Full Press Release Details
Applied DNA Reports First Fiscal Quarter
2021 Revenues at Upper End of Guided Range
of $1.6 Million Compared with $634,000 in the Year-Ago Period and $314,000 in the Fourth Quarter of Fiscal 2020 -
- Leverages EUA-Authorized
Assay's Ability to Discriminate for Certain SARS-CoV-2 Variants to Pursue Market for Genomic Surveillance, Receives Initial
BROOK, N.Y. - February 11, 2021 - Applied DNA Sciences, Inc. (NASDAQ: APDN) (the
"Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced consolidated financial
results for the quarter ended December 31, 2020.
marked a very strong start to the fiscal year, reflecting burgeoning demand for our COVID-19 diagnostics and surveillance testing
offerings (cumulatively "our COVID-19 testing business"). Our revenue performance was driven primarily by new client
acquisitions for safeCircle , our pooled surveillance testing service, the full benefit of which we believe will be evident
in our March 31, 2021 quarter. We also began to deliver quantities of our Linea COVID-19 Assay Kit (the "Assay Kit")
and from which we anticipate recurring orders under the existing contract," said Dr. James A. Hayward, president and CEO,
Applied DNA Sciences. "Our emphasis remains on client acquisition, and, to that end, safeCircle business momentum has continued
into the March quarter both organically and through CLEARED4, our channel partner, with whom we now enjoy a fourth joint customer.
From a COVID-19 testing capacity perspective, we believe we can capably manage demand for safeCircle we see on the horizon and
are prepared to deploy additional equipment and further automation beyond that.
develop genomic surveillance as a third application of our Assay Kit to potentially expand our COVID-19 testing business. Whereas
safeCircle tests within populations for SARS-CoV-2 positivity generally, genomic surveillance seeks to monitor positivity specifically
for certain SARS-CoV-2 variants to inform public health decisions. We recently confirmed via in silico analysis and in the
field that the unique design of our Assay Kit gives it the ability to discriminate positive virus infections for the presence of
certain SARS-CoV-2 variants, some of which that have increased transmissibility. Given the limited gene sequencing capacity available
nationally with which to confirm the presence of a variant, variant spread can go, and likely is going, undetected. We have discussions
underway with the Departments of Health of multiple States on how our Assay Kit can be utilized to help them implement broader
genomic surveillance while variants are less prevalent in the national population and action can be taken against them. We have
already received several, initial orders for genomic surveillance from certified laboratories.
ability to discriminate for certain variants is also relevant to our safeCircle service that seeks to keep safe and healthy an
under-vaccinated populace now also being beset by variants. With a unique test and service offering, an evolving virological threat
to which we can help public health officials craft a response, and upon CLEP-CLIA-certification of our diagnostic laboratory, which
we continue to progress, we believe we are primed for continued growth in our COVID-19 testing business."
Continued Dr. Hayward,
"Looking beyond the pandemic, we continue to advance our long-term strategy to establish our LinearDNA manufacturing
platform as a potentially disruptive alternative to plasmid DNA that is used in the manufacture of all nucleic acid-based therapies.
We are in the early stages of the assessment of a cGMP (Current Good Manufacturing Practice) production capacity and capability
within our LinearRx subsidiary that directly speaks to the maturation of our preclinical CRO (contract research organization) pipeline.
Our customers have made clear their expectation for us to support them as a CMO (contract manufacturing organization) and under
cGMP conditions for when they initiate animal trials of their therapeutic candidates. The expected initiation of our linear DNA
veterinary COVID-19 vaccine trial is in furtherance of our long-term strategy and sets a path to having a therapeutic in the market
with an animal health partner."
Concluded Dr. Hayward,
"Our supply chain security business is beginning to show early signs of a recovery. COVID-19 has made companies more focused
on the need to secure their supply chains and made consumers and brand builders more aware of their exposure to counterfeiting
and diversion. We believe that the year lost to the pandemic has created a backlog of demand for our CertainT platform across
several end-markets, including textiles, nutraceuticals, and cannabis."
Fiscal First Quarter 2021 Financial Results:
Fiscal First Quarter 2021 Conference Call Information
The Company will hold a conference call and webcast to discuss
its fiscal first quarter-end 2021 results on Thursday, February 11,2021 at 4:30 PM ET. To participate on the conference call, please
follow the instructions below. While every attempt will be made to answer investors' questions on the Q&A portion of
the call, not all questions may be answered.
Live webcast: https://services.choruscall.com/links/apdn210211.html
Replay (available 1 hour following the conclusion of the
live call through February 18, 2021):
Webcast replay: https://services.choruscall.com/links/apdn210211.html
For those investors unable to
attend the live call, the webcast and accompanying PowerPoint presentation will also be archived on the IR
Calendar' page listed under the Investor Relations drop-down menu on the Company's website.
Information about Non-GAAP Financial Measures
As used herein, "GAAP" refers to accounting principles
generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and
presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined
in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a
numerical measure of a company's historical or future performance, financial position, or cash flows that either excludes
or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented
in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation
or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial
measure for internal financial and operational decision-making purposes and as a means to evaluate period-to-period comparisons
of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures
provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not
be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow
for greater transparency with respect to key metrics used by management in its financial and operational decision making.
"EBITDA"- is defined as earnings (loss) before interest
expense, income tax expense and depreciation and amortization expense.
"Adjusted EBITDA"- is defined as EBITDA adjusted
to exclude (i) stock-based compensation and (ii) other non-cash expenses.
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA , its proprietary,
large-scale polymerase chain reaction ("PCR")-based manufacturing platform that allows for the large-scale production
of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based
in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used
to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug
development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies,
clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established
a COVID-19 diagnostics and testing offering that is the early stages of commercialization and is grounded in the Company's
deep expertise in DNA.
The LinearDNA platform also has non-biologic applications, such
as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and
nutraceuticals, and cannabis, among others.
The Company's common stock is listed on NASDAQ under ticker
symbol APDN', and its publicly traded warrants are listed on OTC under ticker symbol APPDW'.
Applied DNA is a member of the Russell Microcap Index.
Forward-Looking Statements
statements made by Applied DNA in this press release may be "forward-looking" in nature within the meaning of Section
27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform
Act of 1995. Forward-looking statements describe Applied DNA's future plans, projections, strategies, and expectations,
and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied
DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources,
limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including
whether any of Applied DNA's or its partner's diagnostic or therapeutic candidates will advance further in the preclinical