Co-Diagnostics, Inc. (CODX) Q3 2022 Earnings Call Transcript

Co-Diagnostics, Inc. (CODX)

Q3 2022 Earnings Conference Call

November 10, 2022, 04:30 PM ET

Company Participants

Dan Bohrer - VP, Finance and Accounting

Dwight Egan - CEO

Brian Brown - CFO

Conference Call Participants

Theodore O'Neill - Litchfield Hills Research

Presentation

Operator

Good afternoon, and welcome to the Co-Diagnostics, Inc. Third Quarter 2022 Earnings Results Conference Call. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Dan Bohrer, Vice President of Finance and Accounting. Please go ahead.

Dan Bohrer

Thank you. I am Dan Bohrer, 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 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 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?

Dwight Egan

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 remained strong as we continued to make progress on the optimization of the Co-Dx 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 Rajnarayanan, 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 variant that form a table meso 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-evasive 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 $86.5 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 Co-Dx 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 CoPrimer 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-Diagnostics' 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 Co-Dx PCR 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 time line to product launch is as follows. Presently, we are performing hundreds of end-to-end runs on our Co-Dx 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(k) submissions for each of these and other tests....

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