Co-Diagnostics Inc New

Good afternoon, and welcome to the Co-Diagnostics second quarter 2022 earnings conference call. All participants will be in a listen-only mode. Should you need any 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, then one on your telephone keypad. To withdraw your question, please press star, then two. Please do note that 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'm 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 2022 financial and operational guidance, the development of regulatory clearance, commercialization and features of new products, plans and objectives of management and market trends are all forward-looking statements. This includes statements concerning the company's forthcoming PCR home testing platform, which is subject to FDA review and is not yet available for sale. 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 results 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 may discuss certain non-GAAP financial measures during today's call. These non-GAAP financial measures should not be considered a replacement or and should be read together with GAAP results. We refer you to the company's earnings release out shortly before this call, which may contain reconciliations in 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. While we maintain strong execution during the second quarter and achieve further progress on the development and optimization of the COTIX PCR home testing platform, Lower volumes for our logic smart COVID-19 test drove a year-over-year decline in revenue. We believe that several factors contributed to the second quarter's results, including a reduction in mandated testing for travel and public venues, a reduction in public funding assistance for testing programs, and an increase in overall weariness for the disruption to daily life after a multi-year pandemic, specifically the Omicron variant earlier this year. This dramatic shift in testing behavior was widely felt across the diagnostics industry. Experts believe other waves of COVID variants are all but inevitable. However, the timing and severity are impossible to predict. With every new variant, including the possibility of immune escape as variants and subvariants vie for dominance. In the U.S. alone, we are still seeing around 100,000 new COVID cases reported per day. over 6,000 COVID-related hospital admissions, and nearly 400 deaths. All evidence to date points to a resilient, mutable virus with no indication it will go away, and that we will be living with it for years to come. Friends observed since the original outbreak of the virus suggest a buildup in the number of positive cases increasing as we move further into the fall and winter seasons. While there is significant public resistance against future lockdowns and other mitigation measures, we are confident that reliable, accurate testing will remain a critical line of defense to identify and counter future waves of the virus. While we were presented with a number of challenges during the quarter, with those challenges came opportunities for growth and for growing our unique portfolio of innovative testing products and devices. Prominent among those is the progress we have made in the Kodiak's PCR home testing platform. The company has assembled a world-class team of developers, scientists, and engineers working tirelessly to bring this platform to market with significant breakthroughs and optimizations that have been made since formally initiating its development. It is important to remember the high standard to which we hold ourselves and our goal of delivering products that are high quality, reliable, and durable, and we look forward to announcing soon that we have commenced clinical trials. This device and platform is transformative, and it will fundamentally alter the way the world thinks about at home and point of care testing. However, timelines for such innovations are always fluid. To put it simply, if it were easy, anyone could do it. With every obstacle we have encountered, the team has presented several solutions each one of which has been rigorously analyzed and tested to determine not just which one works, but which works best. Just one example of this was when the presence of bubbles in the saliva or swab samples was interfering with the results. Several options were considered and evaluated. Variations of the device and sample collection cups were engineered, built, and thoroughly tested to determine which combination of options yielded the most optimal solution. What might have been considered a challenge was instead an opportunity for an even better, more robust, higher quality platform. Our progress in the development of the Kodi X PCR home platform is reflected in the expansion of our campus where it is being developed, optimized, and manufactured. We have expanded our operations to include four buildings housing more than 70 engineers, scientists, and support staff working to help make gold standard PCR ubiquitously available. including in areas of the world where infrastructure and pricing have traditionally made PCR unfeasible. With e-commerce, sales and customer support, marketing, and logistics initiatives well into the advanced planning stages, incorporating the lessons learned from observing others entering into this relatively uncharted space, and from extensive market research by a recognized research firm, We look forward to the time in the near future where we are able to remind the public that while we have never said we would be the first, we have always believed that we would be the first to get it right. To this end, the optimizations continue to ensure the platform and manufacturing processes will fit the needs of a dynamic but enduring market for affordable, operationalized, and decentralized gold standard PCR testing for COVID-19 and a range of other pathogens. We would like to emphasize that we believe this PCR platform, which is subject to FDA review and not yet available for sale, will come to represent the highest level of utility for at-home point-of-care applications, encompassing far more than just COVID. The device has been designed to incorporate specialized optics and other innovative features to accommodate multiplexed assays as we expand its future suite of products to include additional respiratory, STI, and other infectious diseases utilizing the company's patented co-primer technology. This patented molecule has unique properties associated with facilitating multiplexing PCR, and we intend to bring the full power and capabilities of our proprietary technology to our new COTIX PCR platform. In addition to ultimately representing the future of at-home and point of care testing, we believe this powerful new platform also has the potential to help build a cloud-based surveillance system to thwart future infections and communicable disease outbreaks. Our conspicuous presence at conferences and trade shows this year has helped reinforce and increase our visibility, not only for this exciting new platform, but also among the centralized lab customers we have served across our growing distribution network of more than 50 countries. The high throughput laboratory market is responsible for driving most of our sales, providing the cash flow for our R&D efforts as we grow the product pipeline for this business channel. In addition to other products, we have discussed in previous public statements, such as our ongoing development of a multiplex STI panel to detect and differentiate between four prevalent causes of sexually transmitted infections, We also recently announced this quarter that we have completed the design of our monkeypox PCR test, and monkeypox testing reagents have already been shipped to a distributor to meet the demands of that region. Sample kits of this product have also been tested by other distributors and labs around the world, helping to provide valuable feedback as we prepare for a wider market release of a multi-gene product that meets and exceeds the global standards of PCR testing for a disease that has been declared a public health emergency in the United States and by the World Health Organization. Already, more than 31,000 cases have been confirmed in 89 countries, 82 of which have historically not reported monkeypox. These figures include over 10,000 in the United States alone. It is important to remember that our co-primer technology is more than just an innovative molecule. It is a platform technology with wide-ranging applications. Other PCR assays are being developed for several pathogens of significance in dentistry, mental health, and liquid biopsy for detection of cancer associated mutations present in human blood. Analytical performance is being evaluated for these assays with partnerships in each of these areas. Our work with Bayer Crop Services and LGC likewise continues within our agricultural vertical, and the company's mosquito abatement business has seen a record number of laboratory installations this year along with continued purchases from our existing customers. Overall, we believe our advancements in the field of at-home and point-of-care testing, our team of experts working diligently to achieve our shared company vision, and our solid balance sheet are positioning co-diagnostics to execute against our strategic growth initiatives. Our continued investments in talent and R&D remain indicators of the progress we are achieving to drive further value for our shareholders. This includes my initial remarks. Let me now turn things over to Brian Brown for a review of key metrics and numbers. Brian.