Co-Diagnostics Inc New

Good afternoon and welcome to the Co-Diagnostics, Inc. Third Quarter 2022 Earnings Results Conference Call. All participants will be in 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 then one on your telephone keypad. 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 Dan Borer, Vice President of Finance and Accounting. Please go ahead.

Thank you. I am Dan Borer, 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 CoDiagnostics 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 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 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 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, Dan, and thank you all for joining us. On this call, we will provide an overview of our results for the third quarter, updates on key financial performance metrics, and a discussion of progress against our strategy. Then we will take questions from our analysts. The company's execution during the quarter remains strong as we continue to make progress on the optimization of the Kodiak's PCR home testing platform. along with development of our other business sectors and in-demand PCR products, with quarter-on-quarter revenue remaining steady. Demand for our suite of COVID-19 testing products reflects our previous assertions, following the analysis of experts and epidemiologists that COVID will be a part of the global community for the long term. As recently reported in Fortune, waves of COVID variants used to be fairly sequential, often with a valley or plateau in between. But now, more than 500 Omicron variants are circulating. Some of these variants have the potential to cause their own subsequent surges. BQ variants, along with XBB, or Gryphon variants, surging in other parts of the world, are believed to be the most immune-evasive strains of COVID yet. According to Raj Rajnarenian, research assistant dean and associate professor at New York Institute of Technology. The coming U.S. COVID wave won't be just one wave, but a series of waves, each fueled by different variants that form a table mesa or a table-like plateau. Aside from our belief that COVID-19 will be with us for a long time, we continue to rely on the advice of experts such as Dr. Fauci, who, according to Fortune, has been warning for months that a new, more immune-invasive variant will emerge over the winter. Fauci also stresses that the pandemic is far from over. The number of deaths from COVID, which still averages around 2,600 a week, remains far too high. Fauci emphasized, adding, we're still in the middle of this. It is not over. 400 deaths per day is not an acceptable level. We have continued to exercise financial intelligence and wise spending practices evident from our 86 and a half million of cash reserves as we look toward the company's future, which certainly includes COVID, but extends far beyond the ramifications of a single pathogen. This is why our focus has been and continues to be on defining and focusing on the total addressable market for our new Codex PCR home platform, and ensuring its robustness, quality and versatility will stand the test of time as the world pivots to a new reality of more widespread at home and point of care testing for a range of infections. It is this ample versatility beyond COVID that has attracted so much attention to our new platform. Among the opportunities that we have already identified have been collaborations with international NGOs and nonprofits. The interest of these groups in the new platform extends beyond COVID to other endemic diseases such as tuberculosis, which killed 1.6 million people in 2021 alone according to the World Health Organization. It is no secret that the COVID-19 pandemic has created a fulcrum that allowed co-diagnostics to leverage our state-of-the-art patented co-primer PCR technology to help more people than ever before and increase our profile both domestically and internationally. We remain firm in our position that the pathway to significantly increasing co-diagnostic success lies in the power of at-home and point-of-care PCR, and in identifying those opportunities where we stand to make the greatest impact, both in the short and long term. We also believe that the versatility goes hand-in-hand with the platform's durability. A device that is first to market is less significant than the device that is the first to do it right. Our highly experienced and renowned team of developers, scientists, and engineers tasked with bringing the CodexPCR home platform from concept to reality have remained fixed on the objective to build a durable platform technology that has the potential to address the plethora of needs in a variety of industries, fueling future growth. To that end, we have continued to optimize and refine the platform and all its myriad components, including the user experience. We believe the additional time spent preparing the platform for clinical evaluations has been worth it, and we are shortly to unveil a device that is considerably more robust than we initially conceived. As you learn about the improvements and capabilities of our forthcoming product, we are confident that you will see the advantage of our platform's value proposition compared to the competition. Our current timeline to product launch is as follows. Presently, we are performing hundreds of end-to-end runs on our Kodiak's PCR home platform. We are concurrently performing additional studies on COVID-19 as well as on testing for tuberculosis and P. gingivalis for the dental market. These studies will continue uninterrupted to collect the data necessary to prepare for respective 510 submissions for each of these and other tests. We just concluded another usability study for our initial COVID-19 test that showed strong results with no major challenges. Clinical evaluations to support our FDA EUA submission are anticipated to begin in January of 2023. We have established success criteria to trigger the countdown to clinical evaluations and submission for FDA EUA will follow successful trials and analytical studies. I want to emphasize that our new at-home point of care platform has been designed and engineered to be versatile and durable. with long-term disruptive potential as a diagnostic medical device, taking advantage of a worldwide shift to at-home point-of-care testing for a wide range of pathogens. Ongoing clinical evaluations will be a regular part of our business routine as we bring an ever-increasing number of pathogens onto this powerful new platform. Our extensive ongoing market research guides our commercialization strategy as we focus our efforts where they will be able to have the most impact once the platform has the requisite authorizations and clearances to begin sales. Analytics provided by a world-renowned field marketing research firm has included gauging interest and concerns from an array of demographics, which has in turn provided invaluable feedback for optimization of the device itself on everything from the price to the packaging, as the company better understands the size, scope, and needs of the platform's total addressable market. Some of the optimization work performed over the last few quarters includes enhanced TTR, or time to result, increased multiplexing capabilities, and greater product stabilization, which results in longer shelf life for the test cartridges. One of the most important new innovations is the ability to test and go, where an end user does not need to maintain proximity to the device or return to it following the runtime, and instead, receives their result from the cloud on the fly. In addition, end users can choose their own testing preference by using either a swab or saliva. As mentioned in previous calls and public statements, 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 our co-primer technology. This pandan molecule has unique properties associated with facilitating multiplex 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, this powerful new platform includes a secure cloud-based data system whereby patients can send test results to their physician or other authorized parties as directed by the end user or regulatory authorities. We have continued our strategy of maintaining a noticeable presence at conferences and trade shows this year to reinforce and increase our visibility among the centralized laboratory business segment 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 and plans for future growth as we continue to grow the product pipeline for the centralized laboratory business channel. And, of course, our co-primer technology is more than just an innovative molecule. It is a platform technology with wide-ranging applications. 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, the company has rolled out one product for monkeypox with another multi-gene monkeypox test in active development and continues to work on its upper respiratory panel test, which includes markers for RSV, an illness currently experiencing a worrying and unusually early surge in 2022 within the United States. Recently, we were pleased to be able to introduce Dr. Mark Poritz as our new Chief Scientific Officer. Mark had previously served as the CSO of the subsidiary we acquired at the end of last year and has been actively involved in the development of the CODIX PCR home since early 2021. Dr. Poritz is a Harvard University and UC San Francisco educated molecular biologist with more than 30 years of experience in the application of PCR and related methods. who has also served as the reviewer for more than 30 different NIH and NIAID study sections focused on infectious disease diagnostics and has several patents issued and pending in his name. Mark played a key role in the growth of BioFire Diagnostics from 2002 to 2018, including in the development of the Filmarray platform, an in vitro diagnostic system that uses a syndromic approach to accurately detect and identify infectious pathogens and which has captured a significant share of the global infectious disease IVD market. We believe that Dr. Porras will play a pivotal role in not only completing and bringing our new platform to market, but also in helping to oversee the numerous research and development efforts of our other initiatives and products. Other PCR tools 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. with their performance being evaluated in conjunction 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 significant growth this year in terms of laboratory installations and continued purchases from our existing customer base. Overall, we believe our advancements in the field of at-home point-of-care PCR testing team of experts working diligently to achieve our shared company vision, growing product pipeline, and our practice of letting financial intelligence drive our smart spending, our positioning co-diagnostics to execute against our strategic growth initiatives. Our continued investments in talent and R&D remain positive indicators of the progress we are achieving to drive further value for our shareholders. This concludes my initial remarks. Let me now turn things over to Brian Brown, for a review of the key metrics and numbers. Brian?