Australian pharmaceutical and consumer health products company Bioxyne Limited (ASX:BXN) and parent company Breathe Life Sciences (BLS) have successfully manufactured and delivered Australia’s first pharmaceutical cannabis pastilles (Gummies) under its Good Manufacturing Practice (GMP) certification.
“BLS is the first Australian manufacturer to complete a commercial production run of pharmaceutical grade GMP-certified THC gummies. As a leading Australian cannabis manufacturer, we are supplying our pharmaceutical goods to both domestic and international markets, using established relationships and existing supply channels," Sam Watson, Founder and CEO of BLS, said.
BLS received its first commercial purchase orders for pharmaceutical cannabis pastilles (gummies and other edible medicines) in July 2024 leading to its initial commercial production runs. Total purchase orders received between 12 July and 12 August 2024 total around $2 million.
This total includes the supply to one of Australia’s top five alternative (Authorised Prescriber) medicine clinics, which has executed an agreement with BLS to manufacture and supply a forecasted minimum $28 million of THC gummy products over the next 24- months.
Terms of the agreement provide for 50% of the purchase order to be paid upfront in the first three months of the contract and the balance on agreed payment terms.
The gummies are manufactured and packaged as three different products according to three distinct formulations with different dosages of cannabidiol (CBD) and/or delta-9- tetrahydrocannabinol (THC), the two primary active pharmaceutical ingredients in cannabis, each with distinct therapeutic benefits.
In addition to manufacturing the gummies, BLS is responsible for all quality assurance, laboratory product testing and packaging in accordance with its GMP license and as part of its supply agreements. The initial purchase orders are underway and scheduled to be completed by mid-September 2024.
Operational Update
After being awarded a GMP licence for the manufacture of medicinal cannabis by the Therapeutic Goods Administration (TGA) earlier this year, BLS has completed a series of initial validation batches of pharmaceutical grade cannabis edibles. Since then, BLS has been scaling its gummy manufacturing capacity to meet anticipated demand of the entire Australian market as of 2024.
Currently gummy products prescribed to patients in Australia are manufactured overseas and imported. The TGA licensing of BLS with a comprehensive GMP Licence for cannabis products in February 2024, has enabled the Company to be a first mover in this emerging high growth domestic market opportunity.
Edible Product Market
In Australia, pastilles (or prescription edibles) are expected to grow from approximately 1% of the ~$500m per year (2023) Australian medical cannabis market to more than 20% by 2030 when the market is expected to surpass $750m in revenue. This presents a potential $150m per year opportunity by 2030. By comparison, edibles account for almost one third (~32%) of the ~CAD$5 billion per year Canadian market, where over 50 million packaged units of edible cannabis products were sold in 2023 to cannabis consumers.
“This is a significant milestone for Australian pharmaceutical manufacturing and the medical cannabis industry as a whole. Australia is fast becoming a global medical cannabis hub and BLS is quickly becoming a substantial proponent of that. Our focus is building strong ties with our business customers and providing high-quality GMP-certified manufacturing services,” Jason Stephens, General Manager of BLS Australia, said.
“Australia is rapidly becoming a world leader in both cannabis and psychedelic medicines. BLS is exceptionally well-positioned to become Australia’s leading manufacturer and supplier of GMP-certified cannabis, MDMA, and psilocybin products.”