Biomerica Reports Fiscal 2023 Year End Results

• Revenues excluding Covid test sales increased 15% for fiscal 2023 vs fiscal 2022
  
  

• Successfully completed inFoods^® IBS pilot program with one of the largest Gastrointestinal physician groups in the US
  
  

• inFoods IBS completes pre-launch phase; Veteran VP of sales and national accounts hired; On track for national launch by calendar Q1 2024

IRVINE, Calif., Aug. 25, 2023 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: ), (the “Company”) a global provider of advanced medical products, today reported its fiscal 2023 financial results.

Net sales for the fiscal year ended May 31, 2023 were $5.3 million as compared to net sales of $18.9 million in fiscal 2022. Net loss was $7.1 million for fiscal 2023 compared to a net loss of $4.6 million for fiscal 2022. The decrease in sales for fiscal 2023 was related to the Company’s decrease in sales of COVID-19 antigen tests in fiscal 2023 compared to the prior fiscal year. Sales revenues excluding Covid test sales increased by 15% for fiscal 2023 compared to fiscal 2022.

The Company also announced the successful advancement of the inFoods^® IBS pilot commercialization program at the flagship office of Gastro Health, one of the largest gastrointestinal physician groups in the US. The Company is working with Gastro Heath to expand the offering of inFoods IBS into other Gastro Health offices.

With the ordering and operational processes now optimized, Biomerica is building the infrastructure and preparing for a full national launch of inFoods IBS across the US during the next six months. The Company has hired a seasoned VP of Sales and National Accounts to lead the national launch and has begun hiring several additional territory sales representatives. The Company is also in discussions with several large medical/hospital groups for the use of inFoods IBS at their centers.

In addition to achieving revenue increases in non-Covid product lines, Biomerica has achieved the following important milestones during fiscal year 2023:

• Successfully Completed inFoods^® IBS pilot commercialization program over the last two quarters and has accomplished the following: (1) completed all validation testing necessary to launch the inFoods IBS product as a CLIA lab developed test (LDT); (2) Launched the inFoods^® IBS product at the flagship office of Gastro Health in Miami; (3) Validated the inFoods^® IBS product for use with simple finger stick blood collection technology, eliminating the need for phlebotomy and making it easier for doctors to collect samples from patients; (4) Streamlined the sales, operations and back-end processing for the inFoods IBS product; (5) Completed patient and physician in office marketing materials; (6) honed the process for practitioners to easily order the inFoods IBS test.
  
  

• Building Sales Organization for a national launch by calendar Q1 2024: The company has hired a veteran VP of sales and national accounts to lead this effort. It is now actively recruiting for territory manager roles across the United States.
  
  

• Intellectual Property: Biomerica now has 19 issued or allowed patents for its inFoods^® technology. In addition to patents on IBS, the Company has filed patents on the inFoods^® technology platform that cover the following other diseases: functional dyspepsia, Crohn’s Disease, ulcerative colitis, gastroesophageal reflux disease (“GERD”), migraine headaches and osteoarthritis.
  
  

• Expansion of Scientific Advisory Board (SAB): Biomerica appointed Mayo Clinic gastroenterologist, Dr. Brian E. Lacy, to the Company’s SAB. Dr. Lacy is the former co-Editor in Chief of the American Journal of Gastroenterology, the former Editor in Chief of Clinical and Translational Gastroenterology, and has served as the co-Chairman for the Rome IV Committee on Functional Bowel Disorders. Dr. Lacy has authored over 225 peer reviewed articles.
  
  

• Helicobacter pylori (“H. pylori”): After review by the FDA and at their request, the Company is now concluding one final set of data for the hp+detect™ which will be sent to the FDA in the coming weeks. The Biomerica hp+detect™ product is designed to detect 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.
  
  

• EZ Detect™ Colorectal Disease Screening Test: In addition to Walmart, the Company announced that CVS is now selling the EZ Detect™ Colon Disease at-home test () in over 7,000 CVS stores and online. Colorectal cancer (CRC) is the second most common cause of cancer death in the United States. Since the COVID-19 pandemic, consumers have become much more comfortable with at-home diagnostic testing and acquiring these tests from retailers. This has increased the demand for many tests that consumers can perform at home.

Jim Leavitt, Director of Clinical Innovation at Gastro Health said, “inFoods IBS has been well received by patients and has shown beneficial outcomes. This personalized approach to IBS treatment has the potential to significantly improve the lives of so many people who are suffering from IBS.”

“We have now completed the back-end and operational set-up to allow us to launch the inFoods IBS product nationally. The product addresses the $30 billion IBS market where surprisingly little relief is currently available for patients. This product offers broad appeal to patients, physicians, and insurers,” stated Zackary Irani, CEO of Biomerica.

About Biomerica (NASDAQ: )

Biomerica, Inc. () 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 inFoods IBS test is designed to assess a patient’s above normal immunoreactivity to specific foods utilizing a simple finger prick blood sample. Instead of difficult to manage broad dietary restrictions, physicians can now use the inFoods IBS information to make targeted, patient-specific recommendations about specific foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. The inFoods IBS test and clinical outcomes were studied at several prominent centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. - a Harvard Medical School Teaching Hospital, Houston Methodist Hospital, and the University of Michigan. The clinical results for improvement in the Abdominal Pain Intensity (API) responder endpoint of >30% reduction in pain, for IBS patients in the treatment diet arm was greater than patients in the placebo diet arm (p-value of 0.0246). The improvement for patients in the treatment arm versus the placebo arm is considered clinically significant and for certain endpoints is similar and, in some cases, better than the current drugs in the market. Further information about Biomerica’s patented inFoods^® Technology Platform can be found at: .

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 Company’s current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company’s products and tests, FDA and/or international regulatory authorization for the Company’s products to be marketed and sold, including the hp-detect product, the inFoods ISB product, and the Company’s other current and future products, the rapidity of testing results, uniqueness of the Company’s products, accuracy of the Company’s tests and products, expected completion of clinical studies, pricing of the Company’s test kits, domestic and/or international market acceptance and demand for the Company’s products, 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, shipping logistics, 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; regulatory compliance and oversite, 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:

Allen Barbieri

949-645-2111

Source: Biomerica, Inc.