. EMERYVILLE, Calif. (May 14, 2020) – NovaBay® Pharmaceuticals, Inc. (NYSE American: NBY) announces that CEO Justin Hall has issued the following letter to stockholders:
To My Fellow Stockholders:
As pandemic-related shelter-in-place restrictions are beginning to lift in certain geographies and Americans are preparing to return to school, work and social activities, NovaBay has focused on offering our fellow Americans products they need to help them stay safe. NovaBay has business contacts around the globe, and we worked tirelessly with them to secure quality COVID-19 personal-protection and diagnostic products, while at the same time continuing to advance our previously announced cost-efficient sales and marketing strategy for Avenova®. I’m gratified to report this parallel strategy is working very well, with combined product sales in the month of April surpassing our total revenue for the entire first quarter.
Just as Avenova is considered the highest quality product in its market segment, we are also confident in the quality of the new products we are securing for U.S. distribution in response to the COVID-19 pandemic. Our confidence is based on the reputation of our suppliers as well as the results from third-party lab testing.
We began selling KN95 masks through our website Avenova.com less than two months ago, and we are already nearing the milestone of one million units sold. These KN95 masks are effective in filtering out at least 95 percent of airborne particles, including microorganisms, dust, pollen and air pollution, making them ideal for personal protection in public places. We are highly confident in their design as they are CE certified and meet the KN95-level requirements. In order to distinguish them from the many inferior quality masks currently in the marketplace, our partner mask manufacturer has submitted the KN95 masks for emergency use authorization (“EUA”) from the U.S. FDA to further validate their quality. Due to the backlog of new COVID-19 related products submitted, the FDA has not given us a timeframe for review. While many Americans continue to have difficulty acquiring masks, our masks are in stock in the U.S. and ready for immediate shipping, with customers typically receiving them within a day or two of ordering.
Most of our current volume is attributable to bulk orders from large institutions. We expect that pattern will continue in the near term and that our KN95 mask sales through Avenova.com will remain fairly steady with April levels. We are also offering a special promotion combo pack of 30 masks and two bottles of Avenova for $199. Avenova, with its antimicrobial properties and applied as a facial spray, is a perfect complement to the mask. I’m pleased to report that some companies are placing bulk orders for this combo pack and shipping them directly to their employees’ homes as a gesture of goodwill.
Less than a month ago, we announced an exclusive U.S. distribution agreement for a highly sensitive rapid, point-of-care, finger prick COVID-19 antibody test. Public health experts and leaders across the country are citing a critical need for mass testing and tracing procedures for those who have been infected with COVID-19 as a condition for safely reopening our economy. As work and social activities resume, we expect that testing will become an even greater priority to determine who is actively infected and who may have antibodies against the pathogen. Importantly, we are confident in the reliability of our product versus some questionable tests that have been introduced to the market. We believe the accuracy of our test is comparable to those already receiving EUA from the FDA. We filed for EUA approval on April 17 and remain in regular contact with the FDA reviewer assigned to evaluate our test. Regulatory reviews of COVID-19 antibody tests have been slow as the FDA is tirelessly working through a backlog of submissions.
To be clear, we will not be selling this point-of-care test until such time as EUA from the FDA has been received. Once granted, we will begin marketing the test through our sales team to healthcare professionals across the country, who then will administer the test. The test uses a drop of whole blood for the detection of COVID-19 antibodies, with results available in approximately 10 minutes. Our test detects for the presence of both IgM and IgG. IgM is usually the first antibody generated by the body in response to the coronavirus. Later, the IgG antibody is generated and replaces IgM as the predominant antibody in response to the infection. While in some ways our test is similar to others on the market, it is differentiated by its use of a slightly larger blood sample to improve accuracy and shortened testing time of 10 minutes versus 20 minutes with others. Additionally, our test is self-contained without the need for additional materials or ancillary reagents, which competing tests require. While we are confident in the quality of our test, because of the fast-changing regulatory landscape, we cannot give guidance on the timeline for FDA review or whether we will receive clearance for commercial marketing and sale. Our sales team is in place and eager for this new opportunity.