Co-Diagnostics Inc New

Welcome to the Core Diagnostic, Inc. first quarter 2022 earning results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star then zero on your telephone keypad. 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 questions, 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 2022 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. This includes statements concerning the company's forthcoming PCR 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 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 code agnostic 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 may contain reconciliation to 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. The first quarter of 2022 saw CoDiagnostics achieve continued solid sales with strong gross margins. And we are proud that we have been able to exceed expectations. This quarter was a momentous period in the company's history. As we continue to integrate Idaho Molecular Inc. and Advanced Conceptions Inc. providing co-diagnostics with all existing and future assets and intellectual property related to our upcoming Codex at-home point-of-care diagnostic platform. We previously announced that the acquisition is expected to streamline the commercialization of this new Codex PCR platform. We have expanded the manufacturing space to incorporate production lines for sample cups, as well as production lines for the device. The device has been designed with highly 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. We are proud to be named as one of only six semifinalists. in the Disruptive Technology Award in connection with the 2022 AACC Annual Scientific Meeting and Clinical Lab Expo in Chicago later this July. AACC's Disruptive Technology Award competition recognizes innovative testing and disruptive technology solutions that improve patient care through diagnostic performance or access to high-quality testing. We are honored to be considered in this search for the next innovative testing solution that will transform patient care. Under the experienced and capable leadership of Dr. Kirk Ryrie, the final optimizations of the new PCR platform are underway, and we are confident that, pending FDA review, we will be able to launch a product that has revolutionary ramifications for the molecular diagnostics market worldwide. We are on track for commencement of clinical trials by our second quarter earnings call this August in anticipation of submission of the device to the FDA following the successful completion of those trials. We would like to emphasize that we believe this PCR platform will come to represent the highest level of utility for at-home point of care applications, extending far beyond COVID. While we have used different working names for this platform in the past, like ICON and Your Test PCR, more important than the name is the fact that it facilitates gold standard PCR results in around 30 minutes, utilizing a disposable sample collection cup or cartridge that is considerably less expensive than other molecular non-PCR COVID-19 product offerings. In addition, a significant benefit of the platform is its ability to multiplex, that is, to test for numerous disease states with one sample. Ultimately, we anticipate end users will be able to differentiate between diseases that have similar symptoms through the multiplex syndromic panels that the company expects to introduce over time. Syndromic testing is a process by which an individual or their physician simultaneously tests for multiple pathogens with overlapping symptomology, which is a limiting factor of other non-PCR molecular technologies. This allows individuals and caregivers to perform one test to see if patients are suffering from any one of multiple causes, rather than having to test for each potential underlying reason for the illness. Our patented coprimer molecule has unique properties associated with multiplexing PCR, and we intend to bring the full power and capabilities of our proprietary technology to our new CODIX PCR platform. With the forthcoming product launch of the platform, we believe the company will be at the epicenter of at-home point of care testing throughout the world. We have been aggressively setting the stage for our product launch through attendance at multiple international and domestic conferences as we position ourselves to participate in a whole new field of at-home point of care testing for a range of pathogens when we are cleared to begin marketing activities for the product. We have made significant additions to our ability to service a worldwide launch of our new platform. This includes back-end support preparedness for logistics, e-commerce, customer support, sales and marketing. The company commissioned a comprehensive marketing study that is helping to guide the forthcoming implementation of our product offering. We have also added new senior level employees, consultants and engineering talent at both the parent and subsidiary companies while also engaging a new advertising agency with significant healthcare experience and an international reach to represent our Codex PCR platform through product launch and beyond. You will begin to see the look and feel of our forthcoming product offering on our website and other appropriate digital media exposures. All of these require compliance with certain regulatory constraints with which the company will carefully adhere. CoDiagnostics believes that in addition to ultimately representing the future of at-home and point-of-care testing, our new powerful platform also has the potential to help build a cloud-based pathogen surveillance system to thwart future outbreaks, all while giving individuals the power to know their COVID or other infectious disease status anytime, anyplace, anywhere. We are also excited about the centralized lab customers. We have served in over 50 countries and growing. This is what currently drives our sales and remains a large focus of our R&D efforts as we grow the product pipeline for this business segment, along with expanding our worldwide network of capable distributors and participating labs. For example, we are continuing our active development of a multiplex STI panel to detect and differentiate between four prevalent causes of sexually transmitted infections for which analytical performance testing is currently underway in collaboration with clinical partners. a malaria test designed to differentiate between the different species of the parasite known to be resistant to treatment, and the expansion of our Logic Smart ABC test to include respiratory synctyle virus, or RSV. As a platform technology company, our co-primer platform has wide-ranging applications, and other assays are being developed for several pathogens of significance in dentistry and mental health. Analytical performance is being evaluated for these assays with partnerships in each of these areas, along with our ongoing development of a liquid biopsy assay for detection of cancer-associated mutations present in human blood. Progress in our agricultural vertical also continues, including our work with Bayer Crop Services and LGC. And the company's mosquito abatement vertical is also seeing a record number of laboratory installations along with continued purchases from our existing customers. Overall, we believe that our strong profits and solid balance sheet are positioning co-diagnostics well for these and other future growth initiatives as significant investments in talent and R&D continue to yield positive results. This concludes my initial remarks. Let me now turn things over to Brian Brown for a review of the key metrics and numbers. Brian. Thanks, Dwight.