June Quarter FY 2026 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





1 July 2025
June Quarter FY 2026 Investor Update
Combogesic IV launches in Canada; R&D progress
Q1 FY 26 HIGHLIGHTS
- Maxigesic IV
®
(marketed as Combogesic IV
®
) launching in Canada this month and
sales kick off for AFT Pharmaceuticals Canada as AFT builds out its presence in
North America.
- US Maxigesic licensing agreement with Hikma Pharmaceuticals extended to
maximise the commercial footprint of the medicine.
- Research and development program significant advances with:
o pre -Investigational New Drug application (pre-IND) for our antibiotic
eyedrop already fil ed and IND to be filed this year with the US Food and
Drug Administration (FDA)
o preparing to file a further pre-IND application for our Strawberry Birth Marks
topical treatment this year
o preparing to file an IND for the novel iron injection around year end
o addition of a further project for an improved formulation

- An interview with AFT managing Director Hartley Atkinson is available from the
following link https://youtu.be/r3nxyp62Khg
AFT Pharmaceuticals (NZX: AFT; ASX: AFP) is this month starting sales for AFT
Pharmaceuticals Canada by launching its patented intravenous pain relief medicine,
Maxigesic IV in Canada (marketed as Combogesic), building on the company’s
strategy to expand in selected international markets.
Combogesic IV combines 1000mg paracetamol and 300mg ibuprofen in a single
injectable formulation for the treatment of mild to moderate pain. When used in
combination with the tablet form of the medicine, it provides clinicians with a valuable
alternative to opioids in both operative settings and in post-discharge care.
AFT Managing Director, Dr Hartley Atkinson, said: “We see strong potential for
Combogesic IV in Canada. The country is seeking safer, non-opioid approaches to
pain management, and our dual-formulation Combogesic patented platform offers
clinicians precisely that—an effective alternative to reduce opioid use.”
The launch comes as Canada continues to grapple with a severe opioid crisis. Since
2016, more than 49,000 opioid-related deaths have been reported, along with over
45,000 hospitalisations and 187,000 emergency department visits
1
. Canada’s opioid-

1
https://www.canada.ca/en/health-canada/services/opioids/federal-actions/overview.html

related mortality rate, 6.9 per 100,000 population, is second only to the United States
globally
2
.
The 2017 Canadian Guideline for Opioid Therapy and Chronic Non-Cancer Pain
recommends prioritising non-opioid pharmacotherapies, including NSAIDs
3
, to reduce
reliance on opioids, which are associated with a 5.5% risk of addiction
4
. Canada’s
analgesics market is forecast to grow at a CAGR of 6.1% to US$1.88 billion by 2030
5
.
AFT will commercialize Combogesic IV through its recently established Canadian
business hub, led by experienced local pharmaceutical executive Sylvain Desjeans.
The Canadian business, which will sell a number of AFT’s own medicines and in-
licensed products, has been established as part of AFTs strategy to extend its footprint
to territories that offer similar trading characteristics as its core Australasian business.
Further launches of OTC products are planned during this FY 26 financial year followed
by a significant pipeline of in-licensed products, products developed by AFT and AFT
Pharm Sinoject. It has set up similar operations in Singapore, Hong Kong, South Africa,
the US, Europe and the UK.
US MAXIGESIC PARTNERSHIP EXTENDED
The expansion into Canada builds on a broader strategy in North America. In late May
AFT announced it had extended its US Maxigesic licensing agreement with Hikma
Pharmaceuticals. The new agreement is aimed to maximise the commercial and
patient care benefits that come with following the intravenous form of the pain relief
medicine (marketed as Combogesic IV in the US) in postoperative care with the tablet
form of the medicine (Combogesic Rapid).
The agreement will see Hikma take over all channels for Combogesic Rapid in the US
— apart from the license granted to Alexso for certain specific market categories —
allowing both forms of AFT’s patented medicines to be marketed across the entire US
market. The US is the world’s largest market for pain relief
6
.
AFT and Hikma have also agreed to a restructure of the profit share arrangements for
Combogesic IV. The agreement amends the previous profit share which featured a
fixed specified profit amount before sharing commenced, to now being a regular
quarterly profit share payment. AFT will be more involved in the sales and marketing
planning for Combogesic IV and Rapid, also making a contribution towards
marketing.
AFT sees potential for the new agreement to deliver greater commercial benefits than
envisaged by the original agreements with Hikma, one of the largest suppliers of
injectable medications by volume in the US.
US healthcare costs associated with opioid abuse are estimated at US$11 billion a
year
7
. With 6% of patients administered an opioid postoperatively observed to

2
https://ourworldindata.org/data-insights/the-united-states-has-by-far-the-highest-death-rate-from-opioids
3
Non-steroidal anti-inflammatory drugs
4
Busse, J. (2017). The 2017 Canadian guideline for opioids for chronic non-cancer pain. Hamilton, Ont.: McMaster
University.
5
https://www.grandviewresearch.com/horizon/outlook/analgesics-market/canada
6
https://www.mordorintelligence.com/industry-reports/pain-management-market
7
https://premierinc.com/newsroom/press-releases/opioid-overdoses-costing-u-s- hospitals-an-estimated-11-billion-
annually

consume the medicine chronically
8
, the two forms of Combogesic offer clinicians an
opportunity to reduce these risks in post operative pain setting.
EXTENDING MAXIGESIC IV TO PAEDIATRIC POPULATION
We are meanwhile preparing to commence a Maxigesic IV study for the paediatric
population. The paediatric population typically has fewer safe and effective options
for managing pain, particularly in hospital settings.
A significant number of physicians have already shown keen interest in data for this
population. We expect the study to generate the clinical data required to support
regulatory approvals and ensure appropriate dosing for children which will further
extend the patient population and sales.
PRE-IND ANTIBIOTIC RESISTANT EYEDROP APPLICATION LODGED WITH FDA
Our antibiotic eyedrop R&D is advancing with the pre-IND (Pre-Investigational New
Drug) already filed with the US Food and Drug Administration (FDA) and we are
targeting an IND application well before year-end.
A pre-IND request is an essential early step, allowing AFT to discuss preclinical data
and study design with FDA guidance. The subsequent IND filing will pave the way for
human clinical trials starting next year within the FDA’s phased approval framework.
Licensed in 2023 from Latitude Pharmaceuticals, the antibiotic drop addresses
resistant ocular infections such as the MRSA
9
superbug and is presently widely
prescribed in the US as a compounded formulation but importantly no registered
formulation is available.
Additionally, good progress has been made for the Topical Strawberry Birthmarks
project with a pre-IND application in preparation for filing this year. Also following a
successful pre-IND meeting, an IND application is in preparation for the novel
injectable iron recently in-licensed with filing planned around the end of this year.
With a significant global market potential, these projects are expected to underpin
the future growth of the company.
AFT’s R&D pipeline now comprises 14 projects, featuring five candidates (multiple
Maxigesic dose forms, Capsaicin creams, Crystaderm
®
, Kiwisoothe
®
, and Micolette
®
)
nearing or in the commercialisation phase.
AFT has also added an improved formulation project targeted at a niche global
market of around US$180M which is planned to be ready for filing within next financial
year.
Notably this last quarter has seen AFT complete five separate out-licensing
agreements with a significant number of agreements and term sheets still under
negotiation.
For and on behalf of AFT Pharmaceuticals Limited by Malcolm Tubby, Chief Financial
Officer.

8
https://jamanetwork.com/journals/jamasurgery/fullarticle/2618383
9
Methicillin Resistant Staphylococcus Aureus

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
10
. 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.