Biomerica Reports First Quarter Fiscal 2025 Financial Results

Total Revenue Increases 6% Over Same Period Last Year

Cost-Saving Measures Now Implemented, Expected to Reduce Annual Expenses by 16% to 23%, Representing $1.0 to $1.4 Million Reduction

Biomerica's At-Home PSA Screening Test Receives Saudi Food and Drug Authority (SFDA) Approval for Early Detection of Prostate Cancer

IRVINE, Calif., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the first quarter of fiscal 2025 ended August 31, 2024.

Saudi FDA Approval for At-Home PSA Screening Test

Biomerica's Fortel® Prostate (PSA) Screening Test has received approval from the SFDA. This at-home diagnostic tool enables men to detect early signs of prostate cancer using a simple finger-prick blood sample. Elevated PSA levels, a potential indicator of prostate conditions such as cancer, can be detected, with results available in just 10 minutes. This user-friendly test is poised to make early detection more accessible, contributing to improved prostate cancer outcomes globally.

inFoods® IBS Pilot with 1,100 Physician Group Completed

Biomerica’s pilot program for its groundbreaking inFoods® IBS product, conducted with a select number of physicians from a large physician group comprising of 1,100 members, has been completed. We anticipate this large physician group will utilize the results of this study to evaluate a possible system-wide launch of inFoods® IBS across all physicians in the group. inFoods® IBS aims to identify individual food triggers for IBS symptoms, offering a personalized approach to symptom relief that has shown strong success in clinical studies and demonstrated significant potential in improving patient outcomes.

Potential Distribution Partnerships for inFoods® IBS

Biomerica is actively engaging in discussions with several potential distribution partners, both within the United States and internationally, to expand the availability of inFoods® IBS.

Progress on H. pylori Product Distribution

The Company is in active discussions with major clinical laboratories and distributors for its hp+detect™ product. This diagnostic test offers significant cost savings for clinical labs and provides superior performance in detecting Helicobacter pylori, a leading cause of stomach ulcers and a risk factor for stomach cancer.

First Quarter Fiscal 2025 Financial Results

Biomerica delivered a 6% year-over-year revenue increase in the first quarter of fiscal 2025, with net sales rising to $1.8 million from $1.7 million in the prior year’s quarter. This growth was primarily driven by a higher demand from new and existing customers as well as new contract manufacturing agreements.

During the fiscal quarter, we implemented our previously announced cost-savings plan, which is expected to reduce expenses by 16% to 23% representing $1.0 million to $1.4 million in savings for the current fiscal year. As part of this plan, we incurred one-time reduction-in-force (RIF) costs aimed at streamlining operations for long-term profitability. These RIF-related expenses impacted both gross margins and operating expenses for the period. Gross margin for the quarter was 16%, compared to 24% in the first quarter of fiscal 2024. Adjusting for the RIF costs, the gross margins were consistent with historical levels.

Operating expenses for the quarter were $1.7 million, a slight increase from $1.6 million in the prior year. The rise was primarily due to one-time severance costs associated with the RIF, as well as expenses related to the introduction of our sales force, which was not in place during the previous year. Excluding these one-time RIF costs, operating expenses would have decreased by 2%, reaffirming our continued focus on operational efficiency and disciplined cost management.

Operating loss for the quarter increased to $1.4 million, compared to $1.2 million in the prior-year quarter, largely driven by the one-time RIF costs mentioned earlier. While these strategic actions were necessary to streamline operations and position the Company for future profitability, they temporarily impacted our financial results. Net loss also rose to $1.3 million, compared to $1.1 million in the same period last year. Excluding the RIF-related expenses, both operating loss and net loss would have been favorable versus prior year, reflecting our ongoing efforts to invest in key growth initiatives while managing costs.

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 focuses on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.

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 inFoods IBS clinical study was performed 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%, for IBS patients in the treatment diet arm had a statistically significant improvement over 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 is similar and, in some cases, better than the current drugs in the market.

The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements relating to the Company’s current and future cash position, balance sheet, cost savings, sales, revenues, overhead, expenses, cost of goods, operations, and earnings; the Company's need for raising additional capital; the Company's expected sales growth for the Company's inFoods IBS product, Hp Detect product and other existing products; and diversification of the Company's revenue streams. Such forward-looking information is based upon the current beliefs and expectations of management and involves important risks and uncertainties that could significantly affect anticipated results. In addition, these forward-looking statements are subject to assumptions with respect to future business strategies and decisions that are subject to change. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Factors that could cause actual results to differ from those expressed in the forward-looking statements are discussed in the "Risk Factors" section of the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the SEC, and available on the SEC's website (www.sec.gov).

The Company is under no obligation to update any forward-looking statements after the date of this release.

Source: Biomerica, Inc.