- Revenues increase 7.6% for fiscal 2021 vs fiscal 2020.
- InFoods® IBS Endpoint Trial expected to be fully enrolled in less than 2 weeks.
- Biomerica receives multiple notices of allowance for patents covering the InFoods® Technology Platform providing patent protection through 2036.
- Biomerica expects to file for FDA 510K clearance for its H. Pylori product in October, 2021. H. Pylori infects approximately 35% of the U.S. population.
- Biomerica negotiating sales agreements with major retailers/distributors for its EZ Detect™ colorectal disease test.
IRVINE, Calif., Aug. 27, 2021 (GLOBE NEWSWIRE) — Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical products, today reported its fiscal 2021 financial results. During the year the Company made significant progress in its business by increasing its number of allowed patents covering its InFoods® diagnostic guided therapy technology, signing a distribution agreement for its H. Pylori product which is expected to be filed with FDA in October, 2021, and has entered into negotiations with major retailers/distributors for sales of its EZ Detect colorectal disease test.
Net sales for the fiscal year ended May 31, 2021 were $7.2 million as compared to net sales of $6.7 million in fiscal 2020, an increase of $0.5 million, or 7.6%. Net loss was $6.5 million for fiscal 2021 compared to a net loss of $2.3 million for fiscal 2020. Research and Development investment was $2.4 million for fiscal year 2021 compared to $1.9 million the previous year. The increased net loss for fiscal 2021 was primarily related to the Company’s establishment of a large inventory reserve for COVID-19 antibody tests during the third fiscal quarter, an increase of $0.5 million in R&D costs, much of which was related to finalizing the InFoods endpoint determination clinical trial, and increased SG&A expenses associated with the expansion of the Company’s management team. The 2021 7.6% increase in revenue follows an increase in revenues of 38.4% for fiscal 2020 versus fiscal 2019. Revenues for both fiscal 2020 and 2021 were positively impacted by sales of our COVID-19 related products, however COVID-19 had a negative impact on revenues of our core diagnostic products. At this point the Company’s core product sales have largely returned and with the COVID-19 Delta variant spreading, the Company is seeing increasing demand for its COVID diagnostic tests. The Company will continue to sell and market its COVID-19 products while maintaining its focus on its core diagnostic business and its further development of the InFoods® platform.
Fiscal Year 2021 and Recent Developments:
- InFoods® Endpoint Study Completion: Biomerica expects to enroll the final patients for its InFoods IBS clinical trial in September 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.
- Intellectual Property: During fiscal 2021, Biomerica was granted three patents for its InFoods® diagnostic therapy technology (“DGT”). The patents were granted in the United States, Singapore and Korea. These patents cover the Company’s InFoods® family of products that allow for a one-of-a-kind diagnostic-guided therapy option for patients suffering from Irritable Bowel Syndrome (“IBS”) and other gastrointestinal diseases once cleared. The Company now has 9 allowed patents, has filed over 100 international and Patent Cooperation Treaty patents; and has 22 provisional and non-provisional patents currently filed with the U.S. Patent and Trademarks Office. The majority of Biomerica’s pending patents pertain to the InFoods® DGT technology platform. The InFoods® DGT technology platform includes other diseases: functional dyspepsia, Crohn’s Disease, ulcerative colitis, gastroesophageal reflux disease (“GERD”), migraine headaches and osteoarthritis.
- InFoods® Depression Patent: The Japanese Patent Office recently issued a notice of allowance for Biomerica’s first patent pertaining to a new treatment option for patients suffering from depression. It is now well established that dysregulation of the immune system occurs in depressed patients, and inflammatory processes have been linked to the pathophysiology of depression. In addition, there is considerable recent clinical research which shows strong correlation between IBS and depression. Depression represents the number one cause of disability worldwide and can be fatal.
- H. pylori: Biomerica signed an exclusive five-year distribution agreement with a Canadian partner for the distribution and marketing of Biomerica’s new and proprietary Helicobacter pylori (“H. pylori”) test, called hp+detect™. The 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. The Company is working to complete its clinical studies for its H. pylori test in September 2021, and plans to file for FDA clearance in October, 2021.
- New Website for EZ Detect™ Colorectal Disease Screening Test: Biomerica launched a new website for the EZ Detect™ Colon Disease at-home test product (https://ezdetect.com). The site features streamlined functionality and easy access to essential and potentially life-saving information about detection and treatment of colorectal diseases, including colon cancer. The new site launched alongside a digital health advertising and social media campaign to promote and drive sales of Biomerica’s EZ Detect™ product.
- Retail opportunities for EZ Detect™ Colorectal Disease Screening Test: The Company is in discussions with major retailers to increase the U.S. and international distribution of the EZ Detect™ Colon Disease Test by adding the product to their online and in-store offerings. 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.
“Biomerica made a great deal of progress during fiscal 2021 and we’re encouraged by the opportunities we’re seeing to bring our products to a broader audience of patients and medical professionals. Our InFoods® IBS diagnostic guided therapy endpoint trial is very close to completion. The product addresses the $30 billion IBS market where surprisingly little relief is currently available for patients. 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. This offers broad appeal to patients, physicians and insurers. Moving forward, we are also optimistic about the market potential for our EZ Detect and H. pylori products. During fiscal 2021, like many in our industry, we encounter challenges related to COVID-19 including having to make a reserve for COVID-19 inventory manufactured early in the pandemic, due to limited knowledge about what products would best address the crisis. Our gross margin and losses during the year were negatively impacted by these reserves for our early COVID-19 tests. We do not anticipate any further significant R&D effort or reserves for these COVID-19 tests going forward and these tests are now incorporated into our other specialty diagnostic tests and,” stated Zackary Irani, CEO of Biomerica.
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 (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.
John Nesbett /Jennifer Belodeau
IMS Investor Relations