Biomerica Announces Fiscal Year End 2019 Financial Results
August 30 2019 - 8:30AM
Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced
medical products, today reported net sales for the fiscal year 2019
were $5,200,682 versus net sales of $5,564,185 in fiscal 2018. Net
loss was $2,393,060 for fiscal 2019 compared to net loss of
$1,465,828 for fiscal 2018. Research and Development investment was
$1,679,098 for fiscal year 2019 compared to $1,398,368 the previous
year, an increase of $280,730, or 20%.
Fiscal Year 2019 Highlights
- We signed an exclusive distribution agreement in China for our
EZ Detect colorectal screening test with a total minimum purchase
requirement of $17 million over 7 years and an upfront pre-payment
of $1 million. It is estimated that there are over 400 million
people over the age of 50 in China, which could benefit from this
test that screens for early warning sign for colon cancer.
- We made significant progress in finalizing the clinical trials
and product validation to submit to the United States Food and Drug
Administration (FDA) for final clearance of the Company’s H. Pylori
diagnostic product. The Company plan to submit to FDA for clearance
by the end of the calendar year. Helicobacter pylori (H. 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.
- We were granted our first U.S. Patent covering a Diagnostic
Guided Therapy for Irritable Bowel Syndrome (IBS). This initial
U.S. patent covers the Company’s InFoods® family of products that
allow for revolutionary new treatment options for patients
suffering from Irritable Bowel Syndrome (IBS) and other
gastrointestinal diseases. It is estimated that over 45 million
Americans suffer from IBS and the symptoms are often 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. The company has filed for
and expects to receive additional patents for the InFoods® IBS and
the InFoods® family of products.
- The Company continues to receive significant interest from
leading medical institutions and researchers in the IBS field and
expects to add new leading clinical sites in the near future to
help expedite completion of the clinical trial underway for the
InFoods® IBS therapy. We will be announcing a progress report on
the InFoods® IBS trial in the upcoming months.
- The country of Colombia’s food and drug regulatory agency
granted clearance for Biomerica’s EZ Detect colorectal screening
test to be sold in Colombia. The Company is in negotiations to
secure a possible Columbian distribution partner for this product
who will be focused on sales to the Columbian government and other
markets.
“We have seen continued increases in sales in Latin
America and we are excited about the prospect for growth in this
region. Sales to our new distribution partner in Mexico continue to
grow, and we’re in discussion with additional new distributors in
three other countries in the region. These increases partly offset
decreases in sales in Europe. In order to expand our European and
Latin America distribution and sales network, we have hired a new
sales and marketing director with extensive distributor
relationships in Europe and South America, many of whom are
evaluating our products for distribution. Our focus in fiscal 2019
was 1) expand distribution and gain country regulatory approvals
for our EZ Detect colorectal cancer screening product, 2) support
and expand the clinical trials for our InFoods® IBS product, which
we see as a blockbuster opportunity, 3) prepare our H. Pylori
product, (called hp+detect), for final FDA submission and market
launch, 4) develop additional InFoods® diagnostic/therapeutic
products for other disease states, 5) begin transition from R&D
focus to manufacture and distribution focus by starting to build
out a global distribution network who will launch these new
products and expand sales of our existing products, and 6) secure
Intellectual Property (IP) protection for the many new products we
are developing, beginning with a USA patent position for the
InFoods® technology. Many of our InFoods® patents are now are in
final examination. Our focus on R&D and IP protection did
require a significant increase in patent related legal expenses
which, combined with costs related to our clinical trials,
negatively impacted earnings in fiscal 2019. However, we see these
IP and clinical expenses as an incredible investment opportunity
with potential for inordinate returns, as these new products
achieve FDA clearance and we hopefully begin to launch them into
the market in the near future. At the same time, since many of the
expenses related to the national phase of our InFoods® patents have
already been paid and we expect to soon conclude our hp+detect
clinical trials, we expect these reductions in expenses should
positively impact our financial performance,” stated Zackary Irani,
CEO of Biomerica.
About Biomerica (NASDAQ:
BMRA)
Biomerica, Inc. (www.biomerica.com) is a global
biomedical company that develops, manufactures and markets advanced
diagnostic products used at the point-of-care (in home and in
physicians' offices) and in hospital/clinical laboratories for the
early detection 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 products for Gastrointestinal Disease, Diabetes and
esoteric testing.
The Biomerica InFoods® IBS product identifies
patient specific foods that when removed may alleviate an
individual's IBS symptoms. This patent-pending, diagnostic-guided
therapy is designed to allow for a patient specific, guided dietary
regimen to improve Irritable Bowel Syndrome (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 will 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
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.
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 intended launch
dates, minimum purchases, sales potential, positive impact in
financial performance, significant benefits, market size,
prospects, new products, favorable outlook, new distributors,
expansion, increases in productivity and margins, expected orders,
leading market positions, anticipated future sales or production
volume of the Company, the launch or success of product and new
product offerings. Such forward-looking information involves
important risks and uncertainties that could significantly affect
anticipated results in the future, and accordingly, such results
may differ materially from those expressed in any forward-looking
statements made by or on behalf of Biomerica. The 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: Zackary Irani |
CEO949-645-2111
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