- Revenues up 239% over prior year fiscal second quarter
- Customer orders backlog of over $4.0 million at November 30, 2021
- Walmart began in-store and online sales of Biomerica’s EZ Detect™ Colon Disease Test during fiscal second quarter
- InFoods® IBS endpoint trial is complete, topline trial results expected by the end of January
IRVINE, Calif., Jan. 13, 2022 (GLOBE NEWSWIRE) — Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical products, today reported its second quarter fiscal 2022 financial results.
Net sales for the three months ended November 30, 2021 were $4.6 million as compared to net sales of $1.4 million for the same three months in fiscal 2021, an increase of $3.2 million, or 239%. On a sequential basis, revenues grew 268% compared to the first quarter of fiscal 2022. Net loss decreased to $1.1 million for the three months ended November 30, 2021 compared to a net loss of $1.7 million for the same three months in fiscal 2021. Cash flows from operations were positive for the quarter ended November 30, 2021. Cash on hand increased to $7.2 million at November 30, 2021 from $4.2 million at fiscal year-end May 31, 2021.
Sales, general and administrative expenses for the three months ended November 30, 2021 were $1.3 million, compared to $1.4 million for the same period in the previous year. The decrease was mainly due to lower legal expenses compared to the same period in the previous year. Otherwise, expenses were similar to the prior year quarter.
- InFoods® Endpoint Study Completion: The final patients were enrolled in the InFoods® IBS endpoint trial and Biomerica is on track to have topline results by end of January, 2022. Rather than simply treating the symptoms of IBS, the InFoods® IBS platform is designed to identify the unique foods that trigger or worsen IBS symptoms in individual patients, paving the way for more effective treatment. 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 the United States alone.
- Walmart/EZ Detect: During fiscal second quarter 2022 Walmart began online and instore sales of the Company’s EZ Detect™ Colon Disease Test. In addition, Biomerica is in negotiations with other large partners for distribution of the EZ Detect™ product in Asia 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 February, 2022. 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 monitor the efficacy of treatment.
- Customer order backlog: At November 30, 2021, outstanding unfilled customer orders (backlog) were over $4.0 million. The Company expects to ship most of these orders in the fiscal third quarter ended February 28, 2022, along with other orders that are placed during the quarter.
“We continued to see strong momentum during the second quarter of 2022, both in terms of finalizing the data analysis of our InFoods® endpoint trial and sales of our specialty diagnostic products,” stated Zackary Irani, CEO of Biomerica. “We are looking forward to releasing the results of our InFoods® IBS clinical trial along with our Principal Investigators at Mayo Clinic, Beth Israel Medical Center Inc., a Harvard Medical School Hospital, the University of Michigan University Hospital, the Texas Health Science Center at Houston, and Houston Methodist (part of Texas Medical Center, the largest medical complex in the world). Additionally, we are in the process of completing the studies necessary for us to file for FDA clearance for our H. Pylori diagnostic test. What’s more, the pandemic has accelerated consumer demand for in-home and point-of-care testing alternatives, which has resulted in increased sales for our COVID-19 testing products and our other in-home testing products. Overall, this was a successful quarter for our Company. As we look to the future, we’re excited about our possibilities of enhancing people’s lives with science, diet and technology.”
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.
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 contains statements that are forward-looking, such as statements relating to the Company’s estimated future financial results, demand for the Company’s products, the Company’s ability to fulfill orders, and possible success of our clinical trials. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the efficacy of the Company’s COVID-19 tests, InFoods® products, hp-detect® test and other products and tests; actual efficacy of the Company’s COVID-19 tests, InFoods® products, hp-detect® test and other products and tests; expected completion of clinical studies and trials; the rapidity of testing results; uniqueness of the Company’s products; regulatory approvals necessary prior to commercialization of the Company’s hp+detect® test, InFoods IBS® test and other products and tests, including FDA clearance, approval by Health Canada, attaining CE Mark and approvals from other international regulatory agencies; availability of the Company’s test kits and other products; capacity, resource and constraints on our suppliers; efficacy of the Company’s COVID-19 tests, InFoods® products, hp-detect® test and other products and tests; regulatory approvals necessary prior to commercialization of the Company’s hp+detect® test, InFoods IBS® test and other products and tests; dependence on our suppliers; 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 could make it difficult or impossible for the company to maintain current operations; the Company’s ability to comply with current and future regulations in the countries where our products are made and sold and the Company’s ability to obtain patent protection and freedom to operate on any aspects of its rapid test 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. 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.
John Nesbett /Jennifer Belodeau
IMS Investor Relations