Full Press Release Details
DNA Announces Fourth Quarter and Fiscal Year 2024 Financial Results, Announces Strategic Restructuring to Prioritize the Manufacture
of Critical Starting Materials for Genetic Medicines
- Pursuing Divestiture
of CertainT Platform, Implements Changes to Corporate Leadership -
GMP Manufacturing Facility to be Completed by January 9, 2025 -
and Conference Call Scheduled for Thursday, January 9, 2025, at 4:30 PM ET -
BROOK, N.Y. - December 17, 2024 - Applied DNA Sciences, Inc. (NASDAQ:
APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today reported financial results
for its fourth quarter and fiscal year ended September 30, 2024. An update on the buildout of the Company's GMP manufacturing facility
is available for viewing via slideshow on the Presentations page of the Investor
Relations portion of the Company's website. The Company's Form 10-K can be viewed on the
the Company announced a strategic restructuring of its business operations to focus its resources on manufacturing critical starting
materials for genetic medicines enabled by its Linea DNA and Linea IVT platforms. Ongoing and future actions supporting
Applied DNA's restructuring strategy include:
1 While the Company is currently
in negotiations for the potential divestiture of the CertainT platform, no assurance can be given that a potential divestiture will be
Management Commentary
"Following a thorough review
of our businesses to enhance value for shareholders, we believe that our expertise and experience in enzymatic DNA production, the wealth
of data generated over years that validate Linea DNA as a compelling alternative to plasmid DNA, and our proximity to GMP manufacturing
is not fully recognized in our current structure. Our actions today will sharpen our focus on commercialization initiatives for our Linea
DNA and Linea IVT platforms to return the Company to revenue growth and expand shareholder value," stated Dr. Hayward. "With
several of our existing customers expected to initiate clinical trials in the next twelve months, we believe the completion of our GMP
manufacturing facility will allow us to win several long-term, high-margin GMP supply agreements for IVT templates, resulting in the significant
utilization of our GMP manufacturing capacity in FY2025."
Recent Operational Highlights
Therapeutic DNA Production Services (LineaRx)
GMP roadmap execution:
Linea DNA/Linea IVT template commercialization:
2 Based on internal company assumptions
and modeling using a 1/100 DNA-to-RNA amplification ratio and an mRNA vaccine dose of 30 g. Manufacture of the final mRNA drug substance
will be conducted by therapy developers or their CDMO.
Linea DNA commercialization for IVT diagnostics:
MDx Testing Services (Applied DNA Clinical
TR8 PGx testing service commercialization:
Financial Highlights
Total revenues for the fourth
quarter of fiscal 2024 were $813 thousand compared with $780 thousand for the same period of fiscal 2023. The year-over-year
increase was a result of higher Service revenues primarily related to an increase in isotopic testing services revenues that offset
lower clinical laboratory services revenues due to a decrease in demand for COVID-19 testing.
Operating loss for the fourth
quarter of fiscal 2024 was $3.3 million compared with $4.2 million in the prior year period. The improvement is primarily attributable
to lower selling, general and administrative costs year-over-year attributable to lower stock-based compensation, offset by an increase
in professional fees.
Net loss for the fourth quarter
of fiscal 2024 was $3.3 million, or $0.32 per share, compared with $3.6 million, or $5.29 per share, in the prior year period and on a
higher number of shares outstanding. Adjusted EBITDA for the fourth quarter of fiscal 2024 was a negative $3.2 million compared with a
negative $3.5 million in the prior year period.
Total revenues for fiscal 2024 were
$3.4 million compared with $13.4 million in fiscal 2023. The decrease was driven by lower clinical laboratory services
revenues due to a decrease in demand for COVID-19 testing services, as the prior fiscal year included testing revenues under our contract
with CUNY, which terminated in June 2023.
Operating loss for fiscal 2024
was $14.0 million compared with $11.0 million in the prior year period. The increase was driven primarily by lower clinical laboratory
services revenues, offset by a decrease in total operating expenses.
Net loss for fiscal 2024 was $7.1
million, or $1.82 per share, compared with $10.0 million, or $15.21 per share in the prior year period and on a higher number of shares
Cash and cash equivalents on September
30, 2024, totaled $6.4 million. On October 31, 2024, the Company completed a registered direct offering and received net proceeds of approximately
$5.8 million after deducting placement agent fees and other estimated offering costs payable by the Company. As a result of this offering,
cash and cash equivalents as of November 3, 2024, were approximately $10.1 million.
January 9 Investor Update Conference Call Information
The Company will hold a conference
call and webcast to update investors on its restructuring and GMP roadmap on January 9, 2025, 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
Live and replay of webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=3UkskFxG
Telephonic replay (available 1 hour following the conclusion of
the live call through January 16, 2025):
An accompanying slide presentation that will be embedded in the webcast
can be accessed under News & Events' tab and Company Events' section 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 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 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 currently operate in three primary business markets: (i) the enzymatic manufacture
of synthetic DNA for use in the production of nucleic acid-based therapeutics and the development and sale of a proprietary RNA polymerase
("RNAP") for use in the production of mRNA therapeutics; (ii) the detection of DNA and RNA in molecular diagnostics and genetic
testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
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