Co-Diagnostics, Inc.

Good day and welcome to the Co-Diagnostics fourth quarter and full year 2023 earnings 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 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, Investor Relations. Please go ahead.

Good afternoon, everyone. Thank you all for participating in today's conference call. On the line today from CoDiagnostics, we have Dwight Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer. Earlier today, CoDiagnostics released financial results from the fourth quarter and full year ended December 31, 2023. A copy of the press release is available on the company's website. We will begin the call with management's prepared remarks and then open the call to analyst Q&A. Before we begin, we would like to inform the listeners that certain statements made by co-diagnostics during 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 2024 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 Codex PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use, is currently being reviewed by the U.S. FDA, and is currently not 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. 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 shortly before this call, which contains reconciliation to the non-GAAP financial measures presented for the 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. Good afternoon, everyone. Thank you all for joining Co-Diagnostics' fourth quarter and full year 2023 earnings call. 2023 was an exciting year for CoDiagnostics as we expanded industry awareness of our CoPrimers technology and the CoDxPCR platform. Throughout the year, we participated in several industry and investor conferences where we spoke about the value proposition of our platform and our commercial and regulatory strategies. We also achieved several key milestones. including the receipt of several prestigious grants, the expansion of manufacturing capacity, and an emergency use authorization submission to the FDA for the Kodiak's PCR Pro and Kodiak's PCR COVID-19 test kit. Today, we will provide an update on our fourth quarter and full year 2023 financial performance and discuss recent activities at the company as we continue to execute across our business and test developments. During the fourth quarter, we were pleased to submit an emergency use authorization application to the FDA for our new Codex PCR Pro instrument, mobile app, and Codex COVID-19 test kit. Our easy-to-use, real-time PCR platform is differentiated by several exciting features and capabilities. Tests run on our instrument utilize CoDiagnostics' unique patented CoPrimers PCR technology. CoPrimers ensure reliability by providing higher quality test results through the significant reduction of primer dimers, which often lead to false positive results. The most notable feature of the platform is our cloud-based analytics, which delivers test results from the instrument to the mobile app in just 30 minutes. The nature of our app also enables Kodiak's PCR real-time HIPAA-compliant integration into the EMR, which we anticipate will allow physicians, public health officials, and even governments to examine and monitor results, tracking outbreaks in communities and countries around the globe. I am proud of the Kodiagnostics team for their collective efforts in finalizing our EUA submission. We are excited for the platform's first regulatory review, which includes several never-before-seen technologies and our strong clinical and analytical results. I would like to thank our world-class team of developers and regulatory experts who contributed to a strong regulatory submission for this platform, which we believe has the potential to revolutionize how and where infectious disease diagnostics take place. We also have already collected enough samples in the ongoing clinical evaluation to allow us to pursue a 510 clearance for our Codex PCR Pro and Kodiak's COVID-19 test, which we anticipate will be submitted in the first half of this year. We look forward to providing you with more updates on this current regulatory review process as they become available. While we plan to initially launch the platform with our COVID test, we also have several other tests currently under development, including tuberculosis and upper respiratory multiplex. Followed by HPV and strep throat. We plan to begin clinical evaluations for our TB test later this year in geographies where the disease is most prevalent. Specific clinical trial testing sites will be located in Africa, Australia, and India, where we have a strong operational presence with our joint venture, CoSERA Diagnostics. Tuberculosis is the most deadly disease in the world. and the eradication of TB remains a focal point for the World Health Organization, or the WHO, as well as the Bill and Melinda Gates Foundation, from whom we have already received two grants to accelerate our TB platform and to expand manufacturing capacity. We plan to first pursue regulatory clearance for this test through two jurisdictions that are recognized by the WHO for diagnostics recommendations. The TGA, or the Australian Regulatory Pathway Authority, and the CDSCO in India. After these submissions, we plan to submit to the WHO for a recommendation. A recommendation from the WHO would aid in the commercialization of our TB test across many regions of the world, especially markets in Africa, where a WHO recommendation is required before a test can be used as a diagnostic. Importantly, India, where we have domestic manufacturing and distribution capabilities with Coursera, is a large and underserved market. We believe that our platform and TB tests have the potential to dramatically improve the state of TB testing in India, where there are 69,000 hospitals, over 115,000 pharmacies, and where roughly 220 million people were screened for TB in 2021. according to the World Health Organization. In addition to TB, we have continued the development of the multiplex upper respiratory test with support from the NIH RADx-TEC grant. CoDiagnostics plans to initiate clinical evaluations during the next flu season later this year in order to collect sufficient data for an FDA submission. Another important indication of focus in our pipeline is our HPV test. which was also the subject of a Gates Foundation grant last year. HPV is an additional high priority infection for the WHO as it remains the most common STI and the greatest risk factor for cervical cancer which has many associated deaths in low income countries. Our development efforts for HPV are currently focused in India where there is a significant underserved population. Lastly, with the Codex COVID-19 test through the development stage and currently under FDA review, we have begun actively developing a strep throat test, which we believe has the potential to increase the attractiveness of the platform as a point-of-care solution. As we approach the launch of the Codex PCR platform, we have begun to ramp our internal processes to ensure we are adequately prepared to serve our target markets. Over the past year, CoDiagnostics has made substantial investments to ensure that we have the appropriate infrastructure for commercialization, and we are fully prepared to begin scaling manufacturing pending authorization. The CodexPCR Pro system has been designed for the point-of-care setting, and we plan to initially target U.S. assisted living facilities, skilled nursing facilities, and physicians' offices. We are prioritizing institutional settings where test volumes and overall demand remain high. We firmly believe that our highly accurate, accessible, and low-cost device can drive improved patient outcomes, both in institutional settings in the US and in low- to middle-income countries where accessibility to testing has been a consistent barrier in healthcare. While testing volumes have fallen from their peak in the height of the pandemic, COVID-19 is second only to tuberculosis in terms of lives lost every year, and it remains one of the most in-demand tests worldwide. This includes for regions like India, Saudi Arabia, and Australia, where we believe we will be able to begin commercializing the CODIAC's COVID-19 test following regulatory clearance or registration in those countries.