Biomerica Reports Fiscal 2022 Year End Results

Rhea-AI Summary

Biomerica, Inc. (Nasdaq: BMRA) reported a remarkable 162% increase in revenues for fiscal 2022, totaling $18.9 million, compared to $7.2 million in fiscal 2021. The net loss also improved to $4.6 million from $7.5 million year-over-year. Significant sales growth was driven by COVID-19 antigen tests and OTC products. Important milestones include positive clinical trial results for its InFoods^® IBS product, six new patents granted, and successful completion of clinical studies for its H. pylori diagnostic test, with FDA clearance anticipated.

Positive

• Revenues increased 162% from $7.2 million in 2021 to $18.9 million in 2022.
• Net loss decreased from $7.5 million in 2021 to $4.6 million in 2022.
• Positive clinical trial results for InFoods^® IBS product.
• Six new patents granted for InFoods^® technology.
• Completion of H. pylori diagnostic studies with FDA submission pending.

Negative

• None.

• Revenues increase 162% for fiscal 2022 vs fiscal 2021
   
• Revenues for fiscal Q4 2022 up 403% vs. fiscal Q4 2021

IRVINE, Calif., Aug. 29, 2022 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical products, today reported its fiscal 2022 financial results.

Net sales for the fiscal year ended May 31, 2022 were $18.9 million as compared to net sales of $7.2 million in fiscal 2021, an increase of $11.7 million, or 162%. Net loss was $4.6 million for fiscal 2022 compared to a net loss of $7.5 million for fiscal 2021. The increased sales for fiscal 2022 was primarily related to the Company’s increase in sales of COVID-19 antigen tests during the year supplemented by an increase in sales of other non-COVID over the counter (OTC) retail products. While the Company continues to sell and market its COVID-19 products, management is focused on its core diagnostic business and its further development of the InFoods^® technology platform.

In addition to achieving record revenues for fiscal 2022, Biomerica has recently achieved the following important milestones:

• Positive Outcome for InFoods^® IBS Endpoint Clinical Study: Biomerica completed its endpoint clinical trial for its InFoods^® IBS product, which was conducted at Mayo Clinic, Beth Israel Deaconess Medical Center Inc. - a Harvard Medical School Teaching Hospital, Houston Methodist, the University of Michigan and other institutions. The top-line trial results showed statistically significant improvements in multiple symptom endpoints, indicating that using InFoods IBS to identify and eliminate specific foods may meaningfully reduce a patient’s IBS symptoms.
• Intellectual Property: During fiscal 2022, Biomerica was granted 6 patents for its InFoods^® technology. The Company now has 12 issued patents, with over 100 additional filed patents still in review and prosecution. Filed patents on the InFoods^® technology platform comprise claims for multiple diseases including: irritable bowel syndrome (IBS), functional dyspepsia, Crohn’s Disease, ulcerative colitis, gastroesophageal reflux disease (“GERD”), migraine headaches and osteoarthritis.
• Helicobacter pylori (“H. pylori”): Biomerica completed its clinical studies for its H. pylori diagnostic test and filed a 510(K) submission for FDA clearance. Clearance is expected anytime. Biomerica’s new and proprietary H. pylori test, called hp+detect™ diagnoses 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: Walmart is now selling the EZ Detect™ Colon Disease at-home test (https://ezdetect.com) in 4,600 stores and online. Colorectal cancer (CRC) is the second most common cause of cancer death in the United States. Consumers have become much more aware of at-home diagnostic testing and more comfortable acquiring these tests from retailers due to the COVID-19 pandemic.
• Aware^® Breast Self Exam product: Walmart is also now selling the Aware breast Self Exam product online (https://www.walmart.com/ip/seort/395477102). In addition, the Aware product is now available through Amazon.com. About 80% of breast cancers are detected because women themselves notice changes in their breasts, highlighting the important role each woman can play in her own health. Breast Cancer is the most common cancer among women.

“We are excited by the progress we’ve made during fiscal 2022. We continue to see opportunities to bring our products to a broader audience of patients and medical professionals. The positive results from our recent endpoint trial, demonstrates that the InFoods IBS product can help physicians provide personalized medicine to their IBS patients. InFoods IBS 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. In addition, I’m optimistic about the market potential for our consumer products such as the EZ Detect and Aware products, both domestically and internationally,” 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.

About InFoods^®
The InFoods^® IBS test involves a simple blood collection procedure, and is designed to assess a patient’s above normal immunoreactivity to specific foods. 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. Further information about Biomerica’s patented InFoods Technology Platform can be found at: https://biomerica.com/infoods/our-technology/

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
investors@biomerica.com

Source: Biomerica, Inc.

 

FAQ

What were Biomerica's financial results for fiscal 2022?

Biomerica reported revenues of $18.9 million, a 162% increase from $7.2 million in fiscal 2021, and a net loss of $4.6 million, improved from a loss of $7.5 million.

What factors contributed to Biomerica's revenue growth?

Revenue growth was primarily driven by increased sales of COVID-19 antigen tests and other retail OTC products.

What milestones did Biomerica achieve in fiscal 2022?

Notable milestones include positive results from the InFoods^® IBS clinical trial, granting of six patents, and completion of clinical studies for the H. pylori diagnostic test.

What is the expected outcome for Biomerica's H. pylori diagnostic test?

Biomerica has filed for FDA clearance for its H. pylori diagnostic test with clearance expected soon.