Pharmaceutical and consumer health company, Bioxyne (ASX: BXN) has become the first manufacturer in Australia to produce cannabis gummies under a Good Manufacturing Practice (GMP) licence.

Through its subsidiary, Breathe Life Sciences (BLS), Bioxyne has completed the first commercial run of these pharmaceutical-grade edibles, taking an early position in Australia’s fast-evolving medicinal cannabis market where general consumption of cannabis products is gaining traction for medical benefits rather than illicit. 

The journey to this achievement began in early 2024 when BLS received its GMP licence from Australia’s Therapeutic Goods Administration (TGA). This certification permits the Company to manufacture medicinal cannabis products domestically, paving the way to produce cannabis products, commonly referred to as gummies or pastilles. Traditionally, medicinal cannabis edibles were imported into Australia, but Bioxyne’s recent development marks a major step towards local production and supply with greater benefits for the domestic economy.

In July 2024, Breathe Life Sciences secured purchase orders amounting to approximately $2 million, reflecting the strong demand for Australian-made cannabis edibles. These orders signalled the completion of the first commercial production of GMP-certified THC gummies. In addition to this, BLS signed a two-year manufacturing and supply agreement with one of Australia’s largest cannabis companies, with a forecasted minimum value of $28 million. 

BLS is ramping up its gummy manufacturing capabilities to meet the projected market demand, scaling from its current production of 2 million single doses per month to 6 million. This growth is critical to supply both the Australian domestic market and international customers in a burgeoning industry.

The cannabis gummies produced by Bioxyne are specifically formulated with precise doses of cannabidiol (CBD) and/or tetrahydrocannabinol (THC). These are the primary active ingredients in cannabis, each offering distinct therapeutic benefits. The products are designed for use under prescription by authorised medical professionals, meaning that they are not available for general sale to the public but are intended for patients requiring medicinal cannabis as part of their treatment.

Patients in Australia who are prescribed cannabis products, including the new gummies, must go through authorised prescribers who are approved to administer medicinal cannabis. These healthcare professionals assess whether cannabis-based treatments, such as gummies, are appropriate for their patients. This restriction ensures that the use of medicinal cannabis remains regulated and focused on therapeutic outcomes.

Bioxyne’s venture into cannabis gummies is part of its broader strategy to become a leading supplier of alternative pharmaceutical products. The Company is also expanding its portfolio to include other emerging therapeutic compounds such as psilocybin and MDMA, which are gaining attention for their potential in treating various mental health conditions. These developments come as Australia positions itself as a global hub for the production and research of cannabis and psychedelic medicines, driven by innovations in both domestic manufacturing and clinical trials.

While edible cannabis products currently make up a small portion of Australia’s $500 million medical cannabis market, this segment is expected to grow significantly over the next decade. By 2030, the market is projected to surpass $750 million, with edibles potentially accounting for 20% or more of the total market. 

For the quarter ended 30 June 2024, Bioxyne reported $3.1 million revenue which took their full year (12 months) figure to $9.4 million. 

With cash primarily used for development and manufacturing costs, Bioxyne reported $4.1 million in negative operating cash flow for FY24 with $1 million of cash on hand at the end of June.