- Sales increase driven by first sales of COVID-19 Antigen Rapid Test in Europe after January 2021 CE Mark approval
- Awarded two new patents for InFoods® diagnostic guided therapy technology, including the first Japanese patent
- InFoods® IBS diagnostic-guided therapy clinical trial expecting top line trial results by the third calendar quarter of 2021
IRVINE, Calif., April 15, 2021 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today announced its fiscal third quarter 2021 financial results for the three months ended February 28, 2021.
The Company reported consolidated sales of $3.62 million for the fiscal third quarter of 2021, compared to $1.18 million for the same period in fiscal 2020, an increase of 208%. The increase in revenues during the quarter was primarily due to sales of the Company’s 15-minute COVID-19 Antigen Rapid Test in Europe, after its January 2021 CE Mark approval, as well as increased sales for several of the Company’s other diagnostic products. For the nine months ended February 28, 2021, consolidated net sales for Biomerica increased 55% to $6.14 million compared to $3.97 million for the same period in fiscal 2020.
The Company’s cost of sales for fiscal third quarter 2021, included an exceptionally large inventory reserve of approximately $1.43 million. Gross margin excluding this exceptionally large inventory reserve would have been 38%. During the quarter the company increased its investment in research and development which is largely focused on several COVID-19 tests and ongoing development of the InFoods® IBS product. The Company incurred higher general and administrative expenses, mainly due to higher reserves, and increased legal, personnel and consulting costs related to the Company preparing for anticipated growth related to the InFoods® Technology, and possible commercialization of other products in the pipeline. Net loss for the fiscal third quarter 2021 was $1.84 million compared to a net loss of $0.86 million for the same period in fiscal 2020. During the fiscal third quarter, the Company recorded a receivables reserve of $0.29 million and recorded a non-cash charge of $0.24 million for stock-based compensation related to the annual equity (stock option) awards granted to its Board of Directors and senior managers. Excluding the exceptionally large inventory and receivables reserves, and the non-cash annual compensation charge, the Company would have reported a profit for the quarter.
Cash and cash equivalents were $5.27 million, and current assets were $10.78 million, on February 28, 2021.
Zack Irani, Chairman and Chief Executive Officer of Biomerica, commented, “This was a strong quarter for the Company. First and foremost, we’ve made great progress enrolling patients for our InFoods® IBS endpoint clinical trial in a tough pandemic environment, with some of the most respected healthcare institutions in the world, including Mayo Clinic, Beth Israel Deaconess Medical Center, Inc., a Harvard Medical School teaching Hospital, Houston Methodist, University of Texas Health Science Center at Houston, and the University of Michigan. While COVID-19 has delayed this clinical trial, we still expect to have top line analysis from this clinical trial by the end of the third calendar quarter of 2021.
“InFoods® IBS is a patented product addressing the $30 billion Irritable Bowel Syndrome market where surprisingly little relief is currently available for patients. Our product is a disruptive technology redefining how patients with gastrointestinal diseases can be treated. InFoods® goes beyond simply treating symptoms of disease, it also is designed to help identify one of the underlying causes. If cleared, InFoods® IBS will be the first FDA-regulated diagnostic therapy identifying both the problematic foods of IBS patients, as well as alleviating the symptoms, offering broad appeal to patients, physicians and insurers. We are also excited to announce we now have six issued patents related to our InFoods® IBS product and platform technology, with many more in active prosecution and review. These patents should provide us strong protection from competition as we plan to launch these products into the market.
“Alongside the progress we are making with InFoods®, the Biomerica team is working with leading institutions to quickly launch accurate COVID-19 tests while maintaining our commitment to providing these tests at a low cost,” Mr. Irani continued. “We have applied our technology and expertise to bring to market COVID-19 tests that drove significant revenue growth in the quarter, and we are encouraged by the traction we saw in Europe and look forward to expanding into other markets to bring our solution to more patients around the world. At the same time, the FDA continues to review our EUA submission for our products in the U.S. market.
“While we are proud to be helping with the current global pandemic and believe that there are considerable revenue opportunities for testing around the world, it is important to note that our primary long-term focus continues to be on validation and commercialization of products based on our patented InFoods® technology platform. Our improved financial results in the quarter demonstrate the earnings leverage in our business model given our low-cost structure and focus on high ROI products. We continue to believe our InFoods® products could revolutionize the way people are treated for a variety of gastrointestinal diseases, while offering Biomerica sizable revenue opportunities,” Mr. Irani concluded.
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’s 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 45 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 tests, FDA clearance, EUA clearance, the rapidity of testing results, uniqueness of a product, accuracy of products, pricing of the Company’s test kits, demand for international orders, availability of the Company’s COVID-19 test kits, and patent protection on the test technology. 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; regulatory approvals necessary prior to commercialization of the Company’s COVID-19 tests; availability of the Company’s COVID-19 test kits; 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 COVID-19 tests; 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 technology. 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.
1. medRxiv preprint doi: https://doi.org/10.1101/2020.03.30.20047365. Accessed 15Jun20
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