Home' Acrux Annual Report : Acrux Annual Report 2016 Contents DIRECTORS’ REPORT
The Directors present their report, together with the Financial Report of the consolidated entity consisting of Acrux Limited and the
entities it controlled for the financial year ended 30 June 2016, together with the independent auditor’s report thereon. This Financial
Report has been prepared in accordance with Australian Accounting Standards.
The principal activities of the consolidated entity during the financial year were the development and commercialisation of
pharmaceutical products. There has been no significant change in the nature of these activities during the financial year.
Net profit after tax
Earnings per share
Cash on hand
The consolidated profit after income tax attributable to the members of Acrux Limited was $13.0 million (2015: $11.1 million). Diluted
earnings per share were 7.8 cents (2015: 6.7 cents).
Review of operations
A review of the operations of the consolidated entity during the financial year and the results of these operations are as follows:
Acrux is a pharmaceutical company dedicated to developing and commercialising specialty and generic transdermal and topical
pharmaceuticals for global markets to deliver attractive returns to shareholders.
Acrux’s strategy is to create new topical or transdermal pharmaceutical products by formulating or reformulating delivery methods
for proven drugs using our internal development capabilities. Transdermal or topical delivery of pharmaceutical products as gels,
patches, creams and ointments is a rapidly growing alternative route of administration of drugs delivered in oral and injectable
forms. Formulating proven drugs means that the development time is usually shorter and both the risk and expenditure profiles
are lower than is typical for new drug development. Intellectual property (IP) remains an important cornerstone of our product
development strategy, both in terms of creating new IP (where relevant), and ensuring freedom to operate in the fields in which
we develop products.
Our topical or transdermal pharmaceutical product portfolio can be segregated into two streams – generic pharmaceutical products
and specialty pharmaceutical products.
Generic topical or transdermal pharmaceutical products are the pharmaceutical and therapeutic equivalents of existing (reference)
branded products. Accordingly, generic products provide a safe, effective and cost-efficient alternative to users of the reference brand
products. Generic product development is generally less time-consuming and complex than the new chemical entity development
process. It usually does not require new preclinical and clinical studies, because it relies on the studies conducted for the referenced
innovator product (often called the Reference Listed Drug or RLD) that had established safety and efficacy of that product. Generic
products may require one or more bioequivalence studies to show that the generic drug is bioequivalent to the previously approved
RLD. These studies are relatively low cost and short term.
Specialty topical or transdermal pharmaceutical products are designed to provide patients with an improved product experience.
Our specialty product development projects are targeting improved formulation of proven active pharmaceutical drugs with Acrux’s
delivery technology to create a patient-preferred product. These products are designed to provide a point of difference in the market
through either improved formulation efficacy, reduced volume of active drug ingredient, improved active drug efficiency or a novel
means of drug administration. Like generic products, specialty product development is generally less time-consuming and complex
than the development process of a new chemical entity. The investment required for specialty products is usually higher than
that required to develop generic transdermal and topical products. The specialty product development cycle requires a number
of preclinical and clinical trials to validate safety and patient outcomes. However, unlike generic product development, specialty
product development enables the creation of new IP, which provides commercial protection against competitors.
18 ACRUX ANNUAL REPORT 2016
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