FINANCIAL RESULTS FOR HALF YEAR ENDED 30 SEPTEMBER 2018
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969
Market Release
November 22 2018
FINANCIAL RESULTS FOR HALF YEAR ENDED 30 SEPTEMBER 2018
AFT Pharmaceuticals Limited (NZX; AFT, ASX; AFP) today announced its half-year unaudited financial
results for the period ended 30 September 2018 (H1FY19).
Performance Highlights
• Operating Revenues of $38.0m for the first half of FY2019 to 30 September 2018
(H1FY2019) were up 4% over the previous corresponding six month period (PCP) ended 30
September 2017 (H1FY18).
• Operating Revenues from the over-the-counter channel were up 20% over the PCP.
• Gross Profit grew by 24% to $17.8m.
• Operating Loss of $0.1m (PCP $6.7m) has improved significantly with the strong growth in
Gross profit and the reduction in the Research and Development expense as the clinical trial
programmes are completed.
•
Maxigesic is now being sold in fifteen countries – Australia, Brunei, El Salvador, Israel,
Iraq/Kurdistan, Ireland, Italy, Malaysia, Malta, New Zealand, Nicaragua, Serbia, Singapore,
United Kingdom and United Arab Emirates. Further country launches are in progress.
• Maxigesic is licensed in 128 countries up from 125 in FY2018.
• Product clinical studies on track with most of the programme from the IPO now completed.
There will be five clinical trials in progress during FY2019.
• Nasosurf device development has also advanced with some device redesign required
following the initial human factor studies in USA and filing for Class IIA Medical Device
registration in the USA is targeted for April/May 2019.
• Research and Development expensed investment in our key global products has reduced to
$2.6m¹ for the six months (PCP $5.6m) and represents 7% of Operating Revenue (PCP 15%).
We have now completed most of the clinical trial programmes that we identified at the time
of IPO. Additional dose forms such as Maxigesic Rapid have been developed within the
existing clinical trial budget and a new Maxigesic cold & flu formulation is under
development but these costs are not material.
• Cash available at 30 September 2018 of $7.4m (PCP $7.1m).
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969
Financial Overview
Group Operating Results
NZ$’000
Six Month Period
Ended September 30
Change
($)
Change
(%)
FY2019 FY2018
Revenue 38,045 36,561
+ 1,484 + 4
Cost of Sales (20,292) (22,256)
- 1,964 - 9
Gross Profit 17,753 14,305
+ 3,448 + 24
Other Income 2,430 1,014
+ 1,416 + 140
Selling and distribution expenses (14,234) (12,771)
+ 1,463 + 11
General and administrative expenses (3,489) (3,618)
- 129 - 4
Research and development expenses (2,225) (4,982) - 2,757 - 55
Equity Accounted Loss of joint venture entity (344) (616)
- 272 - 44
Underlying Operating Loss (109) (6,668)
- 6,559 - 98
Operating Revenue
Operating Revenue grew 4% to $38.0m for the six month period ended 30 September 2018 (PCP
$36.6m) with the continued growth in our primary Australian market and the emerging Rest of
World and Southeast Asia markets offset by the trading out of lower margin products, most
noticeably in New Zealand. Operating revenue in the over-the-counter channel grew by 20% (PCP
20%). The upside of these revenue shifts has been the 24% growth in gross profit. The
implementation of the new reporting standard NZ IFRS15 has not changed the timing or amount of
revenue recognised in operating revenue.
The following tables set out revenues from our four markets:
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969
• Australia Revenue grew by 7% to $21.6m (PCP $20.2m) and this market now makes up 57%
of Group Operating Revenue. Strong growth, up 17%, continued in its main over-the-counter
channel. Maxigesic grew two fold over the PCP following the shift of codeine based
painkillers from over-the-counter to prescription only in February 2018 and maintains its
leadership of the combination product section of the market. The launch of Novatears at the
beginning of the year further supplements the eye care range which continued to experience
good growth. The Hospital channel retracted by 10% with the trading out of lower margin
products. The new Hospital products being introduced, which are at higher margins, will
replace this revenue by the end of FY2019 or early in FY2020. The prescription channel grew
by 10% on existing products.
•
New Zealand Revenue declined by 11% to $12.6m (PCP $14.1m) and now represents 33% of
the Group Operating Revenue. The decline is due to the trading out of lower margin
products at the end of FY2018 in the Hospital channel, the ceasing of the sole supply tender
prescription product Metoprolol with the final sales made in FY2018 and some price
reductions on other tender products. The upside of this shift from lower margin product is
that Gross Profit in New Zealand grew by 23%. The over-the-counter channel experienced
good revenue growth, up 9%. Maxigesic also grew two fold in New Zealand, and also as with
Australia, the launch of Novatears at the beginning of the year further supplemented the
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969
eye care range which continued to experience good growth. Vitamin C Liposachets were
launched at the beginning of the year and are selling well.
•
Rest of World Revenue grew by 70% to $2.8m (PCP $1.6m) and now represents 7% of Group
Operating Revenue. Most of the revenue is from Maxigesic sales and royalties with sales in
this half made to Italy, Ireland, Israel, Iraq, United Arab Emirates and the Central American
Common Market (CACM). Further launches are imminent and are dictated by regulatory
timelines.
•
Southeast Asia Revenue grew by 81% to $1.1m (PCP $0.6m) and represents 3% of the Group
Operating Revenue. Most of this growth is from the launch of Maxigesic in Malaysia with the
initial sell in to the distributor there and the re-launch of Maxigesic in Singapore with its re-
classification to an over-the-counter product.
Gross Margin
Gross Profit grew 24% to $17.8m (PCP $14.3m) driven by the operating revenue growth of 20% in the
higher margin over-the-counter channel and the trading out of lower margin tender products in the
Hospital and Prescription channels. The Gross Profit Margin accordingly improved to 47% (PCP 39%),
driven by this growth of the higher margin over-the-counter products in all markets.
We expect the Gross Profit Margin to remain in this zone as the over-the-counter products particularly
in Australia and Rest of World markets continue to grow.
Other Income
Licensing Income comprises the upfront and milestone fees from out licensing arrangements we have
in our Rest of World markets and the fees we have received from the divestment of non-core hospital
products. It is classified in the Financial Statements as Other Income. These totalled $2.2m (PCP
$0.8m), with a combination of new out licensing agreements commencing and milestones on existing
agreements, together with the divestment fees. The implementation of the new reporting standard
NZ IFRS15 has not materially changed the timing or amount of licence income recognised in operating
revenue.
The balance of Other Income of $0.2m (PCP $0.2m) is the Callaghan Innovation growth grant that we
receive on eligible research and development expenditure.
Operating Overheads
• Research and Development investment reduced to $2.2m (PCP $5.0m), and in addition our
50% of the spend on Pascomer reduced to $0.3m (PCP $0.6m). This is reported under joint
venture equity accounting in the Financial Statements as required by GAAP.
We have now completed most of the clinical trial programmes that we identified at the time
of IPO. This has resulted in a number of publications in scientific journals during this year.
Maxigesic 325 results have been published in the major US journal Clinical Therapeutics,
Maxigesic Oral Liquid study results have resulted in 2 publications and the pivotal Maxigesic
IV study has been submitted to a major US journal. A further two publications are in
preparation covering pharmacokinetics of the different Maxigesic dose forms and a further
study on consolidated safety data. This data is important to back up commercialization and key
marketing claims.
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969
Completion of this development work has also allowed commencement of regulatory filings of
both Maxigesic IV and Oral Liquid. Additional oral dose forms, hot drink sachets and dry stick
sachets are still in development and regulatory filings are targeted to commence within the
2019 calendar year.
A pre-NDA filing meeting with FDA for Maxigesic IV has clarified some additional data
requirements and this will result in some additional clinical trial expenditure before the USA
regulatory filing which again is targeted within 2019 calendar year.
Formulation work has been completed on a fast dissolving formulation, Maxigesic Rapid which
utilizes proprietary technology in-licensed from a US company. Additionally a new product,
Maxigesic Cold & Flu is being developed for treatment of cold & flu which will be commercially
attractive for the Australian market and additional territories. The development costs for this
programme are modest and not expected to contribute significantly to R&D costs.
The key aim is now to complete US registrations and to commercialize Maxigesic and its line
extensions in major markets.
The Pascomer development programme has confirmed that the formulation is stable at room
temperature which was challenging as the active ingredient is easily oxidized in topical
formulations. A significant preclinical development programme has now been completed
culminating with a successful FDA meeting to open the IND and obtain clearance to initiate
clinical studies in patients. Options to fund this significant clinical development programme
are currently being investigated.
NasoSURF device development has also advanced with some device redesign required
following the initial human factor studies in USA. Human factors are a relatively new regulatory
requirement and a further additional human factor study will be required after completion of
the redesigned engineering batches.
Initial clinical distribution studies are underway in Sydney and a further study in New Zealand
is to commence prior to the end of calendar Q1 2019. Class II Medical Device filing in USA is
targeted for April/May 2019 which is a quarter behind schedule necessitated by the redesign
features identified in the human factor studies. The key remains the initiation and completion
of the clinical programme which is targeted to start during FY2020 after approval to open an
IND is obtained from US FDA.
• Selling and Distribution expenses increased by 11% to $14.2m (PCP $12.8m) in support of the
20% revenue growth in the over-the-counter channel, particularly in Australia. We continually
monitor this spend and some efficiencies have been identified which are being implemented
during the H2FY19 time period in Australia and the Asian markets.
• General and Administration expenses reduced to $3.5m (PCP $3.6m) with cost savings made
where possible.
Cash Flow and Balance Sheet
Total Assets of $59.4m are up on the March 2018 year end’s $56.6m. This is mainly due to the
capitalised investment made into research and development both directly and through the joint
venture.
Working Capital increased to $26.3m (PCP $24.1m) with the $4.1m increase in inventory to $27.8m
(PCP $23.7m) for the stock build for the larger sales volumes during the summer months together with
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969
the $0.2m increase in trade payables and provisions to $14.5m (PCP $14.7m), offset by the $2.0m
reduction in receivables and prepayments to $13.0m (PCP $15.0m).
Cash holdings of $7.4m are up from the $6.8m at the March 2018 year end, primarily reflecting the
breakeven underlying operating result and the drawdown under the term loan facility.
The long term CRG loan of $42.0m has a maturity date of 31 March 2020. The company are working
with CRG to extend the existing facility and expand the available capital to US$40-50m.
Product Development
• Maxigesic is now being sold in fifteen countries – Australia, Brunei, El Salvador, Israel,
Iraq/Kurdistan, Ireland, Italy, Malaysia, Malta, New Zealand, Nicaragua, Serbia, Singapore,
United Kingdom and United Arab Emirates. The company founder personally attended
launch meetings to give talks on Maxigesic to Healthcare Professionals in Malaysia and
Ireland. Further country launches are in progress with exact timings dependent upon
multiple factors around the finalising of the regulatory processes at a country and licensee
level. These are either completing registration updates or the transfer of existing
registrations to local licensees in Europe. Getting to launch requires a number of steps in
each country and these timings are hard to forecast. Launch planning is currently underway
in a number of significant countries or regions such as Belgium, Eastern Europe, France,
Mexico, Portugal and Spain.
Registration in the remaining EU countries (Cyprus, Greece and Lithuania) is currently being
finalised and additional filings in a number of countries in Africa and the Middle East, which
are reliant upon an EU registration, are underway. The recent registration in Mexico has
been re-scheduled to over-the-counter status. The Netherlands, Portugal and Spain have
also achieved over-the-counter status.
Maxigesic is now licensed in 128 countries with the recent addition of Russia, South Korea,
Taiwan and Hong Kong. A few additional territories remain on our targeted list: USA,
Canada, Germany and selected territories in South America with discussions underway in
most of these currently.
Maxigesic IV out-licensing discussions are now underway which once achieved will
contribute significantly to other income as up fronts are anticipated in general to be larger
than for the oral formulations. The first out-licensing deal has recently been signed for South
Korea.
Maxigesic sales in the Rest of World are starting to grow and contributions will become
more significant once additional countries and dose forms are added. In following years the
contribution will become significant and for the first time we have seen during H1 FY19, the
sales from the Rest of the World and Southeast Asia exceeding 10% of the group operating
revenue. Important features of Rest of World sales are that overhead costs are lower so
more of the profit contribution is realised in the profit line.
• Product clinical studies. The majority of the R&D programme flagged in the IPO has now
been completed for Maxigesic oral dose forms which has been a significant exercise.
Additional dose forms such as Maxigesic Rapid have been developed within the existing
clinical trial budget and a new Maxigesic cold & flu formulation is under development but
these costs are not material.
Additional specific Maxigesic IV data for the USA filing is required and this is being organized
to commence during the 2019 calendar year.
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969
Pascomer patient clinical studies are being planned and alternatives to fund this significant
programme are being currently investigated.
• NasoSURF development is proceeding with the US Food and Drug Administration
development pathway confirmed. Class I Medical Device has been completed. However, the
major market opportunities lie in indications covered by a Class II Medical Device
registration pathway which is consequently the targeted opportunity and underway. Human
Factor study results required some redesign work which is well underway.
Following preclinical programme completion and final Human Factor Studies, an IND with FDA
will be opened and clinical studies commence. This will be in FY2020. Consequently, some of
the spend will be delayed which will offset, to some extent, the additional spend required for
Maxigesic IV.
The company will continue to carefully run its Research and Development budgets to stay within profit
targets.
Outlook
Sales continued to grow in Australia but were soft in the first quarter due to divestment of Claris
Hospital Products and the effects of the planned Australian Pharmacy stocking up with Maxigesic prior
to the 1 February 2018 re-scheduling of codeine-based painkillers from over-the-counter to
prescription. However, growth is picking up again and additional hospital products with better margins
are being launched and will continue to be launched over the next few years.
Additionally, market research identified that there was a considerable amount of stock piling of
codeine-based products with a significant number of consumers buying up to 12 months’ worth of
product. Hence there remains an ongoing opportunity to encourage consumers to switch from codeine
medications. Maxigesic has obtained a market leadership position in Australia for paracetamol-
ibuprofen combinations. We see the opportunity for significant ongoing organic growth from
Maxigesic tablets and additional dose forms such as Maxigesic IV and Maxigesic Oral Liquid which are
planned to be launched in the next 12-18 months. Further sales growth from our eye care channel is
also expected together with a number of new product launches.
Top line sales declined in New Zealand due to the divestment of Claris Hospital Products and the final
effects of the Metoprolol tender sales being lost. However, we have continued to transition sales to
products in the over-the-counter market resulting in the positive growth of gross margins and overall
gross profit. We expect this gross profit sales growth to continue in New Zealand which has been
helped by organic sales growth in over-the-counter products and new product launches Maxigesic PE,
NovaTears and Vitamin C Liposachets.
The timing of Rest of World sales still remains difficult to determine due to the multitude of countries
and differing regulatory requirements and related timelines. Further launches have occurred and are
ongoing with a number of significant markets being close to launch. The estimates from licensees
continue to indicate that the sales will increase significantly over the next few years with new launches,
growth in already launched markets, and new line extensions.
Further progress has been achieved in the out-licensing programme with the addition of a significant
major market, Russia, for Maxigesic oral dose forms and our first significant Maxigesic IV deal with a
licensee in South Korea. Additional discussions are currently underway for the remaining oral dose
form and IV territories which once achieved will add significantly to Other Income. As commercial sales
milestones are achieved under our existing out licensing programme they will provide further licence
income.
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969
The clinical trial programmes have progressed well with a significant proportion successfully
completed thereby considerably reducing the clinical risk for the Maxigesic programme. Further R&D
costs are required for the Maxigesic IV USA programme in addition to the two new lines, Maxigesic
Rapid and Maxigesic Cold & Flu.
Market research has identified that the NasoSURF project represents a significant commercial
opportunity. Completion of this programme in order to file the registration in major territories will
become a major development focus in FY2020.
Completing additional trials within existing financial resources remains the key aim and as signalled we
remain confident that we will return to profitability during the FY2019 time period. The small operating
loss during 1H FY2019 is positive progress and we expect the second half of the financial year to
generate greater revenues and profitability than the first half.
[End of release]
For more information:
Malcolm Tubby
Chief Financial Officer, AFT Pharmaceuticals Ltd
Phone: +64 9 488 0232
Email: malcolm@aftpharm.com
About AFT
AFT is a growing multinational pharmaceutical business with a broad range of products, both
developed itself and in-licensed from third parties. AFT’s products cover all major pharmaceutical
distribution channels: over-the-counter, prescription and hospital. Historically, AFT’s home markets
have been Australia, New Zealand and South-East Asia. However the company is out-licensing its
own products to licensees and distributors to sell in an increasing number of countries around the
world. The company’s intensive Research and Development programme forms the basis of its
international sales strategy. For more information about the company, visit our website
www.aftpharm.com
.
---
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969
AFT Pharmaceuticals Limited
Results for announcement to the market
Reporting Period: For the six month reporting period to September 30 2018
Previous Reporting Period: For the six month reporting period to September 30 2017
Amount
NZ$’000
Percentage
Change
Revenues from ordinary activities 38,045 Up 4%
Loss from ordinary activities after tax attributable to security holders (109) Down 98%
Net loss attributable to security holders (4,188) Down 39%
Interim / Final Dividend
Amount per
security NZ$
Imputed
Amount per
security NZ$
No dividends have been paid
Net Tangible Assets per Share
September
30 2018
NZ$
September
30 2017
NZ$
Net Tangible Assets per Share (0.04) 0.11
Comments:
Accompanying this announcement are the Group’s unaudited consolidated financial statements for the six
months ended 30 September 2018. These financial statements and the half year results commentary dated
November 22 2018 provide the balance of information requirements in accordance with NZX Listing Rule
10.3.2 and Appendix 1.
Pursuant to ASX listing rule 1.15.3 AFT Pharmaceuticals Limited confirms that it continues to comply with the
rules of its home exchange (NZX Main Board).
The unlisted Redeemable preference shares issued on 24 March 2017 attract a dividend rate of 9.4% per
annum, or 25.8 cents per share per annum. For the 30 June 2018 and 30 September 2018 quarter ends, no
dividends were paid. The dividends net of withholding taxes for these two quarter ends have been
accumulated in the Redeemable Preference Share Reserve.
No dividends have been paid on ordinary shares.
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969
Additional Information
The following is additional information to accompany the Company’s interim report for the six months ended
30 September 2018.
Summary of waiver granted
On 21 December 2015, NZX granted the Company a waiver (Original Waiver) from NZX Main Board Listing
Rule 5.2.3 in respect of its quoted shares (Shares) for a period of 12 months to the extent the Rule
required the Company to have at least 25% of Shares held by Members of the Public holding at least a
Minimum Holding (as that term is defined in the NZX Main Board Listing Rules). The Original Waiver has
expired. On 21 December 2016, a further waiver from NZX Main Board Listing Rule 5.2.3 was granted to
AFT for an additional 12 month period. This waiver was renewed by NZX Regulation for a further 12
month period on 20 December 2017.
The waiver was granted on the following conditions:
• NZX receives an undertaking from the Atkinson Family Trust (AF Trust) that it will not increase its
holding in AFT during the term of the waiver, otherwise than as a result of an allotment pursuant to
an offer or issue of shares that is made pro- rata to all AFT shareholders;
• At least 10% of shares are held by more than 500 Members of the Public, with each Member of the
Public holding at least a Minimum Holding;
• AFT clearly and prominently discloses this waiver, its conditions, and its implications in AFT’s half
year and annual reports, and in any Offer Documents relating to any offer of shares undertaken by
AFT, during the period of the waiver;
• AFT consistently monitors the total number of Members of the Public holding shares and the
percentage of shares held by Members of the Public holding at least a Minimum Holding;
• AFT notifies NZX as soon as practicable if there is any material reduction to the total number of
Members of the Public holding at least a Minimum Holding of shares, and/or the percentage of
shares held by Members of the Public holding at least a Minimum Holding; and
• AFT provides NZX with a written quarterly update of the total number of Members of the Public
holding shares holding at least a Minimum Holding and the percentage of shares held by Members of
the Public holding at least a Minimum Holding. The quarterly updates are from the date the waiver is
granted, for the period of the waiver. The updates are to be provided to NZX within ten business
days of the end of each quarter.
• AFT provides NZX, with the second quarterly update, an update on the proposed initiatives AFT
intends to undertake to materially increase the percentage of shares held by Members of the Public
before the expiry of the waiver.
The implication of the waiver is that the Shares may not be widely held and that there may be reduced liquidity
in the Shares following quotation. A copy of each waiver can be viewed at www.aftpharm.com.
[End of release]
For more information:
Malcolm Tubby
Chief Financial Officer, AFT Pharmaceuticals Ltd
Phone: +64 9 488 0232
Email: malcolm@aftpharm.com
---
Doing
Interim Report 2019
This Interim Report is dated 22 November 2018.
Signed on behalf of the Board of AFT Pharmaceuticals Limited by:
Hartley Atkinson
Chief Executive Officer
David Flacks
Chairman
Financial Calendar
Half-Year End 30 September 2018
Interim Results Announcement 22 November 2018
Financial Year End 31 March 2019
Annual Results Announcement May 2019
Annual Meeting August 2019
Contents
01 Financial calendar
02 Key highlights
04 Interim financial results summary
08 Financial statements
25 NZX Waiver
26 Directory
Full report available online at investors.aftpharm.com
Note: $ in this report are NZ$ unless otherwise stated.
Maxigesic now being
sold in 15 countries
Over-the-counter
operating revenues
up 20% (PCP)
–– MAXIGESIC NOW LICENSED
IN 128 COUNTRIES.
–– NASOSURF DEVICE
US FOOD AND DRUG
ADMINISTRATION
PATHWAY CONFIRMED.
–– NOVATEARS LAUNCHED
IN NEW ZEALAND AND
AUSTRALIA.
–– IPO RESEARCH AND
DEVELOPMENT PROGRAMME
LARGELY COMPLETED.
AND THERE’S MORE TO COME.
Achieving
Key Highlights
Operating revenues
Operating revenues of $38.0m for the first half of FY2019
to 30 September 2018 (H1FY2019) were up 4% over the
corresponding six month period ending 30 September 2017
(H1FY2018) previous corresponding period (PCP).
Operating revenues from the over-the-counter channel
were up 20% over the same period.
Maxigesic
Maxigesic is now being sold in 15 countries – Australia,
Brunei, El Salvador, Israel, Iraq/Kurdistan, Ireland, Italy,
Malaysia, Malta, New Zealand, Nicaragua, Serbia, Singapore,
United Kingdom and United Arab Emirates. Further country
launches are in progress.
Maxigesic is licensed in 128 countries up from 125 in
FY2018.
Clinical trials
Most of the research and development programme from the
IPO has now been completed. There will be five clinical trials
in progress during FY2019.
NasoSURF
NasoSURF device development has also advanced with
some device redesign required following the initial human
factor studies in USA and filing for Class IIA Medical Device
registration in the USA is targeted for April/May 2019.
AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
02
1. Total Research and Development includes the equity accounting for the joint venture.
Research and development
Research and Development expensed investment in our
key global products has reduced to $2.6m¹ for the six
months (PCP $5.6m) and represents 7% of Operating
Revenue (PCP 15%). We have now completed most of the
clinical trial programme that we identified at the time of
IPO. Additional dose forms such as Maxigesic Rapid have
been developed within the existing clinical trial budget
and a new Maxigesic Cold & Flu formulation is under
development but these costs are not material.
Operating result
The operating loss of $0.1m (PCP $6.7m) has improved
significantly with the strong growth in Gross profit well
ahead of the Revenue growth due to margin improvement
gains from the strategic shift in Revenue to the higher
margin over-the counter channel and the reduction in the
Research and Development expense as the clinical trial
programmes are completed.
Cash available
Cash available at 30 September 2018 of $7.4m
( P C P $ 7. 1 m) .
03
Operating revenue
Operating Revenue grew 4% to $38.0m
for the six month period ended
30 September 2018 (PCP $36.6m) with
the continued growth in our primary
Australian market and the emerging
Rest of World and Southeast Asia
markets offset by the trading out of
lower margin products, most noticeably
in New Zealand. Operating Revenue in
the over-the-counter channel grew by
20% (PCP 20%). The upside of these
revenue shifts has been the 24% growth
in gross profit. The implementation of the
new reporting standard NZ IFRS15 has
not changed the timing or amount of
revenue recognised in operating revenue.
Australia revenue
grew by 7% to $21.6m (PCP $20.2m)
and this market now makes up 57%
of Group Operating Revenue. Strong
growth, up 17%, continued in its main
over-the-counter channel. Maxigesic
grew twofold over the PCP following
the shift of codeine based painkillers
from over-the-counter to prescription
only in February 2018 and maintains
its leadership of the combination
product section of the market. The
launch of NovaTears at the beginning
of the year further supplements the
eye care range which continued to
experience good growth. The Hospital
channel retracted by 10% with the
trading out of lower margin products.
The new Hospital products being
introduced, which are at higher
margins, will replace this revenue
by the end of FY2019 or early in
FY2020. The prescription channel
grew by 10% on existing products.
New Zealand revenue
declined by 11% to $12.6m (PCP
$14 .1m) and now represents 33%
of the Group Operating Revenue.
The decline is due to the trading
out of lower margin products at
the end of FY2018 in the Hospital
channel, the ceasing of the sole supply
tender prescription product Metoprolol
with the final sales made in FY2018
and some price reductions on other
tender products. The upside of this
shift from lower margin product is
that Gross Profit in New Zealand grew
by 23%. The over-the-counter channel
experienced good revenue growth,
up 9%. Maxigesic also grew twofold
in New Zealand, and also as with
Australia, the launch of NovaTears
at the beginning of the year further
supplemented the eye care range
which continued to experience
good growth. Vitamin C Liposachets
were launched at the beginning of
the year and are selling well.
Rest of World revenue
grew by 70% to $2.8m (PCP $1.6m)
and now represents 7% of Group
Operating Revenue. Most of the
revenue is from Maxigesic sales and
royalties with sales in this half made
to Italy, Ireland, Israel, Iraq, United
Arab Emirates and the Central
American Common Market (CACM).
Further launches are imminent and
are dictated by regulatory timelines.
Southeast Asia revenue
grew by 81% to $1.1m (PCP $0.6m)
and represents 3% of the Group
Operating Revenue. Most of this
growth is from the launch of Maxigesic
in Malaysia with the initial sell in to the
distributor there and the re-launch
of Maxigesic in Singapore with its
re-classification to an over-the-
counter product.
Gross margin
Gross Profit grew 24% to $17.8m
(PCP $14 .3m) driven by the operating
revenue growth of 20% in the higher
margin over-the-counter channel and
the trading out of lower margin
tender products in the Hospital and
Prescription channels. The Gross Profit
Margin accordingly improved to 47%
(PCP 39%), driven by this growth of
the higher margin over-the-counter
products in all markets.
We expect the Gross Profit Margin
to remain in this zone as the over-the-
counter products particularly in
Australia and Rest of World markets
continue to grow.
Other income
Licensing Income comprises the
upfront and milestone fees from out
licensing arrangements we have in our
Rest of World markets and the fees
we have received from the divestment
of non-core hospital products. It is
classified in the Financial Statements
as Other Income. These totalled $2.2m
(PCP $0.8m), with a combination
of new out licensing agreements
commencing and milestones on
existing agreements, together with
the divestment fees.
The balance of Other Income of
$0.2m (PCP $0.2m) is the Callaghan
Innovation growth grant that we
receive on eligible research and
development expenditure.
Interim Financial
Results Summary
AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
04
Group operating results
Six month period
ended September 30
$NZ000’s FY2019 FY2018 Change ($)Change (%)
Revenue38,04536,561 + 1,484+ 4
Cost of sales(20,292) (22,256) - 1,964- 9
Gross profit1 7,7 5 3 14,305 + 3,448+ 24
Other income2,430 1,014 + 1,416+ 140
Selling and distribution expenses(14,234)(12,771)+ 1,463+ 11
General and administrative expenses(3,489)(3,618)- 129- 4
Research and development expenses(2,225)(4,9 8 2)- 2,757- 55
Equity accounted loss of joint venture entity(344)(616)- 272- 44
Underlying operating loss(109)(6,668)- 6,559- 98
Australia
New Zealand
Rest of World
Southeast Asia
FY2018 Interim
(NZ$m)
FY2018 Interim
(percentage)
FY2018 Annual
(NZ$m)
FY2018 Annual
(percentage)
FY2019 Interim
(NZ$m)
FY2019 Interim
(percentage)
The following tables set out revenues from our four markets:
0
7. 5
15.0
22.5
Rest of
World
South
East Asia
New
Zealand
Australia
0
7. 5
15.0
22.5
Rest of
World
South
East Asia
New
Zealand
Australia
0
10
20
30
40
50
Rest of
World
South
East Asia
New
Zealand
Australia
55.3%61.4%56.8%
4.4%3.1%7.3%
1.7%1.6%2.9%
38.6%33.8%33.0%
Operating revenue
05
Operating overheads
Research and development
investment reduced to $2.2m (PCP
$5.0m), and in addition our 50% of
the spend on Pascomer reduced to
$0.3m (PCP $0.6m). This is reported
under joint venture equity accounting
in the Financial Statements as required
by GA AP.
We have now completed most of
the clinical trial programmes that we
identified at the time of IPO. This has
resulted in a number of publications
in scientific journals during this year.
Maxigesic 325 results have been
published in the major US journal
Clinical Therapeutics, Maxigesic
Oral Liquid study results have resulted
in two publications and the pivotal
Maxigesic IV study has been submitted
to a major US journal. A further two
publications are in preparation covering
pharmacokinetics of the different
Maxigesic dose forms and a further
study on consolidated safety data.
This data is important to back
up commercialisation and key
marketing claims.
Completion of this development work
has also allowed commencement of
regulatory filings of both Maxigesic IV
and Oral Liquid. Additional oral dose
forms, hot drink sachets and dry
stick sachets are still in development
and regulatory filings are targeted
to commence within the 2019
calendar year.
A pre-NDA filing meeting with FDA
for Maxigesic IV has clarified some
additional data requirements and
this will result in some additional
clinical trial expenditure before the
USA regulatory filing which also is
targeted within 2019 calendar year.
Formulation work has been
completed on a fast dissolving
formulation, Maxigesic Rapid which
utilises proprietary technology
in-licensed from a US company.
Additionally a new product, Maxigesic
Cold & Flu is being developed for
treatment of cold & flu which will
be commercially attractive for the
Australian market and additional
territories. The development costs
for this programme are modest and
not expected to contribute significantly
to R&D costs.
The key aim is now to complete US
registrations and to commercialise
Maxigesic and its line extensions in
major markets.
The Pascomer development
programme has confirmed that
the formulation is stable at room
temperature which was challenging
as the active ingredient is easily
oxidised in topical formulations.
A significant preclinical development
programme has now been completed
culminating with a successful FDA
meeting to open the IND and obtain
clearance to initiate clinical studies
in patients. Options to fund this
significant clinical development
programme are currently being
investigated.
NasoSURF device development
has also advanced with some device
redesign required following the initial
human factor studies in USA. Human
factors are a relatively new regulatory
requirement and a further additional
human factor study will be required
after completion of the redesigned
engineering batches.
Initial clinical distribution studies are
underway in Sydney and a further
study in New Zealand is to commence
prior to the end of calendar Q1 2019.
Class II Medical Device filing in USA is
targeted for April/May 2019 which is a
quarter behind schedule necessitated
by the redesign features identified in
the human factor studies. The key
remains the initiation and completion
of the clinical programme which is
targeted to start during FY2020 after
approval to open an IND is obtained
from US FDA.
Selling and distribution
expenses increased by 11% to $14 .2m
(PCP $12.8m) in support of the 20%
revenue growth in the over-the-counter
channel, particularly in Australia. We
continually monitor this spend and
some efficiencies have been identified
which are being implemented during
the H2FY19 time period in Australia
and the Asian markets.
General and administration
expenses reduced to $3.5m (PCP
$3.6m) with cost savings made
where possible.
Cash flow and balance sheet
Total Assets of $59.4m are up on
the March 2018 year end’s $56.6m.
This is mainly due to the capitalised
investment made into research and
development both directly and
through the joint venture.
Working Capital increased to $26.3m
(PCP $24.1m) with the $4.1m increase
in inventory to $27.8m (PCP $23.7m)
for the stock build for the larger sales
volumes during the summer months,
together with the $0.2m decrease in
trade payables and provisions to
$14 .5m (PCP $14 .7m) offset by the
$2.0m reduction in receivables and
prepayments to $13.0m (PCP $15.0m).
Cash holdings of $7.4m are up from
the $6.8m at the March 2018 year
end, primarily reflecting the breakeven
underlying operating result and the
drawdown under the term loan facility.
The long term CRG loan of $42.0m
has a maturity date of 31 March 2020.
The company are working with CRG to
extend the existing facility and expand
the available capital to US$40-50m.
Product development
Maxigesic
is now being sold in 15 countries
– Australia, Brunei, El Salvador, Israel,
Iraq/Kurdistan, Ireland, Italy, Malaysia,
Malta, New Zealand, Nicaragua, Serbia,
Singapore, United Kingdom and
United Arab Emirates. The company
founder personally attended launch
meetings to give talks on Maxigesic
to Healthcare Professionals in Malaysia
and Ireland. Further country launches
are in progress, with exact timings
dependent upon multiple factors
around the finalising of the regulatory
processes at a country and licensee
level. These are either completing
registration updates or the transfer of
existing registrations to local licensees
in Europe. Getting to launch requires
a number of steps in each country
and these timings are hard to forecast.
Launch planning is currently underway
in a number of significant countries.
Registration in the remaining EU
countries (Cyprus, Greece and
Lithuania) is currently being finalised
and additional filings in a number
of countries in Africa and the Middle
East, which are reliant upon an
EU registration, are underway.
Maxigesic is now licensed in 128
countries with the recent addition
of Russia, South Korea, Taiwan
and Hong Kong. A few additional
territories remain on our targeted
list: USA, Canada, Germany and
selected territories in South America
with discussions underway in most
of these currently.
AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
06
Maxigesic IV out-licensing discussions
are now underway which once
achieved will contribute significantly
to other income as upfronts are
anticipated in general to be larger
than for the oral formulations. The first
out-licensing deal has recently been
signed for South Korea.
Maxigesic sales in the Rest of World
are starting to grow and contributions
will become more significant once
additional countries and dose forms
are added. In following years the
contribution will become significant
and for the first time we have seen
during H1FY2019, the sales from
the Rest of the World and Southeast
Asia exceeding 10% of the group
operating revenue. Important features
of Rest of World sales are that overhead
costs are lower so more of the profit
contribution is realised in the profit line.
Product clinical studies
the majority of the R&D programme
highlighted in the IPO has now been
completed for Maxigesic oral dose
forms which has been a significant
exercise. Additional dose forms such
as Maxigesic Rapid have been
developed within the existing clinical
trial budget and a new Maxigesic Cold
& Flu formulation is under development
but these costs are not material.
Additional specific Maxigesic IV data
for the USA filing is required and this
is being organised to commence during
the 2019 calendar year.
Pascomer patient clinical studies are
being planned and alternatives to fund
this significant programme are being
currently investigated.
NasoSURF
development is proceeding with the
US Food and Drug Administration
development pathway confirmed.
Class I Medical Device has been
completed. However, the major
market opportunities lie in indications
covered by a Class II Medical Device
registration pathway which is
consequently the targeted opportunity
and underway. Human Factor study
results required some redesign work
which is well underway.
Following preclinical programme
completion and final Human Factor
Studies, an IND with FDA will be
opened and clinical studies commence.
This will be in FY2020. Consequently,
some of the spend will be delayed
which will offset, to some extent,
the additional spend required for
Maxigesic IV.
The company will continue to carefully
run its Research and Development
budgets to stay within profit targets.
Outlook
Sales continued to grow in Australia
but were soft in the first quarter due to
divestment of Claris Hospital Products
and the effects of the planned
Australian Pharmacy stocking up
with Maxigesic prior to the 1 February
2018 re-scheduling of codeine-based
painkillers from over-the-counter
to prescription. However, growth is
picking up again and additional
Hospital products with better margins
are being launched and will continue
to be launched over the next few years.
Additionally, market research identified
that there was a considerable amount
of stock piling of codeine-based
products with a significant number of
consumers buying up to 12 months’
worth of product. Hence there remains
an ongoing opportunity to encourage
consumers to switch from codeine
medications. Maxigesic has obtained a
market leadership position in Australia
for paracetamol-ibuprofen combinations.
We see the opportunity for significant
ongoing organic growth from Maxigesic
tablets and additional dose forms such
as Maxigesic IV and Maxigesic Oral
Liquid which are planned to be
launched in the next 12-18 months.
Further sales growth from our eye
care channel is also expected together
with a number of new product
launches.
Top line sales declined in New Zealand
due to the divestment of Claris Hospital
Products and the final effects of the
Metoprolol tender sales being lost.
However, we have continued to
transition sales to products in the
over-the-counter market resulting in
the positive growth of gross margins
and overall gross profit. We expect
this gross profit growth to continue in
New Zealand which has been helped
by organic sales growth in over-the-
counter products and new product
launches Maxigesic PE, NovaTears
and Vitamin C Liposachets.
The timing of Rest of World sales still
remains difficult to determine due to
the multitude of countries and differing
regulatory requirements and related
timelines. Further launches have
occurred and are ongoing with a
number of significant markets being
close to launch. The estimates from
licensees continue to indicate that the
sales will increase significantly over
the next few years with new launches,
growth in already launched markets,
and new line extensions.
Further progress has been achieved
in the out-licensing programme with
the addition of a significant major
market, Russia, for Maxigesic oral
dose forms and our first significant
Maxigesic IV deal with a licensee in
South Korea. Additional discussions
are currently underway for the
remaining oral dose form and IV
territories which once achieved will
add significantly to Other Income.
As commercial sales milestones are
achieved under our existing out
licensing programme they will provide
further licence income.
The clinical trial programmes have
progressed well with a significant
proportion successfully completed
thereby considerably reducing the
clinical risk for the Maxigesic
programme. Further R&D costs
are required for the Maxigesic IV
USA programme in addition to the
two new lines, Maxigesic Rapid and
Maxigesic Cold & Flu.
Market research has identified that
the NasoSURF project represents a
significant commercial opportunity.
Completion of this programme in
order to file the registration in major
territories will become a major
development focus in FY2020.
Completing additional trials within
existing financial resources remains
the key aim and as signalled we
remain confident that we will return
to profitability during the FY2019
time period. The small operating loss
during H1FY19 is positive progress
and we expect the second half of the
financial year to generate greater
revenues and profitability than the
first half.
07
Financial
Statements.
Contents
09 Consolidated Income Statement
09 Consolidated Statement
of Comprehensive Income
10 Consolidated Statement
of Changes in Equity
11 Consolidated Balance Sheet
12 Consolidated Statement
of Cash Flows
13 Notes to the Financial Statements
FY19
08AFT PHARMACEUTICALS LIMITED
Interim Report for the six months ended 30 September 2018
Consolidated Income Statement
For the six months ended 30 September 2018
$NZ000’s Note
Unaudited
6 months
ended
30 Sep 2018
Unaudited
6 months
ended
30 Sep 2017
Revenue 1138,04536,561
Cost of sales(20,292)(22,256)
Gross profit
1 7,7 5 314,305
Other income2,4301,014
Selling and distribution expenses(14,234)(12,771)
General and administrative expenses(3,489)(3,618)
Research and development expenses(2,225)(4,9 8 2)
Equity accounted loss of joint venture entity
10(344)(616)
Operating loss(109)(6,668)
Finance income1696
Finance costs(2,481)(1,590)
Other gains/(losses)(1,690)1,589
Loss before tax(4,264)(6,573)
Tax credit/(expense)76(300)
Loss after tax attributable to owners of the parent(4,188)(6,873)
Basic and diluted earnings (loss) per share ($)(0.4)(0.07)
Consolidated Statement of Comprehensive Income
For the six months ended 30 September 2018
$NZ000’s
Unaudited
6 months
ended
30 Sep 2018
Unaudited
6 months
ended
30 Sep 2017
Loss after tax(4,188)(6,873)
Other comprehensive (loss)/income
May be subsequently reclassified to profit and loss:
Foreign currency translation reserve(224)(10)
Other comprehensive (loss)/income for the period, net of tax(224)(10)
Total comprehensive loss for the period
attributable to owners of the parent(4,412)(6,883)
09
Consolidated Statement of Changes in Equity
For the six months ended 30 September 2018
$NZ000’s Note
Share
capital
Share
options
reserve
Redeemable
preference
share reserve
Foreign
currency
translation
reserve
Retained
earnings
Total
equity
Balance as at 31 March 201762,944 295–256(4 4,025)19,470
Unaudited
Six months to 30 September 2017
Loss after tax––––(6,873)(6,873)
Other comprehensive loss–––(10) –(10)
Movement in share options reserve –104–––104
Preference dividends accumulated291––291
Issue of ordinary shares
71,065––––1,065
Capital raising expenses(266) ––––(266)
Dividends paid and provided ––––(4 51)(4 51)
Balance as at 30 September 201763,743 399291246(51,349)13,330
Unaudited
Six months to 31 March 2018
Loss after tax––––(5,851)(5,851)
Other comprehensive income–––84 –84
Movement in share options reserve–31–––31
Preference dividends accumulated––192––192
Dividends paid and provided ––––(444)(444)
Balance as at 31 March 201863,743 430483330 ( 57, 6 4 4)7, 3 4 2
Unaudited
Six months to 30 September 2018
Loss after tax –– – –(4,1 8 8)(4,1 8 8)
Other comprehensive loss –––(224)–(224)
Movement in share options reserve–91–––91
Preference dividends
accumulated – –396––396
Dividends paid and provided––––(4 57 )(4 57 )
Balance as at 30 September 201863,743521879106(62,289)2,960
10AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
Consolidated Balance Sheet
As at 30 September 2018
$NZ000’s Note
Unaudited
as at
30 Sep 2018
Audited
as at
31 Mar 2018
Unaudited
restated
as at
30 Sep 2017
Assets
Current assets
Inventories2 7, 8 1 524,412 23,697
Trade and other receivables12,99316,95415,029
Cash and cash equivalents7, 4 0 06,770 7, 1 2 2
Derivative assets
12481176127
Total current assets
48,68948,312 45,975
Non-current assets
Property, plant and equipment335330 374
Intangible assets7, 0 8 95,118 2,74 4
Deferred income tax assets800708 342
Investment in joint venture entity
102,4932,1351,808
Total non-current assets10,7178,291 5,268
Total assets
59,40656,603 51,243
Liabilities
Current liabilities
Trade and other payables13,2451 7, 3 9 1 13,245
Provisions1,2631,098 1,424
Current income tax liability–118–
Total current liabilities
14,50818,607 14,669
Non-current liabilities
Interest bearing liabilities
641,93830,654 23,244
Total liabilities
56,44649,261 3 7, 91 3
Equity
Share capital763,74363,743 63,743
Retained earnings/(losses)(62,289)( 5 7, 6 4 4 )(51,349)
Share options reserve521430399
Redeemable preference share reserve879483291
Foreign currency translation reserve106330 246
Total equity
2,9607, 3 4 213,330
Total liabilities and equity
59,40656,60351,243
Net tangible assets per ordinary share$(0.04)$0.02$0.11
For and on behalf of the Board who authorised these financial statements for issue on 22 November 2018.
Hartley Atkinson
Managing Director and
Chief Executive Officer
David Flacks
Chairman
11
Consolidated Statement of Cash Flows
For the six months ended 30 September 2018
$NZ000’s Note
Unaudited
6 months
ended
30 Sep 2018
Unaudited
restated
6 months
ended
30 Sep 2017
Cash flows from operating activities
Receipts from customers44,62140,322
Interest received1696
Payments to suppliers and employees(4 6,670)(4 7, 2 8 2 )
Tax paid(134)(143)
Interest and finance cost paid(1,640)(671)
Net cash used in operating activities
9(3,807)(7,678)
Cash flows from investing activities
Purchases of property, plant and equipment(57)(4 6)
Investment in joint venture
10(702)(1,797)
Purchases of intangible assets(2,062)(301)
Net cash used in investing activities
(2,821)(2,144)
Cash flows from financing activities
Proceeds from issue of share capital7–1,065
Share issue costs–(188)
New borrowings7, 41 7–
Dividends paid8–(132)
Net cash generated from financing activities
7, 4 1 7745
Net increase/(decrease) in cash789(9,077)
Impact of foreign exchange on cash and cash equivalents(159)294
Opening cash and cash equivalents6,77015,905
Closing cash and cash equivalents
7, 4 0 07, 1 2 2
12AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
Notes to the Financial Statements
For the six months ended 30 September 2018
1. General information
AFT Pharmaceuticals Limited (the 'Company') is a company which is incorporated and domiciled in New Zealand.
It is registered under the Companies Act 1993. These financial statements comprise AFT Pharmaceuticals Limited
and its subsidiaries (together referred to as the Group). The Group is a pharmaceutical distributor and developer
of pharmaceutical intellectual property.
These consolidated interim financial statements were approved by the Directors on 22 November 2018, and are
not audited, but have been reviewed by Deloitte Limited in accordance with the New Zealand Standard on Review
Engagement 2410.
2. Basis of preparation
These general purpose financial statements for the six months to 30 September 2018 have been prepared in accordance
with New Zealand Generally Accepted Accounting Practice (NZ GAAP). They comply with NZ IAS 34 and IAS 34, Interim
Financial Reporting. The Group is a for-profit entity for the purposes of complying with NZ GAAP.
These condensed consolidated interim financial statements do not include all the notes normally included in an annual
financial report. Accordingly, this report should be read in conjunction with the audited financial statements for the
year ended 31 March 2018, which have been prepared in accordance with the New Zealand equivalents to International
Financial Reporting Standards (NZ IFRS) and International Financial Reporting Standards (IFRS).
All accounting policies have been applied on a basis consistent with those used in the audited financial statements for
the year ended 31 March 2018, as described in those annual financial statements, with the exceptions as described in
notes 4 and 5.
3. Going concern assumption
At 30 September 2018, the Group has drawn an interest bearing loan of $41.9m ($30.7m at 31 March 2018) and held
a cash balance of $7.4m ($6.8m as at 31 March 2018). During the period ended 31 March 2018 a new loan facility of
US$10m was entered into, with US$5m drawn down in January 2018, and the remaining US$5m in August 2018.
The Group incurred a net loss in the 6 months ended 30 September 2018 of $4.2m (30 September 2017 net loss of
$6.9m) and had a net operating cash outflow for the period of $3.8m (30 September 2017 $7.7m).
The loan is due for repayment in full on 31 March 2020 (refer to note 6).
The Directors have a reasonable expectation that the Group will be in a position to repay this loan on or before
31 March 2020 from a combination of positive cash flows, issuance of new equity, if required, and refinancing from
debt market sources. Accordingly, the Directors have adopted the going concern assumption for the purposes
of the preparation of these financial statements.
The Company’s listing on NZX and ASX, and resultant ready access to new capital support the Directors’ confidence.
The Directors have approved internal forecasts through to 31 March 2020, considered achievability of the assumptions
under these forecasts, reviewed the existing working capital against Group requirements and considered forecast
compliance with applicable debt covenants. The key revenue assumptions, which like all assumptions, are subject to
a degree of uncertainty are:
• the ability to execute further licensing agreements for the key innovative products: Maxigesic, Pascomer and
NasoSURF;
• the ability to generate future international revenues from the existing and potential licensing agreements for the
key innovative products: Maxigesic, Pascomer and NasoSURF; and
• the continued Australian sales growth for Maxigesic due to the re-scheduling of codeine-based painkillers from
over-the-counter to prescription only from 1 February 2018 (Maxigesic is codeine-free and is therefore exempt
and remains available over-the-counter).
13
Notes to the Financial Statements (continued)
For the six months ended 30 September 2018
4. IFRS 9: Financial Instruments
This new accounting standard came into effect on 1 April 2018 and has been applied by the Group since then. As the
Group does not apply hedge accounting, no reporting changes have been identified under the adoption of this standard.
5. IFRS 15: Revenue From Contracts With Customers
The Group implemented the new standard effective 1 April 2018. The new standard replaced NZ IAS 18 'Revenue' and
NZ IAS 11 'Construction Contracts'. NZ IFRS 15 establishes a comprehensive framework for determining whether, how
much and when revenue is recognised. The core principle in that framework is that revenue is recognised dependent
on the transfer of promised goods or services to the customer for an amount that reflects the consideration which is
expected to be received in exchange for those goods or services. The objective of the standard is to provide a five-step
approach to revenue recognition that includes identifying contracts with customers, identifying performance obligations,
determining transaction prices, allocating transaction prices to performance obligations, and recognising revenue when or
as performance obligations are satisfied. Judgement is applied, including making estimates and assumptions for multiple-
element contracts in identifying performance obligations, in constraining estimates of variable consideration and in
allocating the transaction price to each performance obligation and to lease components (if any).
Changes introduced by the standard relevant to AFT
The new standard provides new requirements and additional guidance that are relevant to the AFT Group, notably
in the following areas:
• “Sale of goods” are derived from the sale of pharmaceuticals where control transfers to our customer and our
performance obligations are satisfied at the time of shipment to or receipt of the products by the customer.
The revenue is recognised at the time of shipment to or receipt of the products by the customer. NZ IFRS 15 does
not change the timing or amount of revenue recognised under these agreements.
• “Royalty income” consists of royalty income from the out-licensing of intellectual property (IP), which is due to the
Group when the licensee has sold the product in their market.
The revenue is recognised as it is earned based on the sales reports provided by the licensees or estimates based on
previous sales reports provided by the licensees. NZ IFRS 15 has a royalty exception which applies to these revenues
and it does not change the timing or amount of revenue recognised under these agreements.
The exemption for sales-based royalties for licenses of intellectual property requires the royalty revenue to be
recognised as the underlying licensee sale has been made and consequently there is no material change to amount of
license income recognised under these agreements.
The Group is also developing its accounting policy for licensing income, which while currently insignificant, is expected to
become increasingly important in future accounting periods.
Transition approach and use of practical expedients.
The Group has applied the full retrospective method for the transition. Certain practical expedients permitted by the
standard during the transition have also been used, notably the relief to not restate contracts that began and were
completed in FY2018 or were completed before 1 April 2017 and to not provide in FY2019 the disclosure requirement
as per NZ IFRS 15 paragraph 120 for the comparative FY2018 period ('amount of the transaction price allocated to the
remaining performance obligations').
Since the new standard, including the use of practical expedients, has not materially modified the timing or amounts of
revenue recognised for FY2018 no restatement is necessary.
14AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
6. Interest bearing liabilities
$NZ000’s
Unaudited
as at
30 Sep 2018
Audited
as at
31 Mar 2018
Unaudited
as at
30 Sep 2017
CRG (Capital Royalty Group) loans41,93830,654 23,24 4
The term loan agreement with CRG commenced in May 2014 and had a facility draw down of up to USD$30 million by
October 2016. USD$15 million was drawn down. Initially this facility was for a six year term with the first four years being
interest only, and the principal to be repaid in equal quarterly instalments in years five and six.
In September 2017, a new loan facility of USD$10 million was entered into, which includes a minimum mandatory
drawdown of USD$5 million on or before 31 March 2018. This was drawn in December 2017, and a second drawdown
for the balance was made in August 2018.
The repayment terms for all facilities were amended in September 2017 to interest only until maturity, and the principal
to be repaid in full on 31 March 2020.
The loans have a general security over the assets of the Group together with a group guarantee. Interest is fixed at 13.5%
p.a. The loans are denominated in United States dollars (USD) and during the period NZD$3.064m was recognised as
unrealised foreign exchange loss. The carrying amount of the CRG loans are substantially in line with the fair market value
as at balance sheet date. At 30 September 2018 the loan balance owing was USD$27.751m (2017 USD$16.759m).
7. Share capital
FY2018:
In May 2017, the Company issued 473,181 Ordinary shares at $2.25 (AUD$2.11) each pursuant to the share purchasing
plan offered to existing shareholders. This share issue raised $1.065million of additional Ordinary share equity.
FY2019:
No ordinary or preference shares have been issued in the 6 months ended 30 September 2018.
Unlisted options to acquire ordinary shares were issued under the AFT Long Term Incentive Plan. 525,000 options issued
have an exercise price being $2.80. Reason for issue is to incentivise employees to grow the share price of the Company
and to attract, motivate and retain employees. The options are issued on the terms of the LTI plan. Therefore vesting dates
and conditions vary dependent on option holder.
8. Dividends paid
Ordinary shares
No dividends have been paid or declared for the ordinary shares.
Redeemable preference shares
The redeemable preference shares issued on 24 March 2017 attract a dividend rate of 9.4% per annum, or 25.8 cents
per share per annum and fall due on a quarterly basis. For the 30 June 2018 and 30 September 2018 quarter ends, no
dividends were paid and accordingly the dividends net of withholding taxes have been accumulated in the Redeemable
Preference Share Reserve.
15
9. Reconciliation of loss after tax with net cash flow from operating activities
$NZ000’s
Unaudited
as at
30 Sep 2018
Unaudited
restated
as at
30 Sep 2017
Loss after tax(4,1 8 8)(6,873)
Non-cash items:
Depreciation5160
Amortisation90105
Impact of Foreign Exchange on cash and cash equivalents(159)(209)
Share options expense91103
Interest costs capitalised to loan804532
Unrealised FX gains/(losses)1,986(699)
Share of JV Loss344616
Movement in working capital:
Decrease/(increase) in inventories(3,404)(4,979)
Decrease/(increase) in trade and other receivables4,7094,145
Increase/(decrease) in trade and other payables(4,014)(636)
Increase/(decrease) in income tax(117)157
Net cash used in operating activities(3,807)(7,678)
Notes to the Financial Statements (continued)
For the six months ended 30 September 2018
16AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
10. Investment in joint venture partnership
$NZ000’s
Unaudited
as at
30 Sep 2018
Unaudited
as at
30 Sep 2017
Interest in joint venture company at cost5,046 3,140
Equity accounted earnings of joint venture partnership(2,553) (1,332)
Net equity investment in joint venture partnership2,493 1,808
The joint venture partnership of the Group and its activities are as follows:
% interest held
Dermatology Specialties LP50%50%
Principal activities: Development and distribution of pharmaceuticals
Dermatology Specialties LP was incorporated on 22 June 2015. Movements in investment in the
joint venture partnership during the 6 months comprise:
$NZ000’s
Balance at start of period2,135 627
Investment during the period702 1,797
Share of current period loss(344) (616)
Balance at end of period2,4931,808
The following table summarises the financial information relating to the Group's joint venture
partnership, and represents 100% of the joint venture partnership net assets, revenues and net profits.
$NZ000’s
Extracts from joint venture partnership balance sheet (unaudited)
Current assets– –
Non-current assets2,2022,178
Current liabilities(96)(181)
Non-current liabilities––
Net assets2,106 1,997
$NZ000’s
Extracts from joint venture partnership income statement (unaudited)
Revenue– –
Net loss after taxation(688) (1,232)
The joint venture did not have any contingent liabilities or capital commitments at balance date (H1FY2018: nil).
17
11. Segment reporting
Operating Segments
Unaudited
September 2018
$NZ000’s AustraliaNew ZealandSoutheast AsiaRest of WorldTotal
Revenue – sale of goods21,60112,5661,1182,6593 7, 9 4 4
Revenue – royalty income–––101101
Revenue21,601 12,566 1,118 2,760 38,045
Other income1,860– –570 2,430
Depreciation and amortisation(10) (128) (3) –(141)
Equity accounted loss of joint venture entity–––(344)(344)
Loss before tax(519)(2,862)(152)(731)(4,264)
Finance income –16 ––16
Finance costs– (2,481) ––(2,481)
Other (gains)/losses(4 47 )(1,278)35–(1,690)
Total assets23,659 33,158 96 2,493 59,406
Property, plant and equipment51 269 15 –335
Intangible assets–7, 0 8 9 ––7, 0 8 9
Investment in joint venture entity–––2,4932,493
Capital expenditure21 2,098 – – 2,119
Unaudited
restated
September 2017
$NZ000’s AustraliaNew ZealandSoutheast AsiaRest of WorldTotal
Revenue – sale of goods20,20614,1136181,56536,499
Revenue – royalty income–––6262
Revenue20,206 14,113 618 1,627 36,561
Other income–––1,014 1,014
Depreciation and amortisation(10)(152) (3)–(165)
Equity accounted loss of joint venture entity–––(616)(616)
Loss before tax(171)(2,294)(371)(3,737)(6,573)
Finance income 294––96
Finance costs–(1,590)– –(1,590)
Other (gains)/losses(66)1,63718–1,589
Total assets21,15129,782 310–51,243
Property, plant and equipment45 309 20 –374
Intangible assets–2,74 4 ––2,74 4
Investment in joint venture entity–––1,8081,808
Capital expenditure23369–347
Notes to the Financial Statements (continued)
For the six months ended 30 September 2018
18AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
12. Financial risk management
(a) Managing financial risk
The Group’s activities expose it to various financial risks as detailed below.
Market risk
Management is of the opinion that the Group’s exposure to market risk at balance date is defined as:
Risk Factor DescriptionSensitivity
(i) Currency riskExposure to changes in foreign exchange rates on assets
and liabilities of the subsidiary, and USD denominated borrowings
As below
(ii) Interest rate riskExposure to changes in interest rates on borrowingsAs below
(iii) Other price riskNo commodity securities are bought, sold or tradedNil
Foreign exchange risk
The Group benefits from the use of derivative financial instruments to manage foreign currency exposures.
The fair value of forward exchange contracts is calculated by reference to current forward exchange rates at period end
and the contract exchange rates, considered level 2 of the fair value hierarchy.
The Group purchases goods and services from overseas suppliers in a number of currencies, primarily AUD, USD, EUR
and GBP and has borrowings that are denominated in US dollar amounts. This exposes the Group to foreign currency
risk. The Group manages foreign currency risk through use of derivative arrangements, in particular forward exchange
contracts. The exposure is monitored on a regular basis based on Group foreign exchange policies. Future revenues from
markets outside Australasia will be denominated primarily in USD and EUR which will provide a natural hedge against
these costs.
In the current period for the six months to 30 September 2018 (H1FY2019) net foreign exchange losses totalled
$1,700,357 (H1FY2018: $1,575,660 gain) of which $3,063,766 (H1FY2018: $699,000 gain) were unrealised losses on the
USD denominated CRG loan. Future revenues from markets outside Australasia will be derived in USD which will be used
towards repaying this debt as it falls due. The balance of the gains/losses are derived from the restatement of the cash
balances at the spot rate on the period end balance date of 30 September 2018 and the change in spot rates during the
time between when expenses are recorded in the general ledger and when they are paid.
In total, the group had assets and liabilities denominated in the following currencies, as at 30 September 2018.
Assets
$NZ000’s Currency
Liabilities
$NZ000’s
11,814AUD3,247
858USD43,233
523MYR62
397SGD58
247EUR2,462
2GBP36
A 1% increase or decrease in foreign exchange rates on assets and liabilities will reduce/increase equity by $352,000
(H1FY2018: $172,000) and reduce/increase the profit or loss by $202,000 (H1FY2018: $57,000).
19
Notes to the Financial Statements (continued)
For the six months ended 30 September 2018
12. Financial risk management (continued)
The following forward foreign exchange contracts were held at 30 September 2018:
Forward Foreign Exchange Contracts
Buy currency
Buy currency
amount (000's)
Sell amount
$NZ000’s
Mark to market
30 Sep 2018
Sell amount
$NZ000’s
Fair value
$NZ000’s
EUR2,2503,8864,001115
GBP1232392445
USD3,0704,2504,570320
Sell currency
Sell currency
amount (000's)
Buy amount
$NZ000’s
Mark to market
30 Sep 2018
Buy amount
$NZ000’s
Fair value
$NZ000’s
AUD2,0002,2242,26541
Total benefit as at 30 September 2018:481
All contracts mature within one year from 30 September 2018.
The following forward foreign exchange contracts were held at the end of the 2018 financial year:
Forward Foreign Exchange Contracts
Buy currency
Buy currency
amount (000's)
Sell amount
$NZ000’s
Mark to market
31 Mar 2018
Sell amount
$NZ000’s
Fair value
$NZ000’s
EUR2,5504,2904,394104
GBP19736538722
USD6,0008,2688,31850
Total benefit as at 31 March 2018: 176
All contracts mature within one year from 31 March 2018.
The following forward foreign exchange contracts were held at 30 September 2017:
Forward Foreign Exchange Contracts
Buy currency
Buy currency
amount (000's)
Sell amount
$NZ000’s
Mark to market
30 Sep 2017
Sell amount
$NZ000’s
Fair value
$NZ000’s
EUR3,316 5,302 5,454 152
GBP524 949 980 31
USD5,080 7, 1 1 87, 0 6 2 (56)
Total benefit as at 30 September 2017: 127
All contracts mature within one year from 30 September 2017.
20
AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
Interest rate risk
Borrowings are at a fixed interest rate, which exposes the Group to fair value interest rate risk. There are no specific
derivative arrangements to manage this risk.
Credit risk
Financial instruments, which potentially subject the Group to credit risk, principally consist of accounts receivable.
Regular monitoring is undertaken to ensure that the credit exposure remains within the Group’s normal terms of trade.
The Group has one significant concentration of credit risk at 30 September 2018 with the largest debtor being $3,604,000
(H1FY2018: $3,131,000). There has been no past experience of default and no indications of default in relation to this
debtor. There are no impaired receivables at 30 September 2018 (H1FY2018: nil).
The Group’s cash and short-term deposits are placed with high credit quality financial institutions. Accordingly,
the Group has no significant concentration of credit risk other than bank deposits, with 11.4% of total assets at the
Bank of New Zealand (H1FY2018: 26.5%), 1.1% at NAB Bank (H1FY2018: 3.3%) and 0% with ANZ (H1FY2018: 0%).
The carrying value of financial assets represents the maximum exposure to credit risk.
Liquidity risk
Liquidity risk is the risk that the Group may encounter difficulty in raising funds at short notice to meet its commitments
and arises from the need to borrow funds for working capital. The directors monitor the risk on a regular basis and actively
manage the cash available to ensure the net exposure to liquidity risk is minimised. Since May 2014, there has been a $1m
BNZ overdraft immediately available.
The liquidity/maturity profile of the liabilities is as follows:
Liquidity profile
$NZ000’s < 1 year1-2 years2-5 years> 5 yearsTotal
30 September 2018
Trade and other payables(13,245)–––(13,245)
Borrowings(3,785)(48,776)––(52,561)
Derivative instruments (outbound)(8,375)–––(8,375)
Derivative instruments (inbound)8,815–––8,815
Totals(16,590)(4 8,776)––(65,366)
$NZ000’s
30 September 2017
Trade and other payables(13,245) –––(13,245)
Borrowings (2,098) (2,176) (28,271)–(32,545)
Derivative instruments (outbound)(13,369)–––(13,369)
Derivative instruments (inbound)13,496 –––13,496
Totals(15,216) (2,176) (28,271)–(45,663)
(b) Fair values
The carrying value of financial assets and liabilities (trade receivables and trade payables) approximates their fair value.
Trade receivables are valued net of provision and trade payables are valued at their original amounts by contract.
21
Notes to the Financial Statements (continued)
For the six months ended 30 September 2018
13. Related parties
The Group had related party relationships with the following entities:
Related party Nature of relationship
CRG (Capital Royalty Group) Shareholder
The following transactions were carried out with these related parties:
(i) Loans
$NZ000’s Note
Unaudited
as at
30 Sep 2018
Audited
as at
31 Mar 2018
Unaudited
as at
30 Sep 2017
CRG (Capital Royalty Group)641,93830,654 23,244
Total loan balances41,93830,654 23,244
(ii) Key management compensation
$NZ000’s
Unaudited
as at
30 Sep 2018
Audited
as at
31 Mar 2018
Unaudited
as at
30 Sep 2017
Directors' fees146286143
Executive salaries5401,084 527
Short term benefits187127134
Share options expense152930
Key management compensation8881,526 834
Key management includes external Directors, the Chief Executive Officer, the Chief of Staff, the Chief Financial Officer and the Director
of International Business Development. These positions are mainly responsible for planning, controlling and directing the activities of the
business. The Chief of Staff is the spouse of the Chief Executive Officer.
14. Correction of error and change in classification
During 2018, the Group modified the classification of provisions for customer rebates from “Provisions” to “Trade and
other receivables” to reflect more appropriately the receipts expected from customers.
Comparative amounts in the Balance Sheet were restated for consistency. As a result, as at 30 September 2017, $1,686k
was reclassified from ‘Provisions’ to ‘Trade and other receivables”.
During 2018, the Group determined that goods in transit should be accounted for according to Incoterms, other than for
specific ownership terms in the contracts. Previously, the Group recognised inventory once it had inspected and accepted
the goods as per its rights under the contracts. As a result of this change, as at 30 September 2017 there was $2,560k
of goods in transit which had not been recorded. As a consequence, inventories and trade and other payables were
understated. The change has been recorded in these financial statements by restating each of the affected financial
statement line items for prior periods.
22AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
The following table summarises the impact of the above changes on the Group’s consolidated financial statements.
Consolidated balance sheet
Impact of correction of error
As previously reportedAdjustmentsAs restated
30 September 2017
Inventories21,1372,56023,697
Trade and other receivables16,640(1,611)15,029
Cash7, 1 9 7(75)7, 1 2 2
Derivative assets127–127
Total current assets45,10187445,975
Total assets50,36987451,243
Trade and other payables10,6852,56013,245
Provisions3,110(1,686)1,424
Total current
liabilities13,79587414,669
Total liabilities3 7,0 3 98743 7, 91 3
There is no impact on the Group’s total equity, basic or diluted earnings per share, net tangible assets per ordinary share,
total comprehensive loss or cash flows for the year ended 30 September 2017.
15. Contingent liabilities
In May 2015, AFT Pharmaceuticals Ltd signed as guarantor of AFT Pharmaceuticals Pty Ltd for its 5-year lease contract
for the premises occupied in Sydney, Australia. AFT Pharmaceuticals Pty Ltd has placed AUD$75 ,000 on term deposit
with NAB in favour of the landlord of the business premises to support this guarantee. The company has placed
NZD$75 ,000 on term deposit with the BNZ. This sum is security for a guarantee issued by the BNZ in favour of the NZX,
should the company ever default on any of its payment obligations to NZX.
16. Capital commitments
The Group has no capital commitments at 30 September 2018 (31 March 2018: nil: 30 September 2017: nil).
17. Subsequent events
There were no material events occurring after balance date and before the date of approval of the financial statements
requiring recognition or disclosure.
23
This review report relates to the unaudited condensed consolidated interim financial statements of AFT Pharmaceuticals Limited for the six months ended
30 September 2018 included on AFT Pharmaceuticals Limited’s website. The Board is responsible for the maintenance and integrity of AFT Pharmaceuticals
Limited’s website. We have not been engaged to report on the integrity of AFT Pharmaceuticals Limited’s website. We accept no responsibility for any
changes that may have occurred to the unaudited condensed consolidated interim financial statements since they were initially presented on the website.
The review report refers only to the unaudited condensed consolidated interim financial statements named above. It does not provide an opinion on any
other information which may have been hyperlinked to/from these unaudited condensed consolidated interim financial statements. If readers of this report
are concerned with the inherent risks arising from electronic data communication they should refer to the published hard copy of the unaudited condensed
consolidated interim financial statements and related review report dated 22 November 2018 to confirm the information included in the unaudited condensed
consolidated interim financial statements presented on this website. Legislation in New Zealand governing the preparation and dissemination of financial
statements may differ from legislation in other jurisdictions.
INDEPENDENT REVIEW REPORT
TO THE SHAREHOLDERS OF AFT PHARMACEUTICALS LIMITED
We have reviewed the condensed consolidated interim financial statements of AFT Pharmaceuticals
Limited and its subsidiaries (‘the Group’) which comprise the consolidated balance sheet as at 30
September 2018, and the consolidated income statement, consolidated statement of comprehensive
income, consolidated statement of changes in equity and statement of cash flows for the six months
ended on that date, and a summary of significant accounting policies and other explanatory
information on pages 9 to 23.
This report is made solely to the company’s shareholders, as a body. Our review has been undertaken
so that we might state to the company’s shareholders those matters we are required to state to them
in a review report and for no other purpose. To the fullest extent permitted by law, we do not accept
or assume responsibility to anyone other than the company’s shareholders as a body, for our
engagement, for this report, or for the opinions we have formed.
Board of Directors’ Responsibilities
The Board of Directors are responsible for the preparation and fair presentation of the condensed
consolidated interim financial statements, in accordance with NZ IAS 34 Interim Financial Reporting
and IAS 34 Interim Financial Reporting and for such internal control as the Board of Directors
determine is necessary to enable the preparation and fair presentation of the condensed consolidated
interim financial statements that are free from material misstatement, whether due to fraud or error.
Our Responsibilities
Our responsibility is to express a conclusion on the condensed consolidated interim financial
statements based on our review. We conducted our review in accordance with NZ SRE 2410 Review of
Financial Statements Performed by the Independent Auditor of the Entity (‘NZ SRE 2410’). NZ SRE
2410 requires us to conclude whether anything has come to our attention that causes us to believe
that the condensed consolidated interim financial statements, taken as a whole, are not prepared, in all
material respects, in accordance with NZ IAS 34 Interim Financial Reporting and IAS 34 Interim
Financial Reporting. As the auditor of AFT Pharmaceuticals Limited, NZ SRE 2410 requires that we
comply with the ethical requirements relevant to the audit of the annual financial statements.
A review of the condensed consolidated interim financial statements in accordance with NZ SRE 2410 is
a limited assurance engagement. The auditor performs procedures, primarily consisting of making
enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical
and other review procedures.
The procedures performed in a review are substantially less than those performed in an audit
conducted in accordance with International Standards on Auditing (New Zealand). Accordingly we do
not express an audit opinion on those financial statements.
Other than in our capacity as auditor and the provision of taxation services, we have no relationship
with or interests in AFT Pharmaceuticals Limited or its subsidiaries. These services have not impaired
our independence as auditor of the Company and Group.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the condensed
consolidated interim financial statements of the Group do not present fairly, in all material respects,
the financial position of the Group as at 30 September 2018 and its financial performance and cash
flows for the six months ended on that date in accordance with NZ IAS 34 Interim Financial Reporting
and IAS 34 Interim Financial Reporting.
Chartered Accountants
Auckland, New Zealand
22 November 2018
24AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
On 21 December 2015, NZX granted the Company a waiver (Original Waiver) from NZX Main Board Listing Rule 5.2.3 in
respect of its quoted shares (Shares) for a period of 12 months to the extent the Rule required the Company to have at
least 25% of Shares held by Members of the Public holding at least a Minimum Holding (as that term is defined in the NZX
Main Board Listing Rules). The Original Waiver has expired. On 21 December 2016, a further waiver from NZX Main Board
Listing Rule 5.2.3 was granted to AFT for an additional 12 month period. This waiver was renewed by NZX Regulation for
a further 12 month period on 20 December 2017.
The waiver was granted on the following conditions:
• NZX receives an undertaking from the Atkinson Family Trust (AF Trust) that it will not increase its holding in AFT during
the term of the waiver, otherwise than as a result of an allotment pursuant to an offer or issue of shares that is made
pro-rata to all AFT shareholders;
• At least 10% of shares are held by more than 500 Members of the Public, with each Member of the Public holding at
least a Minimum Holding;
• AFT clearly and prominently discloses this waiver, its conditions, and its implications in AFT’s half year and annual
reports, and in any Offer Documents relating to any offer of shares undertaken by AFT, during the period of the waiver;
• AFT consistently monitors the total number of Members of the Public holding shares and the percentage of shares held
by Members of the Public holding at least a Minimum Holding;
• AFT notifies NZX as soon as practicable if there is any material reduction to the total number of Members of the Public
holding at least a Minimum Holding of shares, and/or the percentage of shares held by Members of the Public holding at
least a Minimum Holding; and
• AFT provides NZX with a written quarterly update of the total number of Members of the Public holding shares holding
at least a Minimum Holding and the percentage of shares held by Members of the Public holding at least a Minimum
Holding. The quarterly updates are from the date the waiver is granted, for the period of the waiver. The updates are to
be provided to NZX within ten business days of the end of each quarter.
• AFT provides NZX, with the second quarterly update, an update on the proposed initiatives AFT intends to undertake to
materially increase the percentage of shares held by Members of the Public before the expiry of the waiver.
The implication of the waiver is that the Shares may not be widely held and that there may be reduced liquidity in the
Shares following quotation. A copy of each waiver can be viewed at www.aftpharm.com.
NZX WAIVER
25
AFT is a company incorporated with limited liability under the New Zealand Companies Act 1993
(Companies Office registration number 873005).
Registered OfficeLevel 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
+64 9 488 0232
www.aftpharm.com
Mertons, Level 7, 330 Collins Street, Melbourne, Victoria 3000, Australia
+61 3 8689 9997
Principal
Administration
Office
Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
+64 9 488 0232
www.aftpharm.com
113 Wicks Road, North Ryde NSW 2113, Australia
+61 2 9420 0420
ARBN: 609 017 969
Directors
(as at date of this
Interim Report)
Dr Hartley Atkinson
Marree Atkinson
Dr James (Jim) Burns
David Flacks
Nathan (Nate) Hukill
Jon Lamb
Dr Douglas (Doug) Wilson
Share RegistrarComputershare Investor Services Limited
Level 2, 159 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
+64 9 488 8777
enquiry@computershare.co.nz
Computershare Investor Services Pty Limited
Yarra Falls, 452 Johnston Street, Abbotsford VIC 3067, Australia
+61 3 9415 4083
enquiry@computershare.co.nz
AuditorDeloitte
Deloitte Centre, 80 Queen Street, Auckland 1140, New Zealand
+64 9 303 0700
DIRECTORY
26AFT PHARMACEUTICALS LIMITED
Interim Report for the period ended 30 September 2018
---
AFTPHARMACEUTICALS
InvestorPresentation: H1 FY2019
November2018
Investor Presentation
November 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 provided for illustrative purposes only, should not be relied upon, and is
not an indication of future performance.
Investor Presentation
November 2018
H1 FY2019 HIGHLIGHTS
2
128
countries that Maxigesicis licensed in – up from 125 at the end of FY2018
15
countries that Maxigesicis launched and sold in
5
number of clinical studies AFT have running in FY2019
$40.2m
total income for H1 FY2019*
$7.4m
available cash as at 30 September 2018 –up from $6.8m at the
end of FY2018.
* Total income comprises Operating Revenue of $38.0m and Other Income of $2.2m
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
UK – launched
IE – launched
Spain& Portugal – launch
pending 4Q 18
CACM – launch underway
Mexico – launch
pending 4Q 18
Brazil - Licensing negotiations
underway
Licensing discussions starting
for USA & Canada
Licensed in Russia
Korea - Licensing negotiations
underway
Licenced in Taiwan
HK launch 4Q FY19
Germany – licensing
negotiations underway
Indonesia and Philippines –
licensing discussions underway
Investor Presentation
November 2018
MAXIGESIC HIGHLIGHTS
Additional out-licensing and distribution agreements for Maxigesicoral dose forms have been
secured to increase the number of countries to 128.
Numerous Maxigesic registrations underway which are required before many launches can occur
EU registrations confirmed in 25 countries. Remaining 3 underway.
Most of the remaining countries use EU registration as a reference standard
Additional dose forms (IV and Oral Liquid) regulatory filings initiated.
Maxigesic IV successful FDA pre NDA filing meeting.
Maxigesic Oral FDA registration expected in calendar 2019.
SUMMARY: Drive sales by
[1] Increasing sales in Australia post codeine switch
[2] Increasing sales in existing territories
[3] Launches in new territories
[4] Launch additional dose forms starting in FY20
4
Investor Presentation
November 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 for the
intranasal delivery of medication and treatment of
chronic sinusitis
Rationale for
investment in
product
•To expand our existing hospital product ranges locally
•Significant global potential
•First drug delivery indication a significant potential
market – US$1.2B in USA alone [Based upon market
research studies in USA and UK]
Current status
•Registered as Class I Device with FDA as planned
•Completed Human Factor Studies
•Targeting Class IIA Device filing Apr/May 19
Ourmedium
term plans
•FDA Pre-IND meeting completed
•Development pathway clarified with FDA
•Human factor studies identified some redesign
requirements
•Distribution studies underway
•IND opening with redesigned device now FY2020
•First Drug PK studies targeted to commence in FY2020
after opening IND
•First Drug Clinical Studies targeted to start FY2020
after opening IND
•Licensing negotiations during FY2020
NASOSURFNEBULISER: Future growth strategy
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
6
Investor Presentation
November 2018
REVENUE BY REGION AND CHANNEL
7
Operatingrevenue by region, H1 FY2019versus H1 FY2018
Operating revenueby channel by region, H1 FY2019
Australia New Zealand Rest of World Southeast Asia Group
Over-the-counterHospitalP re s c rip t io n
NZ$000's Half Year to 30 SeptemberH1 FY2019% of totalH1 FY2018% of total
Australia21,601 56.8%20,206 55.3%
YoY growth7%
New Zealand12,565 33.0%14,113 38.6%
YoY growth-11%
Rest of World2,760 7.3%1,624 4.4%
YoY growth70%
Southeast Asia1,118 2.9%618 1.7%
YoY growth81%
Total Operating Revenue38,045 100%36,561 100%
YoY growth4%
11.1%
28.1%
60.7%
32.4%
17.3%
50.3%
-
6.1%
93.9%
0.1%
54.4%
45.5%
17.0%
23.7%
59.2%
Investor Presentation
November 2018
-
7.5
15.0
22.5
$ m
H1 FY2018
FY2018 Annual
REVENUE GROWTH
8
Operating revenue by region, H1 FY2019– H1 FY2018
H1 FY2019
7% -11%70% 81%
Au s tra liaNew ZealandRe s t o f Wo rldSoutheast Asia
-
7.5
15.0
22.5
$ m
-
15.0
30.0
45.0
$ m
2.9%
7.3%
33.0%
56.8%
1.6%
3.1%
33.8%
61.4%
1.7%
4.4%
38.6%
55.3%
Investor Presentation
November 2018
SUMMARY P&L
9
NZ$'000's Half Year to 30 SeptemberH1 FY2019% ofH1 FY2018 % of
revenuerevenue
Revenue38,045 36,561
Cost of Sales(20,292) 53.3%(22,256)60.9%
Gross Profit17,753 46.7%14,305 39.1%
Other Income2,430 6.4%1,014 2.8%
Selling and distribution expenses(14,234) 37.4%(12,771)34.9%
General and administrative expenses(3,489) 9.2%(3,618)9.9%
Research and development expenses(2,225) 5.8%(4,982)13.6%
Equity accounted loss of joint venture entity(344) 0.9%(616)1.7%
Operating Loss(109) (6,668)
Finance Income16 96
Finance Costs(2,481) (1,590)
Other gains / (Losses)(1,690) 1,589
Loss before tax(4,264) (6,573)
Tax benefit/(expense)76 (300)
Loss after tax(4,188) (6,873)
Investor Presentation
November 2018
10
SUMMARY BALANCE SHEET
UnauditedAudited
Unaudited
NZ$'000's 30 Sept '1931 March '18
30 Sept '18
ASSETS
Current Assets
Inventories27,815
24,412 23,697
Trade and other receivables12,993 16,954 14,954
Cash and cash equivalents7,400
6,770 7,197
Derivative assets
481
176 127
Total current assets48,689 48,312 45,975
Non-current Assets
Property, plant and equipment
335 330 374
Intangible assets7,089 5,118 2,744
Deferred income tax assets
800 708 342
Investment in joint venture entity2,493 2,135 1,808
Total assets59,406 56,603
51,243
LIABILITIES
Current liabilities
Trade and other payables11,628 17,391 13,245
Provisions2,880 1,098 1,424
Current income tax liability - 118 -
Total current liabilities14,508 18,607 14,669
Non-current liabilities
Interest bearing liabilities41,938 30,654 23,244
Total liabilities
56,446 49,261 37,913
Equity
Share Capital63,743 63,743 63,743
Retained earnings(62,289)(57,644) (51,349)
Share options reserve521
430 399
Redeemable Preference Share Reserve879 483 291
Foreign currency translation reserve106 330 246
Total equity2,960 7,342 13,330
Total liabilities and equity59,406 56,603 51,243
Investor Presentation
November 2018
11
SUMMARY CASHFLOW STATEMENT
NZ$'000's Half Year to 30 SeptemberH1 FY2018H1 FY2017
Net cash used in operating activities(4,339) (7,678)
Net cash used in investing activities(2,821) (2,144)
Net cash generated from financing activities7,417 745
Net increase in cash257 (9,077)
Impact of foreign exchange on cash and cash equivalents373 294
Opening cash and cash equivalents6,770 15,905
Closing cash and cash equivalents7,400 7,122
Investor Presentation
November 2018
SUMMARY OF NEAR TERM PLANS
Drive Increased International Sales
Phased launches of Maxigesicin additional countries including larger EU
territories and North America
Drive Increased Upfront Payments
Further licensing agreements for Maxigesicand Maxigesic IV in larger markets
including North America
Drive Value of NasoSURFand Pascomer Projects
Completing the key development targets for NasoSURF
Initiating human clinical studies program for Pascomer
Drive Local Australian Key Market Sales
Build on Maxigesicmarket share and sales post codeine changes
Register and launch line extensions starting in FY2020
Build further revenues of OTC product sales in Australia
12
Drive Revenues to Achieve Break Even
Break even targeted in the FY2019 time frame from increased higher margin
product sales in home markets; increased licensing income from existing and
new agreements; increased Maxigesicsales from existing and new markets
Control of costs
Data sourced from publicly available filings. Our datasets may not be complete. Automated analysis can produce errors. If you believe any data on this page is incorrect, please contact us at hello@nzxplorer.co.nz. For informational purposes only. Not investment advice.
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