Quality Controls for Respiratory Viral, Pharyngitis, and Genital Ulcer Disease Panels
MISSISSAUGA, CANADA & BIRMINGHAM, ALABAMA, December 7, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces a collaboration with BioGX, Inc. (“BioGX”), a global provider of easy molecular diagnostic solutions. The companies are collaborating to make Microbix’s Quality Assessment Products (“QAPs™”) available to BioGX Xfree™ customers that perform tests on the portable BioGX pixl™ real-time PCR platform, and other systems such as the Applied Biosystems Quantstudio™ 5 and 7500 Fast Dx, the BD MAX™, and the Bio-Rad CFX96 Touch™ and CFX384 Touch™.
Microbix was chosen by BioGX to be the primary External Quality Controls provider for assays on their newly-launched pixl platform – a benchtop instrument with capabilities for syndromic testing. To date, BioGX recommends nine PROCEEDx™FLOQ® QAPs to be used in conjunction with assays that detect a wide variety of infectious organisms, including but not limited to SARS-CoV-2 (COVID), Influenza A&B (Flu), Group A Streptococcus (Strep), Herpes Simplex Virus 1&2 (Herpes), Varicella Zoster Virus (Chicken Pox), Treponema pallidum (Syphilis), and Mpox virus (Monkeypox).
Microbix QAPs are now referenced in BioGX Assay Product Inserts (available at https://www.biogx.com), with additional QAPs to be referenced as the collaboration expands. Microbix’s current QAPs catalogue is available on its website at https://microbix.com/request-catalogue/.
Xfree technology provides a complete lyophilized test in a single tube – using the trusted BioGX Sample-Ready™ format for extraction-free, direct sample addition in real-time PCR testing. This format eliminates pre-treatment and nucleic-acid extraction steps, enabling labs with a simple Sample-to-Answer workflow. The tests can be shipped anywhere in the world without refrigeration, as can the QAPs.
Phil Casselli, SVP of Sales & Business Development at Microbix, commented, “It has been a pleasure to work with Robert and his team at BioGX to support their customer base with robust External Quality Controls. They selected our unique FLOQSwab® based QAPs because they replicate a patient specimen closely, are extremely convenient to ship, store, and use, and allow end-users to monitor their entire diagnostic workflow from sample collection to result.”
Robert Martinez, VP of Business Development & Scientific Affairs at BioGX, also commented, “We considered other external quality controls, but selected Microbix QAPs as the best solution to support assay optimization and to significantly simplify QC procedures with minimal to no pipetting steps. Microbix’s technical expertise, product design, performance, and superior customer service are impressive. We look forward to continuing our collaboration.”
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
About BioGX, Inc.
BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama and Dallas, TX, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards. The proprietary Sample-Ready™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing. BioGX’s 60+ multiplex real-time PCR products are marketed and sold in several countries through its Global Distribution Network.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of BioGX and its Xfree™ Assays or pixl™ instrument, Microbix and its QAPs, their relevance, or others’ products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by many material factors, some of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or https://www.sedarplus.ca for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome, CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793 ir@microbix.com
For Repurchase of up to 5% of its outstanding shares over 12 months
MISSISSAUGA, CANADA, December 6, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the initiation of a Normal Course Issuer Bid (“NCIB”) program for the repurchase and cancellation of outstanding common shares.
Specifically, the NCIB enables Microbix to repurchase up to 6,827,518 Common Shares (“Shares”), that number being approximately five percent (5%) of the 136,550,374 Shares outstanding as at December 1, 2023. Repurchases will be made through the facilities of the Toronto Stock Exchange (“TSX”) over a 12-month period starting on December 8, 2023. The actual number of Shares which may be repurchased pursuant to the NCIB will be determined by management under applicable rules and policies.
The NCIB has been approved by Microbix’s Board of Directors and will be conducted in accordance with the applicable rules and policies of the TSX and Canadian securities laws, including TSX approval of Microbix’s notice of intention to conduct a NCIB. Under the NCIB, Shares may be repurchased in open market transactions on the TSX, or by such other means as may be permitted by the TSX and applicable Canadian securities laws. Microbix will pay the prevailing market price at the time of its Share repurchases.
Pursuant to TSX rules and policies, the maximum number of Shares that may be repurchased in one day via the NCIB will be 12,286, that being 25% of the average daily trading volume (“ADTV”) of the Shares on the TSX for the most recently completed six calendar months, subject to certain prescribed exceptions such as periodic block trades. The ADTV on the TSX for six calendar months ended November 30, 2023 is 49,145. Microbix conducted a prior NCIB for the 12-months from October 3, 2022 under which it sought and obtained approval to purchase up to 6,948,568 shares and under which it repurchased a total of 2,892,000 shares with a volume weighted average price of $0.385.
Microbix has entered into a pre-defined automatic securities purchase plan with its NCIB broker, Pl Financial Corp., to allow for the repurchase of Shares at times when it ordinarily would not be active in the market due to Microbix’s internal trading blackout periods, insider trading rules, or otherwise. Such plans will be conducted in accordance with applicable Canadian securities laws. Outside of such restricted periods, the timing of repurchases will be determined by Microbix management. Decisions regarding repurchases will be based on market conditions, Share price, best uses of available cash, and other factors. The funding for any repurchases pursuant to the NCIB will be financed from working capital and all Shares will be repurchased for cancellation. Microbix may also use its NCIB to acquire Shares pursuant to the exercise of stock options to offset the dilutive effect of options that have been exercised.
The Board of Directors believes Microbix’s underlying value is not reflected in the current market price of its Shares. As a result, depending upon future price movements and other factors, the Board believes that the repurchase of Shares is an appropriate use of corporate funds and in the best interests of Microbix and its shareholders. Furthermore, the NCIB is expected to benefit persons who continue holding Shares by increasing their proportionate equity interest in Microbix as the repurchased Shares are cancelled.
A copy of Microbix’s notice of the NCIB to the TSX may be obtained by any shareholder without charge, by contacting Jim Currie, the Company’s Chief Financial Officer.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots, and viral transport medium (DxTM™), to stabilize patient samples for lab-based molecular diagnostic testing. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of the NCIB and its goals and processes, the TSX and related rules, regulations, or laws, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or https://www.sedarplus.ca for recent Microbix news and filings.
or further information, please contact Microbix at:
Cameron Groome, CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793 ir@microbix.com
Meetings with Growth-Oriented Investors, November 17 to 19, 2023
MISSISSAUGA, CANADA, November 17, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it will be presenting to investors at the Florida Capital Event Conference, organized by Capital Event Management Ltd. and being hosted at the JW Marriott Turnberry, in Aventura, Florida, November 17 to 19, 2023.
Microbix’s CEO & President, Cameron Groome, will undertake a series of 18 one-on-one meetings with growth company investors during the formal portion of the conference. The presentation slides to which he will be speaking will be posted to the Microbix website at https://microbix.com, along with other business information and financial disclosures.
Shareholders may also join a webinar reviewing announced progress on Kinlytic® and overall operations. This webinar is being hosted by Adelaide Capital at 10:00 AM ET on Friday, November 17, 2023. Participants can register here: https://us02web.zoom.us/webinar/register/WN_ssbGvk0gT9arZNyp6BkHcQ.
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™ IVD or RUO test-controls) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical lab and point-of-care diagnostic workflows. Microbix antigens enable the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic drug used to dissolve blood clots, and viral transport medium (DxTM™) used to stabilize patient samples for lab-based molecular diagnostic testing. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
About Capital Event Management Ltd. and the Event
Capital Event Management Ltd. produces multiple investor events each year, across North America, on Bermuda, and in the Bahamas. Attendees include leading public and private companies, and a range of investors consisting of investment advisors, fund managers, and high net worth investors. Capital Event’s unique event formats aim to allow principals to establish new and lasting relationships that lead to financings, open market support, and increased awareness within the investment community. Further information about the Florida event is available at https://cem.ca/conference/florida-capital-event-2023/
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Capital Event Management Ltd. and its conferences, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation or verbal comments, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining profitability and adequate working capital, or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain, and that actual performance may be affected by many material factors, some of which are beyond the Company’s control. Accordingly, actual future events, conditions, and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome,
CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793
ir@microbix.com
Sequel Pharma Reconfirms Kinlytic® urokinase Support for Catheter Clearance Indication
MISSISSAUGA, CANADA, November 16, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the reconfirmation of its agreement (“Agreement”) with Sequel Pharma, LLC (“Sequel”) to return Kinlytic® urokinase (“Kinlytic”) to market, initially for dissolving blood clots that block venous catheters (“Catheter Clearance”) in the United States (“U.S.”), followed by other geographies and clinical indications.
Sequel is a U.S. based specialty pharma company with expertise in developing and commercializing niche drugs. A further payment of US$ 2.0 million has been received by Microbix relating to this reconfirmation.
Kinlytic is an enzyme derived from human cell cultures that dissolves the material of a blood clot. Kinlytic is already approved for clinical use in the U.S. and the parties’ work is to validate new manufacturing for the drug and to re-enter the market by way of a supplemental biologics licensing application (“sBLA”).
The Agreement provides for Sequel to fund and undertake the necessary work to complete the sBLA and return Kinlytic® to the U.S. for the clinical indication of Catheter Clearance, currently a market of at least US$ 350 million per year. Long-term venous catheters are used to administer pharmaceuticals, nutrition, or dialysis, often needing to remain in place for extended periods. About 25% of such catheters become blocked with blood clots which, if not cleared, require costly surgical catheter replacement.
Microbix received a closing payment of US$ 2.0 million in May 2023. Following a satisfactory consultation with the U.S. Food and Drug Administration (“FDA”) to reconfirm and build upon prior regulatory guidance, Microbix has received this second payment of a further US$ 2.0 million. The parties are now proceeding toward filing of the sBLA, with funding for needed work fully provided by Sequel. As detailed in May, Microbix will receive further milestone and royalty payments tied to the re-launch of Kinlytic.
Advancement of the Agreement is initially expected to influence Microbix’s results for the fourth quarter of fiscal 2023 (“Q4 2023” ending September 30, 2023) and the first quarter of fiscal 2024 (“Q1 2024” ending December 31, 2023). In Q4 2023, Microbix expects to reverse an impairment of the value of its Kinlytic assets recorded in fiscal 2020, resulting in an increase to net earnings of approximately C$ 3.1 million. In Q1 2024, Microbix expects to record additional revenues of US$ 3.0 million, comprised of US$ 1.0 million of the May 2023 closing payment and the full US$ 2.0 million of the current milestone payment.
Cameron Groome, CEO and President of Microbix commented, “Reconfirming our fully-funded partnership to return Kinlytic to widespread clinical use is a most fitting tribute to Microbix’s founder, Bill Gastle, whose vision drove this important program. We are now delighted to be working closely with Sequel leadership to restore availability of this clinically-important biologic drug. We expect that Kinlytic will return to the U.S. market, meaningfully help patients, and significantly contribute to Microbix’s revenues and net earnings.”
Microbix will update shareholders about Kinlytic, the Agreement, and its overall operations via a webinar hosted by Adelaide Capital at 10:00 AM ET on Friday, November 17, 2023. Participants can register here: https://us02web.zoom.us/webinar/register/WN_ssbGvk0gT9arZNyp6BkHcQ.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots, and viral transport medium (DxTM™), to stabilize patient samples for lab-based molecular diagnostic testing. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Sequel, the Agreement, Kinlytic® or its relevance, Microbix’s products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by many material factors, some of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or https://www.sedarplus.ca for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome,
CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793
ir@microbix.com
Onboarding Tools and Quality Controls for Extended Genotype HPV Assays
MISSISSAUGA, CANADA & TRIESTE, ITALY, November 10, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces a collaboration with Ulisse Biomed S.p.A. (BIT: UBM, Ulisse), a company developing innovative diagnostics, theranostics, and therapeutics. The companies are collaborating to make Microbix’s Quality Assessment Products (“QAPs™”) available and optimized to support the clinical use and accuracy of Ulisse molecular tests for high-risk types of Human Papilloma Virus (“HPV Assays”).
Molecular (i.e., “PCR”) HPV Assays are used to diagnose infections and distinguish between the virus types that generate higher or lower risks of fatal cancers. HPV is a family of approximately 100 sub-types of virus, of which 14 are directly implicated to cause human cancers – most notably cervical tumors. Molecular tests for high-risk types of HPV identify at-risk patients years before cancers arise, thereby permitting them to be carefully monitored to prevent the development of invasive and potentially lethal tumors. However, HPV Assays must be stringently monitored to ensure their accuracy – ideally with Microbix QAPs.
Ulisse has obtained EU “CE mark” approval for its high-risk extended genotype HPV Assays, which will now be commercialized on an automated sample-to-result closed system with an installed base of over 1,500 instruments. Moreover, Ulisse’s HPV Assays are validated with the most widely used open platforms and with Hyris bCUBETM, a miniaturized PCR instrument particularly suitable for small-medium laboratories that Ulisse is proposing to clients in conjunction with its assays. Ulisse has validated Microbix’s HPV QAPs as tools to support the ongoing accuracy of its HPV Assays and will recommend their usage in its instructions for use (“IFUs”). Additionally, Microbix has created custom ONBOARDx™ kits of QAPs to assist the Ulisse sales teams in demonstrating the HPV Assays to prospective customers, as well as for training operators and for qualifying new HPV Assay installations.
Phil Casselli, SVP of Business Development at Microbix, commented, “We met the Ulisse senior team at a conference in Europe. Shortly thereafter we began working with them as they finalized the performance evaluation of their assays. We are proud to be selected as their preferred controls and to be referenced on their IFUs. This is another success as we bring these sophisticated high-risk HPV control products to the global markets for HPV screening”.
Bruna Marini, COO of Ulisse, also commented, “We were looking for a set of controls that fully covered the range of high-risk HPV types and Microbix is the only company to have such a portfolio. After an extensive evaluation process, we concluded the performance of Microbix QAPs are exactly what Ulisse needs and the interactions with their team are delightful.”
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
About Ulisse Biomed S.p.A
Ulisse Biomed S.p.A. is a healthcare biotech company operating in diagnostics, theranostics and therapeutics with the mission to develop innovative solutions in these fields. The company has three proprietary technology platforms capable of generating innovative and competitive products: Sagitta (molecular diagnostics), NanoHybrid (theranostics & diagnostics), and Aptavir (therapeutics). UBM owns a portfolio of nine patent families that cover those three technology platforms. The core business of the company is the design, manufacturing and distribution of assays based on Sagitta technology which allows real-time PCR, deep multiplexing capabilities, and high sensitivity that can be executed even without nucleic acid extraction and purification. Ulisse is ISO 9001 & 13485 accredited and provides CE marked products. More information about the company is available at https://ulissebiomed.com.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Ulisse and its HPV Assays, Microbix and its QAPs, their relevance, or others’ products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by many material factors, some of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or https://www.sedarplus.ca for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome,
CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793
ir@microbix.com
Flu season is upon us, and with it comes the annual threat of influenza, respiratory syncytial virus (RSV), and more recently, the coronavirus, SAR-CoV-2. These viruses pose serious health risks to individuals around the world. The flu, in particular, can lead to a range of health complications and even death. In this blog, we’ll delve into the implications of flu on one’s health, its seriousness, and how quality controls, specifically Multiplex FLU controls, play a pivotal role in combating these viruses.
Distribution Partner Secures Contract Relating to Cervical Cancer Screening
MISSISSAUGA, CANADA, October 27, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that its quality assessment products (“QAPs™”) are supporting a testing program for Human Papilloma Virus (“HPV”) using molecular diagnostic (“MDx”) technology at Dublin’s The Coombe Hospital, in the Republic of Ireland, an EU member-state.
Microbix’s local distribution partner, The Medical Supply Company of Ireland (“MSC”), has secured a tender-based contract to supply goods and services to support this national-level MDx and HPV-based cervical cancer screening program. The program is being driven by the instrumentation and reagents of the Roche Diagnostics Corporation cobas® 6800/8800 Systems and cobas® HPV test system, with Microbix REDx® liquid-format IVD-regulated multiplex QAPs providing quality management system support to help ensure test accuracy. It is expected that the program will see regular participation by a majority of women of reproductive age within Ireland’s overall population of 5.1 million.
HPV is a family of over 100 virus sub-types, 14 of which are deemed “high-risk” as they may directly cause cancers, most notably cervical cancer, if not resolved by the immune system. Most sexually-active adults become infected with one or more HPV types and such infections can be persistent. MDx tests permit early detection and timely preventative healthcare by identifying those at-risk years before cancer develops.
However, MDx-based screening programs require rigorous quality systems and ongoing revalidation to ensure their accuracy. This includes creating workflow algorithms, implementing strict QC/QA practices, training staff to be proficient, and sourcing materials and methods to evaluate testing workflows. Microbix’s portfolio of HPV-directed QAPs are used to help ensure the ongoing accuracy of MDx testing.
Dr. Lisa Tang, Head of Sales and Marketing of MSC commented, “We are pleased to support this important women’s health initiative with Microbix’s HPV QAPs. We now look forward to the roll-out of MDx-based cervical cancer screening throughout the Republic of Ireland.”
An initial purchase order for HPV-directed QAPs has been received by Microbix and it is expected that recurring QAPs sales into Ireland will become routine. Microbix and its distribution partners are likewise targeting support of MDx and HPV-based cervical cancer screening programs in other countries, including within the EU and in North America.
Phil Casselli, Senior Vice President of Sales and Business Development of Microbix also commented, “Ireland provides an example of Microbix’s technological leadership by way of our HPV quality controls being selected to support another national HPV screening program. We are proud to have collaborated with Coombes, MSC, and Roche to help bring this program online.”
About Microbix Biosystems
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Coombes, MSC, Roche, or any MDx screening programs, MDx testing for HPV or its relevance, the products or services of Microbix, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by many material factors, some of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome, CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793 ir@microbix.com
In this episode of Diagnostics: Beyond the Lab we talk to two very distinguished guests, Christine Elliott, who served as the deputy premier of Ontario and the Minister of Health from 2018 to 2022, and Ivy Parks, President of Becton Dickinson (BD, for short) Canada, one of the oldest and largest diagnostics companies.
Meetings with Growth-Oriented Investors, September 29 to October 1, 2023
MISSISSAUGA, CANADA, September 29, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it will be presenting to investors at the Muskoka Capital Conference, organized by Capital Event Management Ltd. and being hosted at the JW Marriott Rosseau Muskoka, in Minett, Ontario, September 29 to October 1, 2023.
Microbix’s CEO, Cameron Groome, and SVP, Sales and Business Development, Phil Casselli, will undertake a series of 18 one-on-one meetings with growth company investors during the formal portion of the conference. The presentation slides to which they will be speaking will be posted to the Microbix website at https://microbix.com, along with other business information and its financial disclosures.
About Microbix Biosystems
Microbix develops proprietary biological products for human health, with over 100 skilled employees and sales now targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™ IVD or RUO test-controls) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Microbix antigens enable the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, supported by a network of international distributors. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
About Capital Event Management Ltd. and the Event
Capital Event Management Ltd. produces multiple investor events each year, across North America and in the Bahamas. Attendees include leading public and private companies, and a range of investors consisting of investment advisors, fund managers, and high net worth investors. Capital Event’s unique event formats aim to allow principals to establish new and lasting relationships that lead to financings, open market support, and increased awareness within the investment community. Further information about the Muskoka event is available at https://cem.ca/conference/muskoka-capital-event/
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Capital Event Management Ltd. and its conferences, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining profitability and adequate working capital, or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome, CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793 ir@microbix.com
Over C$ 1 Million in Orders from Leading Diagnostics Industry Test-Maker
MISSISSAUGA, CANADA, September 27, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it has secured record purchase orders (“P.Os.”) for over one million Canadian Dollars (“C$ 1 Million”) of its quality assessment products (“QAPs™”) from a leading global maker of infectious disease diagnostic tests, QuidelOrtho Corporation (“QuidelOrtho”) – for its largest set of QAPs P.Os. to date.
The P.Os. are for Microbix QAPs formatted onto Copan® FLOQSwabs® to support the use of point-of-care-tests (“POCTs”) for multiple infectious diseases and disease categories. The QAPs will be supplied to QuidelOrtho for two applications, (i) inclusion into kits/boxes of test consumables at a fixed ratio on a “white-label” basis and (ii) as Microbix-branded “ONBOARDx™” kits for verification, validation, and training at new instrument-user installations. When included in kits/boxes, test-users should use a test-cartridge and the QAP every time a new box is opened – to verify operator competency, cartridge and reagent function, and instrument operation as an integral part of the POCTs’ quality management system.
The P.Os. are targeted for delivery principally in the fourth quarter of calendar 2023. This set of P.Os. is nearly equivalent to a full quarter’s worth QAPs sales from 2022 and is indicative of Microbix beginning to realize its targeted sales growth for this segment. The unit number of QAPs supplied under the P.Os. is in the tens of thousands and Microbix expects ongoing sales to QuidelOrtho, with which it executed a Purchase and Supply Agreement on August 10, 2022.
Management believes this order substantiates diagnostics industry trends that are beneficial to Microbix and its QAPs business. Specifically, that (i) there is a growing volume of POCT sales, (ii) Diagnostics makers must integrate test controls (QAPs) with their POCTs for quality management and regulatory compliance, and (iii) safe, reliable, room-temperature stable, and FLOQSwab-formatted QAPs are the optimal in-kit controls for POCTs. These trends relate to both antigen and molecular test formats, as do the P.Os.
Cameron Groome, CEO & President of Microbix, stated, “We’re delighted to advance our relationship with QuidelOrtho and support their emerging POCTs with our expertise and capabilities. We’re thankful for their confidence and look forward to the success of their diagnostic tests across the global marketplace while we continue expanding our manufacturing capacity and range of QAPs, reagents, and antigens.”
Phil Casselli, SVP of Sales and Business Development of Microbix also commented, “Over the last several years, we’ve refined our expertise and expanded our product range supporting the POCT industry. These orders are the result of those efforts. We strongly believe multi-pathogen POCTs will become more prevalent in society as they can deliver more timely results, improved access, and net cost savings. Our team is proud to be helping to enable this evolution.”
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales now targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of the QuidelOrtho purchases of QAPs and their relevance, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome, CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793 ir@microbix.com
In this episode we’re going to talk about current and emerging diagnostics technologies, how they’re viewed by government leaders, and how we can encourage their optimal use.
Microbix Honours the Passing of its Founder
William J. Gastle – 1948 to 2023
MISSISSAUGA, CANADA, September 13, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, honours the passing of its founder, William J. (Bill) Gastle, surrounded by family in Edmonton, Alberta on September 6, 2023.
Bill trained as a virologist and founded Microbix in 1984. The Company began with the sale of bacterial and cellular growth media to Canadian public health laboratories. It was soon entrusted with culturing different pathogens of concern for those labs and later with producing them as critical ingredients for infectious disease test developers around the world. Today, Microbix is a manufacturer of not only vital test ingredients, but of a wide range of medical devices that help ensure the accuracy of diagnostic tests.
Bill served as Microbix’s CEO for 28 years and as a director for 36 years. Bill retired in October, 2020, after which he and his wife Susan moved west to be closer to their son, Angus, and his family.
Martin Marino, Independent Chairman of Microbix, expressed condolences on behalf of the Board, “Bill was a courageous entrepreneur who loved leading a team of talented people in exploring new ideas and opportunities. I will remember him most as a world-class advocate for the return of Kinlytic urokinase, a life supporting thrombolytic drug. I have always believed that his unwavering dedication to the Kinlytic project was based much more on humanitarianism than financial reward, and that the world will one day be blessed by this enduring legacy. Bill’s contributions to Microbix are immeasurable and, alongside his family, we’ll sorely miss his good cheer, wit, and intelligence.”
Cameron Groome, CEO and President of Microbix, also commented on behalf of management and staff, “Beyond excellence in science and innovation, Bill created a culture of honesty, loyalty, and caring. His leadership and vision will live on at Microbix, which remains an irreplaceable reservoir of Canadian life sciences expertise and the longest-standing locally-headquartered public company in this field.”
Everyone at Microbix wishes the best to the Gastle family at this difficult time.
A service in memory of William J. (Bill) Gastle will be held at the A.W. Mackenzie Chapel at Lakefield College School, located at 4391 County Rd 29, Lakefield, Ontario on Saturday, October 14th, 2023 at 2:00 pm EST with a reception following the service.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Bill Gastle and his accomplishments, Microbix’s or others’ products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by a number of material factors, many of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome,
CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets(647) 203-8793 ir@microbix.com
Strong Sales of $5.5 million alongside Drug Partnering Agreement
MISSISSAUGA, August 10, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its third quarter and YTD fiscal 2023 ended June 30, 2023 (“Q3” and “YTD”), a period in which strong revenues were realized along with a fully-funded partnering of its drug asset Kinlytic® urokinase (“Kinlytic”).
Management Discussion
Q3 posted revenues of $5.5 million, with continued strength in sales of test ingredients (“Antigens”) and test-controls (“QAPs™”) totaling $4.0 million, but none of sample collection media (“DxTM™”). Revenues in Q3 benefited from the recognition of over $1.3 millon of Kinlytic license fees, however this was more than offset by a write-down of aging DxTM inventory and other expense increases totaling $2.2 million. Such expenses resulted in an off-trend net loss of $0.8 million for Q3. Microbix remains well-capitalized and continues to build its customer relationships and systems with the goal of reaching annual sales of $100 million within several years.
For the three months ending June 30, 2023 (“Q3”)
Q3 revenue was $5,530,152, an increase of 10% from Q3 2022 revenues of $5,011,025. Antigen sales of $2,608,521 grew 14% versus Q3 2022 ($2,283,621), while QAPs sales were $1,456,905 (2022 – $1,305,896). In turn, revenue from DxTM was zero in Q3 (2022 – $1,326,410) and royalties were $116,226 (2022 – $95,099). In Q3, there were also Kinlytic-related revenues of $1,348,500 recognized from a licensing and funding agreement (“Agreement”) that was announced on May 16, 2023. Agreement-related licensing revenue largely offset the lack of Ontario-driven deliveries of DxTM in Q3 compared to the prior year.
Q3 gross margin was 42%, down from 55% in Q3 2022. This decline was due to a write-down of aging DxTM inventory of close to $1.0 million and a product-mix related increase to cost-of-goods-sold (“COGS”) of $0.6 million relative to Q3 2022. Beyond COGS, operating expenses (“OpEx”) in Q3 increased by 46% relative to Q3 2022. OpEx increases were in large part due to increased investment in IT infrastructure to support our continuing growth objectives – software start-up costs relating to our “ERP” and “eQMS” implementations. Such IT systems start-up costs were heaviest in Q3, as Microbix drove toward a Q4 2023 “go-live” for its new ERP system. Along with prior-year foreign exchange gains that were replaced by losses, such costs totaled $0.3 million in Q3, to which were added $0.4 million of consulting fees and expenses relating to the Kinlytic Agreement. Finance expenses were lower than the prior year due to repayment of debentures and long-term debt during fiscal 2022 and higher returns from short-term investment of cash balances.
Overall, Q3 sales led to an operating and net loss of $769,108 versus a Q3 2022 operating and net income of $638,502. Cash provided by operating activities remained strong at $2,131,358 in Q3 compared to cash provided by operating activities of $2,709,545 in Q3 2022, with the relative reduction coming from a greater deployment of cash into working capital account balances during the quarter.
Nine Months Ending June 30, 2023 (“YTD”)
YTD revenue was $12,250,547, with a 17% decrease from YTD 2022 due to a lack of DxTM sales. Included were Antigen sales of $6,615,040, up 17% from last year ($5,658,007). QAPs revenues of $3,892,090 were largely flat from YTD 2022 ($3,773,429), due in large-part to delays in the test finalization and launch timelines of customers intending to include Microbix QAPs in their kits of test consumables. YTD Kinlytic revenues were $1,350,517 compared to zero in YTD 2022, which is due to the announced Agreement. In turn, YTD revenue from DxTM was zero (2022 – $ 5,004,359) due to agents of the Province of Ontario unexpectedly returning to imported product for all domestic needs. Finally, YTD royalties were $392,898 (2022 – $ 311,394). In summary, the lower YTD sales result was driven by the lack of any deliveries of DxTM for the Province of Ontario.
YTD gross margin was 49%, down from 62% in YTD 2022, due to the lack of DxTM sales, the material writedown of DxTM inventory in Q3 and the effects of a greater proportion of antigen sales that have lower margins than QAPs or DxTM. In addition, we continue to see double-digit materials price increases across our supply chain, which take time to pass-through in product pricing to Microbix customers.
Operating expenses in YTD increased by 18% relative to YTD 2022, due to increased investment in IT infrastructure, unfavourable foreign exchange impact vs. 2022 and the recognition of Kinlytic Agreement costs. This was partly offset by lower finance expenses due to repayment of debentures and long-term debt during fiscal 2022 and short-term investment of cash balances. Overall, weaker YTD sales led to an operating loss and net loss of $2,036,756 versus a YTD 2022 operating income and net income of $2,252,769. Cash provided by operating activities YTD was $361,635, compared to cash provided by operating activities of $3,318,763 in YTD 2022, with much of the change coming from the change in operating income and the repurchase of shares through our Normal-Course Issuer Bid, which used $0.9M YTD.
At the end of Q3, Microbix’s current ratio (current assets divided by current liabilities) was 4.39 and its debt-to-equity ratio (total debt over shareholders’ equity) was 0.51.
Corporate Outlook
Microbix continues working to grow revenues across its business lines, and to improve gross margins to drive bottom-line results. Management remains committed to a profitable growth model, a goal that should be aided by the Agreement to advance Kinlytic to a successful re-launch into the U.S. market.
Microbix continues working to grow revenues across its business lines, and to improve gross margins to drive bottom-line results. Management remains committed to a profitable growth model, a goal that should be aided by the Agreement to advance Kinlytic to a successful re-launch into the U.S. market
A replay of the webinar will also be made available on Adelaide Capital’s YouTube channel.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biologics expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of financial results or the outlook for the business, risks associated with its financial results and stability, its current or future products, development projects such as those referenced herein, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedarplus.ca for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome,
CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets(647) 203-8793 ir@microbix.com
Achieves “Go-Live” with New ERP and eQMS Solutions
MISSISSAUGA, CANADA, August 4, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces its successful adoption of software to upgrade, digitize, and integrate its Enterprise Resource Planning (“ERP”) platform and electronic Quality Management System (“eQMS”). These logistics IT systems are intended to facilitate growth in sales of Microbix’s product lines and thereby enable achievement of its business objectives.
Microbix announced its selection of new ERP and eQMS systems in March, 2022, with its goal being to achieve “Go-Live” with each by the end of fiscal 2023 (i.e., September 30, 2023). That goal is now achieved, with the new ERP software supporting operations from raw materials procurement through to receivables collection. In turn, processes relating to product development, SKU manufacturing, QC/QA, and staff training are now being digitized via the new eQMS system. These logistics software upgrades are deemed essential for Microbix to realize its objective of driving sales toward C$ 100 million per year while maintaining optimal quality and pricing for its customers.
NetSuite® is Microbix’s chosen ERP software, approaching 30,000 unique clients with over 1,000 in the Medtech/Pharma fields. This ERP integrates seamlessly with eQMS to provide a complete and scalable solution including manufacturing, QC/QA, finance, sales & CRM, inventory control, and compliance.
MasterControl® is the chosen eQMS provider, having been a market leader for over 25 years, active in over 50 countries and with over 750 Medtech clients. Its eQMS fully-digitizes manufacturing batch-production-records, testing documentation, and training processes to increase throughput and reduce errors.
Jim Currie, Microbix’s Chief Financial Officer commented, “Over the past few years we’ve effectively doubled sales and also increased our number of SKUs. The growing scale and complexity of Microbix has made it critical that our ERP supports all our transactional, reporting, and analytical needs. We’re now pleased to be actively using both new software systems to support Microbix’s daily operations.”
Dr. Ken Hughes, Microbix’s Chief Operating Officer, also commented, “While our rigorous paper-based Quality Management System has ably supported us, we needed to future-proof our business as we continue our growth. Moving to state-of-the-art MasterControl eQMS solutions is doing exactly that. Every department across Microbix has done excellent work in implementing these vital systems upgrades.”
Since the announcement of these projects in spring of 2022, Microbix has invested an estimated C$ 0.8 million in subscription fees and implementation costs, approximately 75% of which has been absorbed in fiscal 2023. These projects have been supported in part by grants from the Ontario Together Fund of the Government of Ontario and loans from the FedDev Ontario program of the Government of Canada. Microbix gratefully acknowledges the contributions from both those programs, as well as the ongoing support of its customers, shareholders, staff, suppliers, and other stakeholders.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of its eQMS and ERP goals or its software providers, Microbix’s business operations and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome
CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793
ir@microbix.com
FLOQSwab-formatted QAPs Supporting Fourplex PCR Tests for Bacterial STIs
MISSISSAUGA, CANADA, July 24, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it is presenting results of its Quality Assessment Products (“QAPs™”) for supporting the clinical use and accuracy of multiplex tests for four of the most prevalent sexually-transmitted infections (“STIs”) at the American Association of Clinical Chemistry (“AACC”) conference taking place in Anaheim, California July 23 to 27, 2023.
At AACC, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of STIs and other infectious diseases. Microbix will thereby showcase its ever-growing portfolio of QAPs that help ensure the accuracy of antigen and molecular (i.e., “PCR”) tests and their workflows.
Also at AACC, Microbix will present a poster titled “Evaluating the Performance of Emerging STI Point of Care Assays Using Novel, Room Temperature Stable CT/NG/TV/MG Positive Swab Quality Control Materials.” The poster reviews the performance of novel PROCEED®FLOQ® (RUO) QAPs to support the clinical use and accuracy of multiplex PCR tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) – four of the most prevalent STIs. The poster can be read at https://microbix.com and a REDx®FLOQ® (IVD) product format is also available.
Point of Care Tests (“PoCTs”) that can distinguish between STI-causing pathogens promise improved access to care and faster turnaround time from patient-sampling to test-result. However, users of such PoCTs must have accurate and robust test-control materials for quality management purposes. Microbix therefore developed a whole-workflow multiplex STI QAP desiccated on a Copan FLOQSwab® that is stable at 2-30°C and contains inactive whole-genome target pathogens. The poster evaluated its performance with multiple diagnostic platforms in current use and in development, namely the Abbott Alinity™ m STI assay, Aprimeo/Bosch Vivalytic™ STI Assay, BD MAX™ CT/GC/TV assay, Cepheid Xpert® CT/NG and TV assays, Seegene Novaplex™ CT/NG/TV/MG assay, an IVD assay in late-stage development, and a lab-developed assay.
Dr. Amer Alagic, an author of the poster and Director of R&D at Microbix, commented prior to his presentation of the poster at AACC “Microbix’s whole-genome and room-temperature stable FLOQSwab-formatted QAPs continue to demonstrate their ability to support quality management on a wide range of molecular assays and instrument platforms. We’re pleased to be offering Microbix QAPs to support clinically-important STI testing – as tools for validation, verification, and training, as external quality assessment samples, and as in-kit controls.”
Purchase enquires for these and all Microbix QAPs can be e-mailed to customer.service@microbix.com.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of AACC, the Poster, the STI QAPs, or their relevance, Microbix’s or others’ products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by a number of material factors, many of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome, CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets(647) 203-8793 ir@microbix.com
Distribution Partner Secures Contract Relating to Cervical Cancer Screening
MISSISSAUGA, CANADA, July 5, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that its quality assessment products (“QAPs™”) have been selected to support a screening program for Human Papilloma Virus (“HPV”) using molecular diagnostic (“MDx”) technology across The Netherlands, an EU member-state.
Microbix’s local distribution partner, R-Biopharm, has secured a tendered contract to supply goods and services to support this national-level HPV-based cervical cancer screening program. The program is being driven by the instrumentation and reagents of the BD COR™ system and its Onclarity™ HPV assay. Microbix REDx® liquid-format IVD-regulated QAPs will be used to support the quality management system monitoring the ongoing accuracy of laboratory performance for the program. The program will invite women between the ages of 30 to 60 within the Dutch population of approximately 17.8 million.
HPV is a family of over 100 virus sub-types, 14 of which are deemed “high-risk” as they may cause cancers, most notably cervical cancer, if not resolved by the immune system. Most sexually-active adults become infected with one or more HPV types and such infections can be persistent. MDx tests permit early detection and timely preventative healthcare by identifying those at-risk years before cancer develops.
However, MDx-based screening programs require rigorous quality systems and ongoing monitoring of test accuracy, in particular when performed in multiple laboratories and using multiple equipment lines. This includes creating workflow algorithms, implementing strict QC/QA practices, training staff to be proficient, and sourcing materials and methods to evaluate testing workflows. Microbix’s portfolio of HPV-directed QAPs are used to help ensure the ongoing accuracy of MDx testing.
Dr. Andreas Simons, Director, Project Management Clinical Diagnostics of R-Biopharm stated, “It’s a pleasure to support this important women’s health initiative of the Dutch national screening agency, Bevolkingsonderzoek Nederland. The next contract period of this primary cervical cancer screening program is now beginning, with its quality management supported by R-Biopharm and Microbix’s QAPs.”
An initial order for HPV-directed QAPs has been shipped by Microbix and it is expected that its QAPs sales under this tender contract will reach several hundred thousand Canadian Dollars. Microbix and its distribution partners are likewise targeting to support MDx and HPV-based cervical cancer screening programs in other countries across the EU and in North America.
Dr. Rob Schuurman, National Reference Officer for the Dutch Cervical Cancer Screening Program (BVO), noted “MDx testing for HPV improves cervical cancer screening by identifying those at-risk efficiently. Close monitoring of the entire HPV testing workflow is critical to realizing this healthcare goal and Microbix’s HPV QAPs have been selected to support the quality assessment monitoring of the molecular testing process, a vital part of BVO’s quality management system.”
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of any customer or distributor herein, or any MDx-based screening programs, MDx testing for HPV or its relevance, the products or services of Microbix, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
by shitika | 2023202320232023,JunJun,TueTue | Blog
Reading Time: 2minutes
So…you got your Respiratory infection test results back from the doctor. Should you trust them?
Well, the answer is YES!
Why? There is a sophisticated quality assurance ecosystem supporting diagnostic testing in most healthcare systems, ensuring reliable and accurate results for you. There are several types of programs including operator training regimens, equipment calibration and verification, the use of daily quality controls checks administered within each laboratory (lab) and finally, another layer you may not have heard about – External Quality Assessment (also known as Proficiency Testing) which accredits the proficiency of the labs doing the testing. EQA for infectious diseases is a way to check the accuracy and reliability of laboratory tests used to detect and diagnose infectious diseases.
Imagine you are going for a swab sample that needs to be tested for a specific infectious disease, such as COVID-19. The laboratory where the testing is done participates in an EQA program. This program:
Sends the laboratory a set of samples with known characteristics, including some that are positive for the disease and others that are negative. These samples are blinder to the laboratory.
After analyzing the samples, the laboratory sends the results back to the EQA program.
The EQA program compares the laboratory’s results to the known characteristics of the samples. They assess whether the laboratory correctly identified the positive samples as positive and the negative samples as negative.
If the laboratory’s results match the known characteristics, it indicates that its testing method is accurate and reliable, and the laboratory maintains its accreditation. EQA is typically conducted regularly depending on the requirements and recommendations of regulatory bodies or accrediting organizations for example annually, semi-annually, or three times a year. The specific frequency may vary based on the type of infectious disease being tested, the volume of testing performed by the laboratory, and industry standards. There are many types of proficiency samples including blood chemistry (think blood glucose level for example), autoimmune diseases, cardiac markers, etc.
Microbix is a major provider of infectious disease external quality controls to the accreditation industry, and these samples, ranging in price from about U$10 to U$50 per sample, are sold only to the accreditation companies. They are positive or negative swabs or liquid vials, covering respiratory infections, sexually transmitted infections, gastrointestinal infections, genital ulcers, and more. Samples are typically provided in sets of 3 vials (or swabs) from the disease state being tested. For example, a respiratory set might include one sample for each of SARS-CoV-2, Influenza A, and Influenza B. The accreditation organization manages the shipments to their lab customers and then collects and stores the data and reports the results back to the labs. All the samples are blinded to the testing facility, and they simply record the result for the code on the sample tested. Microbix works with global accreditation bodies such as the College of American Pathologists (CAP), American Proficiency Institute (API), WSLH (Wisconsin State Laboratory of Hygiene), Labquality, Oneworld Accuracy, Randox, and Qnostics, to name a few.
Ultimately, EQA or proficiency testing plays a crucial role in maintaining the overall quality and reliability of infectious disease testing, which is essential for effective disease control and patient care.
Isn’t it good to know there are external, reputable organizations that help check the performance of the labs returning results to their customers?
Subscribe to Microbix or, Download our product Catalogue to learn more.
Innovative “EQA” Program to Qualify Labs for Genital Ulcer Disease Testing
MISSISSAUGA, CANADA & HELSINKI, FINLAND – June 20, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter and Labquality Oy (Labquality), a global provider of laboratory external quality assessment (“EQA”) programs, announce their creation of the world’s first program to support accreditation of clinical laboratories for detecting the pathogens most commonly causing genital ulcer disease (“GUD”).
This novel Labquality EQA program will help ensure the proficiency of clinical labs testing to diagnose the pathogens that cause GUD. Initially, the program ascertains lab competency in detecting the four pathogens that are the most common causes of GUD – the organisms of Herpes Simplex 1 and 2 (HSV 1&2), Varicella Zoster (VZV/Chicken Pox), and Treponema pallidum (TP/Syphilis). As the clinical presentation of these infections can be similar, testing distinguishes between them to better direct treatment decisions. Other GUD pathogens, such as Mpox (Monkeypox), can be added to the program as-needed.
A Microbix fourplex quality assessment product (“QAP™”), formatted onto a Copan® FLOQSwab®, is used to establish the proficiency and accuracy of the GUD testing. In turn, Labquality has designed and is managing this GUD-oriented EQA program – which is now offered to labs in 60 countries.
The QAPs and EQA program were validated by way of a pilot-study that involved 18 clinical laboratories in 9 countries. In the EQA rounds performed thus far, the Microbix “PTDx™FLOQ® – HVT” QAPs were detected by 97% of the participants using tests across different instrument/assay platforms. Full results will be presented by Labquality or Microbix at an appropriate industry forum over the coming months.
Juha Wahlstedt, Sales Director at Labquality, commented, “We’re pleased to be employing Microbix’s innovative QAPs for this new and important EQA program. Genital ulcers are the cause of a considerable and growing burden of disease that can only be alleviated by way of accurate diagnosis and treatment.”
Pavel Zhelev, Director of Project Management at Microbix also commented, “We’re pleased to enable the creation of EQA for these clinically-important diseases. Our expertise was joined to that of Labquality and Copan to ensure accurate testing and properly-directed treatment is widely available for GUD patients.”
Canadian labs can enroll in this GUD EQA program (product code 5556) via R-Biopharm Clinical Canada at orders@r-biopharm.ca, international labs via their local Labquality distributor or info@labquality.fi, and enquires about Microbix QAPs can be directed to customer.service@microbix.com.
About Labquality Oy, a part of COR Group Oy Based in Helsinki, Labquality is a Finnish owned and operated life sciences company that provides clinical laboratories with external quality assessment (EQA) programs to evaluate their proficiency and attain necessary accreditations. Labquality services approximately 8,000 customers in over 60 countries and maintains an extensive network of sub-distributors to support its products and programs.
About Microbix Biosystems Inc. Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab EQA and proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of GUD, the EQA program, Labquality, Copan, or their relevance, Microbix’s products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by a number of material factors, many of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome,
CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets(647) 203-8793 ir@microbix.com
FLOQSwab-formatted QAPs supporting PCR Tests for Antibiotic-Resistant Pathogens
MISSISSAUGA, CANADA, June 13, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter announces that it is presenting results of its Quality Assessment Products (“QAPs™”) for supporting the clinical use and accuracy of tests for antimicrobial-resistant (“AMR”) sexually-transmitted infections (“STIs”) at the ASM Microbe conference of the American Society of Microbiology (“ASM”) , taking place in Houston, Texas June 15-19, 2023.
At ASM Microbe, Microbix will exhibit alongside leading firms that provide tests to diagnose and direct treatment of STIs and other infectious diseases. Microbix will thereby showcase its ever-growing portfolio of QAPs that help ensure the accuracy of antigen and nucleic acid (i.e., “PCR”) tests and their workflows.
Also at the conference Microbix will present a poster titled “Evaluating the Performance of Nucleic Acid Amplification Tests that Detect Mycoplasma genitalium and Mutations Associated with Macrolide Resistance Using Novel Quality Controls Formatted on Swabs.” The poster reviews the performance of novel REDx®FLOQ® (IVD) and PROCEEDx™FLOQ® (RUO) QAPs to support the clinical use and accuracy of tests for AMR variants of the STI Mycoplasma gentialium (“Mgen”), a common cause of urethritis, cervicitis, pelvic inflammatory disease, and infertility. The poster will be made available at https://microbix.com.
As is becoming increasingly common with many infections, the emergence of AMR variants of Mgen is leading to a high rate of first-line treatment failure (i.e., 44-90%). If accuracy can be ensured, PCR-based testing can greatly improve treatment outcomes, but quality-control materials to support such tests were largely unavailable. Using innovative and proprietary methods, Microbix created and manufactured such materials – including for five AMR variants of Mgen. Formatted onto COPAN® FLOQSwabs®, the resulting Microbix QAPs were then used to validate and support novel tests for AMR detection, namely the SpeeDx Pty. Ltd. ResistancePlus® MG and the Seegene Inc. Allplex™ MG & AziR Assay.
Ms. Sydney Rivers, lead author of the poster and Product Manager at Microbix, commented “Microbix’s whole-genome samples of antibiotic-resistant Mgen were successfully designed, manufactured, titrated, buffered, applied to FLOQSwabs, stabilized, and dried. The resulting room-temperature stable QAPs demonstrate that they support testing with varied advanced PCR-assay workflows and elution buffers. Microbix is therefore pleased to be offering flocked-swab formatted QAPs that support clinically-important AMR Mgen testing as cross-platform IVD quality controls, validation, verification, and training panels, and as external quality assessment samples.”
Purchase enquires for these and all Microbix QAPs can be e-mailed to customer.service@microbix.com.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of ASM Microbe, the Poster, the AMR Mgen QAPs, or their relevance, Microbix’s or others’ products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by a number of material factors, many of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
In vitro diagnostics play a critical role in diagnosing and monitoring infectious diseases. Accurate and reliable test results are essential for guiding patient treatment and improving outcomes. However, with the increasing complexity of diagnostic tests, ensuring the quality of these tests has become a major challenge. Multiplex quality control is a critical aspect of maintaining the accuracy and reliability of diagnostic tests. In this blog post, we will discuss the importance of multiplex quality control in in vitro diagnostics, best practices for conducting multiplex quality control, and the challenges associated with it.
Applies for 12-month Term Extension of May 2021 Warrants
MISSISSAUGA, CANADA, May 18, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces it has applied to the TSX to extend the term of an aggregate of 5,750,000 common share purchase warrants (“Warrants”) which were issued in connection with Microbix’s May 19, 2021 prospectus and private placement financings.
The Warrants now entitle holders to purchase common shares of Microbix at a price of $0.80 until May 19, 2023. Microbix has applied to the TSX to extend the term of the Warrants by one year. The Warrant extension is approved by the Company’s board of directors but remains subject to TSX acceptance. The TSX Company Manual requires disclosure of warrant amendments to be made by press release at least ten (10) business days prior to the effective date. Accordingly, the term extensions will not be effective until May 29, 2023. Warrant holders will therefore not be permitted to exercise warrants between May 19, 2023 and May 29, 2023. All other Warrant terms will remain unchanged.
The Warrant series for which term extensions are being sought are 87.9% held by parties that are arm’s length to Microbix. Term extensions for the 12.1% of Warrants held by Microbix insiders will be contingent on disinterested shareholder approval, and insiders will not be permitted to exercise such Warrants unless and until such approval is obtained. Microbix proposes to include the warrant extension in respect of insiders as an item of business at the Company’s next shareholder meeting. All proposed Warrant term extensions are subject to TSX approval.
The decision to seek extension of the term of these Warrants was undertaken by the board of directors. After analysis, the board concluded that additional capital could be put to effective use by Microbix and that improving the prospect of the exercise of these Warrants at $0.80 could help provide additional capital without the discounts or transactional costs associated with new private placements or public offerings of equity.
The Toronto Stock Exchange does not accept responsibility for the adequacy or accuracy of this release.
About Microbix Biosystems
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of the term extension of the Warrants and its rationale, financial results or the outlook for the business, risks associated with its financial results and stability, its current or future products, development projects such as those that may be referenced herein, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix filings.
Point of care (POC) testing has revolutionized the way we diagnose and manage various infectious diseases, including sexually transmitted infections (STIs). The ability to obtain rapid, accurate results from POC tests has led to improved patient outcomes, reduced treatment delays, and decreased transmission rates. However, as with any diagnostic test, accuracy and reliability are critical factors that must be taken into consideration. This is where external quality controls come into play. In this blog post, we will explore the importance of External Quality Controls in POC testing and how Microbix’s Quality Assessment Products (QAPs™) can provide a solution to ensure accuracy and reliability in STI diagnostics.
Kinlytic® urokinase to be developed for re-entry into U.S. market
MISSISSAUGA, CANADA, May 16, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces execution of an agreement (“Agreement”) to return Kinlytic® urokinase (“Kinlytic”) to market, initially for dissolving blood clots in venous catheters in the United States and to be followed by other geographies and clinical indications. Its Agreement is with Sequel Pharma, LLC (“Sequel”), a specialty pharma company with expertise in developing and commercializing drugs for the U.S. market that is funded by a leading private equity firm.
The Agreement provides for Sequel to fund and undertake the necessary work to return Kinlytic® to the U.S. for the clinical indication of venous catheter clearance, currently a US$ 350 million per year market that is a monopoly. Long-term venous catheters are used to administer pharmaceuticals, nutrition, or dialysis, often needing to remain in place for extended periods. About 25% of such catheters become blocked with blood clots and, if not cleared, can require costly surgical replacement.
Microbix will receive a closing payment of US$ 2.0 million under the Agreement. Sequel and Microbix will now prepare for an updated consultation with the U.S. Food and Drug Administration (“FDA”) to confirm that prior regulatory guidance received by Microbix remains pertinent. Should FDA guidance be satisfactory, the parties will undertake the work needed to file a supplementary Biologics Licensing Application (“sBLA”) filing, with funding for such work to be fully provided by Sequel.
Upon a satisfactory FDA consultation, Sequel will make a further US$ 2.0 million payment to Microbix, followed by a US$ 1.0 million milestone on U.S. re-approval via sBLA, sales-driven milestone payments of up to US$ 30 million, and ongoing royalties targeted to be a double-digit percentage of net sales. Should the FDA consultation be unexpectedly negative, Sequel may terminate the Agreement and recoup US$ 1.0 million of the closing payment.
Mike Anderson, CEO of Sequel commented, “We’ve completed extensive technical and market diligence on Kinlytic and are excited to partner with Microbix in bringing it back to market. It is important that safe, effective, and economic drugs such as Kinlytic are available to address the needs of millions of patients.”
Cameron Groome, CEO and President of Microbix also commented, “For many years Microbix has sought to apply its expertise to restore availability of this clinically-important cell-culture derived biologic drug. Lack of capital has always been a principal constraint, which this agreement fully addresses. Additionally, Sequel and its backers provide tremendous expertise in helping to navigate the processes for U.S. drug approval, marketing, and reimbursement, which are not core skills of Microbix. We are delighted to be working with Mike and the Sequel team to bring Kinlytic back into widespread clinical use.”
About Sequel Pharma, LLC
Sequel Pharma, LLC has been established as an affiliate of New American Therapeutics, Inc. (https://newamericantx.com) for the purpose of restoring Kinlytic® to market. Sequel’s management team has almost 100 years of life science experience and leadership and has expertise in branded pharmaceutical products, generic pharmaceuticals, injectable products, and devices. Sequel also has broad international experience.
About Microbix Biosystems Inc.
Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Sequel, the Agreement, Kinlytic® or its relevance, Microbix’s products or services, business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its presentations, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity or timeliness of delivery), currency exchange rates, maintaining adequate working capital or raising new capital on acceptable terms or at all, and other similar statements about anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions, and expectations; they are not guarantees of future performance. Microbix cautions that all forward-looking information is inherently uncertain and actual performance may be affected by a number of material factors, many of which are beyond its control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions, and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent Microbix’s judgement as of the date of this new release, and it is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome, CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide Capital Markets
(647) 203-8793 ir@microbix.com
MISSISSAUGA, May 11, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its second quarter and first half of fiscal 2023 ended March 31, 2023 (“Q2” and “H1”), a period in which a loss was incurred in the first quarter and profitability restored in Q2. Microbix remains well-capitalized and is targeting to continue increasing sales of its testing-related medical devices and ingredients, thereby growing sales, margins, and earnings.
Management Discussion Q2 sales of $4.2 million reflected a recovery in sales of test ingredients, flattish sales of test-controls (“QAPs”) and none of sample collection media (“DxTM™”). The resulting gross margin dollars and control of expenditures enabled a small profit for Q2. For the balance of fiscal 2023, Microbix expects increased sales of both Antigens and QAPs to enable it to generate positive net earnings for the full-year – for a third consecutive year of profitability while further growth-oriented initiatives continue to be executed.
For the three months ending March 31, 2023 (“Q2”) Q2 revenue was $4,218,323, a decrease from Q2 2022 revenues of $4,880,564. Included were antigen revenues of $3,004,730 (2022 – $1,607,970). QAPs revenues were $1,101,684 (2022 – $1,318,382). In turn, revenue from DxTM was zero in Q2 (2022 – $1,860,704), and royalties were $111,910 (2022 – $93,508). The Q2 2022 sales mix and total was most greatly influenced by the recovery of antigen sales and a lack of Ontario-driven deliveries of DxTM.
Q2 gross margin was 60%, down slightly from 64% in Q2 2022 due to a greater proportion of lower margin antigen test-ingredient sales, which tend to have lower margins than fully-regulated and branded medical devices such as QAPs and DxTM. In addition, we continue to see double digit increases in our supply chain costs, which can only be passed-through to end-customers over time.
Q2 Operating expenses increased by 5% relative to 2022, principally due to investment in IT infrastructure to support growth objectives – namely start-up costs relating to our “ERP” and “eQMS” implementations. Finance expenses were lower due to repayment of debentures and long-term debt during 2022 and short-term investment of cash balances. Overall, Q2 sales led to an operating profit and net income of $31,616 versus a Q2 2022 operating income and net income of $733,489. Cash used in operating activities was $1,055,856, compared to cash provided by operating activities of $893,232 in Q2 2022, with the majority of the change coming from deployment of cash into working capital accounts during the quarter.
Six Months Ending March 31, 2023 (“H1”) H1 revenue was $6,720,395, a 31% decrease from H1 2021 revenues of $9,736,164. Included were antigen revenues of $4,008,537 (2022 – $3,374,386), up 19% from last year. QAPs revenues of $2,435,186 were flat year-over-year (2022 – $2,467,533) due largely to delays in test finalization and launch timelines of customers intending to incorporate Microbix’s QAPs in their kits of test consumables. In turn, revenue from DxTM was zero (2022 – $3,677,949), and royalties were $276,672 (2022 – $216,296). As a whole, the lower H1 sales result was most driven by the lack of deliveries of DxTM for the Province of Ontario.
H1 gross margin was 55%, down from 65% in H1 2022, due to the lack of VTM sales and the effects of a greater proportion of antigen sales that have lower margins. In addition, we continue to see double digit materials price increases across our supply chain.
Operating expenses in H1 increased by 5% relative to H1 2022, due to increased investment in IT infrastructure that was partly offset by lower finance expenses due to repayment of debentures and long-term debt during fiscal 2022 and short-term investment of cash balances. Overall, weaker H1 sales led to an operating loss and net loss of $1,267,647 versus a H1 2022 operating income and net income of $1,614,267. Cash used in operating activities was $1,769,723, compared to cash provided by operating activities of $609,218 in H1 2022, with much of the change coming from changes in working capital balances during the period.
At the end of H1, Microbix’s current ratio (current assets divided by current liabilities) was 6.29 and its debt to equity ratio (total debt over shareholders’ equity) was 0.42.
Corporate Outlook Microbix will continue working to drive sales growth across its three revenue-generating business lines, and on improving percentage gross margins and driving bottom-line results. Management currently expects Microbix to generate meaningful net earnings across full-year fiscal 2023. Additionally, work continues upon securing a partnership to advance its Kinlytic® urokinase project.
A replay of the webinar will also be made available on Adelaide Capital’s YouTube channel.
About Microbix Biosystems Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of over 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of financial results or the outlook for the business, risks associated with its financial results and stability, its current or future products, development projects such as those referenced herein, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Trichomonas vaginalis, also known as trich, is a sexually transmitted infection (STI) caused by a parasitic protozoan. According to WHO more than 1 million new STIs are acquired every day and approximately 357 million people contract STIs each year. Despite its prevalence, trichomoniasis often goes undiagnosed, leading to serious health consequences if left untreated.
Did you know that sexually transmitted infections (STIs) are shockingly common? Millions of cases are diagnosed every year, with young people and men who have sex with men being particularly at risk. And the scariest part? Many people don’t even know they have an STI because they don’t always have symptoms. In fact, up to 80% of people with the most common STI, chlamydia, have no symptoms at all. But here’s the good news: STI testing is available, and it’s an important step in protecting your sexual health. With early detection and treatment, you can prevent serious health problems down the road. So don’t wait – get tested today!
Antimicrobial resistance (AMR) is a serious global health issue that is affecting millions of people every year. It refers to the ability of microorganisms to resist the effects of antimicrobial drugs, such as antibiotics. This phenomenon has been on the rise in recent years, and it poses a significant threat to public health and the global economy. In this blog post, we will explore the rise of AMR and its impact on the healthcare industry.
MISSISSAUGA, CANADA, April 20, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces it will be attending and presenting at the Bloom Burton & Co. Healthcare Investor Conference (the “Conference”) taking place at the Metro Toronto Convention Center, North Building, on April 25th and 26th, 2023.
The Conference provides an opportunity to connect with Canadian, U.S., and international investors who are interested in the latest developments in the Canadian healthcare sector. Cameron Groome, Microbix’s CEO and President, will make an in-person group presentation to investors on Wednesday, April 26 at 11:30 AM Eastern Time. Senior management will also participate in multiple one-on-one meetings with investors. Presentation slides will be posted to https://microbix.com.
About Bloom Burton & Co.
Bloom Burton & Co. is a firm dedicated to accelerating returns in the healthcare sector for investors and companies. Bloom Burton has an experienced team of medical, scientific, industry and capital markets professionals who perform a deep level of diligence, which combined with a creative and entrepreneurial approach, assists its clients in achieving monetization events. Bloom Burton and its affiliates provide capital raising, M&A advisory, equity research, business strategy and scientific consulting, as well as advisory on direct investing, company creation and incubation services. Bloom Burton Securities Inc. is a member of the Investment Industry Regulatory Organization of Canada (IIROC) and is also a member of the Canadian Investor Protection Fund (CIPF).
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, all discussion of Bloom Burton & Co., its abilities, or its conference, the products of Microbix, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced herein or in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Sexually transmitted infections (STIs) are a significant public health issue, with millions of new cases diagnosed each year. Accurate and timely diagnosis is crucial to prevent the spread of these infections and ensure that patients receive appropriate treatment. Multiplex CT/NG/TV/MGEN is a molecular diagnostic test that can detect several of the most common STIs, including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MGEN). The test uses a polymerase chain reaction (PCR) technique to amplify and detect genetic material from these pathogens.
Syphilis is a sexually transmitted infection (STI) caused by the bacterium Treponema pallidum. The infection can cause serious health problems if left untreated, including blindness, deafness, and even death. In Canada, syphilis rates have been on the rise in recent years, which is a concerning trend for public health officials.
Sexually transmitted infections (STIs) affect millions of people globally, yet there remains a significant amount of stigma around these infections. This stigma prevents people from discussing their STI status, leading to negative health outcomes and further spread of the infection. In this blog post, we’ll explore the stigma surrounding STIs, the importance of testing and treatment, and tips for managing STIs in today’s world.
MISSISSAUGA, March 30, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF)( “Microbix®” or the Company”), a life sciences innovator, manufacturer, and exporter, announces the voting results from the Annual and Special Meeting of Shareholders of the Company (the “Meeting”) which was held on March 29, 2023.
At the Meeting, 48.77% of the issued and outstanding shares were represented. Shareholders voted in favour of all resolutions brought before the Meeting. Details of all resolutions that were voted upon are set out in the Management Information Circular (the “Circular”) dated February 17, 2023. The Circular is available on the Company’s website (www.microbix.com) and on SEDAR (www.sedar.com).
All of the board of directors nominees listed in the Circular were re-elected as directors of Microbix. Results of the vote were as follows:
Nominee
Votes For
% Votes For
Withheld
% Withheld
Peter M. Blecher
60,346,509
97.56%
1,512,357
2.44%
Mark A. Cochran
60,208,504
97.33%
1,650,362
2.67%
Vaughn C. Embro-Pantalony
61,267,509
99.04%
591,357
0.96%
Joseph D. Renner
61,088,504
98.75%
770,362
1.25%
Martin Marino
60,203,004
97.32%
1,655,862
2.68%
Cameron Groome
60,461,092
97.74%
1,397,774
2.26%
Jennifer Stewart
60,167,504
97.27%
1,691,362
2.73%
Shareholders also approved a resolution re-appointing the Company’s auditors, Ernst & Young LLP, with 99.80% of the votes cast in favour.
The slides of management’s presentation at the Meeting have been posted at www.microbix.com.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, all discussion regarding Microbix products, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced herein or in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Get to know these outstanding guest speakers: Daniel Taylor from 1WA, Danielle Casey from API, and Heidi Berghäll from Labquality! Discover their expertise and insights on healthcare, technology, and more.
Laboratory testing requires accuracy and reliability for patient care. External Quality Assessment (EQA) is an effective tool to ensure testing accuracy and reliability. EQA compares laboratory test results with peer groups or reference labs worldwide. This article discusses the importance of EQA, its benefits, and limitations.
Remote Access to the AGM Provided to Avoid Physical Attendance
MISSISSAUGA, CANADA, March 22, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator making critical ingredients that enable the production of clinical diagnostics and creating medical devices that help ensure test accuracy, provides an update about its Annual General Meeting (“AGM”). The AGM will still be held on March 29, 2023, at 1:00 pm.
Options to Attend the Meeting
In order to access the Meeting, shareholders will have two options: Audio only teleconference or Zoom conferencing application
The COVID-19 pandemic has taught us that pandemics can be incredibly disruptive to our society, economy, and daily lives. In order to be better prepared for future pandemics, the whole industry has invested in scaling up the production of everything that would be needed. However, this strategy cannot be left to the private sector alone. These investments must be maintained somehow, and some sort of continuous control is needed in order to detect weak signals and recognize new pandemics. This requires coordinated global intervention with rules and the flow of information to react in time to control risks. As a pre-analytic company, Copan is here to serve any need that could emerge, including creating safe, simple, and economically viable technological tools for decentralized diagnostic testing.
$ 1.68 Million in Funding for Capabilities and Capacity Expansions
MISSISSAUGA, CANADA, March 20, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it is undertaking further expansions to its capabilities and capacity for manufacturing specialized products relating to diagnostic testing for infectious diseases. The Government of Ontario is supporting the expansions at Microbix’s three adjacent sites in Mississauga with a grant of $ 840,000 from the Ontario Together Fund (“OTF”). A separate $ 840,000 of interest-free loan funding has also been provided by the Government of Canada through its FedDev Ontario program. The balance of costs will be provided by Microbix from its current funds or ongoing cash flow.
This project has three principal objectives, (i) build and equip further product manufacturing space and capabilities for Microbix’s core diagnostics businesses, (ii) build and equip new development and quality control laboratory spaces, and (iii) commission a Containment Level 3 production suite. The project will be completed in 2024, at which time Microbix will be able to optimally service all its current initiatives and rapidly develop further product lines in its field of business. The project is anticipated to create and support dozens of new life sciences manufacturing, product development, and related jobs in Ontario.
Microbix was the recipient of a prior grant from OTF (2020) and prior FedDev Ontario funding (2019). Since its first funding from the two programs, Microbix has created two entirely new product lines comprising dozens of fully-registered medical devices, built many strategic customer relationships and a global distribution network, almost doubled its sales, gone to three facilities from one, nearly doubled its staff, and supported healthcare in Ontario, across Canada, and internationally.
Vic Fedeli, Ontario’s Minister of Economic Development Job Creation and Trade, said, “Through the Ontario Together Fund, our government is proud to support innovative companies like Microbix, who are developing the next-generation of made-in-Ontario health care solutions. This exciting new project will further grow Ontario’s life sciences sector and ensure that our province remains a global leader in innovation and life sciences.”
Dr. Ken Hughes, Microbix’s COO stated “Microbix is honoured to receive these second rounds of funding from MEDJCT (OTF) and from FedDev Ontario. We are very thankful for this ongoing support, which clearly illustrates the objective success of our previously funded initiatives. As before, we will deploy these funds to further support our business growth, while ensuring that Microbix’s operations remain rooted in Ontario, Canada and maximally effective during that growth.”
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Governments, OTF, or FedDev Ontario, the project or the products of Microbix, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced herein or in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
by shitika | 2023202320232023,MarMar,TueTue | Blog
Reading Time: 2minutes
The Role of Diagnostics in HPV Screening
The Importance of HPV Screening
Human papillomavirus (HPV) is a common sexually transmitted infection that is linked to the development of cervical cancer. The primary screening for HPV infection is an important tool in the prevention of cervical cancer, as it enables the identification of individuals who are at increased risk for the disease. However, it is crucial to ensure the accuracy and reliability of molecular diagnostic methods used for HPV primary screening, through quality control measures.
Factors affecting reliability and accuracy
Molecular diagnostic methods, such as polymerase chain reaction (PCR), are used for HPV primary screening, as they enable the detection of viral DNA in cervical samples with high sensitivity and specificity. However, the accuracy and reliability of these methods can be affected by several factors, including the quality of the sample, the presence of inhibitors, and the specificity of the primers used for the PCR reaction.
Quality Control measures
To ensure the accuracy and reliability of molecular diagnostic methods used for HPV primary screening, quality control measures are essential. These measures include the use of appropriate positive and negative controls, to verify the performance of the assay, and the use of standardized protocols and reagents, to ensure consistency and reproducibility of the results. In addition, regular monitoring of the performance of the assay, through proficiency testing and external quality assessment schemes, can provide assurance of the accuracy and reliability of the results.
Accurate and reliable diagnostics
The importance of HPV primary screening and quality control of molecular diagnostic methods used for this cannot be overstated, as the accuracy of the screening results can impact patient management and treatment decisions. Early detection of HPV infection through primary screening, followed by appropriate management and treatment, can prevent the development of cervical cancer and improve patient outcomes. Therefore, it is essential to ensure the accuracy and reliability of molecular diagnostic methods used for HPV primary screening, through quality control measures, to maximize the benefits of this screening approach in the prevention of cervical cancer.
Microbix’s approach to HPV Screening
Microbix is proud to offer External Quality Controls & RUO (QAPs™) for HPV Molecular and Immunoassay Diagnostics.
Whole-process samples (including extraction).
Inactivated to meet clinical laboratory biosafety requirements and verified performance on leading IVD platforms.
They are also commutable and cross-platform compatible.
The 1mL vials are stable at 2-8°C, making storage easy.
Contact us to learn more or place an order on our HPV panel.
QAPs used in Diagnostic Testing for STIs in Remote Communities
MISSISSAUGA, CANADA, March 1, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that its Quality Assessment Products (“QAPs™”) are now supporting test accuracy within a program to provide Point-of-Care Testing (“PoCT”) for Sexually-Transmitted Infections (“STIs”) in remote communities across Australia. An initial supply of QAPs has been delivered to the end-customer via Microbix’s regional distributor, r-Biopharm Australia Pty Ltd, for support of the program.
The program being supported by QAPs is directed to improving the health of Australians in more-remote areas by using PoCTs to improve access to diagnosis and treatment of STIs. The program involves 60 sites across five regions of Australia and is using a well-known molecular diagnostics (“MDx”) PoCT instrument system to test for and distinguish between three bacterial STIs, namely Chlamydia trachomatis, Neisseria gonorrhea, and Trichomonas vaginalis.
Microbix is supplying its QAPs formatted onto the FLOQSwabs® of its strategic partner, Copan®, under the PROCEEDx™FLOQ® brand. The PROCEEDxFLOQ QAPs have been formatted as multiplex positives that contain whole-genome MDx targets for each of the three targeted STI pathogens and as STI-free negatives, each with sample-adequacy control. Microbix’s QAPs dry FLOQSwab® formulations are validated to be stable for two years at temperatures as high as 30 Celsius – a critical property for use in the targeted regions of Australia. Microbix concludes that ease of access to fast and accurate diagnosis, followed by effective treatment, is key to reducing the disease burden and healthcare costs of STIs. It is therefore honoured to be supporting this Australian program for STI testing in remote communities, which Microbix believes is providing a worldwide model for helping underserved populations.
Philip Hill, General Manager of r-Biopharm Australia commented, “r-Biopharm is pleased that the program will be delivering world-class diagnostic testing to some of the most remote populations in Australia. It has been a privilege to work with the program’s operational team and Microbix to integrate the use of the best possible test and test-workflow controls into the program.”
Phil Casselli, SVP of Sales & Business Development of Microbix stated “We believe that accessible and accurate testing for STIs is critical to being able to direct effective treatment and reduce re-transmission. It is often impractical for more-remote areas to use testing that relies on distant central labs and they can therefore benefit from the usage of PoCTs. This program, supported by PROCEEDxFLOQ QAPs, should help to provide the kind of testing needed in these Australian communities.”
Microbix’s FLOQSwab-based QAPs support both STIs and other disease categories, with the full catalogue available at https://microbix.com and purchase enquiries directed to customer.service@microbix.com.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of r-Biopharm Australia, the products of Microbix or its collaborators, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced herein or in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Using Shareholder-Approved Plan to Incentivize and Retain
MISSISSAUGA, CANADA, February 27, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer and exporter, announces the issuance of stock options under its shareholder-approved 2018 stock option plan (the “Stock Option Plan”), as part of its compensation programs to incentivize and retain its board of directors, executives, and managers.
Details of the Option Issuance
In consultation with management, Microbix’s Board of Directors has approved the issuance of 2,815,000 options in accordance with the terms of the Stock Option Plan. The approved options are exercisable at a price of $0.37 per share, as determined by the closing price of the TSX on 23 February, 2023. Each option will vest and be exercisable after three (3) years and have a total life of five (5) years. The stock option grants form part of the total remuneration package for the recipients and are subject to TSX approval.
Management Discussion
Microbix management believes that stock options are an important tool to incentivize and retain senior personnel, particularly for smaller, publicly-listed companies. In February 2019, Microbix announced its intention to broadly use its stock option plan once per year – following the issuance of its Q1 results.
The options now issued are being allocated across 33 individuals that comprise the more senior tiers of Microbix’s approximately 110 employees, inclusive of its independent directors. The quarterly expense incurred as a result of this option award is estimated to be $50,000, and will represent approximately 2% of total company compensation costs. The potentially dilutive impact of this option issuance may be up to 2% of the issued and outstanding shares of Microbix, offset in part by normal-course issuer bid (“NCIB”) share repurchases that have totaled approximately 1,100,000 shares since the initiation of the NCIB in October, 2022.
About the Microbix Stock Option Plan
Details of the Stock Option Plan are available on Microbix’s website (www.microbix.com), via SEDAR (www.sedar.com), and are provided as an appendix to the current Management Information Circular. The Stock Option Plan is a “rolling” plan that permits issuance of options representing up to 10% of Microbix’s issued and outstanding common shares. Prior to the current issuance, a total of 9,374,000 options had been issued and are outstanding, with an average exercise price of $0.44 and average remaining life of 2.7 years. Following the current issuance, a total of 12,189,000 options will be outstanding, comprising approximately 90% of the current plan availability. The plan is administered under the supervision of the Board of Microbix or the human resources, compensation and governance committee of the Board.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of the Stock Option Plan, the NCIB or opinions relating to usage of the plan, financial results or the outlook for the business, risks associated with its financial results and stability, its development projects, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix filings.
For further information, please contact Microbix at:
Cameron Groome, CEO
(905) 361-8910
Jim Currie, CFO
(905) 361-8910
Deborah Honig (Investor Relations, Adelaide Capital Markets)
The Antimicrobial Resistance (AMR) crisis and how we can overcome it
Antimicrobial Resistance (AMR)
Antimicrobial resistance or AMR occurs when microorganisms build resistance to an antibiotic drug. With AMR on the rise, the World Health Organization has deemed this a top 10 global public health threat. This is not only an issue for humans but other living organisms, such as livestock. Therefore, industry and research leaders around the world have come together in recent years in order to combat this crisis.
MISSISSAUGA, February 9, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its first quarter ended December 31, 2022 (“Q1”), a period in which reduced sales across two major product lines resulted in the first quarterly net loss in two years. Microbix remains well-capitalized and is targeting to continue increasing sales of its testing-related medical devices and ingredients, thereby growing sales, margins, and earnings.
Management Discussion
Q1 sales were $2.5 million, meaningfully below the past several quarters. This sales decline was due to zero sales of viral transport medium (“DxTM™”) as a result of the ongoing reorganization of provincial procurement, lower sales of test ingredients (“Antigens”) caused by the timing of deliveries being outside of Q1, and delays in order-flow of quality assessment products (“QAPs™”). The resulting reduction in gross margin dollars created a meaningful net loss for Q1. For the balance of fiscal 2023, Microbix expects increasing sales of both Antigens and QAPs to enable it to generate positive net earnings for the full-year of fiscal 2023 – for a third consecutive year of profitability, as well as there being further activity with the company’s portfolio of liquid sample stabilization devices, including DxTM.
Quarter Ending December 31, 2022 (“Q1”)
Q1 revenue was $2,502,072, a decrease from Q1 2022 revenues of $4,855,600. Included were antigen sales of $1,003,807 (2021 – $1,766,416). QAPs revenues were $1,333,503 (2021 – $1,149,151) for segment growth of 16%. In turn, revenue from DxTM was zero in Q1 (2021 – $1,817,245), and royalties were $164,762 (2021 – $122,787). The Q1 2022 sales shortfall was most influenced by lack of Ontario-driven deliveries of DxTM and weaker antigen sales due to order timing, which were only partly offset by continued diagnostics industry uptake of QAPs.
Q1 gross margin was 47%, down from 66% in Q1 2021 and due to a high proportion of sales of lower-margin antigens, a lack of DxTM sales, and the impact of a supplier quality issue collectively more than offsetting ongoing growth in QAPs sales. In addition, Microbix continues to see double digit increases in supply chain costs, which take time to pass-through into product pricing.
Operating expenses in Q1 increased by 6% relative to Q1 2022, due mainly to increased investment in IT infrastructure to support our continued growth objectives – namely start-up costs relating to our “ERP” and “eQMS” implementations. Finance expenses were lower than the prior year due to repayment of debt during fiscal 2022 and short-term investment of cash balances. Overall, weaker sales led to an operating loss and net loss of $1,299,262 versus a Q1 2022 operating income and net income of $880,778. Cash used in operating activities was $713,867, compared to cash used in operating activities of $284,014 in Q1 2022, with the majority of the change coming from the operating loss incurred during the quarter.
At the end of Q1, Microbix’s current ratio (current assets divided by current liabilities) was 6.32 and its debt to equity ratio (total debt over shareholders’ equity) was 0.39.
Corporate Outlook
Microbix will continue working to drive sales growth across its three revenue-generating business lines, and on improving percentage gross margins and driving bottom-line results. Management currently expects Microbix to generate meaningful net earnings growth across full-year fiscal 2023. Additionally, work continues upon securing a partnership to advance its Kinlytic® urokinase project.
A replay of the webinar will also be made available on Adelaide Capital’s YouTube channel.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of over 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of financial results or the outlook for the business, risks associated with its financial results and stability, its current or future products, development projects such as those referenced herein, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
QAPs for HPV Test Verification within Cervical Cancer Screening Program
MISSISSAUGA, CANADA, February 6, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it will be presenting results of its collaboration with the Microbiology Laboratory of the Queen Elizabeth Hospital of Health PEI (“Health PEI”), in support of provincial adoption of molecular diagnostic (“MDx”) screening for Human Papillomavirus (“HPV”) infections – at the annual congress of the European Research Organization on Genital Infections and Neoplasia (“EUROGIN”), taking place in Bilbao, Spain from February 8 to 11, 2023.
Prince Edward Island (“PEI”) is the first Canadian Province to undertake full implementation of MDx HPV testing to improve cervical cancer screening from the pathology-based “Pap Tests.” Directly testing for HPV provides earlier and more reliable detection of infections that are at higher risk of progression to cervical cancer, thereby helping to prevent deaths, illness, and healthcare costs. Microbix’s Quality Assessment Products (“QAPs™”) supporting test and test-workflow accuracy enabled it to assist Health PEI in verifying functionality and implementing use of the Becton Dickinson (“BD”) Onclarity™ HPV assay.
The poster being presented at EUROGIN is titled “Performance of High-Risk HPV Single Analyte and Multiplex Panel External Quality Controls for Verification of Extended Genotyping on the BD Onclarity™ HPV Assay.” The poster details precisely how QAPs supported verification of these HPV tests and Microbix gratefully acknowledges the work and support of its collaborators in PEI and at BD. The poster will be available on Microbix’s website (https://microbix.com) and from EUROGIN following its presentation.
At EUROGIN, Microbix will also exhibit its portfolio of HPV QAPs, comprised of single-analyte products covering 9 high-risk and 1 low-risk types, and 3 multiplexes for “extended genotyping” of additional high-risk types. Microbix HPV QAPs are available for sale in Canada, Australia, Europe, the United States, and other jurisdictions under its “REDx™ Controls” (IVD) or “PROCEEDx™” (RUO) brand names.
Most sexually-active adults become infected with one or more types of HPV and if not cleared, its high-risk types are firmly established as the cause for development of various cancers, of which cervical cancer is one. Diagnostic tests to detect infection with high-risk HPV provide important preventative health information and require validated, regulated, and third-party test-controls to help ensure their accuracy.
MDx-based HPV screening programs can identify at-risk individuals years before cancerous cells can be detected using pathology. Such programs were delayed due to testing capacity limitations during the height of the pandemic, but are now being resumed. Microbix believes high-risk HPV infections and resulting cancers have gone undiagnosed and is pleased to help enable new MDx screening programs. Purchase enquires for Microbix’s products or services can be directed to customer.service@microbix.com.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Health PEI, BD, or EUROGIN, the poster or its relevance, the products of Microbix or its collaborators, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced herein or in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Driven by Customer Requests, Mpox Test Control Now Available
MISSISSAUGA, CANADA, January 30, 2023 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it is launching a new quality assessment product (“QAP™”) to support molecular diagnostic (“MDx”) testing for the Non-Variola Orthopoxvirus (“Mpox”), the cause of the cutaneous infection colloquially-known as “Monkeypox.”
From traditional low-level incidence in Central and Western Africa, incidence of Mpox surged meaningfully within many countries in 2022, leading to increased testing for this virus. However, transmission of this virus currently requires close or prolonged contact between individuals, limiting its pandemic potential.
Microbix chose to create a QAP to support Mpox testing following requests from its customers that provide proficiency-testing and accreditation services to clinical laboratories (i.e., “PT” or “EQA” providers) and to prepare for the inclusion of Mpox in standard worldwide genital ulcer disease diagnostic programs. Although the frequency of testing for Mpox is currently limited, labs must become and remain accredited for such testing by PT/EQA providers. Microbix will be providing Mpox QAPs in liquid or FLOQSwab® formats for that PT/EQA need and as a result, its sales are not expected to be correlated to the rates of Mpox infection or with how much this virus is the subject of news media coverage.
In otherwise healthy persons, Mpox infection is usually self-limiting and non-fatal in nature. However, Mpox viral DNA has been detected in human blood, which raises the question of whether blood-borne transmission is a possibility with this emerging pathogen. If blood-borne transmission of Mpox is proven at any future time, the need for routine screening of blood and blood products could arise.
In collaboration with its PT/EQA partners, the Microbix Mpox QAP has now been validated for use across 11 leading MDx testing systems and multiple Lab Developed Tests, at 33 clinical laboratories in multiple European and Scandinavian nations. The Mpox QAP validation results may be presented by Microbix or its collaborators at a future scientific conference, in accordance with industry practices and standards. PT/EQA shipments of the Mpox QAP can now commence and Microbix expects material sales of this product starting in its current fiscal year.
Pavel Zhelev, Microbix’s Director of Product Management, remarked, “Microbix’s Mpox QAPs contain a whole viral genome that includes each primer sequence targeted by leading commercial (IVD) tests and known lab-developed assays. Our proprietary formulation and consensus genome is thereby targeted to provide lasting support for MDx Mpox tests and future support for extended genital ulcer disease panels including this pathogen, even if this virus continues to mutate at a relatively fast rate.”
Purchase enquiries for QAPs can be directed to Microbix via customer.service@microbix.com.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Mpox, Microbix collaborators, any MDx screening programs, MDx testing for Mpox or its relevance, the products or services of Microbix, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Here are all of Microbix’s upcoming events including conferences, trade shows, presentations, and more! Make sure to check regularly to stay up to date with the latest news from us!
In this episode of Diagnostics: Beyond the Lab we talk to Giorgio Triva, CEO and Strategic Project Manager of Copan Group, based in Italy, about what his company and the work it has done to become a global leader in sample collection, transport and test accuracy for infectious diseases.
In this episode of Diagnostic: Beyond the lab, we talk to Colin Denver, CEO of SpeeDX about antimicrobial resistance and using diagnostics to target treatment.
In this episode we discuss the Human papillomavirus or HPV, vaccines, testing and cervical cancer. What is HPV and what is the way forward for testing?Joining us for this discussion is Larry Vaughan, director scientific affairs integrated diagnostic solutions at Becton Dickinson, one of the largest global medical technologies in the world, and Dr. Cathy Popadiuk, an OB-GYN at Memorial University in Newfoundland and Labrador, and a member of numerous committees at CPAC and other cervical cancer screening groups.
Record Sales of $19.1 million, Net Earnings of $1.8 million
MISSISSAUGA, December 22, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its year and fourth quarter ended September 30, 2022 (“2022” and “Q4”), with record sales and continued positive net earnings, plus ongoing progress upon its strategic goal of increasing its capacity for medical devices production and, over time, to thereby grow sales, margins, and earnings.
Management Discussion
2022 sales achieved a new record of $19.1 million as Microbix continues to emphasize operational excellence and increase sales of innovative, proprietary, and branded medical devices. Sales of test quality assessment products (“QAPs™”) and viral transport medium (“DxTM™”) each realized double-digit percentage increases over fiscal 2021. Sales of antigens were down versus prior year due to continued pandemic impacts on the diagnostics business. Product royalties were higher than 2021 due to higher sales from licensees. Overall, sales achieved a favourable gross margin but were suppressed by inflationary pressures. On a net basis, these factors resulted in strong EBITDA performance and continued positive operating and net income. Microbix continues to pursue growth in sales of its medical devices and expects that full-year fiscal 2023 will realize further sales growth and continuing positive net earnings.
Year ending September 30, 2022 (“2022”)
2022 revenue was $19,076,241, a 3% increase from prior year revenues of $18,592,960. Included were antigen revenues of $8,287,908 (2021 – $9,082,021). QAPs revenues grew by 14% in 2022 to $5,375,329 (2021 – $4,704,671). Revenue from DxTM was strong in 2022 at $5,004,359, up 11% from the prior year (2021 – $4,506,900), and royalties were $408,694 (2021 – $299,368). 2022 revenues were most influenced by the continued uptake of our growing base of QAPs products and strong DxTM sales.
2022 gross margin was 58%, down slightly from 2021 gross margins of 59%. Margins were impacted by increased labour and manufacturing expenses, and higher supply costs; all due to inflationary pressures.
Operating and finance expenses in 2022 increased by 19% relative to 2021, due to increased QAPs product development, investment in IT infrastructure, additional marketing spend to support sales growth, and there being no grant funding as had been received in fiscal 2021; collectively offsetting reduced interest costs due to the repayment of debt and greater interest income from short-term investments.
Stronger sales were offset by lower percentage gross margin and increased operating expenses (due to increased investment into business growth and infrastructure), leading to an operating income (before finance expenses) of $2,610,213 and net income of $1,788,689 versus a 2021 operating income of $4,836,595 and net income of $3,233,390. Cash provided by operating activities was $3,465,199 compared to $2,106,736 in 2021, an improvement largely driven by non-cash working capital account balances.
At the end of 2022, Microbix’s current ratio (current assets divided by current liabilities) was 8.45 and its debt to equity ratio (total debt over shareholders’ equity) was 0.33. Both of these financial health ratios continued to improve from those in 2021.
Quarter Ending September 30, 2022 (“Q4”)
Q4 revenue was $4,329,052, down from 2021 revenues of $5,629,694. Included were antigen sales of $2,629,783 (2021 – $2,020,861), up 30% due to order timing and some bounce-back in business. QAPs revenues were $1,601,950 up 34% in fiscal 2022 (2021 – $1,195,545). In turn, revenue from DxTM was $0 due to timing of orders (2021 – $2,327,600), and royalties were $97,319 (2021 – $85,689). The Q4 sales decline was most influenced the lack of Ontario-driven deliveries of DxTM, offset by continued diagnostics industry uptake of QAPs and stronger antigen sales.
Q4 gross margin was 47%, down from 58% during Q4 2021, due to a greater proportion of lower margin antigen sales, the antigen product sales mix for the quarter, and the lack of DxTM sales in the quarter.
Operating expenses (including financial expenses) in Q4 were relatively flat when compared to Q4 2021. The quarter also showed greater QAPs product development investment, additional spending in sales and marketing to support sales growth, and the lack of Ontario Together Fund (“OTF”) grant funding this year vs. last year. This was offset by a reduction in interest costs due to the repayment of debt and increased short term investment income in fiscal 2022.
Overall, lower sales and less available gross margin dollars led to a Q4 operating loss (before finance expenses) of $256,885 and net loss of $464,080 versus Q4 2021 operating income of 1,580,553 and net income of $778,929. Cash provided by operating activities was $146,437 for Q4, compared to cash provided by of $1,621,623 for Q4 2021, with the majority of the change coming from change in Q4 operating income and changes in non-cash working capital.
Corporate Outlook
Microbix will continue to drive sales growth across all of its three revenue-generating business lines, and work to keep improving percentage gross margins and driving bottom-line results. Management currently expects Microbix to generate meaningful net earnings growth across full-year fiscal 2023. Additionally, work continues upon securing a partnership to advance its Kinlytic® urokinase project.
A replay of the webinar will also be made available on Adelaide Capital’s YouTube channel.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of over 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of financial results or the outlook for the business, risks associated with its financial results and stability, its current or future products, development projects such as those referenced herein, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
MSwab® & PROCEEDx™FLOQ® Supporting Self-Collection for HPV Screening Programs
MISSISSAUGA, CANADA, October 6, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that, on behalf of Santina Castriciano of Copan Italia S.p.A. and in collaboration with Victorian Cytology Service of the Australian Centre for the Prevention of Cervical Cancer (VCS Pathology), it will present results of novel methods to support diagnostic accuracy and whole-process workflow validation of cervical cancer screening tests on self-collected patient specimens. The poster presentation will be made at the 12th European Meeting on Molecular Diagnostics (“EMMD”) taking place in Noordwijk, Netherlands from October 12 to 14, 2022.
Ample evidence supports use of self-collected vaginal samples to improve participation in cervical cancer screening programs based on molecular (“MDx”) detection of Human Papilloma Virus (“HPV”). However, broad adoption of self-collection has been set-back by a lack of materials and methods to evaluate the whole workflow experienced by a specimen – from collection to final diagnostic result. This critical gap is bridged by the current study using Microbix PROCEEDx™FLOQ® simulated positive HPV samples eluted into Copan MSwab® medium – evaluating whether HPV was effectively eluted from the simulated self-collected swabs and then detected by commercial in vitro diagnostic (“IVD”) PCR-based MDx assays.
The study determined that three positive specimens simulating infection with high-risk HPV types (16, 18 & 45) and a negative sample were detected and individually identified on six IVD MDx assays: the Abbott Alinity m HPV & Abbott Realtime HPV, Qiagen NeumoDx HPV, Roche cobas 4800 HPV & Roche cobas 6800 HPV, and Seegene Anyplex II HPV28. Accuracy was 100% across all sample types and assays. The poster will be available on Microbix’s website (https://microbix.com) and from EMMD after its presentation.
HPV represents a family of over 100 virus sub-types, of which 14 are deemed “high-risk” as they are proven to directly cause cancers, including but not limited to cervical cancer. Most sexually-active adults become infected with one or more types of HPV and such infections can be persistent. MDx tests permit early detection and guide timely preventative healthcare by identifying those at-risk years before the development of cancers. However, MDx-based screening programs require rigorous workflow design and ongoing validation to ensure their accuracy. Many healthcare systems now plan to resume the roll-out of MDx-based HPV screening programs that were delayed as a result of the COVID-19 pandemic, important diagnostic healthcare advancements that Microbix is pleased to support with its products and services.
Empowering women to collect vaginal samples in private, safe, and convenient locations is expected to promote patient access to healthcare and accelerate the widespread adoption of MDx-based HPV and cervical cancer screening programs. Microbix is proud to be a strategic partner of Copan and help to accelerate the evolution to self-collection by offering HPV-oriented “PROCEED™FLOQ®” (RUO) and prospective “REDx™FLOQ®” (IVD) quality assessment products (QAPs™) worldwide. Purchase enquiries for Microbix’s QAPs can be e-mailed to customer.service@microbix.com.
About Microbix Biosystems
Microbix develops proprietary biological products and services for human health and well-being, with over 100 skilled employees and sales approaching C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™ IVD or RUO test-controls) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Microbix antigens enable the antibody tests of over 100 international diagnostics companies, while its QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Copan, HPV, EMMD, or VCS, the poster or its relevance, the products of Microbix or its collaborators, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Microbix to Repurchase up to 5% of its outstanding shares over 12 months
MISSISSAUGA, CANADA, September 28, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the initiation of a Normal Course Issuer Bid (“NCIB”) program for the repurchase and cancellation of outstanding common shares.
Specifically, the NCIB enables Microbix to repurchase up to 6,949,568 Common Shares (“Shares“), that being approximately five percent (5%) of the 138,991,374 Shares outstanding as at September 26, 2022, through the facilities of the Toronto Stock TSX (“TSX”) over a 12 month period starting on October 3, 2022 and ending on October 2, 2023. The actual number of Shares repurchased pursuant to the NCIB will be determined by management.
The NCIB has been approved by Microbix’s Board of Directors; however it is subject to acceptance by the TSX and, if accepted, will be conducted in accordance with the applicable rules and policies of the TSX and Canadian securities laws. Under the NCIB, Shares may be repurchased in open market transactions on the TSX, or by such other means as may be permitted by the TSX and applicable Canadian securities laws. Microbix will pay the prevailing market price at the time of its Share repurchases.
Pursuant to TSX rules and policies, the maximum number of Shares that may be repurchased in one day pursuant to the NCIB will be the greater of 1,000 or 11,532 (25% of the average daily trading volume (“ADTV”) of the Shares on the TSX for the most recently completed six calendar months, subject to certain prescribed exceptions). The ADTV on the TSX for the six calendar months ended August 31, 2022 is 46,128.
Microbix has entered into a pre-defined automatic securities purchase plan with its broker, Haywood Securities Inc., to allow for the repurchase of Shares at times when it ordinarily would not be active in the market due to Microbix’s internal trading blackout periods, insider trading rules, or otherwise. Any such plans will be adopted in accordance with applicable Canadian securities laws. Outside of such restricted periods, the timing of repurchases will be determined by Microbix management. Decisions regarding repurchases will be based on market conditions, Share price, best uses of available cash, and other factors. The funding for any repurchases pursuant to the NCIB will be financed out of working capital and all Shares will be repurchased for cancellation. Microbix may also use its NCIB to acquire Shares pursuant to the exercise of stock options in order to offset the dilutive effect of options that have been exercised.
The Board of Directors believes Microbix’s underlying value is not reflected in the current market price of its Shares. As a result, depending upon future price movements and other factors, the Board believes that the repurchase of Shares is an appropriate use of corporate funds and in the best interests of Microbix and its shareholders. Furthermore, the NCIB is expected to benefit persons who continue holding Shares by increasing their proportionate equity interest in Microbix as the repurchased Shares are cancelled.
A copy of Microbix’s notice of the NCIB to the TSX may be obtained by any shareholder without charge, by contacting Jim Currie, the Company’s Chief Financial Officer.
About Microbix Biosystems
Microbix develops proprietary biological products and services for human health and well-being, with over 100 skilled employees and sales approaching C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its quality assessment products (QAPs™ IVD or RUO test-controls) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens enable the antibody tests of over 100 international diagnostics companies, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of the NCIB and its goals and processes, the TSX and related rules, regulations, or laws, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Meetings with Growth-Oriented Investors, September 23-25, 2022
MISSISSAUGA, CANADA, September 21, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it will be presenting to investors at the Muskoka Capital Conference, organized by Capital Event Management Ltd. and being hosted at the JW Marriott Rosseau Muskoka, in Minett, Ontario, September 23-25, 2022.
Microbix’s CEO, Cameron Groome and COO, Ken Hughes, will undertake a series of 18 one-on-one meetings with growth company investors during the formal portion of the conference. The presentation slides to which they will be speaking will be posted to the Microbix website at https://microbix.com, along with other business information and its financial disclosures.
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with over 100 skilled employees and sales approaching C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, most notably antigens for immunoassays and its laboratory quality assessment products (QAPs™ IVD or RUO test-controls) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Microbix antigens enable the antibody tests of over 100 international diagnostics companies, while its QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
About Capital Event Management Ltd. and the Event
Capital Event Management Ltd. produces multiple investor events each year, across North America and in the Bahamas. Attendees include leading public and private companies, and a range of investors consisting of investment advisors, fund managers, and high net worth investors. Capital Event’s unique event formats aim to allow principals to establish new and lasting relationships that lead to financings, open market support, and increased awareness within the investment community. Further information about the Muskoka event is available at https://cem.ca/conference/muskoka-capital-event/
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of Capital Event Management Ltd. and its conferences, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining profitability and adequate working capital, or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Q3 Sales of $5.0 million, Q3 Net Earnings of $0.6 million
MISSISSAUGA, August 11, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its third quarter and year-to-date fiscal 2022 ended June 30, 2022 (“Q3” and “YTD”), with strong sales and continued positive net earnings, plus ongoing progress upon its strategic goal of increasing its capacity for medical devices production to thereby continue growing sales, margins, and earnings.
Management Discussion
Q3 revenues were $5.0 million, down 8% from Q3 2021, while YTD top-line increased 14% to $14.7 million. In Q3, antigens provided 46% of sales, rebounding 42% from a pandemic low-point in the prior quarter. Q3 Sales of QAPs™ test quality assessment products and DxTM™ viral transport medium continued to be strong at $1.3 million for each product line. This mix of sales achieved a gross margin of 55% for Q3, in comparison to 63% in Q3 2021 and reflective of a greater proportion of lower margin ingredients (antigens) sales in the quarter but still driving continuing net earnings and strong cash flow. Microbix considers Q3 to be a satisfactory result as it continues to pursue greater sales of its medical devices and thereby expects to achieve material growth in net earnings over coming quarters and longer term.
Three Months Ending June 30, 2022 (“Q3”)
Q3 revenue was $5,011,025, an 8% decrease from Q3 2021 revenues of $5,451,834. Included were antigen revenues of $2,283,621 (2021 – $$2,398,969). QAPs revenues were $1,305,896 (2021 – $1,051,617). Revenue from DxTM was $1,326,410 (2021 – $1,924,300), and royalties were $95,099 (2021 – $76,948). Year-over-year, Q3 sales were most influenced by the timing of deliveries of DxTM, which were higher in Q3 2021.
Q3 gross margin was 55%, down from 63% in Q3 2021, due a lower margin antigen product sales mix and pressure on supply chain costs due to inflation that has not yet been mitigated by Microbix price increases.
Operating expenses in Q3 increased by 10% relative to Q3 2021, due to greater investment in product development for QAPs customers, additional spend on trade shows and marketing to support sales growth, and no offsetting Ontario Together Fund grant money. Those factors outweighed the meaningful reductions in interest costs due to the repayment of debentures and BDC loans. Overall, lower sales and fewer gross margin dollars during the period led to an operating income and net income of $638,502 versus a Q3 2021 operating income and net income of $1,516,178. In turn, cash provided by operating activities (cash flow) was very strong at $2,709,545, compared to cash used of $683,335 in Q3 2021.
Nine Months Ending June 30, 2022 (“YTD”)
YTD revenue was $14,747,189, a 14% increase from YTD 2021 revenues of $12,963,266. Included were antigen revenues of $5,658,007 (2021 – $7,061,161). QAPs revenues were $3,773,429 (2021 – $3,509,127). In turn, revenue from DxTM was $5,004,359 (2021 – $2,179,300), and royalties were $311,394 (2021 – $213,679). YTD sales growth was most influenced by Ontario-driven deliveries of DxTM, followed by continued diagnostics industry uptake of QAPs, and offset by weaker antigen sales.
YTD gross margin was 62%, up from 60% YTD 2021, due to a greater proportion of sales of QAPs, new VTM sales, and the effects of antigen product sales mix.
Operating expenses YTD increased by 28% relative to YTD 2021, due to increased investment in QAPs product development, additional spending in sales and marketing to support sales growth, and no Ontario Together Fund (“OTF”) grant funding this year vs. last year; more than offsetting reduced interest costs due to the repayment of debt.
Overall, greater sales and more available gross margin dollars during the YTD period, offset by increased operating expenses, led to an operating income and net income of $2,252,769 versus a YTD 2021 operating income and net income of $2,454,461. Cash provided by operating activities was $3,318,763, compared to cash provided of $485,115 in YTD 2021, with the majority of the change coming from improvements in non-cash working capital.
At the end of Q3, Microbix’s current ratio (current assets divided by current liabilities) was 7.84 and its debt to equity ratio (total debt over shareholders’ equity) was 0.35.
Corporate Outlook
Microbix will continue to drive sales growth across all of its three revenue-generating business lines, and work to keep improving percentage gross margins and driving bottom-line results. Management currently expects Microbix to generate meaningful net earnings growth across fiscal 2022 and 2023. Additionally, work continues upon securing a partnership to advance its Kinlytic® urokinase project.
A replay of the webinar will also be made available on Adelaide Capital’s YouTube channel.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and sales approaching C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of over 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of financial results or the outlook for the business, risks associated with its financial results and stability, its current or future products, development projects such as those referenced herein, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Microbix QAPs to Support Molecular & Antigen Test Platforms for Multiple Diseases
MISSISSAUGA, CANADA, August 10, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the execution of a purchase and supply agreement (“Agreement”) by which Microbix “QAPs™” quality assessment products will support assays on industry-leading molecular (PCR) and antigen-based point-of-care testing platforms.
QAPs mimic positive or negative patient samples to validate the proper functioning of operators, assays and instruments. QAPs formatted onto Copan® FLOQSwabs® are ideal support for point-of-care test workflows and are room-temperature stable for 24 months for compatibility with test-cartridge storage and handling conditions. Microbix has over 80 types of QAPs, including multiplexes to support clear diagnosis of cutaneous, gastrointestinal, respiratory, and sexually-transmitted infectious diseases. QAPs are used to support staff training and qualification of new instruments as “ONBOARDx™” kits, or incorporated into kits of assay consumables as an integral part of test quality management procedures.
Under the Agreement, Microbix is providing a leading multinational diagnostics developer, manufacturer, and marketer with monoplex and multiplex QAPs – for incorporation into kits of test cartridges for the customer’s molecular instrument platform across multiple disease categories. Additionally, Microbix ONBOARDx kits are being provided to assist new purchasers with staff training and assay qualification for both the antigen-based and molecular-based instrument platforms of the customer. Purchase and supply has already begun under the Agreement, which has an initial term of five years and includes provisions for development of further QAPs to support future assays of this customer.
The Agreement is expected to materially increase Microbix’s QAPs revenues starting in Q4 fiscal 2022. In connection with this Agreement, the customer will be providing confidential QAPs demand forecasts to Microbix, with a portion of such forecasts being binding and to be updated on a regular basis. If its current expectations are realized, Microbix may generate incremental QAPs sales of approximately C$ 5.0 million related to this Agreement in its initial year of fiscal 2023.
Phil Casselli, Senior Vice President of Sales and Business Development of Microbix, stated, “Our firms have been working together for many months and it is a pleasure to fully formalize our close and positive relationship. This Microbix customer is continuing to ensure optimal diagnosis of infectious diseases via leading-edge point-of-care PCR and antigen-based testing, including the quality management system support provided by our FLOQSwab-formatted QAPs.”
Cameron Groome, CEO and President of Microbix also commented, “We’re delighted to support making clinically-important diagnostic testing more widely available. Microbix believes accurate multi-pathogen point-of-care testing will improve patient care and that multiplex QAPs will help enable this evolution.”
About Microbix Biosystems
Microbix develops proprietary biological products for human health and well-being, with over 100 skilled employees and sales approaching C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens enable the antibody tests of over 100 international diagnostics companies, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of the Agreement between the parties, the customer and its assay platforms, the relevance of the customer’s purchases of QAPs, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Quality Control Materials for Genital Ulcer Disease Molecular Assays
MISSISSAUGA, CANADA, July 26, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces it is presenting about the utility of its multi-pathogen (“multiplex”) and swab-formatted Quality Assessment Products (“QAPs™”) to monitor molecular assays that detect and distinguish between four sexually-transmitted infections (each an “STI”) that cause Genital Ulcer Disease (“GUD”) – at the 2022 conference of the American Association of Clinical Chemistry (“AACC”) taking place in Chicago, Illinois from July 24-28, 2022.
Its poster presentation is titled “Novel Herpes Simplex Virus, Varicella Zoster Virus, and Treponema pallidum Quality Control Material for use with Genital Lesion Molecular Detection Assays.” The poster details the use of Microbix’s PROCEEDx™FLOQ® HSV1&2/VZV/Syphilis Swab Positive Sample QAPs to monitor the performance, procedures, and workflows of molecular assays that detect STIs from the oral and genital types of the Herpes Simplex Virus (“HSV 1” and “HSV2”), Varicella Zoster Virus (“VZV”) and Treponema pallidum (the spirochete bacteria causing “Syphilis”). The PROCEEDxFLOQ QAPs proved compatible with 13 molecular assays across both commercially-available diagnostic platforms and laboratory-developed tests, and were used to support an external quality assessment pilot study.
These assessments were coordinated by the Microbix team and consolidated data provided from 16 laboratories, notably including the Cadham Manitoba Provincial Laboratory (Winnipeg, Canada) and Labquality Ltd. (Helsinki, Finland), the support of which are gratefully acknowledged.
GUDs are a current and growing global health concern, with over 20 million new cases each year. Traditionally, diagnosis of GUD has relied on clinical assessment of symptoms, which lacks specificity given the similar appearance of ulcers caused by different etiological agents. Such non-specific diagnosis leads to misclassification, delayed treatment, and the development of complications. Although there is now a growing pipeline of molecular assays for sensitive and specific diagnosis of GUD, external quality control materials to verify performance have been largely unavailable. Microbix has overcome challenges in formulation and appears to be the first to develop a multiplex whole-workflow control for GUD assays. This STI-oriented PROCEEDxFLOQ multiplex QAP adds to Microbix’s expanding portfolio, which includes Health Canada, U.S. FDA, EU “CE mark,” or TGA (Australia) in-vitro-diagnostic (“IVD”) regulated REDx™ and research-use-only (“RUO”) PROCEEDx™ SKUs across both liquid-vial and Copan FLOQSwab® formats.
Further information about Microbix’s QAPs and its services offerings is available at https://microbix.com and purchase enquiries for QAPs™ can be e-mailed to customer.service@microbix.com.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and sales approaching C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of over 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of AACC, the poster or its relevance, the products of Microbix or its collaborators, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Microbix Biosystems Inc. develops and commercializes proprietary biological and technological solutions for human health and well-being. We manufacture a wide range of biological materials for the global diagnostics industry, notably antigens used in immunoassays and Quality Assessment Products (QAPsTM).
Microbix has 3 buildings with a total of 34,000 square feet on its campus. Each building houses a mixture of warehousing, office, and manufacturing space.
Usage of QAPs to Validate Whole Workflow Quality Control of Testing
MISSISSAUGA, CANADA, June 3, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces it is presenting about the utility of its Quality Assessment Products (“QAPs™”) to monitor the end-to-end diagnostic process, including the impact of “preanalytical” sample-handling variables on test accuracy, at the 2022 “Preanalytical Phase Conference” of the American Association of Clinical Chemistry (“AACC”) taking place in Alexandria, Virginia from June 3-4, 2022.
Microbix is attending this AACC conference to present about these important aspects of infectious disease testing, alongside leaders in the global medical diagnostics industry. Microbix will also be conducting business development activities in relation to its expanding portfolio of QAPs, which includes Health Canada, U.S. FDA, EU “CE mark,” or TGA (Australia) in-vitro-diagnostic (“IVD”) regulated SKUs and research-use-only (“RUO”) designated SKUs across both liquid-vial and Copan FLOQSwab® formats.
Its poster presentation is titled “Simulated Swab Specimens for Whole Workflow Quality Control of SARS-CoV-2 Molecular Diagnostic Testing.” The poster details methods of using Microbix’s REDx™FLOQ® SARS-CoV-2 Swab Positive Control QAPs to assess the influence on patient-samples of hold-period durations of up to five (5) days, high temperatures of 35-40 °C, or a freeze-thaw cycle, relative to more optimal conditions. The study examined the effects of such conditions on the detectability of Microbix’s positive QAPs at full-strength and in 1:100 diluted form relative to strong-positive and weak-positive clinical specimens, using two different viral transport mediums (Microbix’s DxTM™ branded viral transport medium and another commercially-available brand) and two different Health Canada approved assays.
The results establish that the effects of sample storage and handling conditions can be accurately modeled using QAPs as proxies for clinical patient-samples. These Microbix products and methods can be used to validate processes for new-generation testing practices, such as at-home sample-collection, for a wide range of disease screening and diagnostic purposes, including COVID-19 and high-risk HPV infection, among others. The study was conducted in collaboration with FH Health Laboratory of Toronto, Ontario, whose support in sourcing clinical specimens, testing, and tabulation is gratefully acknowledged.
Further information about Microbix’s QAPs and its services offerings is available at https://microbix.com and purchase enquiries for QAPs™ can be e-mailed to customer.service@microbix.com.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and sales approaching C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of over 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of AACC, the poster or its relevance, the products of Microbix or its collaborators, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Record Q2 Sales of $4.9 million, Q2 Net Earnings of $0.7 million
MISSISSAUGA, May 12, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its second quarter and first half of fiscal 2022 ended March 31, 2022 (“Q2” and “H2”), with record sales and strong earnings, plus ongoing progress upon its strategic goal of increasing the proportion of revenues derived from medical devices to thereby continue growing sales, margins, and earnings.
Management Discussion
Q2 revenues achieved a record level of $4.9 million, up 12% from Q2 2021, as Microbix continues to emphasize operational excellence and the sale of innovative, proprietary, and branded medical devices. Microbix’s viral transport medium (branded “DxTM™”) contributed strongly, with Q2 sales of $1.9 million versus $255,000 in Q2 2021. Sales of antigens in Q2 were $1.6 million (with improved margins) and royalties were higher than Q2 2021. Sales of test quality assessment products (“QAPs™”) continued to be strong at $1.3 million. Overall, sales achieved a very favourable gross margin of 64% for Q2, in comparison to 60% in Q2 2021 and thereby drove strong net earnings and cash flow.
Microbix continues to pursue growth in sales of its medical devices and expects that fiscal 2022 will realize materially-positive net earnings, as were achieved in fiscal 2021.
Three Months Ending March 31, 2022 (“Q2”)
Q2 revenue was $4,880,564, a 12% increase from Q2 2021 revenues of $4,353,773. Included were antigen revenues of $1,607,970 (2021 – $$2,524,363). QAPs revenues were $1,318,382 (2021 – $1,495,088). In turn, revenue from DxTM was $1,860,704 (2021 – $255,000), and royalties were $93,508 (2021 – $79,322). Q2 2022 sales growth was most influenced by Ontario-driven deliveries of DxTM and offset predominantly by weaker antigen sales.
Q2 gross margin was 64%, up from 60% in Q2 2021, due to a greater proportion of sales of QAPs, new VTM sales, and the effects of antigen product sales mix with improved margins.
Operating expenses in Q2 increased by 33% relative to Q2 2021, due to increased investment in R&D projects for our QAPs business, additional spending in sales and marketing to support continued sales growth, no Ontario Together Fund (“OTF”) grant funding this quarter vs. Q2 2021; more than offsetting a reduction in interest costs due to the repayment of debentures and BDC loans. Overall, greater sales and more available gross margin dollars during the period led to an operating income and net income of $733,489 versus a Q2 2021 operating income and net income of $807,463. Cash provided by operating activities was $893,232, compared to cash provided by of $981,648 in Q2 2021.
Six Months Ending March 31, 2022 (“H1”)
H1 revenue was $9,736,164, a 30% increase from H1 2021 revenues of $7,511,432. Included were antigen revenues of $3,374,386 (2021 – $4,662,192). QAPs revenues were $2,467,533 (2021 – $2,457,509). In turn, revenue from DxTM was $3,677,949 (2021 – $255,000), and royalties were $216,296 (2021 – $136,731). H1 2022 sales growth was most influenced by Ontario-driven deliveries of DxTM, followed by continued diagnostics industry uptake of QAPs, and offset by weaker antigen sales.
H1 gross margin was 65%, up from 58% in H1 2021, due to a greater proportion of sales of QAPs, new VTM sales, and the effects of antigen product sales mix with improved margins.
Operating expenses in H1 increased by 38% relative to H1 2021, due to increased investment in R&D projects for our QAPs business, additional spending in sales and marketing to support continued sales growth, lack of eligibility for any Canada Emergency Wage Subsidies in Q1 and no Ontario Together Fund (“OTF”) grant funding this period vs. H1 2021; more than offsetting a reduction in interest costs due to the repayment of debentures and BDC loans. Overall, greater sales and more available gross margin dollars during the period led to an operating income and net income of $1,613,267 versus a H1 2021 operating income and net income of $938,282, growing 72% vs. prior year. Cash provided by operating activities was $609,218, compared to cash provided by of $1,168,450 in H1 2021, with the majority of the change coming from higher accounts receivables due to increased sales levels in the latter part of H1 2022.
At the end of H1, Microbix’s current ratio (current assets divided by current liabilities) was 6.49 and its debt to equity ratio (total debt over shareholders’ equity) was 0.38.
Corporate Outlook
Microbix will continue to drive sales growth across all of its three revenue-generating business lines, and work to keep improving percentage gross margins and driving bottom-line results. Management currently expects Microbix to generate meaningful net earnings growth across fiscal 2022. Additionally, work continues upon securing a partnership to advance its Kinlytic® urokinase project.
A replay of the webinar will also be made available on Adelaide Capital’s YouTube channel.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and sales approaching C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of over 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of financial results or the outlook for the business, risks associated with its financial results and stability, its current or future products, development projects such as those referenced herein, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
QAPs Supporting Molecular Diagnostic Tests for Dominant COVID-variant
MISSISSAUGA, CANADA, April 29, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces it will present performance results of its Quality Assessment Products (“QAPs™”) supporting molecular-diagnostic tests for the Omicron variant of the SARS-CoV-2 virus (“Omicron”) at the 2022 Clinical Virology Symposium of the American Society for Microbiology (“CVS”) taking place in West Palm Beach, Florida from May 1-4, 2022.
At CVS, Microbix will be exhibiting alongside leading diagnostics firms that provide tests for detection of COVID and other infectious diseases. Microbix will also review performance of its QAPs to support quality management of testing for infection with Omicron (the B.1.1.529 variant of SARS-CoV-2).
Its poster presentation is titled “Use of SARS-CoV-2 Omicron External Controls for Verifying the Performance of Primary and Reflex SARS-CoV-2 Molecular Detection Methodologies.” The poster details the performance of Microbix’s Copan® FLOQSwab® formatted, room-temperature stable, and whole-genome Omicron-focused QAPs in challenging the accuracy of molecular (e.g., PCR-based) assays testing for mutations specific for this dominant variant and the generic tests designed to target only the wild type. The poster will be made available on Microbix’s website (https://microbix.com) and from CVS following its presentation.
With over 50 reported mutations in its viral genome, Omicron can lead to reduced assay sensitivity or the outright inability of assays to detect it. Use of Microbix’s REDxFLOQ or PROCEEDxFLOQ QAPs offer whole-genome controls that contain all Omicron mutations and provide lot-to-lot consistency in order to optimally support clinical laboratories and test-makers in monitoring their assay performance.
Microbix now has QAPs to support tests for six (6) variants of the virus that causes COVID available for sale in Canada, Europe, the United States, and other commercially-important jurisdictions under its “REDx™” or “PROCEEDx™” brand names. Its QAPs support tests for the “Wuhan” strain, as well as those variants that have since become most prevalent, including the Alpha (B.1.1.7 or UK), Beta (B.1.351 or South African), Delta (B.1.617 or Indian), Gamma (P.1 or Brazilian), and Omicron (B.1.1.529 or Botswana).
Microbix is proud to be a strategic partner of Copan and offer a broad portfolio of infectious-disease oriented “PROCEED™FLOQ®” (RUO) and “REDx™FLOQ®” (IVD) QAPs to support testing programs worldwide. Further information about Microbix’s QAPs is available at https://microbix.com and purchase enquiries for Microbix’s QAPs™ can be e-mailed to customer.service@microbix.com.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and sales approaching C$ 2.0 million per month. It makes a wide range of critical ingredients and devices for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Its antigens drive the antibody tests of over 100 diagnostics makers, while QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of CVS, the poster or its relevance, the products of Microbix or its collaborators, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital or raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
Please visit https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
customer.service@microbix.com 
