Full Press Release Details
Fourth Quarter and Full Fiscal Year 2021 Financial Results, Continuing Momentum in Diagnostic Testing
- FQ4 Revenues of $3.0 Million, Up 868% Over FQ4'20 and Up 79% Over FQ3'21
- Record Full-Year Revenues
of $9.0 Million, up 367% Over Fiscal 2020 -
- Company Submits Linea
2.0 COVID-19 Validation Package to New York State Department of Health -
- Company to Hold Conference
Call and Webcast Today, Thursday, December 9, 2021, at 4:30 PM ET -
N.Y. - December 9, 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 full fiscal year and quarter ended September 30, 2021.
"We are pleased to report
a fourth consecutive quarter of year-over-year revenue growth in the fourth quarter and record revenues for the fiscal year, both of which
are the result of our decision to enter the COVID-19 testing and assay manufacturing markets and leverage our expertise in PCR refined
in our Industrial DNA and LinearDNA businesses," said Dr. James A. Hayward, president and CEO of Applied DNA. "COVID-19-related
revenues in the fiscal year were driven by the establishment of ADCL, our clinical laboratory subsidiary, to meet the need for population-scale
COVID-19 testing, as well as from sales of our Linea 1.0 COVID-19 Assay Kit and testing consumables. Momentum in COVID-19 testing
client acquisition, especially in the second half of the fiscal year, supported our continued investment in ADCL that is now largely complete.
We recorded strong year-over-year quarterly revenue comparisons that nevertheless fell short of a key client's projections due to
the combination of increased vaccination rates and vaccine mandates. Average weekly testing levels remain in flux but are on an uptrend:
new clients are onboarding in FQ1; the key client's testing needs have increased since Thanksgiving to include the random testing
of vaccinated individuals.
"We were also pleased to
see the re-emergence of demand for Industrial DNA from the textile industry and repeat and new orders for LinearDNA in the second half
of the fiscal year," continued Dr. Hayward. "The pandemic has impacted demand trends; nevertheless, we believe our textiles
practice has gained the attention of global apparel and footwear brands seeking to reprioritize their post-pandemic supply chains towards
sustainability, brand protection, and traceability. At LineaRx, vaccine development against COVID-19 has put a large spotlight on nucleic
acid therapies, so much so that plasmid manufacturers are projecting long lead times with growing capital and labor costs that are incenting
developers to seek an alternative to plasmid DNA-based manufacture. With both factors playing to LinearDNA's strengths, we believe
a window is opening for a disruptive force in the market for therapeutic DNA and particularly as we believe we will generate compelling
data from our clinical veterinary trials."
Concluded Dr. Hayward, "In
fiscal 2022, the emergence of a new SARS-CoV-2 variant of concern, the unpredictable trajectory of the virus' mutations, asymmetric
vaccine distribution, and potentially waning effectiveness of vaccines, we believe, keep testing on the front lines of the global battle
against the virus. Our COVID-19 diagnostic development plan and go-to-market strategy are aligned with our capacity to conduct population-scale
testing to meet the evolving demands of current and prospective customers. We are progressing a dual-COVID-19/influenza test and an at-home
sample collection system, advancing our Linea SARS-CoV-2 Mutation Panel EUA request, and recently submitted our Linea 2.0
COVID-19 Assay Kit, a new N and E gene-based test for COVID-19 that we believe is well suited to serve our future testing needs as new
variants continue to emerge, to the New York State Department of Health for its review as a laboratory developed test. In the non-COVID-19
arena, we are leveraging our deep scientific bench to explore new areas of cutting edge molecular testing that will further leverage our
"We are also prepared
to capitalize on opportunities cultivated in fiscal 2021 in Industrial DNA and the therapeutic application of LinearDNA. In fiscal
2022 our textiles practice is focused on commercial-scale trials and certain scale-up programs. With LinearDNA, we believe our
roadmap to an initial cGMP production capacity is ideally timed given the biotech industry's increasing investments in cell
and gene therapies and nucleic acid vaccines and through valuable third-party validation of the benefits of LinearDNA. We intend to
continue to pursue the use of LinearDNA for veterinary therapeutics. In addition, we are in discussions with one of our
international customers for a potential first-in-human clinical trial opportunity subject to necessary regulatory
Fiscal Fourth Quarter 2021 Financial Highlights:
Fiscal Year 2021 Financial Highlights:
Fourth Quarter and Full Year Fiscal 2021 Conference Call Information
The Company will hold a conference call and webcast to discuss its
fourth quarter and fiscal full year 2021 financial results on Thursday, December 9, 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 September 19, 2021):
The webcast and accompanying
PowerPoint presentation will be archived on the Company Events' sub-page of the
Company's Investor Relations 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.
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.
Leveraging its deep expertise in nucleic acid-based
technologies, the Company has also established safeCircle , a high-throughput turnkey solution for population scale COVID-19 testing.
safeCircle is designed to look for infection within defined populations or communities utilizing high throughput testing methodologies
that increase testing efficiencies and provide for rapid turn-around-times. The Company has also submitted a request for an EUA-authorization
for its LineaTM SARS-CoV-2 Mutation Panel, an assay-based panel for the detection of certain SARS-CoV-2 genetic mutations.
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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