Good day, and welcome to the Co-Diagnostics, Inc. Fourth Quarter and Full Year 2021 Earnings Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] 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 or future events or performance are forward-looking statements.

For example, statements concerning 2021 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. 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 reconciliations to the non-GAAP financial measures presented to 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?.

number 1, COVID-19 with its variance will be a permanent endemic disease along with the many other endemic infectious diseases circulating throughout the world, just like they did before COVID. As COVID-19 continues to spread, the virus has more opportunities to mutate potentially resulting in mutation characteristics that increase its spread.

Other infectious diseases will also need to be diagnosed and differentiated from COVID-19. Dr. Michael Osterholm recently commented on a blueprint to a new normal in dealing with COVID-19. He said, "We’re not going to get rid of COVID.

It’s not going to happen." He also said, "We can do much better with testing." We believe we are well positioned to address the ongoing testing needed for this disease, along with the many others that exist today. Pillar number 2, inexpensive at-home and point-of-care diagnostics will be utilized everywhere, worldwide. Dr.

Scott Gottlieb, former FDA Commissioner, asserted that testing needs to be operationalized with regular testing and reliable protocols to normalize society. To go back to school, to go back to work or to travel, regular testing with reliable protocols will need to be done. We agree with Dr.

Gottlieb and believe at-home testing will become ubiquitous, and that the at-home rapid test is probably the biggest paradigm shift and change in regulation and medical products to come out of the pandemic. Dr.

Gottlieb goes on to say, "This is going to open up a whole new field of at-home testing for a range of pathogens." I want to repeat that, "This is going to open up a whole new field of at-home testing for a range of pathogens." Going on to pillar number 3, the Co-Dx YourTest PCR platform is the exact prescription for addressing a whole new field of at-home and point-of-care testing for a range of pathogens, meaning infectious diseases that can be detected with real-time PCR, enhanced with multiplexing.

Finally, pillar number 4, Co-Diagnostics believes the Co-Dx YourTest platform includes certain key differentiators compared to other less robust at-home and point-of-care systems. Co-Dx test results are PCR gold standard results compared to less accurate antigen test results.

Moreover, going forward, our system will facilitate significant multiplexing results compared to other non-PCR technologies that, while molecular, are too expensive and do not provide the same robust multiplexing opportunities as real-time PCR. Many diseases present with similar symptoms.

Syndromic panel testing or testing of several infections with one patient sample with a single test such as flu A, flu B, RSV and COVID will provide more robust testing with multi-target differentiation from a single sample that is possible in non-PCR-based testing protocols from our competitors.

To reiterate, the Co-Dx YourTest PCR platform takes about the same time and will cost about the same as antigen tests, but the results are gold standard PCR instead of the less reliable antigen tests. Compared to other non-PCR molecular tests, the Co-Dx YourTest PCR platform will cost significantly less and has more robust multiplexing capabilities.

Our platform delivers all three testing objectives of affordable testing, fast and gold standard accuracy. It then goes further to provide robust multiplexing enhanced by CoPrimers, our patented and proprietary PCR technology. We believe that our new powerful platform represents the future of at-home and point-of-care testing.

We continue to invest in the platform, and expect that it will drive significant growth and expand our market reach. There is a substantial domestic and international market that remains for COVID-19 testing, especially for advanced and innovative technologies such as the Co-Dx YourTest PCR platform.

Our team is highly focused and committed to bringing this exciting device to commercialization. The time required to prepare the device for clinical trials has unfortunately been extended.

This extension is due to a number of factors, including a major user factor study that was conducted in order to meet regulatory requirements for a device with an even broader market potential. This study is required in order to simultaneously submit for clearance for both, direct saliva and swab samples.

Receiving this clearance is critical because the use of swabs will be necessary to collect samples from the throat, such as for strep A, or from other sample sources associated with STIs. As our knowledge and understanding of COVID has continued to mature, it has presented opportunities to future-proof the device and testing platform.

We are firm believers that if a device requires the fewest possible changes to clinical practice, it will accelerate the adoption of the device by experts. Our goal is to deliver a device that is accurate and reliable and becomes a standard in PCR testing.

We have focused our efforts on optimization that will enable our instrument to achieve the highest possible standards of performance. Our world-renowned design and engineering experts have brought incredible innovation and expertise to this device.

And our goal is to position the company as a platform that will significantly contribute to the ongoing science of real-time PCR applications in at-home and point-of-care settings. The Company is currently executing on final optimizations preparatory to a clinical trial, which we expect will soon enable submission for regulatory authorization.

Having the right submission that will facilitate the broadest range of market opportunities, once authorized, is our most critical objective. We believe others have developed short-term solutions to permanent problems. With our platform, we are planning on providing a robust permanent solution to permanent problems.

Our strategic objective to get it right with the Co-Dx YourTest PCR platform should enable the Company to play a significant role in syndromic panel testing, covering a large number of ongoing pernicious infections.

Immediately upon receiving regulatory authorization, the Company expects to conduct sales campaigns to a vast number of potential clients, which include outreach to the public sector, including as applicable to schools and college campuses, enterprise sales, including airlines, theme parks, cruise ships, restaurants, entertainment venues, the healthcare sector, including doctors and dental offices and the residential or individual consumer sector.

Company infrastructure is currently being enhanced to address our product launch. We are also very excited about the centralized lab segment and distributor network covering more than 80 countries.

The hard work and dedication of our team to deliver superior service is unmatched, and has driven over $170 million in sales over the last two years as we have leveraged our patented CoPrimer platform to provide state-of-the-art diagnostic products to this important business segment.

In addition to our suite of COVID-19 diagnostics that have been developed over the last two years, these diagnostics include other CoPrimer-based IVD products developed either in our U.S.-based laboratory or our joint venture in India, including tests for diseases like tuberculosis, Zika, dengue, chikungunya, malaria, hepatitis B and C and human papillomavirus.

We also continued to see our mosquito abatement CoPrimer product experienced even wider adoption, allowing municipal mosquito abatement districts to better serve the public good by identifying the presence of diseases like West Nile virus, Western and Eastern Equine Encephalitis and St.

Louis Encephalitis, in mosquito pools and targeting the areas where those diseases are found. We will continue to prioritize R&D efforts as we grow that product pipeline along with expanding our worldwide network of capable distributors and participating labs.

Among the other exciting and innovative product offerings that are actively in development include 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.

Additionally, a malaria test that was designed to differentiate between the different species of the parasite known to be resistant to treatment and also an expansion of our Logix Smart ABC test to include respiratory syncytial virus, or RSV.

As a technology company, our CoPrimer platform also has applications that extend far beyond COVID and infectious disease. These include liquid biopsy for cancer detection, the development of which is ramping up as we position the Company to take part in this historic and challenging development in human healthcare.

The exquisite specificity of CoPrimers has been shown to have excellent capabilities in the detection of cancer-associated mutations present in human blood, and a panel has been developed that detects six of the most common single nucleotide mutations of the EGFR gene associated with non-small cell lung cancer.

This panel is undergoing performance verification with clinical samples, which will also have applications for the paper authored last year that will be subjected to peer review after the conclusion of the study. Other assays have been developed for several pathogens of significance in dentistry, mental health and veterinary medicine.

Analytical performance is being evaluated for these assays. We continue to make progress in our agricultural vertical, including in our work with Bayer Crop Services and LGC. We signed a contract with Bayer pursuant to an ongoing proof-of-concept project using our patent-pending NGS library prep technology.

Bayer is now offering products based on our proprietary CoPrimer technology to the agricultural market. Overall, we believe that our operational and executional enhancements, including investments in talent and R&D, continue to yield positive results and are further positioning Co-Diagnostics for future growth.

Every action we have taken since becoming a public company has been deliberate. Our strong margins and a healthy balance sheet have positioned us well to fully realize our vision and continue to expand our menu of state-of-the-art molecular diagnostics.

The Co-Dx YourTest PCR platform has been designed from the beginning with the ability to operationalize testing on a regular basis in at-home and point-of-care settings. We believe it is the optimal solution, not only for COVID, but for other infectious diseases that we intend to add to our testing menu over time.

It is inexpensive, fast, accurate, with gold standard PCR results and capable of multiplex syndromic testing going forward. We believe that our history of remaining ahead of the curve since the onset of the pandemic will continue to drive this trajectory of growth.

I would like to conclude my prepared remarks by thanking our employees, distributors and customers for their dedication and action in helping to deliver tremendous results for 2021. This concludes my initial remarks. Let me now turn things over to Brian Brown for a review of the key metrics and numbers.

Brian?.

Revenue in the range of $21.0 million to $22.0 million, a 7.5% increase at the midpoint compared to the first quarter of 2020; diluted EPS in the range of $0.17 to $0.20, based on 32.4 million diluted shares outstanding; and adjusted EBITDA in the range of $9.0 million to $10.0 million.

Again, adjusted EBITDA is defined as earnings before interest, taxes, depreciation and amortization, with an add back for stock-based compensation and any material nonrecurring expenses. Before I turn the call back to Dwight, I want to reiterate the gratitude and appreciation we have for our dedicated employees and customers.

Without their hard work and support, we would not have been able to achieve the strong financial performance we did during fiscal 2021. Moving forward, we have a strong foundation that provides us with momentum to achieve further growth.

We are enthusiastic about the opportunities that the Co-Dx YourTest PCR device platform will provide, once regulatory approval is received.

We remain committed to continue investing in people, processes, and research and development, and focused on building upon the platform we have already established, which we believe places us in a position of strength to capture market share during 2022. I’ll now turn the presentation back over to Dwight..

Thank you, Brian. This concludes our prepared remarks. Operator, we will now take questions from our analysts..

Thank you. [Operator Instructions] Our first question comes from Yi Chen with H.C. Wainwright. Please go ahead..

Thank you for taking my questions. The first question is regarding the repurchase program. Could you share with us how many shares have already been repurchased? And also, do you think it would be better to save the cash for additional acquisition opportunities? Thank you..

Actually, Dwight, if you don’t mind, I can answer this question..

Go ahead, Brian..

Yes. We haven’t purchased any shares back because we’re in a blackout. So, we certainly can’t do that during a blackout. And so that’s answer to number one. Number two is, we’re looking at both, the need to commercialize the Co-Dx YourTest PCR device in addition to share buybacks. So, we’re managing both of those needs simultaneously.

And so, we’ve done our analysis on our end and know what makes the most sense for us, both -- on both things. We know that it’s going to require cash to be able to commercialize the product. So, we’re making sure we have that still with us so we can make that happen because that’s our number one goal..

Got it.

And could you comment on the -- any potential new initiatives outside the infections -- infectious disease space, such as oncology diagnostics?.

Thank you for joining the call, and it’s nice to hear from you again. We’re very enthused about several different initiatives other than the COVID and infectious disease opportunity.

But, let me touch a little bit more on the infectious disease, because I mentioned the sexually transmitted infections or STI, which is a big area that we’ve been working on and with some of our clinical partners. And there are about 1 million STIs every day in the world.

And so, this is another huge market that we think we can play an important role in. And also, in India, we have had a dozen of our tests approved by the CDSCO, which is their version of the FDA. And so, we’ve done a lot of work preparing India. COVID has given us an opportunity to do a tremendous expansion.

And we’ve spent some money there to open up the number of labs, which now are at about 250 within the country. And this is an area where we expect it to be one of the largest healthcare markets in the world. COVID gave us an opportunity to garner market share at a significant rate.

And now that we have the opportunity to go forward with a whole bunch of new tests, about a dozen in all, that significantly expand the market opportunity there. With respect to liquid biopsy, as you know, we have been doing research, significant research in that space for some time now.

This is an area that is one of the most exciting areas in human healthcare. And we have done significant work, learned a lot of things and prepared a 6 different EGFR panel test that we expect we’ll be able to move towards commercialization in the future. This is rocket science in molecular biology.

So, it’s not something that will be looked at in anything but a very serious context in terms of how ready we are to enter into that market and provide a product. I think, like in infectious diseases, our ability to service the liquid biopsy market will center mostly in the areas of high-burden developing countries.

It will also have appeal in the United States, but we will be concentrating not on the diagnostic side of it, but on the monitoring side and in looking at people that don’t know they have cancer, don’t know they have symptoms.

So, it’s something that goes ahead of the diagnostic where we can detect a way ahead of time, the presence of these mutations in a person’s blood. That’s a significant area for us. We’ve done a great deal of research on it, and we look forward to commercializing a product in the future.

We’ve also done very important work in other areas, including what we’re doing with Bayer Crop Services and LGC.

We’re happy that, recently, the Bayer Crop Services has begun offering products utilizing our CoPrimers in certain places of the world, and that’s the combination of a great deal of research and development and having them look at our product and our technology and being able to embrace it. So, we’re excited about that.

Of course, we’ve continued to make strides in our mosquito abatement program. We continue to sign counties in certain places in the United States, and we think this is going to be an ongoing and growing product. I’d just add that the mosquito is the most deadly creature on the planet.

And it’s one of the areas that we have developed a specific product with some real good results and continue to sell new counties on this program. I think, finally, with respect to what we’re developing, I mentioned what we’re doing in dentistry, for example, done a lot of significant research there.

And some of the things that we’re doing are in preparation for not only what we’re doing with our centralized lab segment, but that we expect to port over to the point-of-care and at-home device.

We think that some of these products like that we’re doing for dentistry and veterinary and even in agriculture we’ll have application in both of those two different business segments, that is centralized lab business segment and the point-of-care and at-home product..

Our next question comes from Jim Sidoti with Sidoti & Company. Please go ahead..

Good afternoon. Thanks for taking the questions.

Can you give us a little more detail on milestones you have left towards the YourTest system?.

The new system is -- I would say, to characterize it as that we’re on the precipice of beginning our clinical trials. As I mentioned in my prepared remarks, our focus has been to make sure that we have a product that meets the highest performance levels that we can possibly obtain before we put it into the market.

And so, we’re in the process of tweaking certain elements of its performance so that when we release it, we have something that is really superior. And we haven’t been trying to hit a particular deadline as much as we’ve been trying to optimize the breadth of the product.

As I mentioned in my prepared remarks, originally, we had contemplated this being a saliva-direct product. But in our work with the FDA, we decided we would expand it to include, not only the saliva-direct, but also the nasal swabs, and swabs, of course, that can be used in other parts of the body, depending on what it is you’re trying to test.

So, it took some -- made a little bit of a delay, but made -- so when we do have an authorization, we anticipate it to be for a much broader market and a lot less sort of fits and starts as we have to continue to develop further iterations of the device. We’re not trying to game the next Omicron surge.

We have a very solid product line to deal with that in the centralized lab environment. We, of course, want to put this point-of-care and at-home device out there as soon as we possibly can. And it is the single biggest focus in the Company.

When we went from our parent company employment base of about 50 people at the end of the year through these two acquisitions, we now have in the neighborhood of 125 people. So, we have a lot of folks that are working on this particular project, a lot of great engineers and PhDs that are really super focused on this.

So, we don’t anticipate it being an extraordinary long period of time until we’re able to commence our clinical trial and then make a submission. But when we do that, we expect it to be a product that is really worthy of notice in its performance and in the breadth of the market that it’s going to be able to serve..

So, is it fair to say the delay is something you measure in months and not in years?.

That’s certainly correct. Yes..

And then on the fourth quarter performance. The revenue was down, but gross margins jumped up from around 84% last -- or in 2020, it looks like it was around 88% in 2021.

What happened there?.

Yes. Jim, that’s a couple of things. One of the biggest things is the mix. Last year, in 2020, we would have sold a significantly higher number of devices that had a much lower margin than the tests. And so it was just -- the biggest thing is the mix between -- one of the biggest things is the mix between what we are selling tests versus devices.

Most of what we sold this year in Q4 would have been tests, very little in devices. So, it’s higher-margin product. The other piece of it is just enhancing the production process and becoming more efficient. Those are, I think, the two key things to think about..

All right.

And seeing as we only have about a week left in the quarter, is it fair to say that you’re fairly confident in the first quarter revenue guidance?.

I guess, the question for you, Jim, is we probably wouldn’t put it out there if we weren’t confident in it. So, I think, yes, we’ve got about a week left in the quarter. We’re confident in the numbers we put out there for guidance..

Our next question comes from Theodore O’Neill with Litchfield Hills Research..

Thanks very much. And congratulations on results for the year. So, first question is a follow-up on margins. Your 2022 margins improved year-over-year, partly because of mix, more test reagents than equipment.

So, can you talk about the margin impact as you start to sell the Co-Dx platform and the reagents for it?.

Yes. We don’t -- just in terms of margins for the new products, we don’t expect that the total margins over time are going to be much different than the margins we have currently. They’re clearly -- initially, if you commercialize a product, clearly, one piece of that product is probably going to be a little lower margin than the other.

And until we get some -- a number of months behind us, I think, our margins will suffer a bit, but they’ll come back to where they currently are, maybe a hair lower than that, I think.

There’s certainly going to be a little bit of a drag when it comes to everyone knows selling a device, the margins aren’t typically as high as just as we experienced with the devices we sell for centralized labs, the margins aren’t as high as they are for the tests.

So, there’s going to be a mix issue also as we commercialize that, and that will have an impact on margin initially..

Okay. Makes sense. And if the U.S.

government does not reauthorize any additional money for COVID testing, would this have an impact on your business?.

I think, we’d have to say that the free money from the government certainly would enhance sales. So, I think it would have an impact on us or anybody else that’s in the COVID space, which is the reason why we have had the foresight 1.5 years ago to say, what happens after COVID traverses from a pandemic to an endemic phase.

Molecular Diagnostics was a big business before COVID. It will continue to be a big business after COVID. The question becomes what kind of platform will win in a post-COVID environment that is a post-pandemic environment. And we believe, and I think other people believe such as Dr.

Scott Gottlieb that this paradigm shift in the FDA allowing the at-home testing is going to make it so these other endemic diseases will also have an opportunity, as Dr. Gottlieb says that it opens up a whole new range of home testing for a whole -- a big range of products of different pathogens.

So, I think it’s just important to realize that we had the foresight more than a year and a half ago to recognize that and to begin the development of a product so that when we came through that whole period, our product offering would have applicability to lots of other diseases.

Keep in mind that COVID is so pernicious in terms of its lethality that these other things like the flu and RSV, even strep, for example, they will need to be tested along with COVID. COVID will have to be a part of the mix of what people are tested for.

And in that regard, the multiplexing capability of our device will be critical in making it so people can test for a number of different diseases for a very small price at home or at the point-of-care. And that’s all part of the strategy going forward.

So, I think if you were to look before COVID and say, what would have been the best device to have on the market during COVID had we been able to do this two years ago, that would, of course, been awesome. But going forward, it is clearly the best solution and going to be very powerful in our belief..

This concludes our question-and-answer session. I would like to turn the conference back over to Dwight Egan for any closing remarks..

Thank you, operator, and thanks to all of you for participating on the call. We look forward to an exciting 2022 as we launch the anticipated commercialization of our new Co-Dx at-home, point-of-care platform. It’s a PCR gold standard platform. And we’re also very excited about the continued progress in our other significant initiatives.

And we look forward to visiting with all of you on our next call. Good day..

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect..