2022 New Year letter to investors
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com
7 January 2022
2022 New Year letter to investors
AFT Pharmaceuticals (NZX: AFT, ASX: AFP) releases the attached new year letter to
shareholders, which sets out the company’s expectations for the 2022 calendar year,
including:
• Key commercialisation milestones for its family of patented Maxigesic
®
pain
relief medicines, including the expected approval of the intravenous and
tablet forms in the US market.
• Planned growth in its Australasian portfolio of over the counter and prescription
medicines.
• Planned milestones for its e-commerce and research and development
programmes.
The company also notes that, assuming no deterioration in current trading conditions,
it retains its guidance for an operating profit for the year to 31 March 2022 of $18 million
to $23 million with the wide range reflecting a number of uncertainties including those
related to the COVID-19 pandemic and the ongoing global supply chain disruptions.
For and on behalf of AFT Pharmaceuticals Limited by Malcolm Tubby, Chief Financial
Officer.
For more information:
Investors Media
Dr Hartley Atkinson Richard Inder
Managing Director The Project
AFT Pharmaceuticals Tel: +64 21 645 643
Tel: +64 9488 0232
About AFT Pharmaceuticals
AFT is a growing multinational pharmaceutical company that develops, markets, and
distributes a broad portfolio of pharmaceutical products across a wide range of
therapeutic categories which are distributed across all major pharmaceutical
distribution channels: over the counter (OTC), prescription and hospital. Our product
portfolio comprises both proprietary and in-licensed products, and includes patented,
branded, and generic drugs. Our business model is to develop and in-license products
for sale by our own dedicated sales teams in our home markets of Australia and New
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com
Zealand and in certain Southeast Asian markets, and to out-license our products to
local licensees and distributors to over 125 countries around the world. 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 investor.relations@aftpharm.com
7 January 2022
Dear shareholder,
AFT Pharmaceuticals is looking to 2022 confident in its prospects, despite the ongoing
uncertainties of COVID-19 and the related global supply chain disruptions.
Building on our strong presence in Australasian and Asian over the counter and
prescription medicines and our growing portfolio of intellectual property, including the
patented Maxigesic family of pain relief medicines, we expect once again to extend
our decades’ long record of growth.
Maxigesic and Pending US approvals
During 2022 we expect to further extend the number of countries in which Maxigesic
tablets and the intravenous form of the medicine are sold.
Of note are our plans for the medicines in the US market, the world’s largest for pain
relief
1
, where we expect approval of both formulations in the current year.
The US Food and Drug Administration (FDA) is due to respond to AFT’s application for
Maxigesic tablets by 27 January 2022. We have not yet signed a licensee in the US for
the tablets and are evaluating US market entry plans to maximise the commercial
potential of the medicine.
As previously announced, the FDA is due to respond to AFT’s application for Maxigesic
IV by 30 June 2022. We will work with our Maxigesic IV licensing partner Hikma
Pharmaceuticals USA to execute a launch as soon as possible following regulatory
approval. Our current expectation remains to launch late in this calendar year.
Work to extend our global Maxigesic footprint continues.
As part of this programme, we are now looking for a new licensee in Russia. Our former
partner for the medicine was recently taken over by a company that is focussed on
1
Mordorintelligence.com. 2021. Pain Management Market (2021 - 26) | Industry Analysis, Size, Share | Covid - 19
Impact.
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com
other medicines in the region. We remain confident of achieving a replacement
licensee for Russia during 2022.
We are meanwhile looking to launch new Maxigesic dose forms, including Maxigesic
Hot Drink Sachet and Maxigesic Oral Liquid, a formulation developed principally for
children.
Australia and New Zealand
AFT continues to make progress in both Australia and New Zealand.
Our growth plans are significant. As previously announced, we are working on
launching some 30 new products across all of our seven key therapeutic areas
2
over
the next 18 months.
We have expanded our internal in-licensing resources and continue to work on further
increasing our portfolio by ongoing in-licensing and further development of AFT’s
intellectual property.
E-Commerce
AFT continues to work on expanding its e-commerce offerings. Our initial trial into
China via T-Mall has given us confidence to expand the product range available
online both in China and further afield. We will provide more guidance on our plans
as they develop.
Research and Development
Our research and development programme continues to strengthen the foundations
for AFT’s future growth.
We have completed enrolment for our pivotal clinical trial of Pascomer (Rascomer in
the EU), a treatment for facial angiofibromas, a symptom of Tuberous Sclerosis
Complex. We expect results for this trial towards the end of the first half of 2022.
Additionally, during 2022, we expect to complete an initial proof of concept study in
humans for the first indication for our patented drug delivery device NasoSURF. Again,
this will be a key development milestone.
Finally, development of additional line extensions to the Maxigesic family of medicines
continue, including a rapid absorption formulation of the tablet and Maxigesic Cold
& Flu Relief.
Financial outlook
Overall, we continue to work hard to execute upon our plans and look forward to
further and accelerating progress during 2022.
Assuming no deterioration in current trading conditions, we retain our guidance for an
operating profit for the year to 31 March 2022 of $18 million to $23 million with the result
underpinned by product launches and the wide range reflecting a number of
2
Pain, Eyecare, Medicated Vitamins, Allergy Gastrointestinal, Dermatology, Hospital
AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com
uncertainties including those related to the COVID-19 pandemic and the ongoing
global supply chain disruptions.
We thank shareholders for their ongoing support and look forward to reporting
progress against these goals.
With our best wishes for the year ahead.
Kind regards
David Flacks Dr Hartley Atkinson
Chair Managing Director
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