Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced
medical products, today announced its fiscal third quarter 2021
financial results for the three months ended February 28, 2021.
The Company reported consolidated sales of $3.62
million for the fiscal third quarter of 2021, compared to $1.18
million for the same period in fiscal 2020, an increase of 208%.
The increase in revenues during the quarter was primarily due to
sales of the Company’s 15-minute COVID-19 Antigen Rapid Test in
Europe, after its January 2021 CE Mark approval, as well as
increased sales for several of the Company’s other diagnostic
products. For the nine months ended February 28, 2021, consolidated
net sales for Biomerica increased 55% to $6.14 million compared to
$3.97 million for the same period in fiscal 2020.
The Company’s cost of sales for fiscal third
quarter 2021, included an exceptionally large inventory reserve of
approximately $1.43 million. Gross margin excluding this
exceptionally large inventory reserve would have been 38%. During
the quarter the company increased its investment in research and
development which is largely focused on several COVID-19 tests and
ongoing development of the InFoods® IBS product. The Company
incurred higher general and administrative expenses, mainly due to
higher reserves, and increased legal, personnel and consulting
costs related to the Company preparing for anticipated growth
related to the InFoods® Technology, and possible commercialization
of other products in the pipeline. Net loss for the fiscal third
quarter 2021 was $1.84 million compared to a net loss of $0.86
million for the same period in fiscal 2020. During the fiscal third
quarter, the Company recorded a receivables reserve of $0.29
million and recorded a non-cash charge of $0.24 million for
stock-based compensation related to the annual equity (stock
option) awards granted to its Board of Directors and senior
managers. Excluding the exceptionally large inventory and
receivables reserves, and the non-cash annual compensation charge,
the Company would have reported a profit for the quarter.
Cash and cash equivalents were $5.27 million,
and current assets were $10.78 million, on February 28, 2021.
Zack Irani, Chairman and Chief Executive Officer
of Biomerica, commented, “This was a strong quarter for the
Company. First and foremost, we’ve made great progress enrolling
patients for our InFoods® IBS endpoint clinical trial in a tough
pandemic environment, with some of the most respected healthcare
institutions in the world, including Mayo Clinic, Beth Israel
Deaconess Medical Center, Inc., a Harvard Medical School teaching
Hospital, Houston Methodist, University of Texas Health Science
Center at Houston, and the University of Michigan. While COVID-19
has delayed this clinical trial, we still expect to have top line
analysis from this clinical trial by the end of the third calendar
quarter of 2021.
“InFoods® IBS is a patented product addressing
the $30 billion Irritable Bowel Syndrome market where surprisingly
little relief is currently available for patients. Our product is a
disruptive technology redefining how patients with gastrointestinal
diseases can be treated. InFoods® goes beyond simply treating
symptoms of disease, it also is designed to help identify one of
the underlying causes. If cleared, InFoods® IBS will be the first
FDA-regulated diagnostic therapy identifying both the problematic
foods of IBS patients, as well as alleviating the symptoms,
offering broad appeal to patients, physicians and insurers. We are
also excited to announce we now have six issued patents related to
our InFoods® IBS product and platform technology, with many more in
active prosecution and review. These patents should provide us
strong protection from competition as we plan to launch these
products into the market.
“Alongside the progress we are making with
InFoods®, the Biomerica team is working with leading institutions
to quickly launch accurate COVID-19 tests while maintaining our
commitment to providing these tests at a low cost,” Mr. Irani
continued. “We have applied our technology and expertise to bring
to market COVID-19 tests that drove significant revenue growth in
the quarter, and we are encouraged by the traction we saw in Europe
and look forward to expanding into other markets to bring our
solution to more patients around the world. At the same time, the
FDA continues to review our EUA submission for our products in the
U.S. market.
“While we are proud to be helping with the
current global pandemic and believe that there are considerable
revenue opportunities for testing around the world, it is important
to note that our primary long-term focus continues to be on
validation and commercialization of products based on our patented
InFoods® technology platform. Our improved financial results in the
quarter demonstrate the earnings leverage in our business model
given our low-cost structure and focus on high ROI products. We
continue to believe our InFoods® products could revolutionize the
way people are treated for a variety of gastrointestinal diseases,
while offering Biomerica sizable revenue opportunities,” Mr. Irani
concluded.
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’s primarily focus is on gastrointestinal and inflammatory
diseases where the Company has multiple diagnostic and therapeutic
products in development.
About
InFoods®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 45 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 tests, FDA clearance, EUA clearance, the
rapidity of testing results, uniqueness of a product, accuracy of
products, 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 tests; regulatory
approvals necessary prior to commercialization of the Company’s
COVID-19 tests; 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 various COVID-19 tests; 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.
1. medRxiv preprint doi:
https://doi.org/10.1101/2020.03.30.20047365. Accessed 15Jun20
Corporate Contact: John Nesbett /Jennifer BelodeauIMS Investor
Relations203.972.9200jnesbett@institutionalms.com
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