Biomerica Reports Fiscal 2024 Year End Results
Biomerica reported fiscal 2024 year-end results with a 1% increase in total revenue to $5.4 million. Core revenue, excluding COVID tests, grew by 5%. The company improved its gross margin to 11% from 8% and reduced its net loss by 15% to $6.0 million. Biomerica implemented a cost-savings plan expected to reduce expenses by $1.0 to $1.4 million in the coming year.
Key achievements include FDA 510(k) clearance for the Hp Detect™ Stool Antigen ELISA test, advancement of the inFoods® IBS diagnostic test with a new patient self-collection system, and an exclusive distribution agreement in the UAE for EZ Detect™ and Aware® products. The company is focusing on three strategic growth areas: expanding at-home tests in the MENA region, capitalizing on H. pylori antigen sales in the U.S., and expanding inFoods® IBS opportunities.
Biomerica ha riportato i risultati di fine anno fiscale 2024 con un aumento dell'1% del fatturato totale a 5,4 milioni di dollari. Il fatturato principale, esclusi i test COVID, è cresciuto del 5%. L'azienda ha migliorato il suo margine lordo all'11% rispetto all'8% e ha ridotto la sua perdita netta del 15% a 6,0 milioni di dollari. Biomerica ha implementato un piano di risparmio sui costi che dovrebbe ridurre le spese di 1,0-1,4 milioni di dollari nel prossimo anno.
I risultati chiave includono il nulla osta FDA 510(k) per il test ELISA dell'antigene fecale Hp Detect™, il progresso del test diagnostico inFoods® IBS con un nuovo sistema di auto-raccolta per i pazienti e un accordo di distribuzione esclusiva negli Emirati Arabi Uniti per i prodotti EZ Detect™ e Aware®. L'azienda si sta focalizzando su tre aree strategiche di crescita: l'espansione dei test domiciliari nella regione MENA, il capitalizzare le vendite dell'antigene H. pylori negli Stati Uniti e l'espansione delle opportunità inFoods® IBS.
Biomerica informó sobre los resultados del año fiscal 2024, con un aumento del 1% en los ingresos totales a $5.4 millones. Los ingresos centrales, excluyendo las pruebas de COVID, crecieron un 5%. La compañía mejoró su margen bruto al 11% desde el 8% y redujo su pérdida neta en un 15% a $6.0 millones. Biomerica implementó un plan de ahorro de costos que se espera reduzca los gastos entre $1.0 y $1.4 millones en el próximo año.
Los logros clave incluyen la aprobación FDA 510(k) para la prueba ELISA de Antígeno Fecal Hp Detect™, el avance de la prueba diagnóstica inFoods® IBS con un nuevo sistema de auto-recolección de pacientes y un acuerdo de distribución exclusivo en los EAU para los productos EZ Detect™ y Aware®. La compañía se está enfocando en tres áreas estratégicas de crecimiento: la expansión de pruebas en casa en la región MENA, capitalizando las ventas del antígeno H. pylori en los EE. UU., y expandiendo oportunidades con inFoods® IBS.
Biomerica는 2024 회계연도 연말 결과를 보고하며 총 수익 1% 증가로 540만 달러를 기록했습니다. COVID 검사를 제외한 핵심 수익은 5% 성장했습니다. 이 회사는 총 마진을 11%로 8%에서 개선하고 순손실을 15% 줄여 600만 달러를 기록했습니다. Biomerica는 향후 1.0~1.4백만 달러의 비용 절감을 기대하는 비용 절감 계획을 시행했습니다.
주요 성과로는 Hp Detect™ 변 검체 항원 ELISA 검사의 FDA 510(k) 승인, 새로운 환자 자가 수집 시스템을 통한 inFoods® IBS 진단 테스트의 발전, 그리고 EZ Detect™ 및 Aware® 제품에 대한 아랍에미리트 독점 유통 계약이 포함됩니다. 이 회사는 MENA 지역에서 가정용 테스트 확대, 미국 내 H. pylori 항원 판매 활용, inFoods® IBS 기회 확장을 포함한 세 가지 전략적 성장 영역에 집중하고 있습니다.
Biomerica a annoncé les résultats de fin d'année fiscale 2024, avec une augmentation de 1% des revenus totaux à 5,4 millions de dollars. Les revenus principaux, hors tests COVID, ont augmenté de 5%. L'entreprise a amélioré sa marge brute à 11% contre 8% auparavant et a réduit sa perte nette de 15% à 6,0 millions de dollars. Biomerica a mis en place un plan d'économies prévu pour réduire les dépenses de 1,0 à 1,4 million de dollars l'année prochaine.
Les réalisations clés incluent l'approbation FDA 510(k) pour le test ELISA des antigènes fécaux Hp Detect™, le développement du test diagnostic inFoods® IBS avec un nouveau système d'auto-collecte pour les patients, et un contrat de distribution exclusif aux Émirats Arabes Unis pour les produits EZ Detect™ et Aware®. L'entreprise se concentre sur trois domaines stratégiques de croissance : l'expansion des tests à domicile dans la région MENA, la capitalisation sur les ventes d'antigènes H. pylori aux États-Unis et l'expansion des opportunités inFoods® IBS.
Biomerica berichtete über die Ergebnisse zum Ende des Geschäftsjahres 2024, mit einem Umsatzanstieg von 1% auf 5,4 Millionen Dollar. Der Kernerlös, ohne COVID-Tests, wuchs um 5%. Das Unternehmen verbesserte seine Bruttomarge auf 11% von 8% und reduzierte seinen Nettoverlust um 15% auf 6,0 Millionen Dollar. Biomerica implementierte einen Kostensenkungsplan, der erwartungsgemäß die Ausgaben um 1,0 bis 1,4 Millionen Dollar im kommenden Jahr senken wird.
Wichtige Erfolge umfassen die FDA 510(k)-Genehmigung für den Hp Detect™ Stuhl-Antigen-ELISA-Test, den Fortschritt des inFoods® IBS-Diagnosetests mit einem neuen Selbstabholungssystem für Patienten sowie einen exklusiven Vertriebsvertrag in den VAE für EZ Detect™ und Aware®-Produkte. Das Unternehmen konzentriert sich auf drei strategische Wachstumsbereiche: die Expansion von Testkits für zu Hause in der MENA-Region, die Nutzung von H. pylori-Antigenverkäufen in den USA und die Erweiterung der inFoods® IBS-Möglichkeiten.
- Total revenue increased by 1% year-over-year to $5.4 million
- Core revenue excluding COVID tests grew by 5%
- Gross margin improved from 8% to 11%
- Net loss reduced by 15% to $6.0 million
- Implemented cost-savings plan expected to reduce expenses by $1.0 to $1.4 million
- Received FDA 510(k) clearance for Hp Detect™ Stool Antigen ELISA test
- Launched inFoods® IBS pilot program with 1,100-member physician group
- Secured exclusive distribution agreement in UAE for EZ Detect™ and Aware® products
- Operating loss of $6.4 million for the fiscal year
- Net loss of $6.0 million, despite improvement from previous year
Biomerica's fiscal 2024 results show a mixed performance. While total revenue increased by
The improvement in gross margin from
While progress is evident, Biomerica needs significant revenue growth to achieve profitability. The success of strategic initiatives like the inFoods® IBS pilot and expansion in the MENA region will be critical for the company's financial future.
Biomerica's product portfolio shows promise in addressing significant medical needs. The FDA clearance for the Hp Detect™ Stool Antigen ELISA test is particularly noteworthy, given that H. pylori affects approximately
The advancement of the inFoods® IBS test, with its new patient self-collection system, represents a significant innovation in IBS management. This could potentially disrupt the current treatment paradigm for IBS, a condition affecting millions. The ongoing pilot with a 1,100-physician group progressing ahead of schedule is a positive indicator of the test's potential market acceptance.
The presentation of inFoods® IBS data at the prestigious Digestive Disease Week conference adds credibility to the technology. However, more comprehensive clinical data will be necessary to fully establish its efficacy and drive widespread adoption.
Biomerica's strategic focus on three key growth areas shows a well-thought-out approach to market expansion. The company's efforts in the MENA region, particularly the exclusive distribution agreement in the UAE, could open up significant opportunities. The potential integration of EZ Detect™ and Aware® into national health protocols could lead to substantial and consistent revenue streams.
The U.S. market for H. pylori testing presents another growth avenue, especially given the high prevalence of the infection and increasing antibiotic resistance. However, Biomerica will face competition from established players in this space.
The inFoods® IBS opportunity is perhaps the most intriguing. If successful, it could revolutionize IBS management. The pilot program with a large physician group is a smart move to gain traction and credibility. However, the company will need to navigate the complexities of the healthcare system and secure reimbursement to achieve widespread adoption.
- Total Revenue Increases
1% Year-Over-Year – Core Revenue Excluding COVID Tests Climbs5% , Reflecting Stronger Growth - Significant Cost Savings Plan Implemented After Year End – Expected to Deliver Expense Reductions of
$1.0 t o$1.4 Million in the Coming Year - inFoods® IBS Pilot with Large 1,100 Physician Group Progressing Ahead of Schedule
IRVINE, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA) today reported its financial results for the fiscal year ended May 31, 2024. The Company achieved a modest increase in net sales to
Excluding revenues from COVID-19 test kits, Biomerica achieved a
Additionally, the Company reduced its net loss for the fiscal year to
| Selected Financial Results | Year Ended May 31, | Year Ended May 31, | |||||||
| 2024 | 2023 | ||||||||
| ($ in millions, except percentages) | |||||||||
| Revenue | |||||||||
| Gross magin | 11 | % | 8 | % | |||||
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| Operating loss | ( | ) | ( | ) | |||||
| Net Loss | ( | ) | ( | ) | |||||
Strategic Growth Areas:
Biomerica is actively working in three key areas to drive revenue growth:
- EZ Detect™ and Other At-Home Tests in the MENA Region: Continued expansion through distribution partners in the Middle East and North Africa region and seeking insurance reimbursement.
- H. pylori Antigen Sales in the U.S.: Capitalizing on market opportunities for the Hp Detect™ Stool Antigen ELISA test.
- inFoods® IBS Opportunities: Expanding the utilization of the inFoods® IBS test in physician groups and possible distribution partnerships.
Key Milestones Achieved in Fiscal Year 2024:
FDA 510(k) Clearance: Biomerica received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Hp Detect™ Stool Antigen ELISA test (K232892). This test detects the presence of the H. pylori bacteria, which infects approximately
Advancement of inFoods® IBS: The inFoods® IBS diagnostic test has progressed significantly with the introduction of a new patient self-collection system. This system allows patients to collect their own blood samples at home using a simple finger-stick device, enabling nationwide access through telehealth and online medical providers. This innovation greatly expands the reach of inFoods® IBS to millions of IBS sufferers.
inFoods® IBS Pilot Program in 1,100 Physician Group: Biomerica launched a pilot program for the inFoods® IBS product with a large 1,100-member physician group, which is progressing ahead of schedule. This novel approach identifies individual dietary triggers for IBS symptoms and has shown remarkable success in alleviating symptoms for most patients in clinical studies.
Exclusive Distribution Agreement in the UAE: Biomerica secured a multi-year exclusive distribution agreement with one of the UAE's largest healthcare conglomerates. This partnership focuses on enhancing the accessibility and efficiency of colorectal cancer screening and breast examination technologies using Biomerica's at-home screening products EZ Detect™ and Aware®. The goal is to integrate these tests into national health protocols in collaboration with various governmental health departments.
Data Presentation at 2024 Digestive Disease Week (DDW): Data from Biomerica's collaborators at the University of Michigan, utilizing inFoods® IBS technologies, were presented at the 2024 Digestive Disease Week (DDW) Annual Meeting in Washington, D.C. DDW is the world's premier scientific and clinical meeting for digestive disease healthcare professionals.
Biomerica remains committed to advancing its financial position and driving long-term growth through innovative medical products and strategic partnerships.
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.
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 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 >
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.
Corporate Contact:
Zack Irani
949-645-2111
investors@biomerica.com
Source: Biomerica, Inc.
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