8/13/2020

speaker
Jamie
Conference Operator

Good afternoon, everyone, and welcome to the Code Diagnostics Q2 2020 earnings conference call. All participants are currently in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one. To withdraw your questions, you may press star and two. Please also note, today's event is being recorded. At this time, I'd like to turn the conference call over to Andrew Benson. Sir, please go ahead.

speaker
Andrew Benson
Director of Investor Relations

Thank you, Jamie, and thank you, everybody, for joining us today. Before we begin, we would like to inform the listeners that certain statements made by co-diagnostics during the course of this call may constitute forward-looking statements. Any statement about company expectations, beliefs, plans, objectives, assumptions of future events or performance are forward-looking statements. For example, statements concerning 2020 financial operational guidance, the development, regulatory clearance, commercialization, and features of new products, plans, and objectives of management and market trends are all forward-looking statements. The company believes these statements are based on reasonable assumptions. However, these statements are not guarantees of performance and may involve known and unknown risks and uncertainties that may cause the actual results to be materially different from any future result expressed or implied by such statements. Important factors which could cause actual results to differ materially from those in these forward-looking statements are detailed in co-diagnostics filings with the SEC. Co-diagnostics assumes no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events. In addition, the company will discuss certain non-GAAP financial measures during today's call. These non-GAAP financial measures should not be considered a replacement for and should be read together with GAAP results. We refer you to the company's earnings release out shortly before this call, which contains reconciliation to the non-GAAP financial measures presented to their most comparable GAAP results. I will now turn the time over to Dwight Egan, CEO of CoDiagnostics. Dwight?

speaker
Dwight Egan
Chief Executive Officer

Hello, everyone, and thank you for joining us on the call. At the beginning of the second quarter, CoDiagnostics received emergency use authorization from the FDA for our Logic Smart COVID-19 test. Since that time, the company has successfully launched an internationally recognized business and brand, with clients in over 50 countries, over 25 U.S. states, and validations of test accuracy from numerous regulatory and reference institutions from around the world, The company has established a durable production and distribution platform designed to continue sales and profitability as our tests have gained widespread acceptance in the market. And while the whirlwind pace of activity during the second quarter has taken the company to record revenues leading to co-diagnostics crossing well into profitability, The sales momentum we are experiencing midway through the third quarter not only provides important context for understanding the progress of the company's past success, but more importantly, a window on where we are going over the coming months and years. In that regard, I'm pleased to report that the company has received and is currently fulfilling orders approaching $50 million in year-to-date business. This includes the sales activity from our India joint venture, which we are also pleased to announce also achieved profitability in the second quarter. In addition to the US FDA, India, and the European community, our COVID-19 test has also been granted clearance in several other large markets, including Mexico, Australia, Colombia, Argentina, South Africa, and others. Authorizations from Anvisa in Brazil and Health Canada are also in process. The Logic Smart COVID-19 test was designed to target the RDRP gene of SARS-CoV-2, which target continues to show 100% coverage for all strains of the virus in the global genetic databases. In order to proactively respond to global concerns about potential genetic drift in viral strains, we have also completed principle design and feasibility for the next iteration of this test to include an additional genetic target to maintain testing specificity and sensitivity. We expect this test to be complete before the end of the current quarter. After having achieved significant earnings during the second quarter, Thank you for joining us. Liquid Biopsy for Cancer Detection, West Nile and Eastern and Western Equine Encephalitis for Mosquito Abatement Programs, and Critical Agricultural Genomics. Today, I will focus on our activities addressing COVID-19 and the current pandemic. The most significant initiative the company has been addressing is the development of a multiplex test designed to differentiate between COVID-19, Flu A, and Flu B. This test is more appropriately referred to as a panel since it interrogates more than two dozen strains in a single test. Why is this important? Experts expect the US alone to have about 100 million cases of the flu and flu-like symptoms in the coming fall and winter months. When a person has symptoms of the flu, which are very similar to COVID-19 symptoms, they will need to know whether their infection is a routine flu or a potentially deadly case of COVID-19. Our tests will make that differentiation. Moreover, our tests will be able to be used in high throughput settings where labs are capable of performing as many as 1,000 to 50,000 tests daily. Many analyses of the testing landscape have failed to recognize the inherent throughput limitations of certain closed system platforms that require single cartridges or cassettes in order to obtain a result. Even if a result can be obtained in a shorter time, the throughput limitations severely constrain the utility of these platforms where wide-scale testing is required. So, while such a closed-system test may have an important role in testing the disease status in a hospital patient bound for surgery in the next few hours, the one-off cartridge does not provide a viable solution to wide-scale testing or surveillance testing applications. The company has attracted important clients, such as the Clinical Reference Lab, which recently obtained FDA emergency use authorization for a saliva-based COVID-19 test that can be self-administered at home, work, or other settings without professional care assistance and then analyzed in their laboratory using co-diagnostics technology. This is a high throughput organization capable of handling the most demanding requirements of companies and other organizations that need high volume testing. The company's strategy has been to attract large numbers of CLIA labs throughout the United States in order to obtain a continuous demand for our tests. As a general rule, CLIA labs fill a vital role in the infectious communicable and genetic disease testing landscape with existing clients who rely on the laboratory services for all kinds of daily testing needs. These same legacy customers often turn to their existing CLIA lab relationships to obtain COVID-19 testing. By building relationships with numerous CLIA labs, We are able to leverage our reach to businesses, schools, senior care centers, and other organizations, both big and small. The value proposition of co-diagnostics tests is self-evident. We provide highly accurate, economical, and open architecture tests that meet the current COVID-19 high throughput needs and also set up a client relationship to sell other tests to these labs, including custom tests using our co-primer platform. It is important to emphasize the significance of the company's development of the upper respiratory flu A, flu B, and COVID-19 panel in relationship to the CLIA lab model. Our competitors who market single-use cartridges for upper respiratory diagnostics will now have to contend with CoDiagnostics' new test. Our test will have significant advantages in pricing and high throughput capabilities. It is well known that the upper respiratory panels provided by these other companies constitute a significant percentage of the sales volume of those organizations. Now, for the first time, CoDiagnostics will enter the competitive landscape with a superb product offering with the previously stated advantages. Now that we have established worldwide distribution channels with a respected COVID-19 test, We are understandably excited to participate in one of the most high volume diagnostic markets in the U.S. and the world. This new test, which we refer to as the ABC test for flu A, flu B, and COVID-19, is one of the most important aspects of our durability and consistency strategy in the near and medium term. Our expectations for the next few quarters anticipate ongoing demand for our existing COVID-19 tests, as businesses, colleges, schools, senior care centers, and other organizations strive to normalize their environments, which should include a testing component in addition to social distancing, masks, contact tracing, and other preventative measures. Our expectations also anticipate the adoption of our new ABC test by customers around the globe who will be able to conduct our new test on the same platforms on which they are running our current COVID-19 tests. We have made key additions to our scientific team during the last couple of quarters. This was done to ensure that the company can continue to move ahead aggressively with other initiatives mentioned earlier as we continue to expand the footprint of our unique patented technology platform across multiple applications. I will now turn the time over to Reid Benson, our Chief Financial Officer, who will take us through the numbers. We will then take questions from our analysts.

Disclaimer

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