The company anticipates approval for its European Good Manufacturing Practice licensing process for its Canadian manufacturing facility by early 2024. Pic via Getty Images.
Health & Biotech
Formerly Creso Pharma, Melodiol Global Health has a new name and a fresh drive to supply best-in-class psychedelic and cannabis products as it pursues growth in global markets.
And the company is certainly chasing global growth, closing in on the key European Good Manufacturing Practice (EU GMP) licence that will allow it to export cannabis to the lucrative markets of Australia and Europe through its work with leading North American regulatory and scientific cannabis consulting agency CannDelta to advance the licensing process for its subsidiary Mernova Medicinal – a leading supplier of recreational cannabis products in the Canadian market.
EU GMP is a minimum standard that a medicines manufacturer must meet in its production processes before it can export to several major global markets.
Mernova has already completed and submitted its Good Manufacturing Practices (GMP) site analysis plan for its manufacturing facility in Nova Scotia, Canada, as well as passing the Good Agricultural and Collection Practices site quality risk assessment, which is a major milestone in the application process.
Melodiol Global Health (ASX:ME1) expects to secure the EU GMP licence in the first quarter of 2024, which will open the door to major sales opportunities in Australia and Europe.
“The strategic decision to pursue an EU GMP license for Mernova will allow Melodiol to significantly scale operations and expand our international footprint outside of Mernova’s national market,” CEO William Lay said.
“This also has the potential to lead to a significant growth in revenue which will underpin group profitability.”
That would mean even better results than ME1’s record breaking Q2 CY2023 revenues of $4.7m which were up 105% on Q1 CY2023.
The company has already set a strong foundation already set for Q3 with $1.6m of new unaudited revenue and confirmed Purchase Orders (POs) achieved as of 17 July 2023.
New sales during Q3 CY2023 takes the total unaudited revenue to date for the year to $8.6m – approaching record breaking revenues of $8.7m for the entire of CY2022.
Let’s break it down even further. Mernova alone delivered a 42% increase in sales on the previous corresponding quarter to round-out record half-year CY2023 sales of $3.095m.
Plus, Mernova secured approval into the province of Alberta in May and is now selling its range of dried flower, pre-roll joint and electronic vaporiser products into eight of the country’s major provinces.
For context, in 2022, Alberta had a total of 755 cannabis retailers which generated C$73.8m in monthly sales – highlighting considerable sales growth potential for Mernova.
Then there’s the company’s new subsidiary Health House International (HHI) – an international pharmaceutical distributor, specialising in the distribution of medicinal cannabis products in Australia and medical products in the UK which it picked up in May – returned adjusted unaudited revenues of $11.04 million for H1 2023, with an adjusted EBITDA margin of 7.4%.
ME1 said HHI’s unaudited revenue during H1 CY2023 highlights a 36% increase on the previous corresponding period (PCP) of $8.11m.
This further reiterates the company’s strategy that the acquisition and integration of HHI significantly increases the scale of ME1’s business.
“HHI continues to witness very strong demand for its medicinal cannabis products in Australia and the UK and we are confident that the company’s growth trajectory will continue over the coming months,” Lay said.
Health House Australia and UK operating units have now become the second and third ME1 business units to achieve a cash flow or adjusted EBITDA positive result, with Mernova achieving a cash flow positive Q1 FY23.
Beyond cannabis, the company’s psychedelics subsidiary Halucenex is currently conducting Phase 2 trials on the use of synthetic psilocybin for the treatment of PTSD, partnering with Dr Hysek AG in Switzerland, a leading manufacturer and supplier of MDMA and synthetic psilocybin.
Plus, the HHI acquisition provides the company with all the licensing requirements necessary to meet TGA guidelines, and is actively broadening its licence suite, lodging applications for state licence amendments to import and distribute medicines containing psilocybin and MDMA for either clinical trial purposes or certain mental health conditions under authorised psychiatrists.
Melodiol says that with supply structures in place and a history of dealing with regulatory frameworks across countries, the company is well-positioned to aid in the supply and distribution of these new therapies.
“Melodiol has already secured the necessary licences to import MDMA and psilocybin products to Australia and our current efforts are focused on roll-out in Australia in conjunction with local partners,” Lay says.
The company is also maintaining a strategic focus on R&D and regulatory pathways for the application of novel treatments to complement its established revenue channels.
Ongoing work in this market was highlighted by a recent Letter of Intent (LOI) to enter an exclusive commercial relationship with Swiss pharmaceutical company Apotheke Dr. Hysek AG for the supply of GMP MDMA and synthetic psilocybin products to the Australian market.
This article was developed in collaboration with Melodiol Global Health Limited, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
