Biomerica Reports Results for Fiscal First Quarter ended August 31, 2021
October 15 2021 - 6:39AM
Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider
of advanced medical products, today reported its first quarter
fiscal 2022 financial results.
Net sales for the three months ended August 31,
2021 were $1.2 million as compared to net sales of $1.1 million for
the same three months in fiscal 2021, an increase of $0.1 million,
or 10%. On a sequential basis, revenue grew 20% compared to the
fourth quarter of fiscal 2021. Net loss decreased to $1.5 million
for the three months ended August 31, 2021 compared to a net loss
of $1.9 million for same three months in fiscal 2021. Cash flows
from operations were positive for the quarter ended August 31,
2021. Cash increased from $4.2 million at May 31, 2021 to $5.0
million at the quarter end, August 31, 2021.
Sales, general and administrative expenses for
the three months ended August 31, 2021 were $1.0 million, compared
to $1.3 million for the same period in the previous year. The
decrease was mainly due to a higher allowance for doubtful accounts
and higher legal expenses for the same period in previous year.
Research and Development (R&D) expense was $0.4 million for the
three months ended August 31, 2021 compared to $0.7 million the
same period in the previous year, a decrease of over 38%. The
decrease in R&D investment expense was primarily due to the
completion of the development of several COVID-19 tests in prior
year.
Recent Developments:
- InFoods® Endpoint Study Completion:
The final patients were enrolled in InFoods® IBS endpoint trial and
Biomerica is on track to have topline results of its InFoods® IBS
Endpoint trial by end of December, 2021. It is estimated that over
40 million Americans suffer from IBS. IBS symptoms are often
triggered by consumption of specific foods (which are unique in
each sufferer). The total direct and indirect cost of IBS has been
estimated at $30 billion annually in just the United States.
- Walmart: Following the close of the
first quarter, Walmart began online sales of the Company’s EZ
Detect™ Colorectal Disease Screening Test. The Company also expects
that the EZ Detect product will be on the shelf at Walmart stores
within weeks. In addition, Biomerica is in negotiations with
several large partners for distribution of the EZ Detect™ product
in Asia, Europe and the Middle East. Colorectal cancer is the
second most common cause of cancer deaths in the United States in
men and women combined. It's expected to cause approximately 52,980
deaths during 2021.
- H. pylori: The Company expects to
file for FDA 510(k) clearance before the end of the calendar year.
While recently finalizing the clinical trials for this product, the
Company found one study needed to be repeated. The Company is now
preparing to repeat the study and expects to file FDA clearance by
year-end. The Biomerica hp+detect™ product detects 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. Physicians and medical
centers can use hp+detect™ to diagnose the presence of H. pylori
and to monitor the efficacy of treatment.
- Customer order backlog: At August
31, 2021 customer order backlog for the Company was $1.5 million, a
majority of which is expected to be shipped in the fiscal second
quarter.
“We continued to see strong momentum during the
first quarter of 2022, both in relation to our progress with our
InFoods® endpoint trial as well as with the demonstrated interest
around our specialty diagnostic products,” stated Zackary Irani,
CEO of Biomerica. “Our customer order product backlog of $1.5
million entering the second quarter demonstrates the appeal of our
products. Also, just after the close of the quarter, we announced
that Walmart has begun selling our EZ Detect™ Colorectal Screening
test, with a first step of offering the product online and an
expected in-store offering soon to follow. We expect this will
bring significant exposure to this product going forward. Finally,
we are moving forward with the development of our H. pylori test
and we anticipate filing for FDA clearance for this product before
the close of the calendar year. The pandemic has accelerated
consumer demand for in-home testing alternatives. We believe our
ability to provide easy-to-use, high-quality, in-home diagnostic
tests that promote the early detection and expedient treatment of
several serious diseases, positions Biomerica to significantly
benefit from this shift in the market.”
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 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 40 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 product, hp+detect product and other tests, FDA
clearance of the Company’s products including the COVID-19 and
hp-detect product, Health Canada and CE Mark clearance of these
products, the rapidity of testing results, uniqueness of the
Company’s products, test result accuracy of products, expected
completion of clinical studies, pricing of the Company’s test kits,
demand for domestic or international orders, 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, 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;
regulations 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:
John Nesbett /Jennifer Belodeau IMS Investor
Relations 203.972.9200 jnesbett@institutionalms.com
Source: Biomerica
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