Co-Diagnostics, Inc.

Thank you for standing by. My name is Cass and I will be your conference operator today. At this time, I would like to welcome everyone to the co-diagnostics first quarter 2025 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, simply press star 1 again. I would now like to turn the call over to Andrew Benson, Head of 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 first quarter and in March 31, 2025. A copy of the press release is available on the company's website. We will begin 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 CoDiagnostics during this call, which are not historical facts, are forward-looking statements. This includes statements concerning the company's CoDx PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale. in addition to diagnostic test developments and timing for commencement of clinical evaluations. Actual outcomes and results may differ materially from what is expressed or implied in any statement. 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 issued 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.

Thank you, Andrew, and good afternoon, everyone. Thank you for joining CoDiagnostics' first quarter 2025 earnings call. During the first quarter, we continued to advance our CODIX PCR platform and associated test pipeline towards initiating clinical evaluations. I am proud of the work our team has done as we seek to bring our low-cost, rapid, and easy-to-use platform to the point-of-care market. Our mission at CoDiagnostics is to increase the accessibility of affordable, high-quality diagnostics in the United States, India, and around the world, and we are nearing several important development milestones in pursuit of that vision, including the commencement of clinical studies for critical indications. As discussed in previous calls, the test pipeline for the new platform includes our diagnostic tests for tuberculosis, or TB, COVID-19, four-plex respiratory panel, and eight-plex HPV panel. Over the past several years, these indications have developed into the most immediate opportunities for our unique technology and platform to impact the current standard of care and ultimately patient outcomes. Throughout our development efforts, we have been supported by several leading organizations who share in our passion for improving the global health infrastructure including the Bill and Melinda Gates Foundation, Smart4TB, and the National Institute of Health's RADx Tech Program. We remain highly focused on bringing our COTIX PCR platform to market, including several advancements that have been developed by our scientific, engineering, and software development teams. These new platform developments will be incorporated into our instrument and test kits as part of upcoming regulatory submissions which we anticipate will drive operating and manufacturing efficiencies down the line for our current and future tests. The design for the augmented COTIX PCR COVID-19 test has been completed, and the test has undergone extensive verification testing, and we have full confidence in the test performance and stability. We plan to submit this updated version of our COVID-19 test to the FDA with a 510K application after updated clinical data has been collected. We are excited about the disruptive potential of our platform and will continue to work tirelessly to introduce this powerful new diagnostic solution to the market. We are pleased by the work that we have done on our TB test so far this year. As discussed last quarter, we have already completed several preliminary analytical studies as well as testing on clinical samples to confirm performance. Moreover, we have identified instruments for the TB sample prep, which takes place prior to samples being added to the COTIX PCR-MTB test cup, enabling an efficient and affordable workflow process. This step is crucial to the commercial launch and success of the TB test, and we believe we are in a great position as we prepare for upcoming clinical evaluations. We are very excited about the potential of this testing solution to provide low cost, high accuracy, real time point of care diagnostics around the world to combat tuberculosis, which remains the leading global infectious disease killer. We see particular need for our TB test in locations like India, our top priority market for TB testing, where we have significant experience, including regulatory, commercial, and manufacturing infrastructure through our joint venture, COSERA Diagnostics. We expect to begin clinical evaluations in India and South Africa in the back half of 2025, gathering data that will be utilized to support regulatory submissions to the Central Drug Standard Control Organization, or CDSCO, in India, and the South Africa Health Products Regulatory Agency, or SAFRA, in Africa. In our clinical evaluation preparations, we continue to engage with local health officials in those regions and potential customers to evaluate the most effective and efficient commercialization strategy. Elsewhere, our team continues to make significant progress on our fourplex respiratory panel, which has been developed with a grant support from the NIH's Radix Tech Initiative. The test has been designed to deliver simultaneous real-time PCR test results for flu A and B, COVID-19, and RSV. Market research has identified a considerable amount of interest in this panel, which we believe is warranted by the burden these diseases place on everyday life in the United States and around the world. Core to our value proposition is the capability to provide de-identified data to health departments at the local, regional, national, or international level to help track outbreaks of infectious diseases, thanks to the cloud-based analysis of tests performed on the CODIX PCR Pro. This situational awareness can provide health officials with key data and insights that could save lives and stop outbreaks. In March, we completed a pre-submission to the FDA for the CODIX PCR-PRO Respiratory Multiplex Panel Test Kit. We have been assigned a reviewer and plan to initiate clinical evaluations for this assay in the second half of this year. Rounding out our pipeline, we continue to make good progress in preparing the APLEX HPV panel for upcoming clinical evaluations. This development has been supported by a grant from the Bill and Melinda Gates Foundation, as there is a vast need for HPV testing around the world. HPV is one of the most widespread and common sexually transmitted infections worldwide. Several human papillomavirus subtypes are linked to cervical cancer, which causes hundreds of thousands of deaths annually. We believe the CODIAX PCR platform can have a significant impact on testing accessibility and efficiency, which remain key constraints to mitigating the impact of HPV on global health. Utilizing our co-primaries technology, our HPV assay can simultaneously detect eight different high-risk HPV subtypes from a single cervical swab sample, providing an affordable and accessible tool for patients around the world. During the first quarter, our teams continued to generate performance data for our test, which has met or exceeded internal expectations. With support from our funding partners and key stakeholders, we look forward to initiation of our clinical evaluations, our regulatory submissions, and platform commercialization. We plan to initially pursue regulatory clearance in India for this test before moving to South Africa and other regions. Leveraging our existing footprint in India through COSERA, we believe we are uniquely positioned to serve the Indian market. Before wrapping up, I would like to highlight events that CoDiagnostics attended in the first quarter to build further awareness of the CODIX PCR platform. Following the inauguration of the oligonucleotide synthesis facility in December, in March, we hosted an HPV and cancer symposium to honor International HPV Awareness Day 2025 in India. This was hosted in collaboration with COSERA, which helped to set the stage as we prepare for analytical and clinical studies for our HPV test. We also hosted a booth at BioUtah's Life Sciences Day on the Hill at the Utah State Capitol Rotunda, which showcased our CodexPCR platform for local health constituents and government officials. These events were well attended with a high level of engagement and interest in our platform, We welcome opportunities to engage with local and international potential customers and key stakeholders, which made these events a productive and collaborative experience for the company. To close out, I want to emphasize our commitment to achieving our regulatory objectives and to successfully launching the Codex PCR Pro instrument and test kits to the world. Our team has been working diligently to advance our pipeline of diagnostic solutions which has resulted in a successful first quarter. We are nearing several critical milestones, including clinical evaluations for all of the indications discussed here and a new submission to the FDA for COVID-19. In India, we remain on track to complete the build out of our manufacturing facility before the end of the year, which has already included an oligonucleotide synthesis facility inaugurated last December. giving us additional manufacturing capability in that region. We believe the Kodiak's PCR platform can revolutionize and set a new bar for the affordability, accessibility, and decentralization of infectious disease testing. I am very proud of the work of our team and look forward to another quarter of success. With that, I will now turn the call over to Brian to discuss our financial results.

Thanks, Dwight. Thanks to everyone who joined today's call. For the first quarter of 2025, total revenue decreased to $0.1 million as compared to $0.5 million in the prior year's same period. All revenue recognition during the first quarter came from product revenue. Total operating expenses for the first quarter of 2025 decreased to $8.6 million from $10.5 million in the first quarter of 2024. Research and development expenses in the first quarter of 2025 were $4.9 million compared to $5.7 million during the first quarter of 2024. For the first quarter of 2025, income before taxes was a loss of $7.5 million as compared to a loss of $9.3 million reported in the prior year period. Net loss for the first quarter of 2025 was $7.5 million. for a loss of 24 cents per fully diluted share compared to a net loss of $9.3 million for a loss of 31 cents per fully diluted share in the prior year period. Adjusted EBITDA was a loss of $7.4 million compared to an adjusted EBITDA loss of $8.4 million in the prior year period. We ended the quarter with $21.5 million in cash, cash equivalents, and marketable investment securities. We continue to manage our spend as we look to maintain a healthy balance sheet to position ourselves for a future commercial launch. Throughout the year, we will continue to make improvements to our operating footprint that will drive efficiency gains and cost savings. We plan to provide for the company's capital requirements through equity financing, seeking additional grant funding, and through operational efficiencies. In the near term, We are focused on progressing our development pipeline towards regulatory submission and are managing our allocation of time and resources accordingly. We are very excited about our continued progress and remain optimistic about 2025 and future developments within our test pipeline. I look forward to providing you with more updates on next quarter's call. With that, I will now turn the presentation back over to Dwight. Thank you, Brian.

To close, we want to extend our gratitude to co-diagnostic shareholders and our employees who work hard each day to progress our test pipeline and missions. We will now take questions from our analysts. Operator?

Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. And your first question comes from the line of Yi Chen with HC Wingright. Your line is open.

Hi there, this is Eduardo on for you. Just had hoping to get a little bit more clarity on the timeline for for resubmission for that you guys were planning on doing it to understand for the COVID test and state of that. And if there's anything else that would be required for that resubmission for the 510 K application.

So thank you for the question. We have already. completed the new design for our new version of the test, and we have done extensive verification on the test. The feedback we had originally received from the FDA on our previous submission surrounding the ability to monitor the shelf stability of one of our test components has been solved, and we are just getting ready to enter our clinical evaluations. In this process, we have continued to enhance our platform's capabilities, and we're now able to incorporate new developments onto the instrument and test cups for the new COVID-19 test for our new submission, along with other tests in our pipeline. So we're confident that in these enhancements, which we believe unlocks greater manufacturing and operational efficiencies for our new platform and the tests, We're now focused on assembling and preparing for this new submission which will be substantially similar to our earlier submission enhanced by the new data that will come from our clinical trial upcoming. So we remain very positive on the functionality and quality of the test. We believe that the revised 510 application will increase the probability of a successful clearance and so we're We're very far along in this process and don't anticipate that it will be a long time coming before we will commence our clinical trials.

Got it. And do you have any specific date by which you expect to submit?

Sort of the governor of that is what the prevalence of COVID is. in the world, in the United States in particular. So, for instance, if we ended up, you know, being ready to go to clinical trials but we weren't seeing a prevalence of COVID-19 at our test sites, we would hold on until we saw the amount of COVID infection that would be required to conduct an effective and efficient test. It's a little bit of a waiting game for when does COVID emerge. As you know, the history of COVID, it tends to have outbreaks that may, for instance, be caused by activities that get group settings together, Thanksgiving, holidays, ball games, those sorts of things. So we don't know exactly what the timing is because there are some exogenous events and characteristics. that we have to pay attention to.

Got it. That's helpful. And regarding the other products that you are planning to launch in India and South Africa, do you have a timeline for that? I don't know what the regulatory process or timeline for that is as well.

So the best guidance I can give you on the other three tests, that would be our multiplex ABCR test, as we refer to it internally, COVID, or it includes COVID-19, it includes RSV, it includes flu A and flu B. That is also governed by the same kind of constraints that I mentioned with respect to COVID. And then there's the HPV test and the TB test we expect all of those tests to be into clinical trials during the remainder of this year. They will commence clinical trials during the main part of 2025. As you can appreciate in places like India, we don't have any problem getting samples. So there's not a constraint with respect to the presence of HPV. HPV, India comprises roughly 25% of all HPV cases in the world. So we don't have an anticipation that we're going to have any trouble getting samples there. And of course, in tuberculosis, it is the number one infectious disease killer on the planet. And India is certainly one of the epicenters of that. So we don't anticipate having any trouble getting those samples. But other than that, from a date standpoint, they will all be entering the clinical trial phase during the rest of this calendar year.

Got it. Got it. That's really helpful. So broadly speaking, it's probable that the HPV and tuberculosis tests or trials might run a little bit quicker, leading to maybe an earlier launch of that affair characterization.

That is certainly a possibility. the largely that stems from the ability to get samples at will basically so keep in mind that all of these indications are you know currently undergoing important testing we have manufactured hundreds of thousands of test cups in our in our facility, our manufacturing facility. So there's been a ton of work done getting ready for these clinical trials. I would add, I think, that our original submission with respect to COVID-19, the FDA did not have a problem with our instrument. They didn't have a problem with You know, the clinical trial that was performed, which involved well over 800 different patients, we just wanted to fix the one internal positive control and make it so that that was not something we had to really ever worry about again. And the same positive control that's RNA-based is also incorporated into the ABCR test. So we are on the lip of the cup of being ready to go into clinical trials. and look forward to that very important step for us during the remainder of this year. And then it's on to regulatory submission and our initial commercialization launch.

Understood. And then just one final one, I guess. If I could, obviously, do you have any idea for pricing and the gross margins for the device and the test cups? I imagine it would vary from geography, but if you could give maybe ballpark estimates if they're available.

Yeah, I think we have long talked about the costs of our instrument initially being in the $300 to $500 range. It kind of depends on how many people buy. And at scale, we know where our target is at the lower end of that number, and we may begin our deployment at a little bit higher number as we scale up. But that's the sort of working number that we're looking for. It's not a guaranteed number, but that's what our target is. And with respect to the test cartridges, as you have mentioned, you're right. It kind of depends on the geography. Low and middle income countries will have a lower price test, generally speaking, than in the US. developed world. So we've typically used the $15 to $20 per cup price in the developed world. And for diseases such as tuberculosis, we've used pricing that is lower than our primary competitors. in places like India. That's as much guidance I think as I can give you on that right now. And the human papillomavirus is probably not as sensitive as TB.

And Eduardo, this is Brian, just to add one little piece of information to that. We would expect in terms of margins that our margins on the device would be similar to the equipment that we sold in the past. and we'd expect that the tests are similar, the margins are going to be similar to the margins we've experienced when we've sold the lab-based tests in the past.

Got it. So using all these past references for those. All right. Really appreciate the answers, and thanks for taking the questions.

Thanks, Eduardo.

Thank you. I'm not showing any further questions in the queue. Ladies and gentlemen, that concludes Thank you all for joining. You may now disconnect.