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Biomerica Reports Results for Fiscal First Quarter ended August 31, 2021

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·8 min read
In this article:
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  • Revenues up 10% over fiscal first quarter 2021, and 20% over fiscal fourth quarter 2021

  • Customer orders backlog of over $1.5 million at August 31, 2021

  • Following close of first fiscal quarter 2022, Walmart began online sales of Biomerica’s EZ Detect™ Colorectal Screening Test, in-store sales expected soon

  • Final patients enrolled in InFoods® IBS endpoint trial, with topline trial results expected by calendar year end

IRVINE, Calif., Oct. 15, 2021 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical products, today reported its first quarter fiscal 2022 financial results.

Net sales for the three months ended August 31, 2021 were $1.2 million as compared to net sales of $1.1 million for the same three months in fiscal 2021, an increase of $0.1 million, or 10%. On a sequential basis, revenue grew 20% compared to the fourth quarter of fiscal 2021. Net loss decreased to $1.5 million for the three months ended August 31, 2021 compared to a net loss of $1.9 million for same three months in fiscal 2021. Cash flows from operations were positive for the quarter ended August 31, 2021. Cash increased from $4.2 million at May 31, 2021 to $5.0 million at the quarter end, August 31, 2021.

Sales, general and administrative expenses for the three months ended August 31, 2021 were $1.0 million, compared to $1.3 million for the same period in the previous year. The decrease was mainly due to a higher allowance for doubtful accounts and higher legal expenses for the same period in previous year. Research and Development (R&D) expense was $0.4 million for the three months ended August 31, 2021 compared to $0.7 million the same period in the previous year, a decrease of over 38%. The decrease in R&D investment expense was primarily due to the completion of the development of several COVID-19 tests in prior year.

Recent Developments:

  • InFoods® Endpoint Study Completion: The final patients were enrolled in InFoods® IBS endpoint trial and Biomerica is on track to have topline results of its InFoods® IBS Endpoint trial by end of December, 2021. It is estimated that over 40 million Americans suffer from IBS. IBS symptoms are often triggered by consumption of specific foods (which are unique in each sufferer). The total direct and indirect cost of IBS has been estimated at $30 billion annually in just the United States.

  • Walmart: Following the close of the first quarter, Walmart began online sales of the Company’s EZ Detect™ Colorectal Disease Screening Test. The Company also expects that the EZ Detect product will be on the shelf at Walmart stores within weeks. In addition, Biomerica is in negotiations with several large partners for distribution of the EZ Detect™ product in Asia, Europe and the Middle East. Colorectal cancer is the second most common cause of cancer deaths in the United States in men and women combined. It's expected to cause approximately 52,980 deaths during 2021.

  • H. pylori: The Company expects to file for FDA 510(k) clearance before the end of the calendar year. While recently finalizing the clinical trials for this product, the Company found one study needed to be repeated. The Company is now preparing to repeat the study and expects to file FDA clearance by year-end. The Biomerica hp+detect™ product detects the presence of the H. pylori bacteria which infects approximately 35% of the U.S. population. Over 80% of gastric cancers are attributed to H. pylori infection, and gastric cancer is the third most common cause of cancer-related death worldwide. Physicians and medical centers can use hp+detect™ to diagnose the presence of H. pylori and to monitor the efficacy of treatment.

  • Customer order backlog: At August 31, 2021 customer order backlog for the Company was $1.5 million, a majority of which is expected to be shipped in the fiscal second quarter.

“We continued to see strong momentum during the first quarter of 2022, both in relation to our progress with our InFoods® endpoint trial as well as with the demonstrated interest around our specialty diagnostic products,” stated Zackary Irani, CEO of Biomerica. “Our customer order product backlog of $1.5 million entering the second quarter demonstrates the appeal of our products. Also, just after the close of the quarter, we announced that Walmart has begun selling our EZ Detect™ Colorectal Screening test, with a first step of offering the product online and an expected in-store offering soon to follow. We expect this will bring significant exposure to this product going forward. Finally, we are moving forward with the development of our H. pylori test and we anticipate filing for FDA clearance for this product before the close of the calendar year. The pandemic has accelerated consumer demand for in-home testing alternatives. We believe our ability to provide easy-to-use, high-quality, in-home diagnostic tests that promote the early detection and expedient treatment of several serious diseases, positions Biomerica to significantly benefit from this shift in the market.”

About Biomerica (NASDAQ: BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focus is on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.

About InFoods®
The Biomerica InFoods® IBS product is designed to allow physicians to identify patient specific foods (e.g. eggs, broccoli, wheat, potatoes, corn, etc.), that when removed from the diet, may alleviate or improve an individual's IBS symptoms including, but not limited to, constipation, diarrhea, bloating, pain and indigestion. This patented, diagnostic-guided therapy is designed to allow for a patient specific, guided dietary regimen to improve IBS outcomes. The point-of-care product is being developed to allow physicians to perform the test in-office using a finger stick blood sample while a clinical lab version of the product is expected to be the first for which the Company will seek regulatory approval. A billable CPT code that can be used by both clinical labs and physicians' offices is already available for InFoods® diagnostic products. Since the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects. An estimated 40 million people in America currently suffer from IBS, making it a leading cause for patient doctor visits.

The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the efficacy of the Company’s COVID-19 product, hp+detect product and other tests, FDA clearance of the Company’s products including the COVID-19 and hp-detect product, Health Canada and CE Mark clearance of these products, the rapidity of testing results, uniqueness of the Company’s products, test result accuracy of products, expected completion of clinical studies, pricing of the Company’s test kits, demand for domestic or international orders, potential revenues from the sale of current or future products, availability of the Company’s test kits, patent protection and freedom to operate on any of the Company’s products or technologies, future production costs and overhead, sales and administrative costs, R&D expenditures, materials costs, needed inventory reserves, collectability of receivables, legal costs and other extraordinary costs. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; results of studies testing the efficacy of the Company’s InFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company’s products; availability of the Company’s test kits and other products; capacity, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; regulations and the Company’s ability to obtain patent protection on any aspects of its rapid test technologies. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.

Corporate Contact:

John Nesbett /Jennifer Belodeau
IMS Investor Relations
203.972.9200
jnesbett@institutionalms.com

Source: Biomerica