Full Press Release Details
Applied DNA Announces Third Quarter Fiscal 2021
Revenues Increased 294% Year-Over-Year to $1.7 Million
- Year-To-Date Revenues
Increase 270% From Last Fiscal Year to $6.0 Million -
- Company to Hold Conference
Call and Webcast Today, Thursday, August 12, 2021, at 4:30 PM ET -
N.Y. - August 12, 2021 - Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"),
a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, today announced consolidated
financial results for the three and nine months ended June 30, 2021.
"We delivered excellent
year-over-year revenue growth in the fiscal third quarter while laying the groundwork to secure a recently awarded COVID-19 testing services
contract that has potential to be the largest contract in the Company's history," said Dr. James A. Hayward, president and
CEO of Applied DNA. "Demand for safeCircle , our pooled COVID-19 testing program, experienced a seasonal decline from the
fiscal second quarter, reflecting the start of the summer recess months for our academic clients and progressively higher vaccination
rates and lower positivity rates in our operating area. Our recent award from the City University of New York for large-scale turnkey
COVID-19 testing services should continue to drive strong year-over-year revenue growth over the period of the contract."
Continued Dr. Hayward, "Our
operating activities during the quarter were distinguished by an expansion of our COVID-19 offerings to drive incremental revenue and
to drive adoption of LinearDNA as an alternative to plasmids for nucleic acid-based therapies. Following constructive interactions
with the U.S. Food and Drug Administration (FDA) as part of a preliminary Emergency Use Authorization application process and the evolving
nature of the pandemic, we revised our LineaTM SARS-CoV-2 Mutation (the "Linea Mutation Panel") (formerly SGS
Mutation Panel) to target three SARS-CoV-2 mutations (E48K, L452R, N501Y) that have been designated substitutions (mutations) of therapeutic
concern by the Centers for Disease Control and Prevention.
"Should the FDA grant an
EUA for the Linea Mutation Panel, we believe that it will offer clinical utility to healthcare systems by enabling precision COVID-19
treatment and commercial utility to monoclonal antibody manufacturers by better characterizing patients before treatments. In recent months,
several monoclonal antibody treatments have had their EUA revoked or have demonstrated a reduction in efficacy on a standalone or in combination
with other treatments due to mutational impact. Use of the Linea Mutation Panel is tied to our Linea COVID-19 Assay Kit to determine
positivity in clinical samples that would drive additional Assay demand if the EUA is granted for our Mutation Panel. We believe that
an EUA-authorized Linea Mutation Panel will also provide additional value to our existing COVID-19 testing customers and, when combined
with our Whole Genome Sequencing assets, provide data of interest to epidemiologists.
"Concurrently, the launch
of our veterinary LinearDNA COVID-19 vaccine trial and the subsequently reported strong immune response that the vaccine candidate
elicited, further reinforce the value proposition of LinearDNA, and, longer-term, generates invaluable preclinical data supporting the
eventual application of LinearDNA to nucleic acid-based therapies in humans."
Concluded Dr. Hayward, "Looking
ahead, the confluence of increasing positivity rates due to the Delta variant, the commingling of vaccinated, partially vaccinated, and
unvaccinated individuals, and new mandatory testing requirements for local and state-level employees in our operating area affirm the
need for ongoing and consistent COVID-19 screening available through safeCircle. Subject to FDA's evolving EUA request review priorities,
we expect to file shortly our formal request for EUA for our Linea Mutation Panel. In addition, in the coming weeks we intend to
launch our COVID-19 veterinary vaccine candidate challenge trial in furtherance of a commercial animal health opportunity.
"Regarding our supply chain
security business, we have cautious optimism within the cotton supply chains we serve as we approach the start of the cotton ginning season
in the U.S. However, with Asia-Pacific beset by the Delta variant, man-made fiber opportunities remain static. With the tailwind of COVID-19
testing at our back supplemented by continued execution on business development initiatives, we believe we are laying the foundation for
sustainable growth."
Fiscal Third Quarter 2021 Financial Highlights:
Nine-Month Financial Highlights:
Fiscal Third Quarter 2021 Conference Call Information
The Company will hold a conference call and webcast to discuss its
fiscal third quarter-end 2021 results on Thursday, August 12, 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.
Telephonic replay (available 1 hour following the conclusion of
the live call through August 19, 2021):
The webcast and accompanying
PowerPoint presentation will be archived on the IR Calendar and Corporate Presentations' page listed under the Investor
Relations drop-down menu on the Company's website.
ADCL's high throughput pooled testing program, known as safeCircle ,
utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community,
school, or workplace. safeCircle provides rapid results using real-time PCR (RT-PCR) testing.
Click through to learn more about how safeCircle can help your community,
school, and workplace: safeCircle
About Linea COVID-19 Assay Kit and LineaTM SARS-CoV-2
The Linea COVID-19 Assay Kit is a real-time RT-PCR test intended
for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens including anterior nasal swabs, self-collected
at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal
washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who
are suspected of COVID-19 by their healthcare provider (HCP). The test is also intended for use with anterior nasal swab specimens that
are self-collected in the presence of an HCP from individuals without symptoms or other reasons to suspect COVID-19 when tested at least
weekly and with no more than 168 hours between serially collected specimens.
The scope of the Linea COVID-19 Assay Kit EUA, as amended, is
expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances
exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated
or until the EUA's prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA's
limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The Linea SARS-CoV-2
Mutation Panel (formally SGS Mutation Panel) (the "Linea Mutation Panel") is for Research Use Only (RUO) and
shall not be used for clinical diagnostic purposes. The Linea Mutation Panel has not been approved or authorized to diagnose, ameliorate
and/or detect any disease by any U.S. or international regulatory authority.
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.