ACRUX PRESENTS AT BIOTRINITY IN EUROPE •Testosterone replacement therapy market is $1 billion+ in...

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ACRUX (ACR) - ASX ANNOUNCEMENT 27 APRIL 2016 ACRUX PRESENTS AT BIOTRINITY IN EUROPE Acrux (ASX: ACR) today announced that CEO and Managing Director, Michael Kotsanis will be presenting at the BioTrinity conference in London today. “I am pleased to present at one of the leading European biotech conferences to discuss the growth strategy for our business and to provide insights into the attractive development programs we are currently executing” said Mr. Kotsanis. The BioTrinity presentation follows this announcement. For further information, contact Michael Kotsanis, CEO and Managing Director: 03 8379 0100 About Acrux Acrux (ASX: ACR) is a drug development company focused on commercialising topical products using its proprietary drug delivery technology. Incorporated in 1998 and using in house facilities and capabilities, Acrux has successfully developed and licensed a number of pharmaceutical products in the US and Europe using the Patchless Patch TM , a fast-drying and invisible topical application technology. Acrux will continue to innovate and bring its developed products to the market in collaboration with licensees. For further information on Acrux, visit www.acrux.com.au

Transcript of ACRUX PRESENTS AT BIOTRINITY IN EUROPE •Testosterone replacement therapy market is $1 billion+ in...

Page 1: ACRUX PRESENTS AT BIOTRINITY IN EUROPE •Testosterone replacement therapy market is $1 billion+ in United States •Only approved testosterone replacement therapy applied in the axilla

ACRUX (ACR) - ASX ANNOUNCEMENT 27 APRIL 2016

ACRUX PRESENTS AT BIOTRINITY IN EUROPE

Acrux (ASX: ACR) today announced that CEO and Managing Director, Michael Kotsanis will be presenting at the BioTrinity conference in London today. “I am pleased to present at one of the leading European biotech conferences to discuss the growth strategy for our business and to provide insights into the attractive development programs we are currently executing” said Mr. Kotsanis. The BioTrinity presentation follows this announcement.

For further information, contact

Michael Kotsanis, CEO and Managing Director: 03 8379 0100

About Acrux Acrux (ASX: ACR) is a drug development company focused on commercialising topical products using its proprietary drug delivery technology. Incorporated in 1998 and using in house facilities and capabilities, Acrux has successfully developed and licensed a number of pharmaceutical products in the US and Europe using the Patchless PatchTM, a fast-drying and invisible topical application technology. Acrux will continue to innovate and bring its developed products to the market in collaboration with licensees. For further information on Acrux, visit www.acrux.com.au

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Acrux (ASX: ACR)Michael Kotsanis CEO & Managing Director

BioTrinity London 25-27 April 2016

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Forward looking statements

This presentation includes forward looking statements that are subject to risks and uncertainties.

Such statements involve known and unknown risks and important factors that may cause the actual results,

performance or achievements of Acrux to be materially different from the statements in this presentation.

Actual results could differ materially depending on factors such as the availability of resources, the results of

clinical studies, the timing and effects of regulatory actions, the strength of competition and the

effectiveness of patent protection.

2BioTrinity London 25-27 April 2016

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Acrux key events

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MONASH UNIVERSITY CREATES IP FOR

PENENTRATION OF DRUGS THROUGH SKIN

ACRUX INCORPORATED

ACRUX LISTS ON ASX

ACRUX SIGNS AXIRON (TESTOSTERONE) DEAL

WITH LILLY

ACRUX RECEIVES US$50 MILLION UPFRONT

FROM LILLY

US APPROVAL FOR AXIRON

ACRUX RECEIVES US$87 MILLION APPROVAL

MILESTONE FROM LILLY

ACRUX RECEIVES US$25 MILLION

SALES MILESTONE FROM LILLY

ACRUX BEGINS DEVELOPMENT OF GENERIC

TOPICAL DRUGS

LENZETTO (ESTRADIOL) APPROVED IN EUROPE

ACRUX RECEIVES US$2 MILLION APPROVAL

MILESTONE FROM RICHTER

BIOTRINITY, LONDON

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• Acrux was founded in 1998 and listed on the ASX in 2004

• Acrux generates the majority of its revenue from royalties from Axiron

• Axiron is licensed to Eli Lilly and was launched in the United States in 2011

BioTrinity London 25-27 April 2016

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FY 2015 Business milestones

$11.1 million – Acrux records its sixth consecutive profitable year

$23.1 million – cash reserves at end June, 2015

Estradiol – approved in Europe. Milestones of US$2 million triggered FY16

Topical generic pipeline – portfolio identified

NSAIDs – superior formulations developed

$1.02 per share – total capital returned to shareholders over the past 5 years

4BioTrinity London 25-27 April 2016

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Growth Strategy

Acrux is building a sustainable business model with a broader portfolio which

leverages its existing topical expertise incompelling market segments

Measures of success: Portfolio with multiple products in

various stages of development Valuable products licensed and

commercialised Profitable and sustainable business

How: Core competency – utilise current

technology, skills and capabilities Highly experienced formulation team Product development focused on

commercially compelling opportunities Partner with strong and capable licensees

BioTrinity London 25-27 April 2016

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Growth Strategy - Framework for continued growth

• Includes Axiron®, Lenzetto®, Evamist®

• Strong cash inflow – facilitating our growth strategy

• Territory expansion being executedExisting topical portfolio

$

BioTrinity London 25-27 April 2016

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Recuvyra®

Axiron®

Evamist ® / Lenzetto®

Existing Topical Portfolio Marketed Products

7BioTrinity London 25-27 April 2016

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Existing Topical Portfolio Lead Product – Axiron

• AXIRON is used to treat adult males who have low or no testosterone due to certain medical conditions

• Approved in the United States and selected other countries

• Testosterone replacement therapy market is $1 billion+ in United States

• Only approved testosterone replacement therapy applied in the axilla• Patented application site

• Marketed by Eli Lilly

• Acrux receives royalties and milestones on sales from Lilly

• Axiron patent litigation case is currently scheduled for June 2016

8BioTrinity London 25-27 April 2016

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Existing Topical PortfolioAxiron volume and market share

• Most recent testosterone FDA Drug

Safety Communication in March 2015

• FDA and sponsors working towards

collaborative long term safety trial

• Testosterone replacement therapy

market remains attractive and

substantial in size

• Axiron market share remains

consistent at approximately 14%

Source: Axiron Net Sales, Eli Lilly; Axiron market share and prescription volumes, IMS

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Axiron US quarterly prescriptions - prior 4 quarters (000s)

BioTrinity London 25-27 April 2016

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• LENZETTO is a hormone replacement therapy for women

• Initial European regulatory approvals granted 2H 2015

• US$2 million milestones received

• First product launches took place in January 2016

• Progressive European roll-out to new markets

• Topical estrogen-only HRT market is valued at over

EURO 85 million

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Existing Topical PortfolioLenzetto® (estradiol) spray approved in Europe

BioTrinity London 25-27 April 2016

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Sources: www.companiesandmarkets.com; www.podiatrytoday.com

Market forecast of

US$3.7 billion by 2017

37 million cases in US by

2022

Prevalence in major markets from 2 – 12% of population

Acrux antifungal development

Indication

For treatment of fungal infection (onychomycosis) of toenails and fingernails

Formulation

Solution for topical administration

Target profile

• Fast drying time with no residue

• Easy and convenient delivery

• Better efficacy than comparator product

• Once daily application

• Low systemic absorption

• Long patent life, with new IP

Topical Specialty Portfolio

Acrux is targeting best in class efficacy in an attractive growing market

11BioTrinity London 25-27 April 2016

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Topical Generic Portfolio

• Portfolio being built, developing topical generic

products in commercially attractive markets

• Reduced development timeframes compared to

topical speciality portfolio

• Generic development opportunities identified

through screen of marketed topical/transdermal

products

• Initial portfolio of 12 potential products identified,

development has been initiated. Current market

value US$2.4 billion

• Building portfolio of topical generic programs

with sustainable returns

Commercially attractive

Existing topical

capabilities

Reduced development

timeframe

Our topical generic pipeline is commercially compelling

12BioTrinity London 25-27 April 2016

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Growth Strategy – Product Pipeline

Indication Product Name Formulation

designPre-clinical development

Phase 1 Phase 2 Phase 3 Registration Commercial Partner

Hypogonadism Axiron® Eli Lilly

Menopausal

symptoms

Estradiol MDTS®

USA – Evamist®Perrigo

Post-operative

pain in dogsRecuvyra® Elanco

Menopausal

symptoms

Estradiol MDTS®

Europe – Lenzetto®

Gedeon

Richter

Onychomycosis ACR-065

Diclofenac ACR-046

Ibuprofen ACR-048

VariousInitial generic

portfolio*

*Development work has been initiated on 3 generic products

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13BioTrinity London 25-27 April 2016

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Half-year earnings result

31 Dec 31 Dec

2015 2014

$'000 $'000

Earnings summary

Royalty revenue 15,224 13,729

Milestone revenue 2,534 -

Interest income 242 313

Other income 4 176

Total revenue and other income 18,004 14,218 26.6%

Expenses 4,700 3,934 19.5%

Profit before income tax expense 13,304 10,284 29.4%

Income tax expense 3,558 3,266 8.9%

Net profit after tax 9,746 7,018 38.9%

Earnings per share $0.06 $0.04 50.0%

Cash & cash equivalents 21,539 15,792 36.4%

Strong earnings growth, earnings per share $0.06 cents (Dec 14: $0.04)

Revenue largely comprises Axiron royalties and Lenzetto milestones.

Axiron sales US$83.0M for half year ended Dec 15 and consistent with prior year of US$83.9M

Lenzetto milestone triggered upon marketing approval being granted in the first 3 countries within Europe

Favourable foreign exchange contributed to revenue growth

Investment in the Company’s growth strategy continued, largely resulting in the recruitment of research and development staff to bring products to market

Income tax expense decreased as a percentage of sales due to utilisation of prior accumulated tax losses

Well positioned to execute growth strategy with cash reserves of $21.5M at Dec 15 and nil debt

14BioTrinity London 25-27 April 2016

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[email protected]

ph: +61 3 8379 0100

www.acrux.com.au

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Ex – Faulding/Mayne/Hospira, Synthon

Acrux Management Team

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Joined Acrux 2001Ex – Austin Hospital, Faulding

BioTrinity – London, 26 April 2016

Joined Acrux 2013Ex – Wyeth

Joined Acrux 2015Ex – Royal Children’s HospitalGSK, Mayne/Hospira

Joined Acrux 2014Ex – KPMG, Mayne/Hospira, Salmat

Michael KotsanisCEO & MD

Sharon PapworthCFO & Company Secretary

Felicia ColagrandeProduct Development &

Technical Affairs Director

Nina WebsterCommercial Director

Charles O’SullivanProject Director

Vvv