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Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Acrux AGM 2016 1

Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

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Page 1: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Acrux (ASX: ACR)

Annual General Meeting

10 November, 2016

Acrux AGM 20161

Page 2: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Introduction: Ross DobinsonNon-Executive Chairman

2

Page 3: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Company review: Michael KotsanisCEO & Managing Director

3

Page 4: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

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, the outcome of legal proceedings and the effectiveness of patent

protection.

Acrux AGM 20164

Page 5: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Axiron® IP outcome

• United States District Court for the Southern District of Indiana

judgment

• Formulation and axilla application patents granted by the US Patent Office for

Axiron® have been invalidated

• Patents therefore would not be infringed by the commercialisation of generic

versions of Axiron® by the generic companies that have challenged these patents

• The applicator patent is valid but not infringed by the majority of parties

• Acrux and Eli Lilly and Company have appealed the District Court

decision

Acrux AGM 20165

Page 6: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

FY 2016 outcomes

Revenue 2016: $28.6 million2015: $25.4 million

Net Profit After Tax

2016: $13.0 million2015: $11.1 million

Cash 2016: $29.4 million2015: $23.1 million

Product approval Lenzetto approved in European Union in 1H FY16Milestones received 1H FY16Lenzetto launched in numerous European markets in 2H FY16

Pipeline progress Initiated and made solid progress on first three generic projectsEncouraging progress on onychomycosis project formulations

Acrux AGM 20166

Page 7: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Finance review: Tim BatemanCFO & Company Secretary

7

Page 8: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Full year earnings

Royalty revenue largely comprises Axiron revenue $25.5M

Milestone income reflects multiple marketing approvals of Lenzetto in the European Union by our licensee Gedeon Richter

R&D investment up $1.7M over prior year, reflecting investment in 3 generic and one speciality product

Operating costs have reduced 8%

Non-operating costs comprise non-cash costs and foreign exchange loss

Income tax expense represents 28.3% of profit before tax and is lower than the company tax rate of 30% due to utilisation of tax losses

Profit after tax up 16.6% or $1.9M over prior year

2015/16 2014/15 %

Royalty 25,469 24,639 3.4%

Milestone 2,540 - n/a

Other revenue 548 729 -24.8%

Revenue 28,557 25,368 12.6%

R&D investment (5,536) (3,780) 46.5%

Operating costs (2,390) (2,597) -8.0%

Non-operating costs (2,539) (2,185) 16.2%

Total Expenses (10,465) (8,562) 22.2%

Profit before income tax 18,092 16,806 7.7%

Income tax expense (5,111) (5,676) -10.0%

Pofit after income tax 12,981 11,130 16.6%

Earnings per share 7.8 cents 6.7 cents +1.1 cents

Cash reserves 29,360 23,068 27.3%

Acrux AGM 20168

Page 9: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Full year cash flow

Cash received from conduct of business activities $28.7M, up 11% over prior year due to milestones on Lenzetto

Increase in payments to suppliers & employees of 22.6% as investment in R&D is increased to drive pipeline program

Reduction in tax payments of $4.6M or 51.7% due to lower net profit in FY15 as compared to FY14 (note: - final tax instalment payment falls into next FY)

As a result cash reserves at year end were $29.4M up 27.3% or $6.3M over prior year

Acrux AGM 20169

2015/16 2014/15 %

Royalties received 25,668 25,203 1.8%

Milestones received 2,540 - n/a

Interest received 515 639 (19.4%)

Other income received - 23 (100.0%)

Total cash received 28,723 25,865 11.0%

Payments to suppliers & employees (7,923) (6,460) 22.6%

Purchase of capital (236) (66) 257.6%

Tax paid (4,294) (8,886) (51.7%)

Total cash payments (12,453) (15,412) (19.2%)

Dividends paid (9,992) (13,322) (25.0%)

Net increase/(decrease) in cash 6,278 (2,869) (318.8%)

Foreign exchange differences on cash holdings 14 162 (91.4%)

Cash at beginning of the year 23,068 25,775 (10.5%)

Cash at end of the year 29,360 23,068 27.3%

Page 10: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Company review: Michael KotsanisCEO & Managing Director

10

Page 11: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Axiron volume and market share• Axiron market share remains

consistent at approximately 14%

• US District Court decision allows

Watson (Teva) generic to launch

• A generic launch will impact Axiron

sales

• US District Court decision has been

appealed. Federal Circuit in

Washington will hear Appeal

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

-

10

20

30

40

50

60

Mar

-11

Jun

-11

Sep

-11

Dec

-11

Mar

-12

Jun

-12

Sep

-12

Dec

-12

Mar

-13

Jun

-13

Sep

-13

Dec

-13

Mar

-14

Jun

-14

Sep

-14

Dec

-14

Mar

-15

Jun

-15

Sep

-15

Dec

-15

Mar

-16

Jun

-16

USD

$M

Axiron Quarterly Net Sales

0%

5%

10%

15%

20%

Mar

ch-1

1

Jun

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Septemb…

Decem

be…

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Axiron Market Share

0

50,000

100,000

150,000

Q3 Q4 Q1 Q2

FY15, FY16 TRx

Acrux AGM 2016

• 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

• Licensed globally to Eli Lilly and Company

• Acrux receives royalties and milestones on sales from Lilly 11

Page 12: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

• Lenzetto® is a hormone replacement therapy for women

• Lenzetto® has been launched in a number of territories

since January 2016, through our licensee Gedeon Richter,

including Germany, Hungary and Romania

• Progressive European roll-out to new markets expected

through 2016 and 2017

• Additional four country launches planned following

European Summer

• Topical estrogen-only HRT market is valued at over EURO 85

million

Lenzetto® (estradiol) spray Launched in Europe

Acrux AGM 201612

Page 13: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

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

Acrux AGM 201613

Page 14: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Total US pharma market size

• Oral market exceeds $200 billion

• Injectable market exceeds $130

billion

• Both oral and injectable markets

are heavily competitive.

• Topical transdermal market is

relatively small at under $20 billion

Topically applied drugs generated sales of over $18 billion in 2015.

Oral and injectable markets account for 84% of total market.

Source: Acrux analysis. IMS June 2015 MAT. US market sales. US$

Acrux AGM 2016

Oral

Injectable

Liquids

Topical

Aerosol Powders Other

14

Page 15: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Topical Generic Portfolio

• First three generic formulations

completed. CMO selection underway

• Topically applied generic products in

commercially attractive market segments

• Reduced development timeframes

compared to topical speciality portfolio

• Building portfolio of topical generic

programs with sustainable returns

• By end FY17 development activities

would have been initiated on 7 topical

generics

• Targeting US market

• Generic market sector grew by 17% year

on year. Branded market sector declined

by 2%

Our topical generic pipeline is commercially compelling

US Transdermal and Topical market size

US$9.6 billion

US$8.5 billion

US$440 million

InitialAcrux

portfolioACR068ACR071ACR072

Generic market sector

Branded market sector

Source: IMS June 2015 MAT. US Transdermal and Topical generic and branded market segments

Acrux AGM 201615

Page 16: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Indication

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

Formulation and intellectual property

• Solution for topical administration

• Improved formulation of efinaconazole selected

• New patent has been filed

• IPR Petition for review of existing Jublia patent filed

Market

• An oral anti-fungal has been the subject of recent FDA Drug Safety Communications

• New topical products growing market volume

• Over 30 million Americans with onychomycosis

• Efficacy of currently marketed topicals is low

Acrux antifungal development Onychomycosis

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

Acrux AGM 201616

Page 17: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Future milestones

• Draft and submit patent application for ACR065 for onychomycosis

• Gedeon Richter to continue country specific launches of Lenzetto in the European Union

• Scale up activities to manufacture exhibit batches for initial generic products

• Contract manufacturing organisation to be engaged to manufacture multiple generic products

• Commence first bioequivalence study

• Portfolio of 7 topical generics in development by end FY17

• Axiron Appeal outcome

Acrux AGM 201617

Page 18: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Formal Business: Ross DobinsonNon-Executive Chairman

18

Page 19: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Resolution 1

Acrux AGM 201619

Adoption of Remuneration Report

Proxy votes received prior to the meeting are as follows:

For 33,645,905 votes 90.2 % of available votes

Open 805,886 votes 2.2 % of available votes

Against 2,845,171 votes 7.6 % of available votes

Page 20: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Resolution 2

Acrux AGM 201620

Re-election of Ross Dobinson as Director

Proxy votes received prior to the meeting are as follows:

For 35,304,738 votes 93.8 % of available votes

Open 892,921 votes 2.4 % of available votes

Against 1,447,959 votes 3.8 % of available votes

Page 21: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Resolution 3

Acrux AGM 201621

Re-election of Timothy Oldham as Director

Proxy votes received prior to the meeting are as follows:

For 34,529,037 votes 91.7 % of available votes

Open 1,863,046 votes 5.0 % of available votes

Against 1,253,535 votes 3.3 % of available votes

Page 22: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Resolution 4

Acrux AGM 201622

Election of Simon Green as Director

Proxy votes received prior to the meeting are as follows:

For 34,609,474 votes 91.9 % of available votes

Open 1,863,046 votes 5.0 % of available votes

Against 1,168,598 votes 3.1 % of available votes

Page 23: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Resolution 5

Acrux AGM 201623

Election of Geoffrey Brooke as Director

Proxy votes received prior to the meeting are as follows:

For 34,175,026 votes 90.8 % of available votes

Open 2,041,446 votes 5.4 % of available votes

Against 1,413,596 votes 3.8 % of available votes

Page 24: Acrux (ASX: ACR) Annual General Meeting 10 November, 2016 Q3 Q4 Q1 Q2 FY15, FY16 TRx Acrux AGM 2016 • AXIRON is used to treat adult males who have low or no testosterone due to certain

Acrux AGM 201624