Biomerica Reports Fiscal 2021 Year End Results
August 27 2021 - 8:36PM
Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider
of advanced medical products, today reported its fiscal 2021
financial results. During the year the Company made significant
progress in its business by increasing its number of allowed
patents covering its InFoods® diagnostic guided therapy technology,
signing a distribution agreement for its H. Pylori product which is
expected to be filed with FDA in October, 2021, and has entered
into negotiations with major retailers/distributors for sales of
its EZ Detect colorectal disease test.
Net sales for the fiscal year ended May 31, 2021
were $7.2 million as compared to net sales of $6.7 million in
fiscal 2020, an increase of $0.5 million, or 7.6%. Net loss was
$6.5 million for fiscal 2021 compared to a net loss of $2.3 million
for fiscal 2020. Research and Development investment was $2.4
million for fiscal year 2021 compared to $1.9 million the previous
year. The increased net loss for fiscal 2021 was primarily related
to the Company’s establishment of a large inventory reserve for
COVID-19 antibody tests during the third fiscal quarter, an
increase of $0.5 million in R&D costs, much of which was
related to finalizing the InFoods endpoint determination clinical
trial, and increased SG&A expenses associated with the
expansion of the Company’s management team. The 2021 7.6% increase
in revenue follows an increase in revenues of 38.4% for fiscal 2020
versus fiscal 2019. Revenues for both fiscal 2020 and 2021 were
positively impacted by sales of our COVID-19 related products,
however COVID-19 had a negative impact on revenues of our core
diagnostic products. At this point the Company’s core product sales
have largely returned and with the COVID-19 Delta variant
spreading, the Company is seeing increasing demand for its COVID
diagnostic tests. The Company will continue to sell and market its
COVID-19 products while maintaining its focus on its core
diagnostic business and its further development of the InFoods®
platform.
Fiscal Year 2021 and Recent Developments:
- InFoods® Endpoint Study Completion:
Biomerica expects to enroll the final patients for its InFoods IBS
clinical trial in September 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.
- Intellectual Property: During
fiscal 2021, Biomerica was granted three patents for its InFoods®
diagnostic therapy technology (“DGT”). The patents were granted in
the United States, Singapore and Korea. These patents cover the
Company’s InFoods® family of products that allow for a
one-of-a-kind diagnostic-guided therapy option for patients
suffering from Irritable Bowel Syndrome (“IBS”) and other
gastrointestinal diseases once cleared. The Company now has 9
allowed patents, has filed over 100 international and Patent
Cooperation Treaty patents; and has 22 provisional and
non-provisional patents currently filed with the U.S. Patent and
Trademarks Office. The majority of Biomerica’s pending patents
pertain to the InFoods® DGT technology platform. The InFoods® DGT
technology platform includes other diseases: functional dyspepsia,
Crohn’s Disease, ulcerative colitis, gastroesophageal reflux
disease (“GERD”), migraine headaches and osteoarthritis.
- InFoods® Depression Patent: The
Japanese Patent Office recently issued a notice of allowance for
Biomerica’s first patent pertaining to a new treatment option for
patients suffering from depression. It is now well established that
dysregulation of the immune system occurs in depressed patients,
and inflammatory processes have been linked to the pathophysiology
of depression. In addition, there is considerable recent clinical
research which shows strong correlation between IBS and depression.
Depression represents the number one cause of disability worldwide
and can be fatal.
- H. pylori: Biomerica signed an
exclusive five-year distribution agreement with a Canadian partner
for the distribution and marketing of Biomerica’s new and
proprietary Helicobacter pylori (“H. pylori”) test, called
hp+detect™. The 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. The Company is working to
complete its clinical studies for its H. pylori test in September
2021, and plans to file for FDA clearance in October, 2021.
- New Website for EZ Detect™
Colorectal Disease Screening Test: Biomerica launched a new website
for the EZ Detect™ Colon Disease at-home test product
(https://ezdetect.com). The site features streamlined functionality
and easy access to essential and potentially life-saving
information about detection and treatment of colorectal diseases,
including colon cancer. The new site launched alongside a digital
health advertising and social media campaign to promote and drive
sales of Biomerica’s EZ Detect™ product.
- Retail opportunities for EZ Detect™
Colorectal Disease Screening Test: The Company is in discussions
with major retailers to increase the U.S. and international
distribution of the EZ Detect™ Colon Disease Test by adding the
product to their online and in-store offerings. 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.
“Biomerica made a great deal of progress during
fiscal 2021 and we’re encouraged by the opportunities we’re seeing
to bring our products to a broader audience of patients and medical
professionals. Our InFoods® IBS diagnostic guided therapy endpoint
trial is very close to completion. The product addresses the $30
billion IBS market where surprisingly little relief is currently
available for patients. 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. This
offers broad appeal to patients, physicians and insurers. Moving
forward, we are also optimistic about the market potential for our
EZ Detect and H. pylori products. During fiscal 2021, like many in
our industry, we encounter challenges related to COVID-19 including
having to make a reserve for COVID-19 inventory manufactured early
in the pandemic, due to limited knowledge about what products would
best address the crisis. Our gross margin and losses during the
year were negatively impacted by these reserves for our early
COVID-19 tests. We do not anticipate any further significant
R&D effort or reserves for these COVID-19 tests going forward
and these tests are now incorporated into our other specialty
diagnostic tests and,” 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 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
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