Co-Diagnostics, Inc.

Good day and welcome to the Co-Diagnostics Q2 2021 Earnings Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing star, then zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Andrew Benson, Head of Investor Relations. Please go ahead.

Thank you. I am Andrew Benson, and joining me this afternoon are members of the Co-Diagnostics Management Team, including Dwight Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer. We will begin the call with management's prepared remarks and then open up the call to questions from our analysts. 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 2021 financial and 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 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. Codiagnostics 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 may 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 reconciliations of the non-GAAP financial measures presented to their most comparable GAAP results. At this time, I would like to turn the call over to Co-Diagnostics Chief Executive Officer Dwight Egan. Dwight?

Thank you, Andrew, and thank you all for joining us. On this call, we will provide an overview of our results for the quarter, updates on key financial performance metrics, and a discussion of progress against our strategy. Then we will take your questions. This quarter saw co-diagnostics achieve record sales and gross margins with foreign sales exceeding domestic as predicted in our previous earnings announcements. And we are proud that we've been able to deliver on those predictions and exceed expectations while providing a valuable product in the ongoing battle with SARS-CoV-2. We believe our international growth, along with our clean balance sheet and strong cash accumulation, are positioning us to become a leading global molecular diagnostics company, and that the sales momentum we have been experiencing over the last year and a half continues to demonstrate demand for our products throughout 2021. CoDiagnostics was able to achieve record sales in Q2 in large part due to the strength of our international partnerships. Thank you for joining us. and our COVID-19 Two-Gene Multiplex Test. Importantly, those overseas relationships are now driving sales not just for our suite of COVID-related offerings, but for our other diagnostic products as well, opening up opportunities for our existing and planned products to an even larger market. We are already seeing this take place as our Zika Dengue Chikungunya or ZDC test, for example, is registered in several countries and experiencing more demand than ever before. This uptake of CoDiagnostics products is a driving factor in our emphasis on expanding our product offerings to better serve our important and profitable centralized laboratory segment. CoSERA, our joint venture in India, posted another profitable quarter in Q2, also driven by demand for its COVID-19 test built on the CoPrimer platform. but also seeing increased demand for its other diagnostics that received IBD clearance prior to the onset of the pandemic. Recently, the Indian government has also lifted its ban on exporting COVID diagnostics from the country. This opens the door for COSER to begin exporting its COVID diagnostic to customers in other countries in the surrounding areas, which we anticipate will serve to augment its domestic test sales operations. Going forward in the infectious disease vertical, the company will pursue two business segments. The first business segment comprises our centralized lab customers, of which there have been many hundreds in domestic and foreign markets. This is what currently drives strong sales in the company and a large focus of our R&D efforts as we grow that product pipeline and we continue to expand our worldwide network. This includes countries like Brazil, where just this week we received notification that our Logic Smart COVID-19 test kit has been registered for sale in that country by Anvisa, the Brazilian health industry. In addition to centralized labs, the company's infectious disease vertical is also composed of the at-home and point-of-care market, which will be addressed by our forthcoming ICON platform, The ICON development continues at a rapid pace with various studies and optimizations in progress to prepare for FDA EUA submission. We believe that the addressable market for at-home and point-of-care diagnostic applications is considerable, and we are optimistic about the potential contribution our new platform will have throughout the world, not just for COVID, but for many other diseases as well. We will be unveiling the particulars of the ICON platform over the coming weeks and months as we prepare for various regulatory authorizations and our international product launch. The YourTest PCR system on the ICON platform is a real-time PCR test for COVID-19 that we anticipate ultimately being available for at-home use. This system is designed to be easy to use, inexpensive, and fast. while maintaining the superior performance of PCR. The result is a low-cost, small footprint platform that can be deployed widely in nearly every setting, comprised of a reusable instrument, a single-use test kit, and a mobile app. Operation is simple and accessible. After introducing an oral rinse sample into the test cup, it is capped and inserted into the instrument. Results are delivered by mobile app. Sample preparation, RNA-DNA amplification, results interpretation and reporting are automatically performed by the system. The system is capable of addressing other testing needs in the future, including the expansion to a variety of multiplex assays. No other hardware or consumables are required. Since our founding in 2013, our mission at CoDiagnostics has always been to bring effective, high-quality, and affordable diagnostics to those people and places who need them most. Since the pandemic, our territory has expanded to include product sales throughout the United States and over 50 countries worldwide, as qualified laboratory personnel in the sophisticated labs utilizing our tests have validated its performance again and again. and found that it meets with their high standards of quality. The vast majority of our sales are from repeat customers who believe in our technology's ability to reliably produce accurate results for their end users with lives potentially hanging in the balance. These results are possible due to the strength of our patented CoPrimer technology platform, originally conceived and developed over eight years ago, and which underpins the performance of our diagnostic and research devices, including the chemistry being used in the ICON product development. More than just a company with high-grade infectious disease diagnostic products, CoDiagnostics is truly a platform technology company. Which platform has applications extending far beyond COVID? These include liquid biopsy for cancer detection, The development of which is ramping up as we position the company to take part in this historic development in human health care. Co-primers have been shown to have excellent capabilities in the detection of cancer mutations present in human blood, and we are developing tests to detect a number of relevant mutations relating to the most pervasive and deadly cancers. A paper was recently authored by scientists at Co-Diagnostics showing the effectiveness of co-primers in cancer detection which is currently pending peer review prior to publication. Progress in our agricultural vertical also continues, especially in our work with Bayer Crop Services and LGC. The company is under contract with Bayer pursuant to an ongoing proof of concept project using our patent pending NGS library prep technology. Overall, we believe that our strong profits are positioning CoDiagnostics well for these and other future growth initiatives. as significant investments in talent and R&D continue to yield positive results. The continuing, continually rising rates of infection, not just in countries without reliable access to a vaccine, but in our own communities in the U.S., illustrate the continuing struggle with this disease on a global basis. The company has long held that mass-scale vaccination would not obviate the need for testing. We have positioned ourselves around this reality since last year before a vaccine was available or even authorized, and our viewpoint in this regard has proven to be correct. This week on CBS's Meet the Press, Dr. Anthony Fauci said, quote, Previously, we have to admit that early on it was said to just give testing to people who have had contact with people who were infected who were symptomatic. Now it's very clear you've got to go beyond that because we know now from experience here and in other countries that you will have people who are asymptomatic who get into contact with an asymptomatic person who's infected and you'll know that there will be more infection that otherwise would have gone undetected. So you're quite right. We need to do more testing." The company has also asserted that in order to normalize society, that is, to go back to school, to go back to work, to travel, et cetera, that regular testing with reliable protocols will need to be done. Earlier this week on NBC's Face the Nation, Dr. Scott Gottlieb said, quote, the other thing schools should be doing is operationalizing testing on a regular basis, end quote. We believe that operationalizing testing on a regular basis will be required wherever we intend to normalize and create safe schools, safe workplaces, restaurants, hotels, shifts, etc. The ICON platform has been designed from the beginning with the ability to operationalize testing on a regular basis in an at-home and point-of-care settings. It is the optimal solution not only for COVID, but for other infectious diseases that will be added to our testing menu over time. It is inexpensive, fast, and very importantly, accurate with gold standard PCR results. We believe that our history of remaining ahead of the curve since the onset of the pandemic will continue to drive this trajectory of growth. I would like to conclude my prepared remarks by thanking our employees and distributors for their dedication and action in helping to deliver outstanding results this quarter. Let me now turn things over to Brian Brown for a review of the key metrics and numbers. Brian?