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AFT Annual Meeting 2018 Presentation

AGM2 August 2018AFTHealthcare

AFTPHARMACEUTICALS
Annual Meeting

3 August 2018

Annual Meeting
2 August 2018

1

IMPORTANT NOTICE

This presentation has been prepared by AFT Pharmaceuticals Limited (“AFT”), to provide a general overview of AFT. It is not

prepared for any other purpose and must not be provided to any person other than the intended recipient.

All amounts are disclosed in New Zealand dollars (NZ$) unless otherwise indicated. All references to FY20XX appearing in this

presentation are to the financial year ending 31 March, unless otherwise indicated.

This presentation is not a recommendation or other form of financial advice. While reasonable care has been taken in compiling this

presentation, none of AFT nor its subsidiaries, directors, employees, agents or advisers (to the maximum extent permitted by law)

gives any warranty or representation (express or implied) of the accuracy, completeness or reliability of the information contai ned in

it nor takes any responsibility for it. The information in this presentation has not been and will not be independently verifiedor

audited.

This presentation may contain certain forward-looking statements and comments about future events, including with respect to the

financial condition, results, operations and business of AFT. These statements are based on management’s current expectations

and the actual events or results may differ materially and adversely from these expectations. Recipients are cautioned not toplace

undue reliance on forward-looking statements.

Past performance information given in this presentation is given for illustrative purposes only and should not be relied upon(and is

not) an indication of future performance.

Annual Meeting
2 August 2018

CHAIRMAN’S INTRODUCTION

22

Annual Meeting
2 August 2018

ORDER OF MEETING

33

AChairman’s Address

BChief Executive Officer’s Presentation

CShareholder Questions

DOrdinary Resolutions

Directors’ and Executives’
Introductions

Annual Meeting
2 August 2018

CHAIRMAN’S ADDRESS

55

AOverview of Financials

BLicensing and registrations

CKeys to growth

DCorporate governance

Annual Meeting
2 August 2018

66

CEO Presentation

Annual Meeting
2 August 2018

SUMMARY OF AFT BUSINESS

Established Business [1997] and growing AU & NZ

Significant further potential growth

•- Growing OTC Products

•- Growing Maxigesic post Codeine switch in AU & NZ post switch

Large Target Markets for Key Innovative Products

•Maxigesic Tablets – Target Market US$10.4B

•Maxigesic IV –Target Market > US$800M

•Maxigesic other oral dose forms –Target Market US$3.7B

Maxiclear PE – Target Market US$1B

Development NasoSURFMedical Device

•Patented Ultrasonic Powered Drug Delivery Device

•Significant Number of Drug Delivery Indications.

•Market research in USA has identified potential US$1.2B for first targeted

development

•Focus development of key indication initially

8

Development Pascomer

•Significant orphan drug indication. Confirmed now in both USA & EU

•Further progress underway

Development of Key Innovative Products with Global Potential

The most significant growth opportunity: Growing Key Innovative

Products outside ANZ via Distributors & Licensees.

Annual Meeting
2 August 2018

-

10

20

30

40

50

60

70

80

90

FY05FY06FY07FY08FY09FY10FY11FY12FY13FY14FY15FY16FY17FY18

Operating revenue (NZ$m)

FINANCIAL PERFORMANCE – REVENUE GROWTH

10 ye ar C AG R: 14%

Operating revenue, FY2005 – FY2018

FY2017 Operating revenue by region

FY2018 Operating revenue by region

10

Australia

53.6%

New

Zealand

42.1%

Rest of World

2.8%

Southeast Asia

1.5%

Australia

61.4%

New

Zealand

33.8%

Rest of World

3.1%

Southeast Asia

1.6%

Annual Meeting
2 August 2018

FINANCIAL PERFORMANCE – REVENUE BY REGION AND

CHANNEL

11

Operatingrevenue by region, FY2016 – FY2018

Operating revenueby channel by region, FY2018

Australia

New Zealand

Southeast Asia

Rest of World

Over-the-counterHospitalP re s c rip t io n

10.5%

32.3%

57.2%

34.2%

21.6%

44.2%

-

4.4%

95.6%

1.0%

69.2%

29.8%

NZ$000'sFY2016% of total

FY2017% of totalFY2018% of total

Australia31,224 48.8%37,063 53.6%49,193 61.4%

YoY growth18.7%32.7%

New Zealand31,135 48.6%29,167 42.1%27,095 33.8%

YoY growth-6.3%-7.1%

Rest of World1,007 1.6%1,968 2.8%2,496 3.1%

YoY growth95.5%26.8%

Southeast Asia648 1.0%1,005 1.5%1,286 1.6%

YoY growth55.1%28.0%

Total Operating Revenue64,014 100%69,205 100%80,071 100.0%

YoY growth13.8%8.1%15.7%

Annual Meeting
2 August 2018

FINANCIAL PERFORMANCE – SUMMARY P&L

12

NZ$'000's year ended 31 March2018 % of2017 % of

revenuerevenue

Revenue80,071 69,205

Cost of Sales(45,880) 57.3%(43,207)62.4%

Gross Profit34,191 42.7%25,998 37.6%

Other Income2,235 2.8%2,659 3.8%

Selling and distribution expenses(28,533) 35.6%(25,964)37.5%

General and administrative expenses(8,308) 10.4%(5,851)8.5%

Research and development expenses(8,230) 10.3%(11,227)16.2%

Equity accounted loss of joint venture entity(1,494) 1.9%(414)0.6%

Operating Loss(10,139) (14,799)

Finance Income125 347

Finance Costs(2,652) (3,878)

Loss before tax(12,666) (18,330)

Tax benefit/(expense)(58) (58)

Loss after tax(12,724) (18,388)

Annual Meeting
2 August 2018

FINANCIAL PERFORMANCE – SUMMARY Balance Sheet

13

NZ$'000's year ended 31 March2018 2017

ASSETS

Current Assets

Inventories24,412 22,198

Trade and other receivables16,954 16,051

Cash and cash equivalents6,770 15,905

Derivative assets176 -

Total current assets48,312 54,154

Non-current Assets

Property, plant and equipment330 386

Intangible assets5,118 2,548

Deferred income tax assets708 610

Investment in joint venture entity2,134 627

Total assets56,603 58,325

LIABILITIES

Current liabilities

Trade and other payables17,391 14,549

Provisions1,098 564

Current income tax liability118 112

Derivative liabilities - 204

Total current liabilities18,607 15,429

Non-current liabilities

Interest bearing liabilities30,654 23,426

Total liabilities49,261 38,855

Equity

Share Capital63,743 62,944

Retained earnings(57,644) (44,025)

Share options reserve430 295

Redeemable preference share reserve483 -

Foreign currency translation reserve330 256

Total equity7,342 19,470

Total liabilities and equity56,603 58,325

Annual Meeting
2 August 2018

FINANCIAL PERFORMANCE – SUMMARY Cashflow

14

NZ$'000's year ended 31 March2018 2017

Net cash used in operating activities(10,904) (19,062)

Net cash used in investing activities(5,855) (1,598)

Net cash generated from financing activities7,600 9,042

Net increase in cash(9,159) (11,618)

Impact of foreign exchange on cash and cash equivalents24 (457)

Opening cash and cash equivalents15,905 27,980

Closing cash and cash equivalents6,770 15,905

Annual Meeting
2 August 2018

Maxigesic – Why is it an important product?

Deaths in USA from opioid overdose

1999200220052008201120142017

0

20,000

40,000

60,000

80,000

Total O verdose D eaths

O pioid D eaths

A ID s peak (1995)

M otor V ehicle D eaths

S ource: U S N ational C enter for H ealth S tatistics, C D C W onder

Annual Meeting
2 August 2018

Maxigesic – Development Progress Report

Dose FormAugust 17August18

O ra l Ta b le t s EUIn re g is t ra t io n in 1 0EU

c ountrie s [AT, BE, DE, ES ,

FR, HR, NL, IE, LX, PT]

F in a lis e d re g is t ra t io n in 2 5 / 2 8 EU

s tates

F ile d re ma in in g EU - C Y, EL, LT

O ra l Ta b le t s US AF ile d w it h F DAS u b mit t e d fin a l re s p o n s e s

S ubmitted s tudy manus cripts

O ra l R a p idS tarted formulation

development

C o mp le t e d p ilo t s c a lebatches

Completed PK studies

O ra l Liq u idPivotal study underwayCompleted pivotal study

R e g u la t o rysubmissions to start

S ubmitted 2 s tudy manus cripts

IntravenousStudy pending completion275 patient completed in USA

Ma n u s c rip t in p re p a ra t io n

First regulatory submissions

made

Hot DrinkC o mp le t e d in it ia l P K s t u d yPilot batches made and on

s t a b ilit y

R e g u la t o rysubmissions 1Q 19

Dry S t ic kDevelopment underwayP atent s ubmitted

R e g u la t o ry S u b mis s io n s 2 Q 1 9

Annual Meeting
2 August 2018

Maxigesic – Clinical Trial Progress since IPO

Clinical TrialTypeNo.of

Subjects

Territories

AF T-MX13APhase 1 PK Study (Maxigesic 325

Ta b l e t s - fa s t in g )

30Jordan

AF T-MX13BPhase 1 PK Study (Maxigesic 325

Ta b l e t s - fe d )

30Jordan

AF T-MX-16AP h a s e 1 P K S t u d y (Ma xig e s ic Ra p id -

fa s t in g )

30Jordan

AF T-MX-16BP h a s e 1 P K S t u d y (Ma xig e s ic Ra p id -

fe d )

30Jordan

AF T-MXC F-03P h a s e 3 Effic a c y (Ma xig e s icPE 2.5)276NZ, UK

AF T-MXIV-06Phase 1P K (Ma xig e s ic IV)30NZ

AF T-MXIV-07Phase3 Effic a c y (Ma xig e s ic IV)276US A

AF T-MX-14APhase1 P K S t u d y (Ma xig e s ic O ra l

S uspension)

30Jordan

AF T-MX-14BPhase1 P K S t u d y (Ma xig e s ic O ra l

S uspension)

30Jordan

AF T-MX-12P h a s e 3 Effic a c y (Ma xig e s icO ra l

S uspension

262NZ, AUS ,Mexico

TOTAL Trials10 Clinical Trials(7PK, 3Efficacy)1024Jordan,NZ, USA,

AUS, Mexico, UK

MAXIGESICGLOBAL UPDATE
Australia – sales growing strongly

post codeine rescheduling.

No #1 Para-Ibu Combo

New Zealand –increasing

sales and codeine

rescheduling confirmed.

Maxigesic PE launched

Singapore/Brunei – launched

including OTC

Malaysia – launched

UAE – sales growth still

strong

Iraq -Kurdistan launch

underway

Italy – successful launch and

sales growing still

Eastern Europe and Balkans –

launches pending FY19

Nordics – launch pending 4Q

FY19

BE/LX & FR– launches pending

4Q18

NL – licensing discussions

underway underway

UK – launched

IE – launch pending

ES/PT – launch

pending 4Q 18

CACM – launch underway

MX – launch pending

4Q 18

Licensing negotiations

underway Brazil

Licensing discussions starting

for USA & Canada

Licensing discussions starting

for Russia and signed term

sheet

Licensing discussions started

for Korea and Taiwan

HK launch 4Q FY19

Germany – licensing

negotiations underway

Indonesia and Philippines –

licensing discussions underway

Annual Meeting
2 August 2018

Maxigesic countries launched and launch plan

19

10

A

Annual Meeting
2 August 2018

EXAMPLE OF MAXIGESIC LICENCEE PROGRESS TO DATE –

tablet sales per month

20

-

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

Annual Meeting
2 August 2018

International Sales to Grow

21

63.4%

28.4%

6.0%

2.2%

Net Revenue F Y' 1 9

Au s tra liaNew ZealandInternationalSoutheast Asia

42.0%

12.0%

43.6%

2.4%

Net Revenue F Y' 2 3

Annual Meeting
2 August 2018

MAXIGESIC: Australian growth strategy

•Codeine switch occurred 1st February 2018.

•Maxigesic attained market leadership in the Paracetamol-Ibuprofen category post switch

despite being significantly outspent by multinational competitors

•Consumer market research indicates further upside still available

•Evidence of significant codeine stock-piling and patients to look for alternatives over

the next 6-12 months

•Evidence of significant number of patients with short term pain currently being

treated with Rx prescribed codeine

•Evidence of a significant number of patients switching to grocery sourced single

analgesics

•AFT sales force targeting additional codeine users identified by market research


22

Annual Meeting
2 August 2018

MAXIGESIC: GOING FORWARDS

Additional out-licensing and distribution agreements for Maxigesicoral dose forms have been secured to

increase the number of countries to 125from 110.

Some additional countries still to be added –Up to about 12

Advanced discussions underway including contract negotiations

Numerous Maxigesic registrations underway which are required before many launches can occur

Launches have been delayed due to regulatory procedures in EU

Maxigesic Income

Product sales to Licensees

Royalties from Licensee Net Sales

Event and sales milestones

SUMMARY: Drive sales by

[1] Increasing sales in existing territories

[2] Launch in new territories

[3] Launch additional dose forms

[4] Gather milestone payments

23

Annual Meeting
2 August 2018

Sales will be generated from

1)device sales,

2)a per use charge

administered through

RFID (radio frequency

identifier) cards, and

3)consumables

Product

description

A handheld ultrasonic nasal mesh nebuliser primarily

for the intranasal delivery of medication

Rationale for

investment in

product

•To primarily expand our existing hospital product

ranges locally

•Significant global potential based upon market research

Current status

•Registered as Class I Device with FDA as planned

•Refined design parameters post Human Factor Study

•Target Class II Device FDA Filing end 2018 Calendar

Year

Ourmedium

term plans

•Engineering Pilot batches with enhanced design

underway

•Distribution studies underway in ANZ

•Specific formulation and dose delivery system work

underway in France

•First Drug PK studies to start late FY2019

•First Drug Clinical Studies to start late FY2019

•Open IND late FY2019

•First drug delivery indication a significant potential

market – US$1.2B in USA alone [Based upon detailed

market research studies in USA and UK]

•Licensing negotiations during late FY2019

NASOSURFNEBULISER: Going Forwards

The NasoSURFNebuliser has desirable features

over currently marketed nebulisers, which are not

approved for delivery of specific drugs intranasally

and do not possess a number of the advantages of

the NasoSURFNebuliser

24

Annual Meeting
2 August 2018

SUMMARY OF MEDIUM TERM PLANS

Phased launches of Maxigesicin over 110 countries including North America

and Europe

Add additional Maxigesicdose forms to the initial launches to extend sales

Further licensing agreements for Maxigesicand Maxigesic IV in larger

markets including Europe and North America, selected additional markets

Expansion of ANZ Opportunities

Advancing additional sales opportunities using strong local sales operations

Pursue the emerging medicinal cannabis market

25

Further build Maxigesicsales post codeine changes and register and launch

line extensions

Further build revenues of OTC product sales in Australia and New Zealand

Key aim is to trade profitably during FY19

Questions & Answers

Ordinary Resolutions

Annual Meeting
2 August 2018

ORDINARY RESOLUTION 1

2828

1.1. That the directors are authorised to fix the fees and

expenses of Deloitte as auditor for the 2019 financial year.

Annual Meeting
2 August 2018

DAVID FLACKS

2929

Annual Meeting
2 August 2018

ORDINARY RESOLUTION 2

3030

2. That David Flacks be re-elected as a director of AFT.

Annual Meeting
2 August 2018

JIM BURNS

3131

Annual Meeting
2 August 2018

ORDINARY RESOLUTION 3

3232

3. That Jim Burns be re-elected as a director of AFT.

Close of Meeting – thanks for attending

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