HALIFAX, NS / ACCESSWIRE / November 28, 2023 / MedMira Inc. (MedMira) (TSXV:MIR), reported today on its financial results for the financial year ended July 31, 2023.
Throughout the reporting period, the Company achieved significant milestones in its pursuit of FDA and Health Canada approvals for a range of products. A standout accomplishment is the progress made with MedMira's 510(k) (FDA) approval for its Reveal G4 Rapid HIV-1/2 antibody test. MedMira has submitted a comprehensive study for the additional HIV-2 claim based on the Company's completed study in the Ivory Coast. The study showed a sensitivity of 100% for HIV-1 and HIV-2. In addition, MedMira's Reveal® G4 rapid HIV antibody test achieved a flawless 100% specificity and was reactive in early HIV-1 infections and seroconverts. In November 2023, MedMira received the feedback and with it the FDA acknowledged the successful substantive review completion. With this the Company will enter into the interactive review process to finalise any outstanding items such as labels and packaging inserts.
The Company anticipates this new approval within December 2023 and with it is able to significantly increase its sales in the US through its existing distribution network. The inclusion of the HIV-2 component allows CLIA laboratories, clinics or hospitals, to use MedMira's test. The Reveal G4 Rapid HIV test has consistently demonstrated outstanding performance, and with the pending approval, it is poised to fulfil the increasing demand for a rapid and reliable testing solution. The approval of the HIV-2 claim will further bolster the test's utility, ensuring compliance with various State laws and solidifying its role as a crucial tool in the fight against HIV. This anticipated approval allows MedMira's existing customers to expand the usage of the Reveal® G4 and provides access to new and larger customers. As a result, the Company anticipates a significant increase in sales over the coming months.
HIV-2 is an essential part in today's HIV testing, notably , all US States have mandated HIV tests to possess the capability to detect both HIV-1 and HIV-2 antibodies. The inclusion of the HIV-2 claim in the Reveal G4 Rapid HIV 1/2 antibody test is of paramount importance, considering the diverse prevalence of HIV subtypes in the United States. This potential approval aligns not only with regulatory requirements but also with the evolving needs of healthcare providers and public health initiatives, ensuring accurate and reliable results for both HIV-1 and HIV-2.
Additionally, we are expediting the completion of the Reveal® TP (Syphilis) rapid test, which is in high demand in both Canada and the USA due to the escalating syphilis infections in these countries. An update will be provided in the coming month with regard to the Company's submission.
Subsequent to FY2023, MedMira signed a product development agreement with a US based governmental agency. The product will be based on MedMira's unique RVF® Medduo platform which allows the detection of up-to 8 biomarkers in one test. Details to the product development are classified and MedMira will provide further details when possible.
Profit and Loss Highlights
- Revenue: The Company recorded sales and service revenues in FY2023 of $432,529 compared to $952,127 in FY2022. This was mainly due to a decrease of $416,455 in service revenue due to the completion of contracted services provided by MedMira and the Company is awaiting the next stage fundings in Q2 FY2024.
- Gross Profit: The Company recorded a gross profit in FY2023 of $300,382 compared to $304,027 for the same period last year. Gross profits were 89% compared to 85% in FY2022.
- Operating expenses: In this financial year, the Company recorded operating expenses of $2,244,700 compared to $1,757,249 in FY2022. This increase is due to additional R&D projects and increased sales and marketing activities in preparation for new approvals.
- Net loss: The Company recorded a net loss of $2,675,658 compared to $1,831,576 in FY2022.
Balance Sheet Highlights
- Assets: The Company decreased its assets by $177,771 compared to last financial year which was mainly due to the depreciation on fixed assets.
- Liabilities: The Company's liabilities increased by $2,497,887 or 15% between FY2022 and FY2023. The increase was mainly due to the advance payments received for new contracts.
- Loans in default: the Company increased its loans in default by $45,114 compared to the previous financial year. All other long and short terms debts are currently under negotiation to restructure terms and conditions of repayment.
- Working Capital deficit: As a result of the increases above, the Company recorded a higher working capital deficit of $1,554,616 or 12% compared to last financial year.
The Company's financial statements and management's discussion and analysis are available on the Company's profile on SEDAR at www.sedar.com. For matters of going concern, reference is made to the Auditor's Emphasis of Matter statement in the fiscal year ended 2023 Auditors Report and note 2b in the audited financial statements which are also available on SEDAR.
MedMira is the developer and owner of Rapid Vertical Flow (RVF)® Technology. The Company's rapid test applications built on RVF Technology provide hospitals, labs, clinics and individuals with instant diagnosis for diseases such as HIV and hepatitis C in just three easy steps. The Company's tests are sold under the Reveal®, Multiplo® and Miriad® brands in global markets. MedMira's corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada and the Company has a sales and customer service office located in the United States. For more information visit medmira.com. Follow us on Twitter and LinkedIn.
This news release contains forward-looking statements, which involve risk and uncertainties and reflect the Company's current expectation regarding future events including statements regarding possible approval and launch of new products, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Markus Meile, CFO
SOURCE: MedMira, Inc.
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