Acrux : Appendix 4D and Half Year Accounts - for the 31 Dec acOpens in a new Window

Appendix 4D -Half year report

Results for announcement to the market

Name of Entity	Acrux Limited
ABN	72 082 001 152
Half Year Ended	31 December 2020
Previous Corresponding Reporting Period	31 December 2019

Results for announcement to the market $A'000
Revenues from ordinary activities	Up 39%to 800
(Loss) from ordinary activities after tax attributable to members	Up 21%to (7,786)
Net (loss) for the period attributable to members	Up 21%to (7,786)

No dividends have been declared for the half year ending 31 December 2020 or for the corresponding period.

Please refer to attached accounts for commentary on the results.

NTA Backing

Net tangible asset backing per ordinary security

Current period	Previous corresponding Period
$0.04	$0.07

ACRUX LIMITED AND CONTROLLED ENTITIES

ABN: 72 082 001 152

FINANCIAL REPORT FOR THE HALF-YEAR ENDED

31 DECEMBER 2020

This half-year financial report is to be read in conjunction with the financial report for the year ended 30 June 2020

ACRUX LIMITED AND CONTROLLED ENTITIES (ABN: 72 082 001 152)FINANCIAL REPORT FOR THE HALF-YEAR ENDED 31 DECEMBER 2020

TABLE OF CONTENTS

Directors' Report

Page 1

Auditor's Independence Declaration

Financial Report for the half-year ended 31 December 2020

Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income

Condensed Consolidated Statement of Financial Position

Condensed Consolidated Statement of Changes in Equity

Condensed Consolidated Statement of Cash Flows

Notes to the Condensed Consolidated Financial Statements

• 1. Basis of Preparation of Accounting Policies

• 2. Segment Reporting

• 3. Research and Development Related Costs

• 4. Income Tax

• 5. Fair Value Measurements

• 6. Intangible Assets

• 7. Leasing

• 8. Contingent Liabilities

• 9. After Balance Date Events

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Directors' Declaration
Independent Auditor's Review Report
Company Information
Directors	Auditor
R Dobinson - Non-executive Chairman	Pitcher Partners
T Oldham - Non-executive Director	Level 13,
G Brooke - Non-executive Director	664 Collins Street
M Kotsanis - CEO and Managing Director	DOCKLANDS, VICTORIA 3008
N Gray - Non-executive Director
Share Registry
Company Secretary	Link Market Services
Deborah Ambrosini	Level 13, Tower 4
727 Collins Street
Registered Office	Docklands
103-113 Stanley Street	Victoria 3008
West Melbourne
Victoria 3003	Australia Toll-free: 1300 554 474 (Australia only)
International: [phone]
Principal Business Address
103-113 Stanley Street	F: [phone]
West Melbourne	F: [phone] (for proxy voting)
Victoria 3003
Telephone: [phone]	E:[e-mail]
Website:www.acrux.com.au	www.linkmarketservices.com.au
Australian Business Number	Australian Securities Exchange Listing
72 082 001 152	Australian Securities Exchange Limited
(Home Exchange: Melbourne, Victoria)
ASX Code: ACR

18 19

ACRUX LIMITED AND CONTROLLED ENTITIES (ABN: 72 082 001 152)

DIRECTORS' REPORT FOR THE HALF-YEAR ENDED 31 DECEMBER 2020

The Directors present their report together with the condensed financial report of the consolidated entity consisting of Acrux Limited ('the Company') and its controlled entities ('the Group'), for the half-year ended 31 December 2020 and independent review report thereon.

DIRECTORS' NAMES

The names of the Directors in office at any time during, or since the end of the half-year are:

Name	Appointed/resigned
Ross Dobinson	Non-executive Chairman	Appointed 19 March 1998
Michael Kotsanis	Managing Director & Chief Executive Officer	Appointed 3 November 2014
Timothy Oldham	Non-executive Director	Appointed 1 October 2013
Geoffrey Brooke	Non-executive Director	Appointed 1 June 2016
Norman Gray	Non-executive Director	Appointed 28 November 2019

The Directors have been in office since the start of the financial period to the date of this report unless otherwise stated.

REVIEW OF OPERATIONS

A review of the operations of the Group during the half-year and the results of these operations are as follows:

Mission

Acrux is a pharmaceutical company dedicated to developing and commercialising generic topical prescription pharmaceuticals.

Business Strategy

Acrux has 2 commercialised products (2 brands of its Estradiol spray) which are being sold in over 30 countries, including the United States and within the European Union. In addition to its commercialised products, Acrux is expanding its range of topical generic products for the US market by leveraging its on-site laboratories, GMP manufacturing suite, clinical and commercial experience to bring affordable products to market. The Company has entered into a number of manufacturing contracts with US Food and Drug

Administration ('FDA') approved contract manufacturers for the supply of its products to the US pharmaceutical market. Acrux has also licensed a number of its products to generic companies in the United States for the commercialisation of its products following FDA approval. The development process required for generic products is substantially shorter and less costly than the equivalent process for new drug development.

Topical Generic Portfolio

At the date of this report, Acrux has 13 generic topical products in various stages of development, including 1 for which approval has been granted by the FDA and 2 for which applications have been submitted for review to the FDA. The addressable market value for this pipeline of 13 products in the United States is approximately US$1.1 billion, based on IQVIA reported annual sales data at September 2020.

A significant proportion of the 13 products in development currently have no marketed generic alternatives in the United States.

Acrux has engaged with 7 contract manufacturing organisations ('CMOs') to manufacture different products from its portfolio and has licensed 9 products to 4 generic companies to commercialise its products. All commercial licensees have successful track records selling generic products in the US market.

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