Applied DNA Second Fiscal Quarter 2021 Financial Results Feature 384% Year-Over-Year Growth in Revenues

Rhea-AI Summary

Applied DNA Sciences (NASDAQ: APDN) reported a significant 384% revenue growth year-over-year for the second fiscal quarter, driven by strong demand for its COVID-19 diagnostics. The company launched a clinical trial for a LinearDNA COVID-19 vaccine aimed at the veterinary market and established a recurring revenue stream through its CertainT platform. They also expanded their COVID-19 testing capabilities, allowing for enhanced monitoring of SARS-COV-2 mutations. Future strategies include pushing for Emergency Use Authorization for their Selective Genomic Surveillance Panel and expanding their therapeutic pipeline.

Positive

• 384% year-over-year revenue growth for Q2.
• Launch of LinearDNA COVID-19 vaccine clinical trial for veterinary use.
• Establishment of recurring revenue from dietary supplements.
• Expanded COVID-19 testing portfolio with the SGS Panel.

Negative

• Uncertainty regarding the timing of global recovery and its impact on supply chain security.

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 three and six months ended March 31, 2021.

“We are pleased to deliver a strong fiscal second quarter with year-over-year revenue growth of 384%, capping an impressive first half of the fiscal year distinguished by demand for our COVID-19 diagnostics and surveillance testing offerings (cumulatively “COVID-19 testing business”),” said Dr. James A. Hayward, president and CEO, Applied DNA. “Our strategic and operational execution across non-COVID-19 testing initiatives was also notable: we launched our first-ever clinical trial for a therapeutic candidate in the form of a LinearDNA™ COVID-19 vaccine candidate for the veterinary market; advanced our cGMP capabilities and compliance roadmap that is a precursor to securing more lucrative CMO relationships and lays the foundation potentially to disrupt the market for the manufacturing of nucleic acid-based therapies; established a recurring revenue stream from the dietary supplements industry via Nutrition21’s use of our CertainT platform; strengthened our capital position, and deepened the management team to support our growth goals.”

Continued Dr. Hayward, “Our COVID-19 testing strategy is increasingly informed by the acceleration in vaccine distribution. While traditional positive/negative testing remains a component of our go-to-market strategy, we believe that we are well-positioned despite increasing vaccination rates given our ability to detect SARS-COV-2 mutations. The expansion of our COVID-19 product portfolio with our Selective Genomic Surveillance™ (SGS™) Panel and expanded intended use of our EUA for our Linea^TM COVID-19 Assay Kit to include asymptomatic serial screening testing reflects a differentiated capability that expands our addressable market to include populations that can serve as a nexus for vaccinated and under-vaccinated populations coming together with increasing frequency, such as skilled nursing facilities, and supports the reopening of schools and workplaces. With our newly expanded intended use, together with the receipt of a New York clinical laboratory permit and CLIA certification for COVID-19 testing using EUA-authorized methods and devices by our Applied DNA Clinical Labs, LLC subsidiary, we believe our COVID-19 testing business presents a compelling opportunity for continued top-line growth.

“During the second half of the fiscal year, we will focus on positioning our COVID-19 testing business for the expected ongoing need for tests and services to support clients’ reopening strategies. While today our SGS Panel is available on a research use only (RUO) basis, our logical next step would be to seek an EUA to bring this critical tool out from the lab and to every Emergency Room and other healthcare providers that serve as the first line of defense against coronavirus variants to potentially inform their use of monoclonal antibody and convalescent plasma therapies. Concurrently and in line with our phased approach to cGMP that is further bolstered by preliminary positive neutralizing antibody results in domestic felines in our LinearDNA COVID-19 vaccine candidate clinical trial, we intend to explore an expansion of our LinearDNA-based therapeutic pipeline into classes of therapies that will best utilize the many benefits of our LinearDNA platform.

“While the speed and shape of the global recovery and timing of its impact on our supply chain security business remain uncertain, over the past year, we have seen brands and their supply chains put more emphasis on supply chain security and transparency to enhance their market position exiting the pandemic. We continue to position our CertainT^® platform as an enabler of the trust

FAQ

What were the financial results for Applied DNA Sciences in Q2 2021?

Applied DNA Sciences reported a 384% year-over-year revenue growth for the second fiscal quarter ended March 31, 2021.

What is the future outlook for APDN's COVID-19 testing business?

APDN aims to position its COVID-19 testing business for ongoing needs post-pandemic, focusing on services that support reopening strategies.

What developments were announced regarding the LinearDNA COVID-19 vaccine?

APDN launched a clinical trial for a LinearDNA COVID-19 vaccine candidate targeting the veterinary market.

How has APDN expanded its COVID-19 testing capabilities?

APDN expanded its COVID-19 testing portfolio with the Selective Genomic Surveillance™ Panel and received a clinical laboratory permit and CLIA certification.