AFT Annual Meeting 2018 Presentation
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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