March investor update

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








31 March 2025
March investor update
AFT partners on new iron medicine; sees global progress
-
AFT agrees to advance a novel injectable iron therapy, to phase 3 trials as part
of a new partnership with Belgium’s Hyloris Pharmaceuticals; targeting a US$7.4
billion global market
- We have successfully launched Crystaderm
®
in China, capping off a year of
achievements for business development, with AFT's medicines accounting for
two of the 19 in -licensing deals in that market for any pharmaceutical
company from around the globe in 2024
- We are seeing strong international interest in our portfolio of developed and
developing products with around twenty agreements under various stages of
discussion.

AFT Pharmaceuticals (NZX: AFT; ASX: AFP) today announces confirmation of a new
agreement to develop a novel innovative injectable iron deficiency therapy. The
agreement caps off the strong progress the diversified pharmaceutical company has
made in the 2025 financial year.
Co-Founder and Managing Director Dr Hartley Atkinson said: “Our new iron deficiency
treatment — first flagged in October 2024 as a conditional agreement — has shown
great potential in Phase 2 trials and offers a significant opportunity to develop an iron
infusion therapy with advantages over existing therapies. Data to support this will have
to be established in the Phase 3 clinical trial program.
“The agreement for the medicine extends AFT’s research and development pipeline
to 13 separate projects – 5 largely completed and 8 underway, all of which offer
strong potential to further accelerate our long-term growth and support the global
diversification of the business across the OTC, Hospital and Prescription channels and
across multiple markets internationally .
“AFT has a decades-long track record for driving strong growth through its ability to
identify unmet clinical needs and then in -license or develop and commercialise
medicines to improve health globally.

“Over the 2025 financial year we have further successfully executed on this strategy.
Our achievements in China — where two of our medicines were among the just 19 in
licensing deals struck in that country in 2024 — is emblematic of this success.
“Our medicines are now sold in more than 80 markets around the world, and we have
distribution or licensing agreements in over 100 markets around the world. We see
significant opportunities to extend and deepen this global footprint by expanding the
number of markets where we operate and by out-licensing our proprietary medicines
including those in development.
“Notably, we have also, in parallel, extended our AFT footprint with business
operations now in Australia, New Zealand, Singapore, Hong Kong, South Africa, USA,
Canada, Europe and the UK.
“We are looking forward to providing a further update on our progress when we
release our FY25 financial results on 22 May

this year.
“As we affirmed in January, we expect to achieve record sales of more than $200
million (excluding license income) in FY25 which would be a significant increase from
the $56 million and $106 million turnover in the FY15 and FY20 financial years
respectively. We meanwhile remain firmly focussed on our target of achieving $300
million turnover by the close of the FY27 financial year. We, meanwhile, continue to
expect operating profit for FY25 to range between $15 million and $20 million.”
Novel Injectable Iron – targeting a market expected to grow to US$7.4 billion in 2033
1

The late-stage research and development program for the New Chemical Entity
(NCE) is a collaboration with Belgium’s Hyloris Pharmaceuticals. The product holds out
the potential for some significant and unique features to alleviate iron deficiency, a
common condition that affects 15% of the world population. It offers AFT and its
partners entry into a market which is forecast to more than double from around US$3.2
billion in 2023 to US$7.4 billion in 2033.
The NCE Injectable Iron is a well-advanced R&D project having completed Phase 2b
trials. Once commercialised it will extend AFT’s strong position in iron medicines in the
over-the-counter channel, into the prescription channel. AFT’s current OTC portfolio
includes Ferro-liquid, FerroTab, Ferro-F-Tab, Ferro-sachets, Ferro Liposachets and
FerroMalt which cumulatively represents a significant position in the Australasian iron
medicines market.
Under the terms of the original conditional agreement — first flagged in October 2024
— upon meeting pre-specified conditions, AFT and Hyloris secure an exclusive global
IP license for the NCE Injectable Iron and together with the original development
company they will co-develop the medicine for registration and global
commercialisation.
Hyloris will oversee product formulation, manufacturing, and the coordination of
commercialisation in Europe. AFT will manage the clinical trials, execution and the
commercialisation outside Europe which will include the world’s second and third
largest pharmaceutical markets – China and Japan. The duo is jointly responsible for
commercialisation in the US, the world’s largest pharmaceutical market.
Phase 3 clinical trial(s) involving approximately 1000 patients will be conducted across
the globe in USA, Europe, India and China for investigation of the products efficacy

1
https://www.biospace.com/intravenous-iron-drugs-market-size-to-worth-around-us-7-41-billion-by-2033

and safety. Development costs, as well as all net margin from sales and licensing, will
be distributed equally between AFT and Hyloris, after a tiered profit participation for
the original development company.
The agreement extends AFT’s partnership with Hyloris. The companies successfully
collaborated to commercialise Maxigesic IV, the intravenous version of AFT’s
patented pain relief medicine now sold in 50 countries and out-licensed to partners
for distribution in a further 50+ countries. AFT is also collaborating with the Belgian
company to develop and commercialise a new treatment for Burning Mouth
Syndrome and another for Vulvar Lichen Sclerosis, both conditions without approved
pharmaceutical treatments.
AFT punches above its weight in China
New research shows that AFT is achieving success, amongst global pharma, in China
that belies its size.
In 2024, according to a report compiled by MybioBD Management Consulting Co.
2
,
AFT medicines – the antiseptic cream Crystaderm and Maxigesic IV – accounted for
two of the just 19 developed medicines in -licensed into China in 2024.
Our partner distributor Hainan Haiyao successfully launched Crystaderm in China in
March this year, after signing the in-licensing agreement in July 2024.
Additionally, we have completed a further four distribution agreements with Hainan
for Vitamin C LipoSachets, Vitamin D LipoSachets, Ferro LipoSachets and Kiwisoothe
tablets. These products are launching initially in the Lecheng Free Trade Zone but
launches in Mainland China are planned over the next 12 months to make a total of
five launches into China within a year.
Meanwhile, Xizang Weixinkang Pharmaceutical Co Ltd (WXK), an established hospital
injectables focused company in China and listed on the Shanghai Stock Exchange
main board, was licensed to distribute Maxigesic IV in this market in September 2024.
WXK and AFT are presently working on pursuing regulatory approval for the medicine
in China.
Strong global interest for our medicines
The progress and interest in our products in China reflect a broader trend we are
seeing around the world. At present we are engaged in some 20 out-licensing
discussions, which we expect to progress in the new financial year. These discussions
cover:
- The Maxigesic family of medicines, where we are gradually filling in gaps in the
global footprint
- Products that have recently emerged from our development programme
including Crystaderm, Capsaicin pain relieving cream, and our Micolette
microenema.
- The portfolio of 24 hospital injectables that we are developing in partnership
with Edge Pharmaceuticals (70:30). Together these injectables target a market
for our affiliates in Australia, New Zealand, Singapore, Hong Kong, South Africa,
Canada and UK worth more than US$450 million. Out-licensing discussions have

2
https://mp.weixin.qq.com/s/EIG5Fjx2xAllqO_LbY88Xw

been initiated in other markets such as the EU and Middle East where the target
market is worth over US$1 billion.
- Niche injectables that we acquired in 2024 from a bankrupt German company
where we have already secured and additionally are working on further
distribution agreements in selected EU markets.
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 New Zealand based 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
3
. Our business model is to
develop and in-license products for in our markets of Australia, New Zealand,
Singapore, Malaysia, Hong Kong, USA, Canada, EU ex Ireland and UK, 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.