Biomerica Reports Fiscal Year End May 31, 2020 Financial Results
September 01 2020 - 8:19AM
Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced
medical products, today reported net sales for the fiscal year
ended May 31, 2020 were $6.7 million versus net sales of $5.2
million in fiscal 2019. This represents an increase of $1.5
million, or 28.7%. Net loss was $2.3 million for fiscal 2020
compared to net loss of $2.4 million for fiscal 2019.
Research and Development investment was $1.9 million for
fiscal year 2020 compared to $1.7 million the previous year, an
increase of over 13%. Year-end cash and cash equivalents were
$8.6 million in fiscal 2020 versus $0.7 million in fiscal 2019
while current assets were $14.8 million in fiscal 2020 versus $4.5
million in fiscal 2019.
The Company also announced that it has been
granted a patent for its InFoods® Diagnostic Guided Therapy for
Irritable Bowel Syndrome (“IBS”) in Singapore.
Fiscal Year 2020
Highlights:
- Biomerica was granted its second
U.S. patent and first patent in Japan covering a Diagnostic Guided
Therapy (“DGT”) for Irritable Bowel Syndrome. These patents
cover the Company’s InFoods® family of products that allow for
revolutionary diagnostic guided therapy option for patients
suffering from Irritable Bowel Syndrome and other gastrointestinal
diseases once cleared. It is estimated that over 40 million
Americans suffer from IBS and the symptoms can be triggered by
consumption of specific foods (which are unique in each
sufferer). The total cost (direct + indirect) of IBS has been
estimated at $30 billion annually in the United States.
- Biomerica significantly expanded
its InFoods® IBS DGT clinical trial by signing definitive
agreements with Mayo Clinic, Houston Methodist (part of Texas
Medical Center, the largest medical complex in the world) and
University of Texas Health Science Center at Houston. These
leading institutions are joining Beth Israel Deaconess Medical
Center Inc., a Harvard Medical School Teaching Hospital, and the
University of Michigan as enrollment centers for this study.
- During the fiscal fourth quarter,
the Company began marketing and selling outside of the U.S. a
disposable rapid finger-prick blood test, which detects COVID-19
IgG/IgM antibodies within 10 minutes. This test is designed to be
performed by trained medical professionals, e.g. airports, schools,
work, pharmacies and doctors’ offices. Additionally, a recently
published Canadian study reported that Biomerica’s rapid test
showed 100% sensitivity and 100% specificity
(https://www.studyfinds.org/not-all-covid-19-antibody-tests-are-created-equal-but-which-ones-are-best/)
Published in Diagnostics 2020, 10, 453; July 2020.
- The Company submitted to the
Federal Drug Administration (“FDA”) an Emergency Use Authorization
(“EUA”) application for an ELISA lab-based serology blood test for
the detection of antibodies that identify if a person has been
infected with the novel Coronavirus. The data submitted to the FDA
under the EUA application showed 100% specificity and 0% cross
reactivity with many common disease states as well as 100% positive
predictive value and 99.8% negative predictive value. The EUA was a
full submission that the Company believes provided all required
information. It is still pending FDA clearance. This ELISA
test can utilize a unique and proprietary whole blood sample
collection method.
- The Company has filed over 100
international and PCT patents and has 22 provisional and
non-provisional patents currently filed with the U.S. Patent and
Trademarks Office. Some of these patent applications pertain to
COVID-19 and other products. However, the majority of Biomerica’s
pending patents pertain to the InFoods® DGT technology
platform. The InFoods® DGT technology platform patents and
research include other disease states: functional dyspepsia,
Crohn’s Disease, ulcerative colitis, gastroesophageal reflux
disease (“GERD”), migraine headaches, and osteoarthritis.
- The Company strengthened its
balance sheet with current assets exceeding $14 million as of May
31, 2020.
- Biomerica strengthened its
management team and Board of Directors with the appointment of
Steve Sloan as the Company’s new Chief Financial Officer effective
September 3, 2020. Mr. Sloan’s background and experience
includes thirteen years at General Electric and recently, Mr. Sloan
spent ten years with medical device maker, Medtronic. At
Medtronic, Mr. Sloan worked in four divisions, most recently
serving as a divisional finance director. The Company also
announced the addition of Ms. Cathy Coste as a new, independent
member of the Board or Directors. Cathy will join the Board
effective September 3, 2020. Ms. Coste has also been elected
by the Board to chair the Board’s Audit Committee, and to be a
member of the Nominating and Corporate Governance Committee.
Cathy Coste is a Senior Partner at Deloitte and Touche, LLP, where
she has spent thirty-two years in audit and advisory services to
global corporations.
- The Company completed its patient
recruitment portion of clinical trials to be submitted to the FDA
for clearance of the Company’s H. Pylori diagnostic product
(hp+detect™). Helicobacter pylori infection is one of
the most common, chronic, bacterial infections affecting humans and
complications include ulcers, inflammation of the stomach lining
and stomach cancer.
“Biomerica technology platforms aim to make the
world a safer and healthier place. The world has large,
unresolved health issues, several of which Biomerica is uniquely
positioned to resolve via our InFoods® diagnostic-guided therapies,
once approved by regulators. At the same time, we used our
technology and expertise to help in the COVID-19 pandemic by
offering a disposable rapid finger-prick blood test, which detects
COVID-19 IgG/IgM antibodies within 10 minutes. Additionally, we
submitted to the FDA a EUA application for an ELISA lab-based
serology blood test for the detection of antibodies that identify
if a person has been infected with the COVID-19 virus. This
ELISA test is unique by simplifying the blood sample collection
process in a proprietary way. This EUA was a full submission that
we believe provided all required information. It is still
pending FDA clearance. Our focus in fiscal 2020 was 1)
expansion of the clinical trials for our InFoods® IBS diagnostic
guided therapy product, 2) the marketing and sales of COVID tests
outside the USA, 3) the submission of an EUA for our ELISA test, 4)
securing Intellectual Property protection for the many new products
we are developing, primarily focusing on the InFoods® diagnostic
guided therapy technology, 5) moving additional InFoods® diagnostic
guided therapy products for other disease states forward. Our
focus on COVID-19, R&D and IP protection did require a
significant increase in patent-related and general legal expenses
in fiscal 2020. We see these IP and clinical expenses as an
investment with the potential for large returns, as any of these
new products achieve FDA clearance,” 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 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 test, FDA clearance, EUA clearance, the rapidity
of testing results, uniqueness of a product, 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 test; regulatory approvals necessary prior to
commercialization of the Company’s COVID-19 test; 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 COVID-19
test; 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.
Corporate Contact: Company
Spokesperson949-645-2111
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