Full Press Release Details
First Quarter Fiscal 2023 Financial Results
- Total Revenues of $5.3 Million, Up 48% Over FQ4 2022 and 26% Over FQ1 2022,
72% and 74% Reduction in Operating Loss, Respectively -
- Included Orders for R&D
Quantities of linearDNA from New Biopharma Customers -
- Maintains Timeline to cGMP
Capacity, Initiates Build-out of Cost-Efficient Facility -
- Business Update Conference
Call/Webcast Scheduled for Today at 4:30 PM ET -
N.Y. - February 9, 2023 - Applied DNA Sciences, Inc. (NASDAQ: APDN)
("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced consolidated financial
results for the first quarter of fiscal 2023, ended December 31, 2022.
"Applied DNA delivered a
solid start to the fiscal year with sequential and year-over-year revenue growth driven by molecular diagnostic testing demand at ADCL,
our clinical laboratory subsidiary, several orders for linearDNA , including a pair of orders from first-time biopharma customers
for mRNA research and development use, and from deferred textile DNA tagging revenue," stated Dr. James A. Hayward, president
and CEO of Applied DNA. "Our top-line performance was paired with a 72% and 74% reduction in operating loss sequentially and year-over-year,
respectively, due in part to higher testing volumes coupled with cost management actions previously taken at ADCL.
"We also achieved progress
on our strategic priority of establishing linearDNA and our LinearDNA platform as the common denominator for the manufacture of
the next generation of nucleic acid-based therapies while working to concurrently position ADCL and our supply chain traceability businesses
for profitable growth and positive cash flows," continued Dr. Hayward. "Since the launch of our linearDNA IVT template
production offering last summer, interest has grown steadily as the industry gains an appreciation for our capacity for high quality,
enzymatically produced template to meet therapy developers' need for this critical mRNA manufacturing starting material. Concurrently,
the industry's clinical interest in mRNA extends beyond COVID-19 vaccines to new applications for mRNA, such as personalized cancer
treatments and other therapeutic uses. Our linearDNA IVT templates can be produced rapidly with chemical modifications and highly homogeneous
poly(T) tails that we believe are very well suited to support this next chapter in mRNA therapeutics.
"Our linearDNA activities
were also centered on fine-tuning our platform and forging relationships with platform materials partners to create a rapid, end-to-end
production platform to capture commercial-scale IVT templating and, potentially, mRNA production opportunities empowered by the unique
qualities of linearDNA. To that end, we remain committed to our timeline to building a cGMP manufacturing facility by the end of the current
calendar year but are pivoting to a cost-efficient footprint within our corporate headquarters that maintains our ability to produce cGMP-grade
product for current and prospective customers to validate for use in clinical trials. We also plan to leverage our platform advantages
in the coming months to offer industry-leading DNA-sequence-to-IVT-template turnaround times."
Concluded Dr. Hayward, "At
ADCL, we believe we are well positioned to leverage the population health platform we built during the pandemic to propel this subsidiary
into the genetic testing marketplace of the future. Approaching enterprise customers with a reference lab model differentiates ADCL from
those labs struggling to gain reimbursement from third parties and insurance companies. We have successfully completed our clinical validation
and data analysis for our pharmacogenomics (PGx) testing panel and plan to file our validation package with New York State Department
of Health in the coming weeks. Prospective PGx customer feedback has been very encouraging and gives us confidence that PGx testing can
be a profitable post-pandemic path forward. In our supply chain traceability business, we continued to add CertainT platform customers
for isotopic analysis testing, which is an excellent complement to DNA tagging. We are encouraged by the macro environment for textile
material provenance testing following the recent passage of the federal Omnibus Bill that increases funding for compliance with the Uyghur
Forced Labor Prevention Act."
First Quarter Fiscal 2023 Financial Highlights:
The year-over-year increase
was offset by a decrease in product revenues of $310 thousand due to a decrease in sales of our molecular diagnostics (MDx) test kits
First Quarter Fiscal 2023 Conference Call Information
The Company will hold a conference call and webcast to discuss its
first quarter of fiscal year 2023 financial results on Thursday, February 9, 2023, at 4:30 PM ET. To participate in 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.
To Participate, please ask to be joined to the Applied DNA Sciences'
Live and replay of webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=gZ93PCbr
Telephonic replay (available 1 hour following the conclusion of
the live call through February 16, 2023):
An accompanying slide presentation will be embedded in the webcast
(live and replay) and can also be accessed in the Company Events' section of the 'News & Events' tab of the Applied DNA
investor relations website at https://investors.adnas.com/
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 businesses. Our management
believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our businesses
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
"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 Sciences is a biotechnology company developing technologies
to produce and detect deoxyribonucleic acid ("DNA"). Using the polymerase chain reaction ("PCR") to enable both the
production and detection of DNA, we operate in three primary business markets: (i) the manufacture of DNA for use in nucleic acid-based
therapeutics; (ii) the detection of DNA in molecular diagnostics testing services; and (iii) the manufacture and detection of
DNA for industrial supply chain security services.
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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.'
Forward-Looking 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, unknown future demand for its biotherapeutics
products and services, the unknown amount of revenues and profits that will result from any diagnostic
testing contract, limited market acceptance for its supply chain security products and services, whether any of Applied DNA's or its
customers therapeutic candidates utilizing the linearDNA platform will advance further in the preclinical research or clinical trial
process, including receiving clearance from the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA)
or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval
as therapeutic products from the FDA, the USDA or equivalent foreign regulatory agencies, the unknown duration of the COVID-19 public
health emergency, changes in guidance promulgated by the CDC, FDA and/or CMS relating to COVID-19 testing, the fact that there has never
been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, and various other factors detailed
from time to time in Applied DNA's SEC reports and filings, including its Annual Report on Form 10-K filed on December 14,