ThermoGenesis Holdings (THMO) Reports Q1 Revenues Miss

ThermoGenesis Holdings (NASDAQ: THMO) reported Q1 revenue for the quarter came in at $3.2 million versus the consensus estimate of $5.4 million.

First Quarter and Subsequent Achievements:

• Net revenues for the first quarter of 2020 increased to $3.2 million, up 8% compared to the same period in 2019.
• Gross profit for the first quarter was $1.5 million, an increase of 19% compared to the same period in 2019.
• On March 31, the Company submitted notification to the U.S. Food and Drug Administration (FDA) of its intention to register and market the ThermoGenesis' SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit in accordance with Section IV. D. of the "Policy for Diagnostic Tests for Coronavirus Disease – 2019 during the Public Health Emergency," issued by FDA on March 16, 2020. ("Policy D").
• On April 15, the Company received an acknowledgement letter from the FDA, confirming that ThermoGenesis' SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit has been appropriately validated for distribution under the Policy D guideline.
• The Company's joint venture, ImmuneCyte Life Sciences, Inc. (ImmuneCyte), acquired worldwide intellectual property for development of fully human antibody therapeutics for COVID-19, including four high-affinity monoclonal antibody drug candidates against SARS-CoV-2 and tools for screening and quantifying efficacy of such neutralizing antibodies.
• The Company bolstered the balance sheet with a $3.5 million registered direct offering of common stock, and Boyalife Asset Holdings II, Inc's conversion of $3.0 million of the outstanding balance under its Revolving Credit Agreement.

"During 2019 and the first quarter of 2020, we continued to improve our financial performance, while simultaneously and proactively leveraging our expertise and global resources in the medical technology field to join the fight against the COVID-19 global pandemic," said Chris Xu, PhD, Chief Executive Officer of ThermoGenesis. "Now that we have an acknowledgment letter from the FDA under the Policy D regulatory filing pathway, this month we began shipping out our COVID-19 IgM/IgG Antibody Fast Detection Test Kit to fill pre-orders and other incoming orders. We have also completed a submission of additional information to the FDA, for the required reviews of the Fast Detection Kit under the Emergency Use Authorization (EUA) pathway and are awaiting the agency's response."

Dr. Xu continued, "Together with ImmuneCyte, we are employing a multi-tiered antibody therapy approach to our COVID-19 strategy. Specifically, we aim to take advantage of our COVID-19 IgM/IgG Antibody Fast Detection Test Kit, ImmuneCyte's recently acquired worldwide intellectual property rights, and our proprietary automated cell processing platform to enable the simultaneous isolation of convalescent plasma and immune cells for the development of potential COVID-19 polyclonal and monoclonal antibody drug candidates for both prophylactic (preventive) and therapeutic uses. We are committed to continuing this systematic approach to address several critical unmet needs in the battle against the pandemic, namely, the need for fast and accurate antibody tests, preventive therapies and therapeutics for the disease."

Jeff Cauble, Chief Financial Officer of ThermoGenesis, added, "We significantly strengthened our cash balance in the first quarter with the closing of a $3.5 million registered direct offering that increased our cash position to $5.7 million, a 78% increase compared to the beginning of the year. We also improved our financial metrics with an 8% increase in net revenues and a five-point increase in gross profit percentage, to 47% of revenues, as compared to 42% of revenues last year. We expect to start recognizing revenues from sales of the SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit in the second quarter, which will add another revenue source moving forward."

For earnings history and earnings-related data on ThermoGenesis Holdings (THMO) click here.

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