services and, after taking into account the opinion of management, 100% of lawfully permitted non-audit services. The Audit Committee may delegate authority to one or more members of the Audit Committee where appropriate, but no such delegation is permitted if the authority is required by law, regulation or listing standard to be exercised by the Audit Committee as a whole.

 

Item 16D. Exemptions from the Listing Standards for Audit Committees

This item is not applicable.

 

Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers

This item is not applicable.

 

Item 16F. Changes in registrant’s Certifying Accountant

This item is not applicable.

 

Item 16G. Corporate Governance

Implications of Being an Emerging Growth Company

Pursuant to The Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), we are classified as an “Emerging Growth Company.” Under the JOBS Act, Emerging Growth Companies are exempt from certain reporting requirements, including the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act. Under this exemption, our auditor will not be required to attest to and report on our internal controls over financial reporting during a five-year transition period. We may avail ourselves of these disclosure exemptions until we are no longer an emerging growth company.

Pursuant to the JOBS Act, we will remain an Emerging Growth Company until the earliest of:

 

    the end of the fiscal year in which the fifth anniversary of completion of our initial resale registration statement in the United States occurs, or June 30, 2020;

 

    the end of the first fiscal year in which the market value of our ordinary shares held by non-affiliates exceeds US$700 million as of the end of the second quarter of such fiscal year;

 

    the end of the first fiscal year in which we have total annual gross revenues of at least US$1.0 billion; and

 

    the date on which we have issued more than US$1.0 billion in non-convertible debt securities in any rolling three-year period.

 

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Implications of Being a Foreign Private Issuer

We are also considered a “foreign private issuer.” In our capacity as a foreign private issuer, we are exempt from certain rules under the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”), that impose certain disclosure obligations and procedural requirements for proxy solicitations under Section 14 of the Exchange Act. In addition, our officers, directors and principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and the rules under the Exchange Act with respect to their purchases and sales of our ordinary shares. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. In addition, we are not required to comply with Regulation FD, which restricts the selective disclosure of material information.

Exemptions from Certain Corporate Governance Rules of the NASDAQ Stock Market, LLC

Exemptions from the corporate governance standards of the NASDAQ Stock Market, LLC (“NASDAQ”) are available to foreign private issuers such as Novogen when those standards are contrary to a law, rule or regulation of any public authority exercising jurisdiction over such issuer or contrary to generally accepted business practices in the issuer’s country of domicile. In connection with Novogen’s National Market Listing Application, NASDAQ granted Novogen exemptions from certain corporate governance standards that were contrary to the laws, rules, regulations or generally accepted business practices of Australia. These exemptions and the practices followed by Novogen are described below:

 

  Novogen is exempt from NASDAQ’s quorum requirements applicable to meetings of ordinary shareholders. In keeping with the law of Australia and generally accepted business practices in Australia, Novogen’s Constitution requires a quorum of three shareholders for a shareholders’ meeting.

 

  Novogen is exempt from NASDAQ’s requirement that each NASDAQ issuer shall require shareholder approval of a plan or arrangement in connection with the acquisition of the stock or assets of another company if “any director, officer or substantial shareholder of the issuer has a 5 percent or greater interest (or such persons collectively have a 10 percent or greater interest), directly or indirectly, in the Company or assets to be acquired or in the consideration to be paid in the transaction or series of related transactions and the present or potential issuance of common stock, or securities convertible into or exercisable for common stock, could result in an increase in outstanding common shares or voting power of 5 percent or more”.

 

  Novogen will rely an exemption from the requirement that at least two members of a compensation committee be “independent” as defined in NASDAQ Rule 5605(a)(2). The ASX Listing Rules and Australian law do not require an Australian company to establish a compensation committee, known in Australia as a remuneration committee, which is comprised solely of non-executive directors if the company is not included in the S&P/ASX300 Index at the beginning of its financial year. Novogen was not included on the S&P/ASX300 Index at the beginning of its its last financial year and, hence, is not required under ASX Listing Rules to have a remuneration (compensation) committee. The ASX Corporate Governance Principles and Recommendations contain a non-binding recommendation that all ASX-listed companies should have a remuneration committee comprised of at least three members, a majority of whom (including the chair) are “independent”. While these recommendations contain guidelines for assessing independence, ASX-listed entities are able to adopt their own definitions of an independent director for this purpose and is different from the definition in NASDAQ Rule 5605(a)(2). That being said, Novogen has, and expects to continue to have, a Remuneration and Nomination Committee consisting of three non-executive directors.

Novogen is listed on the ASX and subject to Chapter 10 of the ASX listing rules which requires shareholder approval for an acquisition from or disposal to a “related party” (including a director) or “substantial shareholder” (who is entitled to at least 10% of the voting securities) of “substantial assets”. The Australian Corporations Act to which Novogen is also subject generally requires shareholder approval for a transaction with a director or director-controlled entity unless on arm’s length terms.

 

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Item 16H. Mine Safety Disclosure

This item is not applicable.

PART III

 

Item 17. Financial Statements

Refer to “Item 18 – Financial Statements” below

 

Item 18. Financial Statements

The financial statements filed as part of this Annual Report commencing on page F-1.

 

Item 19. Exhibits

 

(a) Exhibits

 

Exhibit
No.
   Exhibit Description

  1.1

   Constitution of Novogen Limited, as amended and restated on November 16, 2016.

   2.1

   Deposit Agreement, dated as of June  13, 2016 among Novogen Limited, The Bank of New York, as Depositary, and owners and holders from time to time of ADSs issued thereunder (incorporated by reference to Exhibit 2.1 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962).

   4.1

   Lease Agreement, dated November  1, 2015 between Coal Services Pty Limited and Novogen (incorporated by reference to Exhibit 4.1 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962).

   4.2

   Employment Agreement for Chief Executive Officer of Novogen Limited, dated December  10, 2015 (incorporated by reference to Exhibit 4.2 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962).

   4.6

   Convertible Note Deed Poll with Triaxial Pty Ltd Noteholders dated December  6, 2012 (incorporated by reference to Exhibit 4.6 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962).

   4.7

   Amendment to Convertible Note Deed Poll with Triaxial Pty Ltd Noteholders dated December  4, 2014 (incorporated by reference to Exhibit 4.7 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962).

   4.8

   Development and IP Assignment Deed with Genscreen Pty. Ltd. and Ian Dixon, dated October  8, 2013 (incorporated by reference to Exhibit 4.8 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962).

   4.9

   Heads of Agreement Clinical Trial Funding with The Kids’ Cancer Project, dated October  29, 2015 (incorporated by reference to Exhibit 4.9 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No. 0-29962).

   4.10

   Novogen Officers’ and Employees’ Share Option Plan (incorporated by reference to Exhibit 4.10 to the Company’s Annual Report on Form 20-F filed with the SEC on October 27, 2016 (File No.0-29962)

 

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  4.11

   Share Sale Agreement dated October 31, 2016 between Kilinwata Investments Pty. Ltd., Mi Ok Chong, Paul Hopper and Novogen Limited.†

  4.12

   Exclusive License Agreement dated October 25, 2016 between Genentech, Inc. and Novogen Limited.†

  4.13

   CRC Project Funding Agreement dated March 21, 2017 between The Commonwealth of Australia as represented by the Department of Industry, Innovation and Science and Novogen Limited.†

  4.14

   Participants Agreement dated June 15, 2017 between Novogen Limited, The University of New South Wales and ICP - Firefly Pty. Limited.†

  4.15

   Employment Agreement for Chief Business Officer of Novogen Limited, dated as of August 16, 2016

  4.16

   Employment Agreement for Chief Medical Officer of Novogen Limited, dated as of August 16, 2016

  4.17

   Sabio Solutions Pty Limited Letter of Appointment – Company Secretary, dated as of September 1, 2016

  4.18

   Sabio Solutions Pty Limited Contract Extension Letter, dated as of March 1, 2017

  4.19

   Sabio Solutions Pty Limited Contract Extension Letter, dated as of August 23, 2017

  4.20

   Employment Agreement for Director of Finance and Administration of Novogen Limited, dated as of July 1, 2017

  8.1

   Company Subsidiaries.

12.1

   Certification of the Principal Executive Officer pursuant to Rule 13a – 14(a) of the Securities Exchange Act of 1934, as amended.

12.2

   Certification of Chief Financial Officer pursuant to Rule 13a – 14(a) of the Securities Exchange Act of 1934, as amended.

13.1

   Certification by the Principal Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as added by Section 906 of the Sarbanes – Oxley Act of 2002.

23.1

   Consent of Grant Thornton Audit Pty Ltd

 

Confidential treatment has been requested with respect to portions of this Exhibit. Omitted portions have been submitted separately to the SEC.

 

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SIGNATURES

The registrant hereby certifies that it meets all the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this Annual Report on its behalf.

 

NOVOGEN LIMITED

/s/ James Garner

Dr James Garner
Chief Executive Officer
Date: October 25, 2017

 

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Index to Financial Statements

 

     Page  

Consolidated Financial Statements for June 30, 2017, 2016 and 2015 and the years then ended:

  

Report of Independent Registered Public Accounting Firm

     F- 2  

Consolidated statements of profit or loss and other comprehensive income

     F- 3  

Consolidated statements of financial position

     F- 5  

Consolidated statements of changes in equity

     F- 6  

Consolidated statements of cash flows

     F- 8  

Notes to the financial statements

     F-10  

 

F-1


Table of Contents

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Board of Directors and Shareholders of Novogen Limited

We have audited the accompanying consolidated statements of financial position of Novogen Limited and subsidiaries (the “Company”) as of June 30, 2017 and 2016, and the related consolidated statements of profit and loss and other comprehensive income, changes in shareholders’ equity, and cash flows for each of the three years in the period ended June 30, 2017. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. We were not engaged to perform an audit of the Company’s internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Novogen Limited and subsidiaries as of June 30, 2017 and 2016, and the results of their operations and their cash flows for each of the three years in the period ended June 30, 2017 in conformity with International Financial Reporting Standards.

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 in the consolidated financial statements, the Group incurred a net loss of $10,670,000 and net operating cash outflows of $11,435,000 during the year ended June 30, 2017. These conditions, along with other matters as set forth in Note 2, raise substantial doubt about the Group’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

/s/ Grant Thornton

GRANT THORNTON AUDIT PTY LTD

Sydney, NSW Australia

October 25, 2017

 

F-2


Table of Contents

Consolidated statements of profit or loss and other comprehensive income

For the year ended 30 June 2017    

 

     Note      2017
A$’000
    2016
A$’000
    2015
A$’000
 

Revenue from continuing operations

     5        249       406       89  

Other income

     6        8,563       3,665       2,753  

Expenses

         

Research and development expense

        (11,136     (9,894     (5,935

General and administrative expense

        (7,764     (5,761     (3,843

Loss on disposal of fixed assets

        (16     (2     —    

Net fair value loss on convertible note derivative

        —         —         (301

Loss on disposal of CanTx, Inc. after income tax expense

        —         (569     —    

Finance costs

     7        (765     —         (69
     

 

 

   

 

 

   

 

 

 

Loss before income tax expense from continuing operations

        (10,869     (12,155     (7,306

Income tax benefits

     8        199       —         —    
     

 

 

   

 

 

   

 

 

 

Loss after income tax expense from continuing operations

        (10,670     (12,155     (7,306

Loss after income tax expense for the year

        (10,670     (12,155     (7,306

Other comprehensive income

         

Items that may be reclassified subsequently to profit or loss

         

Loss on the revaluation of available-for-sale financial assets, net of tax

        9       (3     (32

Net exchange difference on translation of financial statements of foreign controlled entities, net of tax

        25       (1     (376

Derecognition of foreign currency reserve relating to CanTx, Inc.

        —         178       —    
     

 

 

   

 

 

   

 

 

 

Other comprehensive income for the year, net of tax

        34       174       (408

Total comprehensive income for the year

        (10,636     (11,981     (7,714

The above consolidated statements of profit or loss or other comprehensive income should be read with the accompanying notes.

 

F-3


Table of Contents

Consolidated statements of profit or loss and other comprehensive income (continued)

For the year ended 30 June 2017    

 

     Note      2017
A$’000
    2016
A$’000
    2015
A$’000
 

Loss for the year is attributable to:

         

Non-controlling interest

        —         (92     (167

Owners of Novogen Limited

        (10,670     (12,063     (7,139
     

 

 

   

 

 

   

 

 

 

Total loss for the year

        (10,670     (12,155     (7,306

Total comprehensive income for the year is attributable to:

         

Non-controlling interest

        —         (96     (205

Owners of Novogen Limited

        (10,636     (11,885     (7,509
     

 

 

   

 

 

   

 

 

 

Total comprehensive income for the year

        (10,636     (11,981     (7,714
     

 

 

   

 

 

   

 

 

 
            2017     2016     2015  
            Aus     Aus     Aus  
            Cents     Cents     Cents  

Earnings per share for loss attributable to the owners of Novogen Limited

         

Basic earnings per share

     39        (2.28     (2.82     (2.99

Diluted earnings per share

     39        (2.28     (2.82     (2.99

The above consolidated statements of profit or loss or other comprehensive income should be read with the accompanying notes

 

F-4


Table of Contents

Consolidated statements of financial position

As at 30 June 2017

 

     Note      2017
A$’000
    2016
A$’000
 

Assets

       

Current assets

       

Cash and cash equivalents

     9        14,455       33,453  

Trade and other receivables

     10        4,262       199  

Income tax refund due

     11        5       4  

Other

     12        758       434  
     

 

 

   

 

 

 

Total current assets

        19,480       34,090  
     

 

 

   

 

 

 

Non-current assets

       

Available-for-sale financial assets

     13        22       13  

Property, plant and equipment

     14        490       592  

Intangibles

     15        15,918       822  
     

 

 

   

 

 

 

Total non-current assets

        16,430       1,427  
     

 

 

   

 

 

 

Total assets

        35,910       35,517  
     

 

 

   

 

 

 

Liabilities

       

Current liabilities

       

Trade and other payables

     16        1,873       1,300  

Provisions

     17        155       132  

Unearned revenue

     18        41       —    

Contingent consideration

     19        3,315       —    
     

 

 

   

 

 

 

Total current liabilities

        5,384       1,432  
     

 

 

   

 

 

 

Non-current liabilities

       

Deferred tax

     20        4,314       —    

Provisions

     21        64       62  

Trade and other payables

     22        106       92  

Contingent consideration

     23        704       —    
     

 

 

   

 

 

 

Total Non-current liabilities

        5,188       154  
     

 

 

   

 

 

 

Total liabilities

        10,572       1,586  
     

 

 

   

 

 

 

Net assets

        25,338       33,931  
     

 

 

   

 

 

 

Equity

       

Contributed equity

     24        193,769       191,301  

Other contributed equity

     25        600       1,716  

Reserves

     26        1,930       1,421  

Accumulated losses

     27        (170,961     (160,507
     

 

 

   

 

 

 

Equity attributable to the owners of Novogen Limited

        25,338       33,931  

Total equity

        25,338       33,931  
     

 

 

   

 

 

 

The above consolidated statements of financial position should be read with the accompanying notes

 

F-5


Table of Contents

Consolidated statements of changes in equity

For the year ended 30 June 2017

 

    

Contributed
equity

A$’000

    

Other
Contributed
equity

A$’000

     Reserves
A$’000
   

Accumulated
Losses

A$’000

   

Non-

controlling

Interest

A$’000

    Total equity
A$’000
 

Balance at 1 July 2014

     142,586        —          231     (141,306     (98     1,413  

Loss after income tax expense for the year

     —          —          —         (7,139     (167     (7,306

Other comprehensive income for the year, net of tax

     —          —          (370     —         (38     (408
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income for the year

     —          —          (370     (7,139     (205     (7,714

Transactions with owners in their capacity as owners:

              

Share-based payments

     —          —          1,527       —         —         1,527  

Contributions of equity, net of transaction costs

     47,636        —          —         —         —         47,636  

Recognition of equity component of compound financial instrument

     —          1,500        —         —         —         1,500  

Transfers

     —          216        (216     —         —         —    

Exercise of options

     182        —          (182     —         —         —    
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at 30 June 2015

     190,404        1,716        990       (148,445     (303     44,362  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 
     Contributed
equity
     Other
Contributed
equity
     Reserves     Accumulated
Losses
   

Non-

controlling
Interest

    Total equity  
     A$’000      A$’000      A$’000     A$’000     A$’000     A$’000  

Balance at 1 July 2015

     190,404        1,716        990       (148,445     (303     44,362  

Loss after income tax expense for the year

     —          —          —         (12,062     (93     (12,155

Other comprehensive income for the year, net of tax

     —          —          174       —         —         174  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income for the year

     —          —          174       (12,062     (93     (11,981

Transactions with owners in their capacity as owners:

              

Share-based payments

     —          —          372       —         —         372  

Contributions of equity, net of transaction costs

     782        —          —         —         —         782  

Derecognition of non-controlling interest

     —          —          —         —         392       392  

Derecognition of foreign currency reserve

     —          —          —         —         4       4  

Exercise of options

     115        —          (115     —         —         —    
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

Balance at 30 June 2016

     191,301        1,716        1,421       (160,507     —         33,931  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

   

 

 

 

The above consolidated statements of changes in equity should be read with the accompanying notes

 

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Consolidated statements of changes in equity (continued)

For the year ended 30 June 2017

 

     Contributed
equity
    Other
Contributed
equity
    Reserves      Accumulated
Losses
    Non-controlling
Interest
     Total equity  
     A$’000     A$’000     A$’000      A$’000     A$’000      A$’000  

Balance at 1 July 2016

     191,301       1,716       1,421        (160,507     —          33,931  

Loss after income tax expense for the year

     —         —         —          (10,670     —          (10,670

Other comprehensive income for the year, net of tax

     —         —         34        —         —          34  
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

Total comprehensive income for the year

     —         —         34        (10,670     —          (10,636

Transactions with owners in their capacity as owners:

              

Share issue costs

     (18     —         —          —         —          (18

Transfers

     —         (216     —          216       —          —    

Conversion of convertible note

     900       (900     —          —         —          —    
Employee share-based payment options      —         —         475        —         —          475  

Share based payment

     1,586       —         —          —         —          1,586  
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

Balance at 30 June 2017

     193,769       600       1,930        (170,961     —          25,338  
  

 

 

   

 

 

   

 

 

    

 

 

   

 

 

    

 

 

 

The above consolidated statements of changes in equity should be read with the accompanying notes

 

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Consolidated statements of cash flows

For the year ended 30 June 2017

 

     Note      2017
A$’000
    2016
A$’000
    2015
A$’000
 

Cash flows from operating activities

         

Loss before income tax expense for the year

        (10,670     (12,155     (7,306

Adjustments for:

         

Depreciation and amortisation

        1,420       643       575  

Net loss on disposal of non-current assets

        16       2       13  

Share-based payments

        517       372       —    

Foreign exchange differences

        454       (796     (508

Make good credit and rental adjustment

        15       101       —    

Net gain on disposal of CanTx, Inc.

        —         569       —    

Net fair value loss on convertible note derivative

        —         —         301  

Interest income accrued

        —         (1     —    

Imputed interest on convertible note

        —         —         68  

Release of discount on the contingent consideration

        764       —         —    
     

 

 

   

 

 

   

 

 

 
        (7,484     (11,265     (6,857

Change in operating assets and liabilities:

         

Decrease/(increase) in trade and other receivables

        (3,968     15       (85

Decrease/(increase) in income tax refund due

        (1     (4     3  

(Increase) in prepayments

        (325     (307     (59

(Decrease)/increase in trade and other payables

        573       (328     1,360  

(Decrease)/increase in derivative liabilities

        —         —         (173

(Decrease) in deposit paid

        (96     (62     —    

(Decrease)/increase in other provisions

        23       (29     51  

Decrease in deferred tax liability

        (198     —         —    

Increase in unearned revenue

        41       —         —    
     

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

        (11,435     (11,980     (5,760
     

 

 

   

 

 

   

 

 

 

Cash flows from investing activities

         

Payment for purchase of business, net of cash acquired

     36        (7,097     —         —    

Payments for property, plant and equipment

     14        (12     (522     (97

Payments for intangibles

     15        (8     (3     —    

Proceeds from disposal of property, plant and equipment

        —         3       8  
     

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

        (7,117     (522     (89
     

 

 

   

 

 

   

 

 

 

The above consolidated statements of cash flows should be read with the accompanying notes

 

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Consolidated statements of cash flows (continued)

For the year ended 30 June 2017

 

     Note      2017
A$’000
    2016
A$’000
    2015
A$’000
 

Cash flows from financing activities

         

Proceeds from issue of shares

     24        —         853       50,356  

Share issue transaction costs

        (18     (71     (2,941
     

 

 

   

 

 

   

 

 

 

Net cash from financing activities

        (18     782       47,415  
     

 

 

   

 

 

   

 

 

 

Net (decrease)/increase in cash and cash equivalents

        (18,570     (11,720     41,566  

Cash and cash equivalents at the beginning of the financial year

        33,453       44,371       2,502  

Effects of exchange rate changes on cash

        (428     802       303  
     

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at the end of the financial year

     9        14,455       33,453       44,371  
     

 

 

   

 

 

   

 

 

 

The above consolidated statements of cash flows should be read with the accompanying notes

 

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Notes to the financial statements

For the year ended 30 June 2017

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 Limited’s 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.

 

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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 entity’s 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.

 

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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.

 

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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 Limited’s 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 entity’s 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 period’s 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:

 

 

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

 

 

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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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 asset’s 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.

 

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Table of Contents

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 asset’s 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.

 

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Table of Contents

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 asset’s useful life or over the shorter of the asset’s 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 asset’s carrying amount exceeds its recoverable amount.

Recoverable amount is the higher of an asset’s 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.

 

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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.

 

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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.

 

   

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.

 

   

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.

 

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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.

 

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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 entity’s 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 IASB’s 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 entity’s 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 entity’s 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 entity’s statement of financial position as a contract liability, a contract asset, or a receivable, depending on the relationship between the entity’s performance and the customer’s 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 entity’s 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.

 

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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 entity’s 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.

 

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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 management’s 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 entity’s 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.

 

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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  

 

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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  
  

 

 

    

 

 

    

 

 

 

 

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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  
  

 

 

    

 

 

 

 

 

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Table of Contents

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  
  

 

 

    

 

 

    

 

 

 

 

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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.

 

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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  
  

 

 

    

 

 

 

 

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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.

 

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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 Company’s 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.

 

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Note 24. Equity - contributed equity (continued)

 

Share buy-back

There is no current on-market share buy-back.

Capital risk management

The consolidated entity’s 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.

 

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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  
  

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 

 

 

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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 entity’s 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 entity’s 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 entity’s 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  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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Table of Contents

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 entity’s 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  
    

 

 

      

 

 

 

 

 

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Table of Contents

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 entity’s 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 entity’s 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


Table of Contents

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 entity’s 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.

 

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Table of Contents

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.

 

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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.

 

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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 Director’s 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 Director’s 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 Director’s fees, Consultancy fees for executive duties were paid to John O’Connor.

     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.

 

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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 Glioblast’s contribution to the Group’s results

Glioblast contributed $nil to the Group’s revenues and profits, respectively from the date of the acquisition to 30 June 2017. Had the acquisition occurred on 1 July 2016, the Group’s revenue for the financial year ended 30 June 2017 would be unchanged.

 

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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.

 

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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 entity’s operations, the results of those operations, or the consolidated entity’s 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.

 

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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.

 

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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 Company’s 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 Company’s shares over a period of time. No special features inherent to the options granted were incorporated into measurement of fair value.

 

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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

 

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