Co-Diagnostics, Inc. Q1 FY2025 Earnings Call

Thank you for standing by. My name is Cath 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 speakers' remarks, there will be a question-and-answer session. 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 Co-Diagnostics, we have Dwight Egan, Chief Executive Officer; and Brian Brown, Chief Financial Officer. Earlier today, Co-Diagnostics released financial results from the first quarter ended March 31st, 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 Co-Diagnostics during this call, which are not historical facts, are forward-looking statements. This includes statements concerning the company's Co-Dx 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.

Thank you, Andrew and good afternoon everyone. Thank you for joining Co-Diagnostics first quarter 2025 earnings call. During the first quarter, we continued to advance our Co-Dx 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 Co-Diagnostics 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 test for tuberculosis or TB, COVID-19, 4-plex respiratory panel, and 8-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 & Melinda Gates Foundation, SMART4TB, and the National Institute of Health's RADx Tech program. We remain highly focused on bringing our Co-Dx 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 Co-Dx 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 510(k) application after updated clinical data has been collected. We are excited about the disruptive potential of our platform and we'll 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 Co-Dx 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 CoSara 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 Drugs Standard Control Organization or CDSCO in India and the South Africa Health Products Regulatory Agency or SAHPRA 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 4-plex respiratory panel which has been developed with grant support from the NIH's RADx 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 Co-Dx 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 Co-Dx 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 8-plex HPV panel for upcoming clinical evaluations. This development has been supported by a grant from the Bill & 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 Co-Dx 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-Primers 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 the 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 CoSara, we believe we are uniquely positioned to serve the Indian market. Before wrapping up, I would like to highlight events that Co-Diagnostics attended in the first quarter to build further awareness of the Co-Dx 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 CoSara 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 Co-Dx PCR 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 Co-Dx 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 Co-Dx 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 and 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 or a loss of $0.24 per fully diluted share compared to a net loss of $9.3 million, or a loss of $0.31 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-Diagnostics shareholders and our employees who work hard each day to progress our test pipeline and missions. We will now take questions from our analysts.

Thank you. We will now begin the question-and-answer session. And your first question comes from the line of Yi Chen with H.C. Wainwright. Your line is open.

Hi, there. This is Eduardo on for Yi. Just hoping to get a little bit more clarity on the timeline for resubmission for that you guys were planning on doing I understand for the COVID test and the 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 in these enhancements which we believe unlock 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 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 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. So 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? And I don't know what the regulatory process or timeline for that is as well?

The best guidance I can provide on the three additional tests, which we internally refer to as the multiplex ABCR test, is that it includes COVID-19, RSV, flu A, and flu B. These tests are subject to the same constraints I previously mentioned regarding COVID. We also have the HPV test and the TB test. We expect to enter clinical trials for all of these tests during the rest of this year, specifically starting in the latter part of 2025. In countries like India, we don't face any issues obtaining samples, so collecting HPV samples will not be a constraint. India accounts for about 25% of all HPV cases globally, so we do not foresee any problems there. Furthermore, tuberculosis is the leading infectious disease killer worldwide, and India is one of the key regions for that issue. Therefore, we do not expect challenges in acquiring those samples either. In summary, all tests will begin the clinical trial phase within the current 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. Is that a fair characterization?

It is certainly a possibility. That largely stems from the ability to get samples at will. So keep in mind that all of these indications are currently undergoing important testing. We have manufactured hundreds of thousands of Test Cups in our manufacturing facility, so there's been a lot of work done to prepare for these clinical trials. I would add that our original submission regarding COVID-19 was not problematic for the FDA. They did not have concerns with our instrument or the clinical trial that involved over 800 patients. We just needed to address one internal positive control, which is something we won't have to worry about again. The same RNA-based positive control is also incorporated into the ABCR test. We are on the verge of being ready to go into clinical trials, and we look forward to this important step for us in the remainder of this year. Then it will be on to regulatory submission and our initial commercialization launch.

Understood. And then just one final question, do you have any information about the pricing and gross margins for the device and the Test Cups? I imagine it could vary by geography, but if you could share any ballpark estimates, that would be helpful.

We have previously mentioned that the cost of our instrument is expected to be in the $300 to $500 range, which varies based on the number of buyers. As we scale, our goal is to aim for the lower end of that range, although we might start our deployment at a slightly higher price. This is our working target, and while it isn't guaranteed, it represents what we are aiming for. Regarding the test cartridges, you are correct that pricing depends on the geography. Generally, low and middle-income countries will have lower test prices compared to developed nations. In the developed world, we usually consider a price of $15 to $20 per cup. For diseases such as tuberculosis, our pricing is often lower than that of our main competitors in countries like India. That's as much information as I can provide at this time, and human papillomavirus testing is likely not as price-sensitive as tuberculosis.

And Eduardo, this is Brian. I just want to add a bit of information. We would expect our margins on the device to be similar to those of the equipment we sold in the past. We anticipate that the margins for the tests will also closely align with the margins we've seen previously from our lab-based tests.

Got it. So, using all these past preferences for those, 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 today's call. Thank you all for joining. You may now disconnect.