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MGC Pharma Reports Strongest Ever Sales as Key Drug Approvals Remain in Limbo

MGC Pharmaceutical has reported its strongest ever quarterly sales figures, but a lack of significant progress on its drug trials and regulatory approvals saw a muted response from investors. 

The young Australian pharmaceuticals company, which is developing a number of cannabis-based drugs to treat Alzheimer’s, Dementia, Epilepsy and COVID-19, says that it achieved sales of $1.8m in the three months to December 31 2021. 

This represented its highest quarterly sales figures to date, and compares to the $2.8m it made in the entire year to June 30 2021. 

While its CEO Roby Zomer hailed the achievement of ‘several major landmarks for the growth’ during the quarter, news regarding the Emergency Use Authorisation of MGC’s flagship drug CimetrA, a development the company believes will transform their finances ‘overnight’, remained scarce. 

This meant that despite the positive sales figures, MGC’s stock fell around 15% on the London Stock Exchange on Monday, alongside similar dips on the Australian Stock Exchange. 

Strong Sales Figures

According to MGC its strong sales figures were ‘largely influenced’ by sales of its ArtemiC one of the company’s key COVID-19 treatments. 

Of the $1.8m in revenues made during the quarter, $1.07m were attributed to ArtemiC sales, which the company predicts will continue to perform strongly ‘over the next half year’ thanks to the recent approval for import and sales into India and the granting of the a Certificate of Free Trade in Germany. 

Its December quarter also saw revenues from MGC’s cannabinoid product range beat previous records by around 4%, hitting circa $720,000 for the first time. 

This included strong sales of its CannEpil product which the company says is thanks to its inclusion onto Ireland’s Primary Care Reimbursement Service, providing the product free of charge to prescribed patients. 

BusinessCann recently reported that Ireland prescribed CannEpil to its first and only patient through the state-approved Medical Cannabis Access Programme (MCAP) in November, but MGC cites this as a key factor in ‘driving the sales increase’. 

In late November, MGC announced that it received its first $750,000 cash deposit from AMC Holdings as part of its three-year $24m supply deal announced in August. 

AMC is understood to have placed a $3m purchase order for 110,000 units of CimetrA, marking the largest single order of the drug to date.

However, this purchase was not included on its December quarter balance sheet, but will reportedly be included in results as soon as the shipment is sent to AMC. 

CimetrA’s Emergency Use Authorisation

During its Annual General Meeting (AGM) in December, MGC’s co-founder and executive chairman Brett Mitchell said that CimetrA was currently in the early stages of approval as an Investigational Medicinal Product (IMP), and is being considered for approval under Emergency Use in the USA, India and several other Eastern European countries. 

He added that if the drug achieved Emergency Use Approval in a major market like India, this would represent a ‘game changing milestone for the company’ and transform its finances ‘overnight’. 

According to the update, MGC says it is continuing to work with its local Indian partner to secure registration for Emergency Use Authorisation in the country, and a further patient study must now be conducted in India to confirm its efficacy. 

The approval process is reportedly ‘ongoing’, while an official response from the Indian government is not expected until the second quarter of this year, meaning any significant developments could yet be months away. 

Further Delays 

Trials of Cognicann, a product designed to treat patients with Dementia and Alzheimer’s have also been pushed back by at least six months. 

Currently in Phase II clinical trials at Australia’s University of Notre Dame in Perth, COVID-19 restrictions have seen completion deadlines pushed back from December 2021 to ‘early in the June 2022 quarter’. 

Restrictions on access to Aged Care Facilities have meant clinical trial staff have been unable to access participants, delaying the randomised double blind cross-over study set to be used to determine the future direction of the clinical trial process. 

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