- Fiscal fourth quarter revenues increase 133.7% over the prior year
- Fiscal 2020 revenues increase 28.7% over fiscal 2019
- New InFoods® patent granted for Singapore
IRVINE, Calif., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today reported net sales for the fiscal year ended May 31, 2020 were $6.7 million versus net sales of $5.2 million in fiscal 2019. This represents an increase of $1.5 million, or 28.7%. Net loss was $2.3 million for fiscal 2020 compared to net loss of $2.4 million for fiscal 2019. Research and Development investment was $1.9 million for fiscal year 2020 compared to $1.7 million the previous year, an increase of over 13%. Year-end cash and cash equivalents were $8.6 million in fiscal 2020 versus $0.7 million in fiscal 2019 while current assets were $14.8 million in fiscal 2020 versus $4.5 million in fiscal 2019.
The Company also announced that it has been granted a patent for its InFoods® Diagnostic Guided Therapy for Irritable Bowel Syndrome (“IBS”) in Singapore.
Fiscal Year 2020 Highlights:
- Biomerica was granted its second U.S. patent and first patent in Japan covering a Diagnostic Guided Therapy (“DGT”) for Irritable Bowel Syndrome. These patents cover the Company’s InFoods® family of products that allow for revolutionary diagnostic guided therapy option for patients suffering from Irritable Bowel Syndrome and other gastrointestinal diseases once cleared. It is estimated that over 40 million Americans suffer from IBS and the symptoms can be triggered by consumption of specific foods (which are unique in each sufferer). The total cost (direct + indirect) of IBS has been estimated at $30 billion annually in the United States.
- Biomerica significantly expanded its InFoods® IBS DGT clinical trial by signing definitive agreements with Mayo Clinic, Houston Methodist (part of Texas Medical Center, the largest medical complex in the world) and University of Texas Health Science Center at Houston. These leading institutions are joining Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, and the University of Michigan as enrollment centers for this study.
- During the fiscal fourth quarter, the Company began marketing and selling outside of the U.S. a disposable rapid finger-prick blood test, which detects COVID-19 IgG/IgM antibodies within 10 minutes. This test is designed to be performed by trained medical professionals, e.g. airports, schools, work, pharmacies and doctors’ offices. Additionally, a recently published Canadian study reported that Biomerica’s rapid test showed 100% sensitivity and 100% specificity (https://www.studyfinds.org/not-all-covid-19-antibody-tests-are-created-equal-but-which-ones-are-best/) Published in Diagnostics 2020, 10, 453; July 2020.
- The Company submitted to the Federal Drug Administration (“FDA”) an Emergency Use Authorization (“EUA”) application for an ELISA lab-based serology blood test for the detection of antibodies that identify if a person has been infected with the novel Coronavirus. The data submitted to the FDA under the EUA application showed 100% specificity and 0% cross reactivity with many common disease states as well as 100% positive predictive value and 99.8% negative predictive value. The EUA was a full submission that the Company believes provided all required information. It is still pending FDA clearance. This ELISA test can utilize a unique and proprietary whole blood sample collection method.
- The Company has filed over 100 international and PCT patents and has 22 provisional and non-provisional patents currently filed with the U.S. Patent and Trademarks Office. Some of these patent applications pertain to COVID-19 and other products. However, the majority of Biomerica’s pending patents pertain to the InFoods® DGT technology platform. The InFoods® DGT technology platform patents and research include other disease states: functional dyspepsia, Crohn’s Disease, ulcerative colitis, gastroesophageal reflux disease (“GERD”), migraine headaches, and osteoarthritis.
- The Company strengthened its balance sheet with current assets exceeding $14 million as of May 31, 2020.
- Biomerica strengthened its management team and Board of Directors with the appointment of Steve Sloan as the Company’s new Chief Financial Officer effective September 3, 2020. Mr. Sloan’s background and experience includes thirteen years at General Electric and recently, Mr. Sloan spent ten years with medical device maker, Medtronic. At Medtronic, Mr. Sloan worked in four divisions, most recently serving as a divisional finance director. The Company also announced the addition of Ms. Cathy Coste as a new, independent member of the Board or Directors. Cathy will join the Board effective September 3, 2020. Ms. Coste has also been elected by the Board to chair the Board’s Audit Committee, and to be a member of the Nominating and Corporate Governance Committee. Cathy Coste is a Senior Partner at Deloitte and Touche, LLP, where she has spent thirty-two years in audit and advisory services to global corporations.
- The Company completed its patient recruitment portion of clinical trials to be submitted to the FDA for clearance of the Company’s H. Pylori diagnostic product (hp+detect™). Helicobacter pylori infection is one of the most common, chronic, bacterial infections affecting humans and complications include ulcers, inflammation of the stomach lining and stomach cancer.
“Biomerica technology platforms aim to make the world a safer and healthier place. The world has large, unresolved health issues, several of which Biomerica is uniquely positioned to resolve via our InFoods® diagnostic-guided therapies, once approved by regulators. At the same time, we used our technology and expertise to help in the COVID-19 pandemic by offering a disposable rapid finger-prick blood test, which detects COVID-19 IgG/IgM antibodies within 10 minutes. Additionally, we submitted to the FDA a EUA application for an ELISA lab-based serology blood test for the detection of antibodies that identify if a person has been infected with the COVID-19 virus. This ELISA test is unique by simplifying the blood sample collection process in a proprietary way. This EUA was a full submission that we believe provided all required information. It is still pending FDA clearance. Our focus in fiscal 2020 was 1) expansion of the clinical trials for our InFoods® IBS diagnostic guided therapy product, 2) the marketing and sales of COVID tests outside the USA, 3) the submission of an EUA for our ELISA test, 4) securing Intellectual Property protection for the many new products we are developing, primarily focusing on the InFoods® diagnostic guided therapy technology, 5) moving additional InFoods® diagnostic guided therapy products for other disease states forward. Our focus on COVID-19, R&D and IP protection did require a significant increase in patent-related and general legal expenses in fiscal 2020. We see these IP and clinical expenses as an investment with the potential for large returns, as any of these new products achieve FDA clearance,” 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 test, FDA clearance, EUA clearance, the rapidity of testing results, uniqueness of a product, 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 test; regulatory approvals necessary prior to commercialization of the Company’s COVID-19 test; 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 COVID-19 test; 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.