AFT PHARMACEUTICALS - Bioshares...Queenstown, New Zealand Bioshares Presentation July 2018 IMPORTANT...

AFT PHARMACEUTICALS2018 Bioshares Summit PresentationJuly 2018Queenstown, New Zealand

Bioshares PresentationJuly 2018

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 contained in it nor takes any responsibility for it. The information in this presentation has not been and will not be independently verified or 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 to place 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.


1

Start Up – Company Formation and Key Elements

3 Sep 1997

Wanted to start “my own company” well before “too old” i.e. 40 years of agePlans hastened by redundancy aged 37Had reasonable experience base BUT knew very little

$50KStart up capital – under-capitalizedSupplemented income for first 3 years with consulting workWas NOT easy

CashflowBusiness was always run off a cashflow sheetCreative financing was important – trade financingAvoided advice like “sell your house and put in the business”

Partnerships Sought business partnerships early e.g. South AfricaContracted out as much as possible BUT not Sales & Marketing or Clinical Trials

StrategyFlexible and developed as we progressedKey was AU expansion in 2004 & starting drug development in 2004 Taking on outside shareholders in 2014


2

Some Timelines


3

• Formed Company in September 1997

• First Sales in August 1998

• Started Maxigesic development 2004

• Filed first patents 2004

• Moved out of our Takapuna garage 2004

• Expanded to AU 2005

• First major Out-licensing deal in EU 2012

• Expanded to MY, SG 2014

• First NZ company to register a patented pharmaceutical in EU in 2014

• First Capital Raise 2014 [CRG and Milford Asset Management]

• IPO on NZX and ASX Dec 2015 after investigating a Nasdaq listing

Home Based Office


4

• Sold circa $8M from our home office

Family Company


5

• Relied very much on family for many years – Pharmacy Tradeshow in Fiji 2011 Greencross Conference

Finance Along the Way

VC’s

Buy-out About 3 unsolicited offers per annum over last 10 yearsRan partnerships without selling out holding company

Bankers

Worked on about 20% EquityWorked with bank

– kept them close- changed budgets and plans

GFC was quite challenging


6

Australia PE example

New Zealand PE example

USA Choice – debt and equity facility

Finally Floating

Nasdaq

NZX-ASX Listed 22 December 2015 on NZX & ASX


7

Spent 3 months working on failed Nasdaq attemptNot enough USA focus in our business

Financials of Floating

Numbers


8

Raised NZ$32.6MSold NZ$3M at floating

Management & Board

Boards Advisory board since 2007Audited since 2007Formal board since 2012Diverse experience is important


9

CURRENT HIGHLIGHTS

125 countries that Maxigesic is licensed in – up from 110 at the end of FY2017

13 countries that Maxigesic is launched and sold in

7 number of clinical studies AFT will have running in FY2019

$81.9m total income for FY2018*

$6.8m available cash as at 31 March 2018

* Total income comprises Operating Revenue of $80.1m and Licensing Income of $1.8m


10

ADVANCED CLINICAL STUDY PROGRAM

• 7 studies across the AFT portfolio and 900+ patients

• 7 countries - Australia, Jordan, Mexico, New Zealand, Russia, United Kingdom, United States

• Significant Clinical Trials for Maxigesic oral and IV dose forms are mainly completed

• Completed Maxigesic IV pivotal study in USA [275 patients]

• Completed Maxigesic Oral Liquid study in AU, NZ & MX [200 patients]

• NasoSURF Device Clinical Studies well underway

• Human Factor Study in USA completed

• 3 Distribution studies underway in AU & NZ [over 50 patients]

• PK-PD study in NZ [30 patients]

• To start large clinical study for first indication in NZ & USA [300 patients]

• Maxiclear PE pivotal study completed in NZ during 2017 [275 patients]


11

EXAMPLE OF MAXIGESIC LICENCEE PROGRESS TO DATE – tablet sales per month


12

-

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

Middle East: Great Local Distributors: UAE


13

-

10

20

30

40

50

60

70

80

90

FY05 FY06 FY07 FY08 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18

Opera

ting r

evenue (

NZ$m

)

FINANCIAL PERFORMANCE – REVENUE GROWTH

10 year CAGR: 14%

Operating revenue, FY2005 – FY2018

FY2017 Operating revenue by region FY2018 Operating revenue by region

Bioshares Presentation

July 201814

Australia53.6%

New Zealand42.1%

Rest of World2.8%

Southeast Asia1.5%

Australia61.4%

New Zealand33.8%

Rest of World3.1%

Southeast Asia1.6%

MAXIGESIC GLOBAL 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 launch underway

Italy – successful launch and sales growing still

Eastern Europe and Balkans –launches pending 2018Nordics – launch pending 4Q 2018

BE/LX & FR– launches pending 4Q18

UK – launched

IE – launch pending

ES/PT – launch pending 4Q 18

CACM – launch underway

MX – launch pending 4Q 18

Licensing negotiations underway Brazil and LATAM

Licensing discussions starting for USA & Canada

Licensing discussions starting for Russia and signed term sheet

Licensing discussions starting for China, Korea and Taiwan

HK launch 4Q 18

Maxigesic countries launched and launch plan


16

MAXIGESIC: GOING FORWARDS

Additional out-licensing and distribution agreements for Maxigesic oral dose forms have been secured to increase the

number of countries to 125 from 110.

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

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

Launches have been delayed due to regulatory procedures in EU

Maxigesic IV filings underway around the globe

Maxigesic OL filings to commence around the globe

Maxigesic PE first launch made in NZ and further filings to be made in selected territories

Maxigesic Dry Stick and Hot Drink Sachets targeting completion of registration files by end FY19

Maxigesic Rapid Formulation work almost completed

SUMMARY: Drive sales by

[1] Increasing sales in existing territories

[2] Launch in new territories

[3] Launch additional dose forms

Investor PresentationMay 2018

17

NasoSURF: Small and Portable Nebuliser

Additional out-licensing and distribution agreements for Maxigesic oral dose forms have been secured to increase the

number of countries to 125 from 110.

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

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

Launches have been delayed due to regulatory procedures in EU

Maxigesic IV filings underway around the globe

Maxigesic OL filings to commence around the globe

Maxigesic PE first launch made in NZ and further filings to be made in selected territories

Maxigesic Dry Stick and Hot Drink Sachets targeting completion of registration files by end FY19

Maxigesic Rapid Formulation work almost completed

SUMMARY: Drive sales by

[1] Increasing sales in existing territories

[2] Launch in new territories

[3] Launch additional dose forms


18

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 for the intranasal delivery of medication and treatment of chronic sinusitis

Rationale for investment in

product

• To primarily expand our existing hospital product ranges locally

• Significant global potential

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

Our medium term plans

• Engineering Pilot batches with enhanced design underway

• Distribution studies underway in ANZ

• Specific formulation and dose delivery system work underway

• First Drug PK studies to start in FY2019

• First Drug Clinical Studies to start in FY2019

• Open IND in FY2019

• First drug delivery indication a significant potential market –US$1.2B in USA alone [Based upon market research studies in USA and UK]

• Licensing negotiations during FY2019

NASOSURF NEBULISER: Going Forwards

The NasoSURF Nebuliser 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 NasoSURF

Nebuliser

19

Market History – Progress to date

IBioshares PresentationJuly 2018

20

SUMMARY OF MEDIUM TERM PLANS

Phased launches of Maxigesic in over 110 countries including North America and Europe

Add additional Maxigesic dose forms to the initial launches to extend sales

Further licensing agreements for Maxigesic and Maxigesic IV in larger markets including North America, selected additional markets

NasoSURF and Pascomer

Advancing developmentsOut-licensing when possible

Bioshares PresentationJulyy 2018

21

Further build upon market leading Maxigesic market shares post codeine changes and register and launch line extensions

Further build revenues of OTC product sales in ANZ

Key aim is to trade profitably during FY19

Maxigesic Development Timelines and Lessons


22

Started Maxigesic development 2004

• Important to follow key processes1. FTO to check for problems2. File patent application

• Pivotal First Study gave strong efficacy signal1. Decreased risk with grant2. Decreased costs by running internally and avoiding a CRO3. First sales achieved in NZ in 2009 and AU 20144. Initial budget circa $0.5M but had to raise capital to fund development for

outside ANZ. 5. Arguably could have raised capital earlier to accelerate developments

• Line Extensions• Different line extensions such as Oral Liquid and IV are important

• Out-Licensing1. Retaining out-licensing experts was important2. Using US based lawyers experienced in Pharma important

Lessons and the Future


23

Local ANZ markets are small for own developments so have to target

overseas

Easier over the years due to improved communications – skype and

fast internet

Tyranny of distance is still real as face to face is still key

Staff are available if recruitment work and training are tackled

ASX & NZX don’t like loss making companies or understand pharma

Harder to implement in the public arena due to:

Disclosure and IR requirements; short term focus

Selling as well as technical is important

AFT PHARMACEUTICALS - Bioshares...Queenstown, New Zealand Bioshares Presentation July 2018 IMPORTANT...

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