Co-Diagnostics, Inc. (NASDAQ:CODX) Q3 2023 Earnings Call Transcript

Co-Diagnostics, Inc. (NASDAQ:CODX) Q3 2023 Earnings Call Transcript November 9, 2023

Co-Diagnostics, Inc. beats earnings expectations. Reported EPS is $-0.2, expectations were $-0.29.

Operator: Hello. Welcome to the Co-Diagnostics Third Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note today’s event is being recorded. I would now like to turn the conference over to Andrew Benson of Investor Relations. Please go ahead, sir.

Andrew Benson: Thank you. Good afternoon, everyone and thank you for participating in today’s conference call. On the call from Co-Diagnostics, we have Dwight Egan, Chief Executive Officer; and Brian Brown, Chief Financial Officer. Earlier today, Co-Diagnostics released financial results from the quarter ended September 30, 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 up 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 2023 financial and operational guidance, the development, regulatory clearance, commercialization and features of new products, plans and objectives of managements and market trends are all forward-looking statements. This includes statements concerning the company’s forthcoming Co-Dx PCR testing platform, which required regulatory approval for diagnostic use, is subject to USA FDA and local regulatory marketing authorization status and is not available for sale. The company believes these statements are based on reasonable assumptions. However, these statements are not guaranties 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-look 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 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?

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Q&A Session

Dwight Egan: Thank you, Andrew. Good afternoon, everyone. Thank you all for joining Co-Dx’s third quarter 2023 earnings call. Today, we will provide an update on our third quarter financial performance and discuss recent developments at the company as we have continued to make progress towards our long-term goals. These developments have included building up capacity in a new manufacturing facility for the Co-Dx PCR platform instruments and test cups, initiating a third party evaluation on our tuberculosis or TB assay. And most importantly, completing the clinical evaluations for our COVID-19 assay on our new platform, which will support an EUA filing before the end of the year. Notably, we were pleased to also recently announced a nearly $9 million grant from the Bill and Melinda Gates Foundation for the tuberculosis assay under development to be run on the Co-Dx PCR platform.

This grant follows three other grants received in July to support our development initiatives. The first of these was a $1.2 million grant from the National Institutes of Health’s RADx Tech program, which is being used to support our upper respiratory multiplex test development. The second and third grants were awarded by the Bill and Melinda Gates Foundation in the amounts of $1.33 million and $987,000 to support the development of respective tests for TB and human papillomavirus or HPV. Both funding organizations conducted extensive independent diligence prior to the execution of these grants covering our technology, research approach, scientific team and manufacturing capability. Recognition from global thought leading organizations highlights the disruptive nature of our technology and the value we believe our company can provide to a global healthcare infrastructure.

This last quarter we also appointed Ivory Chang as our Chief Regulatory Affairs Officer. Ms. Chang has years of experience working at global diagnostic companies. And we are confident that her expertise in regulatory affairs, including regulatory submissions for point-of-care, and in vitro diagnostic products will be invaluable to Co-Diagnostics’s future regulatory submissions. Amidst the work that we have continued to put into our platform since our last call, we participated in a number of industry and investor conferences, sharing Co-Diagnostics’s vision for increasing accessibility of PCR Diagnostics worldwide, our unique value proposition and updates on our new platform. We also showcased our platform at other trade shows and expos where our presence has reinforced the global unmet need for an easy to use, accurate and affordable point-of-care diagnostic platform.

Overall, it has been a busy time at Co-Diagnostics and we anticipate the next several months to be an exciting time for the company as well. As we look ahead, I’d like to discuss the reasons why we are so excited about the near future. Co-Diagnostics is a leading diagnostics company developing high quality real time PCR solutions across multiple infectious diseases to be delivered at home, and at point-of-care settings. We have designed and developed the platform technology, including a simple, easy to use real time PCR instrument that uses a disposable test cup, and delivers PCR results to a user’s mobile device in approximately 30 minutes. The assays or tests that run on our new platform utilize our patented Co-Primers PCR technology developed by Co-Diagnostics, which improves the quality of test results by dramatically reducing the occurrence of amplification errors known as primer dimers, which can lead to false positive results.

These assays provide reliable PCR diagnostics results, which can drive improve healthcare outcomes. Additionally, because our platform is real time PCR, it is better suited for multiplexing or testing for multiple disease indications within the same sample and reaction when compared to other technologies. When combined, our Co-Primers technology and multiplexing capabilities augment the already disrupted nature of the Co-Dx PCR platform. Co-Diagnostics has taken additional steps to evaluate the Co-Dx platform through third party studies. Prior to initial grant awards from the Bill and Melinda Gates Foundation in July, the Apollo Project organized by Seattle based PATH and funded in part by the Gates Foundation, performed an analytical and usability study on the Co-Dx PCR platform.