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
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:
Healthcare Investor Conference in Toronto on May 2 & 3, 2022
MISSISSAUGA, CANADA, April 28, 2022 – 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 taking place at the Metro Toronto Convention Centre, North Building, in Toronto, Ontario, Canada on May 2nd and 3rd, 2022. Cameron Groome, Microbix’s CEO and President, will make an in-person presentation to investors in Hall C/D on May 2nd at 11:30 AM Eastern Time. The Company will also participate in multiple one-on-one meetings with healthcare-focused investors. Presentation slides will be posted to https://microbix.com.
About the Conference
The Bloom Burton & Co. Healthcare Investor Conference brings together U.S., Canadian, and international investors who are interested in the latest developments in the Canadian healthcare sector. Attendees will have an opportunity to obtain corporate updates from the premier Canadian publicly-traded and private companies through presentations and private meetings.
About Bloom Burton & Co.
Bloom Burton & Co. is a firm dedicated to accelerating returns in the healthcare sector for investors and companies. Bloom Burton’s medical, scientific, pharmaceutical, legal, and capital markets professionals perform a deep level of diligence, which combined with its 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, advisory on direct investing, and company creation and incubation services. Bloom Burton Securities Inc. is a member of the Investment Industry Regulatory Organization of Canada (IIROC) and the Canadian Investor Protection Fund (CIPF).
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 Bloom Burton, its abilities, or its conference, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, products or 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:
QAPs Supporting Tests That Simultaneously Detect Multiple Respiratory Viruses
MISSISSAUGA, CANADA, April 19, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces it will be presenting performance results of its quality assessment products (“QAPs™”) that support molecular-diagnostic (“MDx”) screening-tests for respiratory viruses at two industry congresses – “Labquality Days” in Helsinki, Finland April 20-21, 2022 and “ECCMID 2022” in Lisbon, Portugal, April 23-26, 2022.
Labquality Days is an annual international congress focusing on quality in laboratory medicine and medical devices. It is sponsored by Labquality Oy, a well-established Scandinavian clinical-lab proficiency and accreditation authority that is also a Microbix distribution partner. ECCMID 2022 is the 32nd annual congress organized by the European Society of Clinical Microbiology and Infectious Diseases.
At these events Microbix will be presenting performance results of its QAPs for support of MDx tests that detect multiple respiratory viruses from a single patient-sample. At Labquality Days, Microbix’s presentation is titled “Microbix’s Cross-Platform Compatible Respiratory Virus Multiplex Samples for use as a Quality Management Tool in Laboratory Syndromic Testing.” At ECCMID, Microbix’s presentation is titled “Respiratory Virus Multiplex Formulations Desiccated on Copan’s FLOQSwab® for use as Cross-Platform Compatible EQA Samples and Laboratory Quality Controls.” Microbix gratefully acknowledges the assistance of its six collaborator firms in planning and executing these evaluations. The posters will be available on Microbix’s website (https://microbix.com) following their presentation.
The two poster presentations detail the performance of three Microbix “multiplex” QAPs that each support testing for three to four pathogens, collectively providing quality management support of testing for 11 common respiratory viruses – Adenovirus, Enterovirus, Influenza A, Influenza B, Metapneumovirus, Parainfluenza 2, Parainfluenza 3, Respiratory Syncytial Virus, Rhinovirus, SARS-CoV-2 (a.k.a., COVID-19), and Seasonal Coronavirus OC43. Each of these 11 viruses continue to cause widespread human disease.
These QAPs support the new-generation diagnostics that simultaneously detect multiple pathogens from a single patient sample – referred to as “multiplex” tests. By establishing the precise cause of disease symptoms, multiplex tests help enable better patient-care while also providing public health with intelligence on institutional or community prevalence of pathogens. Multiple new multiplex MDx tests are also suitable for use outside clinical laboratories – at point-of-care (“POC”) sites such as clinics or pharmacies – and thereby provide easier access to care and faster test results. Microbix “PROCEEDx™FLOQ®” and “REDx™FLOQ®” QAPs formatted onto Copan® FLOQSwabs® are ideal for supporting POC tests, as they fully-emulate test-workflows and are room-temperature stable.
Purchase enquiries for Microbix’s QAPs can be e-mailed to customer.service@microbix.com.
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with over 100 skilled employees and sales now approaching C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 Labquality Days, Labquality, or ECCMID 2022, the posters or their 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:
QAPs Supporting Screening-Tests for High-Risk Human Papilloma Viruses
MISSISSAUGA, CANADA, April 8, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces it will present performance results of its Quality Assessment Products (“QAPs™”) supporting Human Papillomavirus (“HPV”) molecular-diagnostic screening-tests at the 2022 annual congress of the European Research Organization on Genital Infection and Neoplasia (“EUROGIN”) taking place in Düsseldorf, Germany from April 10-12, 2022.
At EUROGIN, Microbix will be exhibiting alongside leading diagnostics firms that provide screening-tests for detection of HPV infections. Microbix has QAPs to support tests for eight (8) high-risk HPV types available for sale in Canada, Europe, the United States, and other commercially-important jurisdictions under its “REDx™ Controls” or “PROCEEDx™” brand names. Most sexually-active adults become infected with one or more types of HPV and its high-risk types are well-known and common causes of human cancers. 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.
Microbix will also review performance of its multiplex high-risk HPV QAPs in supporting quality management of testing for high-risk types of HPV via full and extended genotyping assays. Its poster presentation is titled “Performance of full and extended genotyping assays using a new high-risk HPV multiplex panel.” The poster details the performance of multiplex high-risk HPV QAPs in supporting BD Onclarity™ assays and Microbix gratefully acknowledges the assistance of Becton Dickinson Life Sciences in planning and executing these evaluations. The poster will be available on Microbix’s website (https://microbix.com) and from EUROGIN following its presentation.
Furthermore, Microbix is proud to announce collaboration with Copan Italia S.p.A. (“Copan®”) and key opinion leaders at VCS Pathology (Victoria, Australia) to advance self-collection HPV molecular diagnostic (“MDx”) testing. A presentation titled “Validation of MSwab™ medium for the elution of FLOQSwabs® for human papillomavirus (HPV) detection on six commercial PCR-based HPV assays” will demonstrate new self-sampling tools for HPV screening programs. Empowering patients to collect samples in private and convenient locations is expected to speed widespread adoption of MDx-driven HPV screening programs. Microbix is proud to be a strategic partner of Copan and offer HPV-oriented “PROCEED™FLOQ®” (RUO) and prospective “REDx™FLOQ®” (IVD) QAPs to support self-collection screening programs worldwide. Purchase enquiries for Microbix’s QAPs™ can be e-mailed to customer.service@microbix.com.
Prior to the pandemic, healthcare systems were preparing MDX-based HPV screening programs to identify individuals at risk years before cancerous cells can be detected using pathology. Such programs were delayed due to MDx capacity being coopted for COVID-testing, but are now being reconsidered as COVID becomes endemic. Microbix believes many high-risk HPV infections and resulting cancers have gone undiagnosed and is pleased to help enable the resumption and expansion of MDx screening programs.
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 biological materials 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. 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 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 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 Announces Annual and Special Meeting Voting Results
MISSISSAUGA, CANADA, March 31, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix®), a life sciences innovator and exporter, announces the voting results from its Annual and Special Meeting of Shareholders (the “Meeting”) which was held on March 30, 2022.
At the Meeting, 44.84% 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 18, 2022. The Circular is available on Microbix’s website (www.microbix.com) and on SEDAR (www.sedar.com).
All of the board of directors nominees listed in the Circular were elected as directors of Microbix. The results of the vote were as follows:
Nominee
Votes For
% Votes For
Withheld
% Withheld
Peter M. Blecher
59,238,916
99.69%
186,570
0.31%
Mark A. Cochran
58,999,416
99.28%
426,070
0.72%
Vaughn C. Embro-Pantalony
58,813,416
98.97%
612,070
1.03%
Cameron L. Groome
58,256,018
98.03%
1,169,468
1.97%
Martin Marino
59,257,416
99.72%
168,070
0.28%
Joseph D. Renner
59,257,416
99.72%
168,070
0.28%
Jennifer Stewart
59,260,157
99.72%
165,329
0.28%
Shareholders also approved a resolution re-appointing Microbix’s auditors, Ernst & Young LLP, with 99.97% 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 develops proprietary biological technology solutions for human health and well-being, with over 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 or the referenced management presentation may include “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 in its corporate presentations, regulatory compliance and approvals, sales to domestic or 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.
Implementing MasterControl® and NetSuite® Solutions to Enable Rapid Growth
MISSISSAUGA, CANADA, March 29, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces investment in programs to upgrade, digitize and fully-integrate its Quality Management System (“QMS”) and its Enterprise Resource Planning (“ERP”) platforms – to better enable its business growth trajectory. These initiatives will support more rapid growth in each of Microbix’s business lines – its test ingredients business (antigens), its test Quality Assessment Products (“QAPs™”), and its Viral Transport Medium (“DxTM™”).
Microbix’s QMS and ERP systems investments will total C$ 600,000 in fiscal 2022 – a sum fully in-line with the use-of-proceeds described in the prospectus supporting its public offering and private placement of May, 2021, from which it raised over C$ 6.0 million to be used primarily for expansion-related initiatives. Since then, Microbix has commissioned multiple new production and release-testing laboratories, secured a 3rd building for high-volume automated DxTM production, and increased its staff complement of highly-trained professionals. Now Microbix is also upgrading its mission-critical QMS and ERP systems.
MasterControl® is Microbix’s chosen electronic-QMS (“eQMS”) provider. MasterControl has been a market leader for over 25 years, is active in over 50 countries, and has a distinct Medtech focus – with over 750 client companies in that field. Its eQMS fully-digitizes manufacturing batch-production-records and testing documentation to increase throughput and reduce errors. It will also integrate with digital Laboratory Information Management Systems (“LIMS”) for completely paper-free operational solutions.
NetSuite® ERP software is also being implemented. NetSuite has over 29,000 unique clients, with over 1,000 in the Medtech/Pharma fields. Its ERP integrates seamlessly with MasterControl eQMS to provide Microbix with a complete and scalable digital solution that combines manufacturing, release-testing, finance, sales and customer relationship management, inventory control, and regulatory compliance. Full implementation will take 18 months, with significant milestones reached by the end of fiscal 2022.
Microbix currently operates a stringent, but paper-based ISO9001 and ISO13485 QMS appropriate for the highly-regulated markets in which it operates. Dr. Ken Hughes, Microbix’s Chief Operating Officer, commented, “Our current QMS/ERP solutions have ably supported Microbix over the last several years. However, a stated objective is to future-proof our business as we continue our rapid growth. Moving to state-of-the-art MasterControl and NetSuite cloud-based digital solutions, as well as expanding into newly-commissioned manufacturing facilities with more-automated processes, is doing exactly that”.
Microbix’s Sales topped C$ 18.6 million fiscal 2021, growth of 77% over the prior year and with a current run-rate of over C$ 20.0 million. Microbix is positioning itself to continue growing rapidly by improving control systems, increasing manufacturing capacity, and expanding the number of its product offerings.
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with over 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 its eQMS and ERP goals or its 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:
Once again, due to COVID -19 Pandemic, Microbix will be hosting a virtual AGM on March 30, 2022 at 1:00 pm. The online link will allow shareholders to listen to the AGM and view a CEO presentation via Zoom. Shareholders without up-to-date computer access can listen-in via telephone by using the teleconference numbers. Details for these modes of remotely attending the AGM and for obtaining information in advance of the meeting are provided below:
The time has come again for the Canadian annual meeting in infectious diseases and diagnostic microbiology. The AMMI Canada – CACMID Annual Conference is returning in a hybrid format: in-person in Vancouver, BC, and online via our virtual platform.
The AMMI Canada – CACMID Annual conference continues to be successful in accomplishing its objectives for delivering a high-quality program. This is achieved, in part, through the continued support and collaboration from our industry partners, who acknowledge the value in being part of this one-of-a-kind meeting.
We strongly believe that open conversation leads to strong partnerships and we encourage your engagement and ideas as you consider your opportunities for the upcoming conference.
Look out for Microbix Biosystems Inc. at the conference on April 6th and April 7th, 2022. Registrations are now open here!
The EUROGIN 2022 Organizing Committee is happy to welcome the HPV community to gather again in person in Düsseldorf on April 10-12, 2022, after a difficult period owing to the COVID-19 pandemic.
EUROGIN Conference 2022 is the first large international in-person conference in the field of HPV-related diseases. This highly awaited event is expected to be attended by over 1,500 delegates from all over the world, including gynecologists, biologists, epidemiologists, immunologists, pathologists, head & neck specialists, public health representatives and other professionals.
Hundreds of abstract submissions for free communications and posters will add to the latest and most relevant scientific developments in the field.
Using Shareholder-Approved Plan to Incentivize and Retain
MISSISSAUGA, CANADA, February 24, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator 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 the CEO, CFO, and COO, Microbix’s Board of Directors has approved the issuance of 2,805,000 options in accordance with the terms of the Stock Option Plan. These approved options are exercisable at a price of $0.60 per share, as determined by the closing price of the TSX on 18 February, 2022. 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
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 30 individuals that comprise the more senior tiers of Microbix’s approximately 100 employees, inclusive of its independent directors. The quarterly expense incurred as a result of this option award is estimated to be $80,000, and will represent approximately 4% of total company compensation costs.
About the Microbix Stock Option Plan
Details of the Microbix Stock Option Plan are available on the corporate 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 the issuance of options representing up to 10% of Microbix’s issued and outstanding common shares. Prior to the current issuance, a total of 9,029,000 options had been issued and are outstanding under the plan, with an average exercise price of $0.35 and average remaining life of 2.52 years. Following the current issuance, a total of 11,834,000 options will be outstanding, comprising approximately 87% of the current plan availability. The plan is administered under the supervision of the board of Microbix or the human resources, compensation and governance committee of the board.
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 S.p.A., 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 2018 Stock Option Plan 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:
For Appointment of Jennifer Stewart, Accomplished Business Leader
MISSISSAUGA, CANADA, February 22, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix®), a life sciences innovator and exporter, announces that Ms. Jennifer Stewart, an accomplished leader in Canadian business, government, and public affairs, has been nominated to become a member of its Board of Directors.
If appointed by a majority of shareholders voting at Microbix’s Annual General Meeting on Wednesday, March 30, 2022, Ms. Stewart will join the Board of Directors and will also be asked to serve as a member of the Human Resources, Compensation & Governance Committee.
Ms. Stewart is founder, President, and CEO of Syntax Strategic a leading firm in the sector of advocacy and communication for the public and private sectors. She is renowned as an expert in this field, often being called-upon by national media for commentary. Additionally, Ms. Stewart has twice been named one of the “Top 25 People in the Capital” by Ottawa Life Magazine, one of Ottawa’s “Top Forty Under Forty” by the Ottawa Business Journal and the Ottawa Chamber of Commerce, and was a finalist for Ottawa’s “Established Female Entrepreneur of the Year.”
Ms. Stewart is a journalism and communications graduate of Carleton University (Ottawa, ON) and has been actively involved in many business and community affairs roles. Her participations have included President & CEO of the Canadian Independent Petroleum Marketers Association (CIPMA), Chair of the Board of the Canadian Transportation Alliance, Co-Host and Co-Founder of The Honest Talk podcast, Chair of the Village of Carp Business Improvement Association, Board Member of the Youth Services Bureau of Ottawa Foundation, Member of the Board of Trustees for The Women in Technology Scholarship of Willis College, and on the Leadership Council of the Ottawa Regional Cancer Foundation.
Martin Marino, independent chair of Microbix’s Board of Directors, commented, “I’m delighted to welcome Jennifer on behalf of Microbix’s Directors, Management, Staff, and Shareholders. Jennifer will add her skill, connectivity, broad perspectives, and expertise to our board-level leadership. Her nomination follows a process by which our board evaluated multiple qualified candidates.”
Jennifer Stewart also remarked about her nomination, “I’ve observed how Microbix is improving public health for Ontarians and Canadians. If appointed, I look forward to helping Microbix achieve still greater success with its medical devices that support the global diagnostics sector. As a board director, I’ll be committed to accelerating its pace of value creation in a manner that also serves the public good.”
Upon her appointment, Ms. Stewart will be granted options to purchase common shares. The options will have an exercise price set by the closing price of Microbix shares on the TSX the day prior to that of their granting, a term of five years, and vest at the end of three years.
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 S.p.A., 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 OTCQB, 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 Ms. Stewart or her qualifications, her or others’ views, the role or actions of the board, 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 domestic or 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, February 18-20, 2022
MISSISSAUGA, CANADA, February 17, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces that it will be presenting to equity investors at the Whistler Capital Conference, organized by Capital Event Management Ltd. and being hosted at the Fairmont Chateau Whistler, in Whistler, B.C., February 18-20, 2022.
Microbix’s CEO, Cameron Groome, will undertake a series of 18 one-on-one meetings with growth company equity 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 its financial disclosures.
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 Whistler event is available at https://cem.ca/conference/whistler-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 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:
Expansion of Capacity for Manufacturing of QAPs & DxTM
MISSISSAUGA, CANADA, February 15, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces progress with expanding manufacturing capacity of its portfolio of Quality Assessment Products (“QAPs™”) and its “DxTM™” brand viral transport medium – via renovating and equipping its second and third manufacturing sites in Mississauga, ON.
First, the final laboratory in Microbix’s second production site, at 235 Watline Ave., is now validated to accommodate automated and larger-scale manufacturing of FLOQSwab®-based and liquid-formatted QAPs, as well as ongoing DxTM production. This validation completes the build-out of this site, which now contains two production labs and a QC lab, along with the majority of Microbix’s administrative offices.
Second, renovations have now commenced at Microbix’s third site, at 275 Watline Ave. This site is being re-engineered to accommodate larger-scale production of DxTM and build-out will be largely completed in the current fiscal quarter. Initially, Microbix’s high-throughput, semi-automated production process will be installed in this site, to be quickly followed by more-automated production as soon as the necessary equipment is received and validated for use, expected in the quarter ending June 30, 2022.
The goal of building-out and equipping these two sites is to expand production capacity for both QAPs and DxTM by five to tenfold current levels. For QAPs, production in such larger quantities will better enable the manufacture of FLOQSwab-based QAPs as in-kit controls for leading diagnostic test-makers. For DxTM, greater production will enable Microbix to offer strategic quantities of this viral transport medium to governments and private industry buyers beyond Ontario. These initiatives were aided by funds from the Ontario Together Fund (OTF) of Ontario’s Ministry of Economic Development, Job Creation and Trade (MEDJCT) and the Federal Economic Development Agency for Southern Ontario (FedDev Ontario).
Microbix now occupies approximately 35,000 square feet across its three adjacent sites at 235, 265 and 275 Watline Ave. in Mississauga, Ontario, Canada. The majority of space within its sites is devoted to the manufacture of test kit ingredients (antigens), DxTM, and QAPs. A skilled staff of more than 100 is employed in making Microbix’s products, which are critical for supporting public health in Ontario, across Canada, and around the world. Sales in fiscal 2021 reached C$ 18.6 million and are targeted to grow substantially for fiscal 2022 and beyond.
Dr. Ken Hughes, Microbix’s Chief Operating Officer, commented, “Our manufacturing spaces at 235 Watline have been designed to support our nearer-term scaling objectives for QAPs. We’re entirely committed to enabling Microbix to make QAPs at the volumes needed to support global-scale test-makers. With respect to DxTM, we are commissioning custom-designed production and warehousing spaces at 275 Watline. Dedication of our third site for DxTM production is intended to provide Ontarians and Canadians a secure and strategic-scale supply of this vital patient-sample collection device.”
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 production capacity or facilities expansions and their relevance or timing, 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:
Record Q1 Sales of $4.9 million, Record Q1 Net Earnings of $0.9 million
MISSISSAUGA, February 10, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, reports results for its first quarter ended December 31, 2021 (“Q1”), with record sales and 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
Q1 revenues achieved a record level of $4.9 million, up 54% from Q1 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 Q1 sales of $1.8 million versus zero in Q1 2021. Sales of antigens in Q1 were also $1.8 million (with improved margins) and royalties were higher than Q1 2021. Sales of test quality assessment products (“QAPs™”) for Q1 increased to $1.1 million, up 19% from Q1 2021. Overall, sales achieved a very favourable gross margin of 66% for Q1, in comparison to 55% in Q1 2021, and resulted in strong EBITDA and record operating and net income.
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.
Quarter Ending December 31, 2021 (“Q1”)
Q1 revenue was $4,855,600, a 54% increase from Q1 2021 revenues of $3,157,659. Included were DxTM revenues of $1,817,245 (Q1 2020 – nil), for strong segment performance. Antigen revenues were $1,766,416 (Q1 2020 – $2,137,829) down year-over-year but with a margin-favourable product mix in the quarter. QAPs revenues were $1,149,151 (Q1 2020 – $962,421) for segment growth of 19% and reflective of both seasonality and some of Microbix’s diagnostics industry customers pausing orders prior to launching new tests or test-platforms. Finally, royalties were $122,787 (2020 – $57,409). Q1 2022 sales growth was most influenced by Ontario-driven deliveries of DxTM, followed by continued diagnostics industry uptake of QAPs, and partly offset by weaker year-over-year antigen sales.
Q1 gross margin was 66%, up from 55% in Q1 2021, due to a greater proportion of sales of QAPs, new DxTM sales, and the effects of a favourable antigen product sales mix – all of which helped to improve margins.
Operating expenses in Q1 increased by 45% relative to Q1 2021, due to increased investment in R&D, additional selling and marketing spend, lack of eligibility for any Canada Emergency Wage Subsidies and no OTF grant funding (vs. Q1 2021). Overall, greater sales and more available gross margin dollars during Q1 led to operating and net income of $880,778 versus a Q1 2021 operating and net income of $130,819 (an increase of 573%). Cash used in operating activities was $284,014, compared to cash provided of $186,802 in Q1 2021, with most of the change from higher accounts receivables connected to late Q1 sales.
At the end of Q1, Microbix’s current ratio (current assets divided by current liabilities) was 5.20 and its debt to equity ratio (total debt over shareholders’ equity) was 0.41.
Corporate Outlook
Microbix will continue to drive sales growth across all of its three revenue-generating business lines, and work to keep improving percentage gross margins and driving bottom-line results. Management currently expects Microbix to generate meaningful net earnings growth across fiscal 2022. Additionally, work continues upon securing a partnership to advance its Kinlytic® urokinase project.
A replay of the webinar will also be made available on Adelaide Capital’s YouTube channel.
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 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:
Helping Ensure Workflow Accuracy of Tests for Respiratory Viruses
MISSISSAUGA, CANADA, February 1, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces the expansion of its portfolio of Quality Assessment Products (“QAPs™”) to include a swab-formatted control that helps validate the accuracy and integrity of the workflows of nucleic-acid based tests (e.g., “PCR” tests) for SARS-CoV-2 (“COVID”) Wuhan strain and the Omicron variant (“Omicron”) – the latter now being the most prevalent form of COVID.
Specifically, Microbix is commercializing its In-Vitro Diagnostic (“IVD”) quality control to support workflow accuracy of clinical laboratory PCR tests that aim to detect and differentiate SARS-CoV-2 Wuhan strain and Omicron infections. This innovative, proprietary, and branded control provides a fully-compliant, comprehensive, and cost-effective quality management tool to help avoid the systemic errors that can be driven by technicians, consumables, or instruments. Users of this IVD control will include lab accreditation agencies, makers of tests oriented to clinical labs or point-of-care, and clinical labs or medical clinics.
This Microbix Omicron QAP is made using Copan® FLOQSwabs® – the optimal format for accuracy and point-of-care use, and with room-temperature stability for 12 months. As for all Microbix’s QAPs, this latest IVD control contains all possible PCR targets and is validated on multiple test platforms. This new QAPs SKU is labelled REDx™FLOQ® SARS-CoV-2 B.1.1.529 SWAB POSITIVE CONTROL and is now available to support clinical laboratory quality management systems (“QMS”) covering central lab and point-of care workflows in both the U.S. and Canada. Research-Use-Only (“RUO”) PROCEEDx™FLOQ® versions are now available for other markets, with REDx® IVD versions to follow.
Microbix’s QAPs portfolio now consists of over 70 proprietary SKUs in the categories of respiratory, sexually-transmitted, and gastrointestinal infectious diseases. Of that portfolio, 17 QAPs are available as REDx Controls for IVD use by clinical labs. In addition to QAPs to support PCR-based testing for the most important respiratory illnesses, including all major COVID variants, Microbix also has IVD QAPs to support antigen-based respiratory pathogen tests (e.g., REDxFLOQ SARS-CoV-2 Ag). Microbix’s QAPs for PCR-test and Antigen-test support are also available as ONBOARDx™ kits that include both positive and negative controls for convenient qualification of new instruments for clinical use and for the training of laboratory staff. This portfolio of QAPs is in widespread use and can be paired with Microbix’s DxTM™ viral transport medium to enable collection and stabilization of patient test-sample specimens.
Cameron Groome, CEO and President of Microbix, commented “For optimal patient care and public health management, clinicians and lab directors need controls that can provide them justifiable confidence in the accuracy and reliability of their testing programs. Microbix’s suite of QAPs to support testing for respiratory pathogens is providing that essential support, driven by our ability to quickly respond to the emergence of new viruses or variants with pandemic-generating potential. We are pleased to add this Omicron-oriented QAP to maintain our complete coverage of all major COVID variants.”
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 QAPs and their relevance or timing, 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:
Follow-on Order from Government of Ontario Procurement Authorities
MISSISSAUGA, CANADA, December 24, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces receipt of a follow-on order of C$ 4.7 million for its viral transport medium (generically known as “VTM” and branded “DxTM™” by Microbix). DxTM is a sample-collection device that is essential for PCR-based testing for viruses that cause COVID-19 disease. This further order has been made by a procurement authority representing the Province of Ontario.
This entire order for DxTM is binding and is expected to result in C$ 1.75 million of revenues in the Q1 of fiscal 2022 ending 31 December, 2021. The balance of the order will be delivered across Q2 and Q3 of fiscal 2022; quarters respectively ending 31 March and 30 June, 2022.
Microbix’s DxTM is providing a secure and Ontario-made supply of highest quality VTM in strategically-relevant amounts. Specifically, DxTM is now supporting COVID-19 sample-collection by labs, pharmacies, public health units, and school systems across Ontario. Microbix remains the only domestic manufacturer of VTM to Ontario and is sourcing its critical raw materials from Canada-based suppliers.
The development of DxTM was assisted by a grant from the Ontario Together Fund (OTF) of the Ministry of Economic Development, Job Creation and Trade (MEDJCT) and by loan financing from the Federal Economic Development Agency for Southern Ontario (FedDev Ontario). Microbix is now proceeding to further scale its production of DxTM through full automation of its filling, capping, and labeling processes, with implementation to be completed at Microbix’s third Mississauga site in spring of 2022. Such scaling will enable Microbix to supply a greater proportion of Ontario’s needs while also becoming able to offer meaningful DxTM supplies to Federal and other Provinces’ agents, and to private testing laboratories.
DxTM provides excellent viral recovery and strong product shelf-life, in vials sized to fit swab segments up to 10 cm in length. DxTM product information is available at https://microbix.com and purchase enquiries can be e-mailed to customer.service@microbix.com. Clinical laboratories are also encouraged to use Microbix’s “QAPs™” IVD controls for COVID-testing, including for variants-of-concern and antigen tests.
Dr. Ken Hughes, COO of Microbix commented, “We are very pleased to be able to rapidly respond to Ontario’s needs for critical healthcare products such as our DxTM viral transport medium and QAPs IVD test controls – reliably delivering when and where these vital products are most needed. The secure and highest-quality domestic innovation and manufacturing that Microbix provides not only helps guard against supply disruptions, it also helps create health and prosperity for Ontarians and Canadians. Microbix is also delighted to note that we soon will hire our 100th full-time employee and expect to continue increasing our team of skilled life-sciences professionals here in Mississauga.”
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 collect 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 VTM or QAPs orders and their relevance or timing, 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:
Record Sales of $18.6 million, Record Net Earnings of $3.2 million
MISSISSAUGA, December 23, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, reports results for its year and fourth quarter ended September 30, 2021 (“2021” and “Q4”), with record sales and earnings, plus progress upon its strategic goal of increasing the proportion of revenues derived from medical devices.
Management Discussion
2021 revenues were up 77% from 2020, achieving a record level of $18.6 million as Microbix continues to emphasize operational excellence and the sale of innovative, proprietary, and branded medical devices. Sales of test quality assessment products (“QAPs™”) for 2021 increased 208% from fiscal 2020. Microbix’s new product line, viral transport medium (branded “DxTM™”) also contributed, with 2021 sales of $4.5 million. Finally, sales of antigens and product royalties were slightly higher than 2020 but with improved margins. Overall, sales achieved a favourable gross margin of 59% for fiscal 2021, in comparison to 44% in fiscal 2020 and resulted in strong EBITDA and record operating and net income.
Microbix continues to pursue growth in sales of its medical devices and expects that fiscal 2022 will realize positive net earnings, as for fiscal 2021.
Year ending September 30, 2021 (“2021”)
2021 revenue was $18,592,960, a 77% increase from prior-year revenue of $10,524,904. Included were antigen product revenues of $9,082,021 (2020 – $8,702,109), a recovery of 4%. QAPs revenues were $4,704,671, an increase of 208% from 2020 sales of $1,527,998. Finally, DxTM revenues were $4,506,900 (2020 – nil) and royalties were $299,368 (2020 – $294,797). 2021 sales growth was most influenced by the start of DxTM sales, followed by the broadening uptake of Microbix’s respiratory-disease related QAPs, especially PROCEEDx®FLOQ® and REDx™FLOQ®, and then a modest recovery in antigen sales.
2021 Gross margin was 59%, up from 44% in 2020, due to significant increase in higher margin QAPs sales, the start of DxTM sales, and changes in antigens product mix and improved yields. 2021 operating expenses increased by 20% from 2020, primarily due to year-over-year incremental foreign exchange losses, increased investment in sales and marketing, and U.S. investor relations efforts. Full-year fiscal 2021 interest accretion expenses related to debentures were up due to a $517,651 one-time and non-cash charge related to the proposed early repayment of the $1.3 million outstanding balance on a non-convertible debenture, repayment of which was made on October 1, 2021.
Stronger sales and improved gross margins led to an operating income of $4,836,595 and net income of $3,233,390 versus an operating loss of $524,601 and a net loss of $6,227,525 in 2020 (which included one-time write-downs totaling $4.6 million). Cash provided by operations (“CFO”) was $2,106,736, compared to $8,566 in 2020, influenced by growth in accounts receivable, offset by strong operating income.
At the end of 2021, Microbix’s current ratio (current assets divided by current liabilities) was 3.68 and its debt to equity ratio (total debt over shareholders’ equity) was 0.55. Both of these financial health ratios are materially improved from fiscal 2020.
Quarter Ending September 30, 2021 (“Q4”)
Q4 revenue was $5,629,694, a 108% increase from 2020 revenues of $2,705,732. Included were antigen revenues of $2,020,861 (2020 – $2,151,767). QAPs revenues were $1,195,545 (2020 – $505,898) for segment growth of 136%. In turn, revenue from DxTM was $2,327,600 (2020 – nil), and royalties were $85,689 (2020 – $48,067). Q4 2021 sales growth was most influenced by Ontario-driven deliveries of DxTM, followed by continued diagnostics industry uptake of QAPs, and helped by stable antigen sales at improved margins.
Q4 gross margin was 58%, up from 35% in Q4 2020, due to a greater proportion of sales of QAPs, new VTM sales, the effects of antigen product sales mix, and improving bioreactor-made antigen yields.
Operating expenses in Q4 increased by 63% relative to Q4 2020, due to increased investment in R&D/Sales and lack of eligibility for Canada Emergency Wage Subsidies during Q4 of fiscal 2021. Interest accretion expenses related to debentures were up by $501,878, for the reasons described in the above financial overview for 2021. Overall, greater sales and more available gross margin dollars during led to an operating income of $1,580,553 and net income of $778,929 versus a Q4 2020 operating loss of $82,111 and net loss of $4,982,997 (the net loss including one-time write-downs). Cash from operating activities was $1,621,621, compared to cash used of $216,083 in Q4 2020, with the majority of the increase coming from the favourable year-over-year growth in net income.
Corporate Outlook
Microbix will continue to drive sales growth across all of its three revenue-generating business lines, and work to keep improving percentage gross margins and driving bottom-line results. Management currently expects Microbix to generate meaningful net earnings growth across fiscal 2022. Additionally, work continues upon securing a partnership to advance its Kinlytic® urokinase project.
A replay of the webinar will also be made available on Adelaide Capital’s YouTube channel.
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 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:
Helping Ensure Workflow Accuracy of Tests for COVID, Flu A, Flu B, and RSV
MISSISSAUGA, CANADA, December 20, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces the expansion of its portfolio of Quality Assessment Products (“QAPs™”) to include single-unit swab-formatted controls that simultaneously support PCR tests for SARS-CoV-2 (“COVID”), Influenza A (“Flu A”), Influenza B (“Flu B”), and Respiratory Syncytial Virus (“RSV”), four of the most-common causes of viral infectious respiratory illness globally.
Specifically, Microbix is commercializing In-Vitro Diagnostic (“IVD”) quality controls to support workflow accuracy of “multiplex” clinical laboratory PCR tests that detect COVID, Flu A, Flu B, and RSV from a single patient-sample. These innovative, proprietary, and branded controls provide a fully-compliant, comprehensive, and cost-effective quality management tool to help avoid the systemic errors that can be driven by technicians, consumables, or instruments. Users of this IVD control will include lab accreditation agencies, makers of tests oriented to clinical labs or point-of-care, and clinical labs or medical clinics.
This Microbix multiplex QAP is made using Copan® FLOQSwabs® – the optimal format for accuracy and point-of-care use, with room-temperature stability for 12 months. As for all Microbix’s QAPs, this latest IVD control contains all possible PCR targets and is validated on multiple test platforms. This new QAPs SKU is branded REDx™FLOQ® SARS-CoV-2/Flu A&B/RSV Swab Positive Control and is now available to support clinical laboratory quality management systems (“QMS”) covering central lab and point-of care workflows in both the U.S. and Canada. Research-Use-Only (“RUO”) PROCEEDx®FLOQ® versions are now available for other markets, with REDx IVD versions to follow.
Microbix’s QAPs portfolio now consists of over 70 proprietary SKUs in the categories of respiratory, sexually-transmitted, and gastrointestinal infectious diseases. Of that portfolio, 16 QAPs are available as REDx™ Controls for IVD use by clinical labs. In addition to QAPs to support PCR-based testing for each of these important respiratory illnesses, Microbix also has IVD QAPs to support antigen-based respiratory pathogen tests (e.g., REDxFLOQ SARS-CoV-2 Ag). Microbix’s QAPs for PCR-test and Antigen-test support are also available as ONBOARDx™ kits that include both positive and negative controls for convenient qualification of new instruments for clinical use and for the training of laboratory staff. This portfolio of COVID-oriented QAPs is in widespread use and can be paired with Microbix’s DxTM™ viral transport medium to enable collection and stabilization of patient test-sample specimens.
Cameron Groome, CEO and President of Microbix, commented “For optimal patient care and public health management, clinicians and lab directors are rapidly moving to tests that can detect multiple infectious organisms from a single patient-sample. Microbix is therefore applying its expertise to develop the leading-edge “multiplex” test controls required to enable and accelerate this very positive evolution. I encourage clinical lab directors to reach out to Microbix or one of our nine distributors to sample these important new products for optimally-ensuring the quality of multiplex PCR-tests for respiratory viruses.”
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 QAPs and their relevance or timing, 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:
Helping Ensure Workflow Accuracy of PCR Tests for COVID “Variants of Concern”
MISSISSAUGA, CANADA, November 17, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces the expansion of its portfolio of Quality Assessment Products (“QAPs™”) to include controls that support PCR tests for each of the four major variants of concern (“VOCs”) of the SARS-CoV-2 virus that is the cause of the COVID-19 pandemic.
Specifically, Microbix has developed, and is now commercializing, In-Vitro Diagnostic (“IVD”) quality controls to support workflow accuracy of clinical laboratory PCR tests for the Brazilian (P.1), Delta (B.1.617), South African (B.1.351), and UK (B.1.1.7) VOCs. These four VOCs are in addition to QAPs for the original Wuhan strain of the virus and are made using COPAN® FLOQSwabs® – the optimal format for accuracy and point-of-care use, plus room-temperature stability for 12 months. As for all Microbix’s QAPs, these VOC products contain all possible PCR targets and are validated on multiple test platforms.
These new QAPs are branded as a REDx™FLOQ® SARS-CoV-2P.1, B.1.617, B.1.351 or B.1.1.7Swab Positive Control respectively and are available to support clinical laboratory quality management system (“QMS”) covering central lab and point-of care workflows in both the U.S. and Canada. Research-Use-Only (“RUO”) PROCEEDx®FLOQ® versions are now available for other markets, with REDx IVD versions to follow.
Microbix’s QAPs portfolio now consists of 70 proprietary SKUs in the categories of respiratory, sexually-transmitted, and gastrointestinal infectious diseases. Of that portfolio, 15 QAPs are available as REDx™ Controls for IVD use by clinical labs. Such Microbix REDx QAPs help manage the accuracy of workflows to avoid the systemic errors that result in false-negative or false-positive test results. Such errors occur and are consequential, as vividly demonstrated by the recent case of an estimated 43,000 false-negative COVID test results at a clinical lab doing COVID PCR testing on behalf of the UK’s National Health Service.
In addition to QAPs to support PCR testing for each of the most important COVID-19 strains, Microbix also has IVD QAPs to support COVID-19 antigen tests (REDxFLOQ SARS-CoV-2 Ag). Microbix’s QAPs for PCR-test and Antigen-test support are also available as ONBOARDx™ kits that include both positive and negative controls for convenient qualification of new instruments for clinical use and for the training of laboratory staff. This portfolio of COVID-oriented QAPs is in widespread use and can be paired with Microbix’s DxTM™ viral transport medium to enable collection and stabilization of patient test-sample specimens.
Cameron Groome, CEO and President of Microbix, commented “Microbix has been providing critical test ingredients to the diagnostics industry for over three decades. So it is our duty and privilege to apply that expertise to helping health authorities, clinical labs, test-makers, and lab accreditation agencies implement and conduct the widespread screening and diagnostic testing needed to mitigate the pandemic. I thank our staff, collaborators, suppliers, customers, and regulators for helping us to create these important new products and make them available to labs across Canada and the United States.”
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 QAPs and their relevance or timing, 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:
Further Capital to Assist with Increasing Capacity and Efficiency
MISSISSAUGA, CANADA, October 27, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces that it has received C$ 2.7 million from the partial exercise of two series of expiring share purchase warrants.
The first series of such warrants were issued in connection with a private placement undertaken in October, 2015, and had an exercise price of C$ 0.55 and a five-year term. The original term of these warrants was extended by one year, as announced by Microbix on September 17, 2020. A total of 1,200,000 of these warrants have been exercised, representing 80% of the total outstanding warrants and providing C$ 660,000 of further equity capital to Microbix.
The second series of such warrants were issued in connection with a private placement undertaken in October, 2017, and had an exercise price of C$ 0.36 and a three-year term. The original term of these warrants was extended by one year, as announced by Microbix on September 17, 2020. A total of 5,658,819 of these warrants have been exercised, representing 97% of the total outstanding warrants and providing C$ 2,037,175 of further equity capital to Microbix.
The total C$ 2,697,175 received from the exercise of these warrants more than offsets the funds used for the early repayment of the C $1.3 million 9% debenture made on October 1, 2021. As of today, Microbix has over C$ 11 million in cash on its balance sheet, along with an undrawn line of credit for up to C$2.0 million. Some of the available funds are being used to drive increasing production capacity for QAPs™ and DxTM™, and for increasing the capacity and efficiency of all operations – to improve margins and earnings.
A total of 375,002 of the 2017 warrants were exercised by Insiders, for whom the term extension was approved by shareholders at Microbix’s Annual General Meeting on March 30, 2021. After addition of all new shares resulting from warrant exercises, Microbix has 129,967,086 common shares outstanding.
Cameron Groome, CEO and President of Microbix, stated, “We greatly appreciate the confidence that our shareholders are demonstrating by exercising their expiring warrants to purchase common shares. We commit to appropriately deploy the additional equity capital that they are committing. Such new equity capital will be used to create further value for our shareholders by helping enable Microbix to support much greater sales and achieve better gross margins and net earnings.”
Jim Currie, CFO of Microbix, also commented, “With these warrant exercises and our recent debenture repayment, Microbix now has a debt-to-equity ratio of less than 0.5 and a current ratio of over 4.0. This financial strength helps demonstrate to prospective customers that we are a reliable long-term partner and should thereby accelerate the growth of our business. Among other matters, our available funds and ongoing positive cash flow are being used to add new product development labs and manufacturing spaces, and to upgrade quality management and enterprise resource planning systems.”
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 the warrant exercises 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:
Advanced SARS-CoV-2 Variants of Concern (VOC) whole genome materials for use as verification, external quality assessment (EQA) and prospective quality control samples
$1.3 million balance repaid, improving cash flow and resulting in non-cash charge
MISSISSAUGA, CANADA, October 4, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces that it has completed the early repayment of a debenture series on which it owed C$ 1.3 million and was paying an interest rate of 9.0%.
This debenture was issued on January 31, 2014 for an outstanding amount C$ 2.0 million and was subsequently being repaid via quarterly payments of interest and principal of $61,100. At October 1, 2021, the balance owing on this debenture was C$ 1,331,758 which has now been fully-repaid. The repayment was made on the basis of a debenture provision permitting early repayment given at least 90 days’ notice.
Microbix elected to fully repay this debenture due to its strong cash flow generation, which has resulted in a positive cash balance of C$ 10.0 million at September 30, 2021, additional to which Microbix has an undrawn line of credit of up to C$ 2.0 million on which it would pay an interest rate of 4.45%. It therefore made little sense to keep this 9% debenture outstanding until its scheduled maturity date of January 31, 2029. Management calculates that this early repayment will add C$ 244,400 to annual cash flow, also meaningfully reducing interest-related outlays and improving the strength of Microbix’s balance sheet.
As a counterpoint to the very real financial benefits of the early repayment of this debenture, there will be a one-time and non-cash charge upon Microbix’s earnings in the fiscal first quarter ending December 31, 2021 (“Q1 2022”). This one-time and non-cash charge is created due to this early and complete repayment expunging capitalized costs associated with the terms of issuance of the debenture that were being expensed over the full term of the debenture. Under the associated “IFRS” accounting rules, the amount of that one-time and non-cash expense is estimated at $0.5 million, which will be charged against Microbix’s earnings for Q1 2022 and the fiscal-year ending September 30, 2022 (“Fiscal2022”). For clarity, Microbix expects that it will remain strongly net earnings and cash flow positive for Q1 2022 even with this one-time and non-cash charge, as it should be for the broader 12-months of Fiscal 2022.
Cameron Groome, CEO and President of Microbix, stated, “Over the course of fiscal 2021, our team has realized long-planned improvements in margins on Microbix’s antigens business, driven triple-digit percentage growth of our sales of innovative, proprietary, and branded QAPs, and successfully-delivered upon creating a secure domestic supply of highest-quality viral transport medium for Ontario. As a direct consequence of those achievements, we now have the ability to repay higher-cost corporate debt.”
Jim Currie, CFO of Microbix, also commented, “The growing financial success of Microbix enables us to provide early repayment of more expensive debt, and still have ongoing availability of lower-cost debt capital if it proves to be needed for future corporate initiatives. The current debenture repayment provides a lasting improvement to Microbix’s cash flow and helps demonstrate our financial stability to current and prospective customers and business partners.”
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 90 skilled employees and sales nearing C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 the debenture repayment and its 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:
MISSISSAUGA, CANADA, September 27, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces that it has been invited to present about the performance of its COVID-19 test quality assessment products (QAPs™) at “AACC” the annual scientific meeting & clinical laboratory exposition of the American Association of Clinical Chemistry, taking place in live and virtual formats from Atlanta, GA, September 26-30, 2021.
The abstract poster presentation is titled “Advanced SARS-CoV-2 Variants of Concern (VOC) whole genome materials for use as verification, external quality assessment (EQA) and prospective quality control samples.” It reviews the performance of Microbix’s novel, innovative, and proprietary PROCEEDx™FLOQ® branded QAPs, formatted on Copan® FLOQ®Swabs and room-temperature stable, for use to help verify the performance of nucleic acid amplification tests (NAATs) that detect SARS-CoV-2 and variants of concern (VOCs). Results reported relate to the B.1.1.7, B.1.351, P.1, and WT variants, formerly known as the UK, South African, Brazilian, and Wuhan strains. The results demonstrate that these Microbix QAPs are compatible with over 20 widely-used COVID-19 NAATs, including those that can detect and differentiate VOCs.
Such results continue to demonstrate how Microbix is addressing the need for workflow controls to effectively support the quality objectives of testing for SARS-CoV-2 variants of concern, as for all forms of testing relating to the pandemic. The overall Microbix QAPs portfolio now comprises more than 70 distinct products across multiple categories of infectious diseases, test types, and test formats.
The abstract presentations were co-authored by ten members of Microbix’s product development (R&D), operating, and customer support teams, led by Pavel Zhelev, Director of Product Management (QAPs), and Dr. Amer Alagic, Director of R&D. The poster details the performance results of the QAPs in a complete and succinct fashion and will be made available on the company website, https://microbix.com, upon their presentation at AACC 2021 on September 29. The poster includes Microbix’s thankful acknowledgement of five collaborator organizations in Canada and internationally.
Purchase enquiries for Microbix’s QAPs can be directed to one of its nine distributors for the Americas, Australasia, Europe, and Scandinavia, as cited later in this news release. QAPs product enquiries can also be e-mailed directly to Microbix at customer.service@microbix.com.
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 90 skilled employees and sales now approaching C$ 2.0 million per month. It makes a wide range of critical biological materials 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. 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 AACC, the abstract, or its relevance, Microbix’s collaborators and their tests, the referenced product lines or their uses, 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 https://microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
customer.service@microbix.com 
+1-905-361-8910 +1-800-794-6694 (Toll Free)
