NovaBay® Pharmaceuticals, Inc. (NYSE American: NBY) announces
that CEO Justin Hall has issued the following letter to
stockholders:
To My Fellow Stockholders:
As pandemic-related shelter-in-place restrictions are beginning
to lift in certain geographies and Americans are preparing to
return to school, work and social activities, NovaBay has focused
on offering our fellow Americans products they need to help them
stay safe. NovaBay has business contacts around the globe, and we
worked tirelessly with them to secure quality COVID-19
personal-protection and diagnostic products, while at the same time
continuing to advance our previously announced cost-efficient sales
and marketing strategy for Avenova®. I’m gratified to report this
parallel strategy is working very well, with combined product sales
in the month of April surpassing our total revenue for the entire
first quarter.
Just as Avenova is considered the highest quality product in its
market segment, we are also confident in the quality of the new
products we are securing for U.S. distribution in response to the
COVID-19 pandemic. Our confidence is based on the reputation of our
suppliers as well as the results from third-party lab testing.
We began selling KN95 masks through our website Avenova.com less
than two months ago, and we are already nearing the milestone of
one million units sold. These KN95 masks are effective in filtering
out at least 95 percent of airborne particles, including
microorganisms, dust, pollen and air pollution, making them ideal
for personal protection in public places. We are highly confident
in their design as they are CE certified and meet the KN95-level
requirements. In order to distinguish them from the many inferior
quality masks currently in the marketplace, our partner mask
manufacturer has submitted the KN95 masks for emergency use
authorization (“EUA”) from the U.S. FDA to further validate their
quality. Due to the backlog of new COVID-19 related products
submitted, the FDA has not given us a timeframe for review. While
many Americans continue to have difficulty acquiring masks, our
masks are in stock in the U.S. and ready for immediate shipping,
with customers typically receiving them within a day or two of
ordering.
Most of our current volume is attributable to bulk orders from
large institutions. We expect that pattern will continue in the
near term and that our KN95 mask sales through Avenova.com will
remain fairly steady with April levels. We are also offering a
special promotion combo pack of 30 masks and two bottles of Avenova
for $199. Avenova, with its antimicrobial properties and applied as
a facial spray, is a perfect complement to the mask. I’m pleased to
report that some companies are placing bulk orders for this combo
pack and shipping them directly to their employees’ homes as a
gesture of goodwill.
Less than a month ago, we announced an exclusive U.S.
distribution agreement for a highly sensitive rapid, point-of-care,
finger prick COVID-19 antibody test. Public health experts and
leaders across the country are citing a critical need for mass
testing and tracing procedures for those who have been infected
with COVID-19 as a condition for safely reopening our economy. As
work and social activities resume, we expect that testing will
become an even greater priority to determine who is actively
infected and who may have antibodies against the pathogen.
Importantly, we are confident in the reliability of our product
versus some questionable tests that have been introduced to the
market. We believe the accuracy of our test is comparable to those
already receiving EUA from the FDA. We filed for EUA approval on
April 17 and remain in regular contact with the FDA reviewer
assigned to evaluate our test. Regulatory reviews of COVID-19
antibody tests have been slow as the FDA is tirelessly working
through a backlog of submissions.
To be clear, we will not be selling this point-of-care test
until such time as EUA from the FDA has been received. Once
granted, we will begin marketing the test through our sales team to
healthcare professionals across the country, who then will
administer the test. The test uses a drop of whole blood for the
detection of COVID-19 antibodies, with results available in
approximately 10 minutes. Our test detects for the presence of both
IgM and IgG. IgM is usually the first antibody generated by the
body in response to the coronavirus. Later, the IgG antibody is
generated and replaces IgM as the predominant antibody in response
to the infection. While in some ways our test is similar to others
on the market, it is differentiated by its use of a slightly larger
blood sample to improve accuracy and shortened testing time of 10
minutes versus 20 minutes with others. Additionally, our test is
self-contained without the need for additional materials or
ancillary reagents, which competing tests require. While we are
confident in the quality of our test, because of the fast-changing
regulatory landscape, we cannot give guidance on the timeline for
FDA review or whether we will receive clearance for commercial
marketing and sale. Our sales team is in place and eager for this
new opportunity.
During this time of shelter-in-place, our team is also focusing
on promoting Avenova, both online and to doctors in historically
high-performing territories. We introduced Avenova Direct as a
prescription-strength consumer product last June, and online sales
during the 2020 first quarter accounted for more than half of all
Avenova revenue for the very first time. We previously announced
the introduction of refreshed consumer branding for Avenova with
new packaging and reinvigorating messaging that emphasizes
quality-of-life themes. While e-commerce sales are becoming a
growing percentage of the total, we are pursuing a strategy to
cost-effectively expand our customer base. We are pleased by the
reception to our refreshed branding, and we're open to the
opportunity to increase sales through affiliate relationships to
help reach the 41 million Americans who suffer from blepharitis and
related eye conditions.
NovaBay’s proprietary pure hypochlorous acid (HOCl) is a form of
an antibacterial/antimicrobial agent naturally produced by the
human body in response to pathogens. HOCl has also been endorsed by
the Centers for Disease Control and Prevention (CDC) as a
disinfectant useful against SARS-CoV-2. We are conducting
third-party laboratory tests to verify the efficacy of our specific
formulation against the SARS-CoV-2 pathogen. The popularity of
Avenova could significantly increase as Americans seek alternative
disinfectant solutions that are proven to be safe and
well-tolerated on human skin, including the face and sensitive area
around the eyes. Americans have become educated to the CDC warning
against touching one’s face as this significantly increases the
risk of potential infection. Avenova is manufactured in the U.S.
and the supply chain for its components is currently robust. We are
increasing our advertising to broaden our customer base of regular
long-term users.
Also in keeping with our strategy, we are targeting ophthalmic
and skin care product line extensions that will leverage our
salesforce and our sales channels under economics that make sense
for NovaBay. We are pursuing a range of options including product
licensing and acquisitions.
While we look forward to a return to more normalized business
operation, NovaBay continues to work hard under remote conditions.
I’d like to thank my colleagues for our shared dedication to
success, and also thank our stockholders for your confidence in the
NovaBay team as we build stockholder value.
Sincerely,
Justin M. Hall, Esq. Chief Executive Officer and General
Counsel
PS. Please note we are holding a virtual Annual Meeting of
Stockholders on May 26, 2020 beginning at 5:00 p.m. Pacific Time.
Instructions for joining the meeting are in the proxy materials
sent to stockholders as of our Record Date. We appreciate your
support for the initiatives our Board has endorsed.
About NovaBay Pharmaceuticals, Inc.: Going Beyond
Antibiotics®
NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company
focusing on commercializing and developing its non-antibiotic
anti-infective products to address the unmet therapeutic needs of
the global, topical anti-infective market with its two distinct
product categories: the NEUTROX® family of products and the
AGANOCIDE® compounds. The Neutrox family of products includes
AVENOVA® for the eye care market, CELLERX® for the aesthetic
dermatology market and NEUTROPHASE® for the wound care market. The
Aganocide compounds, still under development, have target
applications in the dermatology and urology markets.
Forward-Looking Statements
Except for historical information herein, matters set forth in
this press release are forward-looking within the meaning of the
“safe harbor” provisions of the Private Securities Litigation
Reform Act of 1995, including statements about the commercial
progress and future financial performance of NovaBay
Pharmaceuticals, Inc. This release contains forward-looking
statements that are based upon management’s current expectations,
assumptions, estimates, projections and beliefs. These statements
include, but are not limited to, statements regarding our business
strategies and current product offerings, potential future product
offerings, possible regulatory clearance of any of our products or
future products, and any future revenue that may result from
selling these products, as well as generally the Company’s expected
future financial results. These forward-looking statements are
identified by the use of words such as “expect,” “future growth,”
“reduce,” and “expand,” among others. These statements involve
known and unknown risks, uncertainties and other factors that may
cause actual results or achievements to be materially different and
adverse from those expressed in or implied by the forward-looking
statements. Factors that might cause or contribute to such
differences include, but are not limited to, risks and
uncertainties relating to the size of the potential market for our
products, the possibility that the available market for the
Company’s products will not be as large as expected, the Company’s
products will not be able to penetrate one or more targeted
markets, revenues will not be sufficient to meet the Company’s cash
needs, and any potential regulatory problems. Other risks relating
to NovaBay’s business, including risks that could cause results to
differ materially from those projected in the forward-looking
statements in this press release, are detailed in NovaBay’s latest
Form 10-Q/K filings with the Securities and Exchange Commission,
especially under the heading “Risk Factors.” The forward-looking
statements in this release speak only as of this date, and NovaBay
disclaims any intent or obligation to revise or update publicly any
forward-looking statement except as required by law.
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Avenova Purchasing Information For NovaBay Avenova
purchasing information: Please call 800-890-0329 or email
sales@avenova.com www.Avenova.com
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version on businesswire.com: https://www.businesswire.com/news/home/20200514005289/en/
NovaBay Contact Justin Hall President and Chief Executive
Officer 510-899-8800 jhall@novabay.com
Investor Contact LHA Investor Relations Jody Cain
310-691-7100 jcain@lhai.com
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