Co-Diagnostics Q1 2025 Earnings Report

Co-Diagnostics EPS Results

• Actual EPS: -$7.20
• Consensus EPS: -$9.90
• Beat/Miss: Beat by +$2.70
• One Year Ago EPS: N/A

Co-Diagnostics Revenue Results

• Actual Revenue: $0.05 million
• Expected Revenue: $0.38 million
• Beat/Miss: Missed by -$325.00 thousand
• YoY Revenue Growth: N/A

Co-Diagnostics Announcement Details

• Quarter: Q1 2025
• Date: 5/8/2025
• Time: After Market Closes
• Conference Call Date: Thursday, May 8, 2025
• Conference Call Time: 4:30PM ET

Co-Diagnostics (NASDAQ:CODX) is a molecular diagnostics company that develops, manufactures, and commercializes diagnostic technologies and test systems. Based in Salt Lake City, Utah, the company focuses on polymerase chain reaction (PCR) testing and related applications for detecting infectious diseases and other medical conditions.

The company’s core technology is its CoPrimer platform, a proprietary approach to designing molecular diagnostic tests intended to support sensitive and specific detection while helping reduce certain costs associated with conventional PCR testing. Co-Diagnostics has developed Logix Smart molecular diagnostic assays for targets that have included respiratory pathogens, tuberculosis, mosquito-borne diseases, and other infectious diseases. It has also worked on integrated testing systems, including instruments and associated software designed for use with its assays.

Co-Diagnostics was founded in 2013 and has sought to serve clinical, public-health, and research customers in the United States and international markets, including through distribution and collaboration arrangements. Its products and technologies have been developed for applications ranging from centralized laboratories to decentralized and point-of-care testing environments. The company’s offerings and regulatory availability may vary by jurisdiction.

Co-Diagnostics Q1 2025 Earnings Call Transcript

Key Takeaways

• Advance CoDiEX PCR platform: Completed design and extensive verification of the updated COVID-19 test, submitted a pre-submission for the 4-plex respiratory panel, and are preparing for clinical evaluations of COVID-19, TB, respiratory, and HPV assays.
• TB and HPV pipeline milestones: TB test sample prep workflow is established and clinical studies are scheduled in India and South Africa in H2 2025 for CDSCO and SAHPRA submissions; HPV assay can detect eight high-risk subtypes from one swab with initial regulatory focus in India via the COSERA joint venture.
• Strategic partnerships and grant support: Collaborations with the Bill & Melinda Gates Foundation, NIH’s RADx Tech, Smart for TB, and others underpin test development and enable cloud-based, de-identified data sharing for outbreak monitoring.
• Q1 financial performance: Reported Q1 revenue of $0.1 M, operating expenses down to $8.6 M, net loss improved to $7.5 M ($0.24/sh) from $9.3 M, and ended with $21.5 M in cash and equivalents, while prioritizing cost management and grant funding for runway.
• Commercial targeting and pricing: Instrument pricing is aimed at $300–$500 based on scale, test cups at $15–$20 in developed markets and lower in LMICs, with gross margins expected in line with prior equipment and lab-based test sales.

Presentation

[Operator]

Thank you for standing by. My name is Kath, and I will be your conference operator today. At this time, I would like to welcome everyone to the Co-Diagnostics Q2 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 * followed by the number 1 on your telephone keypad. If you would like to withdraw your question, simply press * again. I would now like to turn the call over to Andrew Benson, Head of Investor Relations. Please go ahead.

[Andrew Benson, Head of Investor Relations at Co-Diagnostics]

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 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 Co-Diagnostics during this call, which are not historical facts, are forward-looking statements. This includes statements concerning the company's CODEX 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.

[Andrew Benson, Head of Investor Relations at Co-Diagnostics]

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.

[Dwight Egan, CEO at Co-Diagnostics]

Thank you, Andrew. Good afternoon, everyone. Thank you for joining Co-Diagnostics Q2 2025 earnings call. During the first quarter, we continued to advance our CODEX 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 tests for tuberculosis, or TB, COVID-19, four-plex respiratory panel, and eight-plex HPV panel.

[Dwight Egan, CEO at Co-Diagnostics]

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, SMART for TB, and the National Institutes of Health's RADx Tech program. We remain highly focused on bringing our CODEX 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.

[Dwight Egan, CEO at Co-Diagnostics]

The design for the augmented CODEX 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 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.

[Dwight Egan, CEO at Co-Diagnostics]

Moreover, we have identified instruments for the TB sample prep, which takes place prior to samples being added to the CODEX 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.

[Dwight Egan, CEO at Co-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 African Health Products Regulatory Authority, 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 four-plex respiratory panel, which has been developed with grant support from the NIH's RADxTech initiative. The test has been designed to deliver simultaneous real-time PCR test results for flu A and B, COVID-19, and RSV.

[Dwight Egan, CEO at Co-Diagnostics]

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 CODEX 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 CODEX 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.

[Dwight Egan, CEO at Co-Diagnostics]

Rounding out our pipeline, we continue to make good progress in preparing the eight-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 CODEX 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-primer 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.

[Dwight Egan, CEO at Co-Diagnostics]

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 Diagnostics, 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 CODEX 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.

[Dwight Egan, CEO at Co-Diagnostics]

This was hosted in collaboration with CoSara Diagnostics, 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 CODEX 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 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.

[Dwight Egan, CEO at Co-Diagnostics]

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 CODEX 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.

[Brian Brown, CFO at Co-Diagnostics]

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.

[Brian Brown, CFO at Co-Diagnostics]

Net loss for the first quarter of 2025 was $7.5 million for a loss of $0.24 per fully diluted share compared to a net loss of $9.3 million for 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.

[Brian Brown, CFO at Co-Diagnostics]

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.

[Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright]

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. Operator.

[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. Your first question comes from the line of Ye Chen with H.C. Wainwright. Your line is open.

[Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright]

Hi there. This is Eduardo on for Ye. Just hoping to get a little bit more clarity on the timeline for resubmission that you guys were planning on doing, I think, to understand for the COVID-19 test and the state of that, and if there's anything else that would be required for that resubmission for the 510(k) application.

[Dwight Egan, CEO at Co-Diagnostics]

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.

[Dwight Egan, CEO at Co-Diagnostics]

We're confident that 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. We remain very positive on the functionality and quality of the test. We believe that the revised 510(k) application will increase the probability of a successful clearance. 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.

[Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright]

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

[Dwight Egan, CEO at Co-Diagnostics]

Sort of the governor of that is what the prevalence of COVID is in the world, in the United States in particular. 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. 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. We don't know exactly what the timing is because there are some exogenous events and characteristics that we have to pay attention to.

[Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright]

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

[Dwight Egan, CEO at Co-Diagnostics]

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. It includes COVID-19, includes RSV, includes flu A and flu B. That is also governed by the same kind of constraints that I mentioned with respect to COVID. 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 remaining part of 2025. As you can appreciate, in places like India, we do not have any problem getting samples. There is not a constraint with respect to the presence of HPV. HPV in India comprises roughly 25% of all HPV cases in the world. We do not have an anticipation that we are going to have any trouble getting samples there.

[Dwight Egan, CEO at Co-Diagnostics]

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. We do not anticipate having any trouble getting those samples. Other than that, from a date standpoint, they will all be entering the clinical trial phase during the rest of this calendar year.

[Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright]

Got it. Got it. That's really helpful. 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?

[Dwight Egan, CEO at Co-Diagnostics]

That is certainly a possibility. Largely, that stems from the ability to get samples at will, basically. Keep in mind that all of these indications are currently undergoing important testing. We have manufactured hundreds of thousands of test cups in our facility, our manufacturing facility. There has 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 did not have a problem with 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. The same positive control that is RNA-based is also incorporated into the ABCR test.

[Dwight Egan, CEO at Co-Diagnostics]

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. Then it's on to regulatory submission and our initial commercialization launch.

[Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright]

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.

[Dwight Egan, CEO at Co-Diagnostics]

Yeah. I think we have long talked about the costs of our instrument initially being in the $300-$500 range. Kind of depends on how many people buy. 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. 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. 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 developed world. We've typically used the $15-$20 per cup price in the developed world.

[Dwight Egan, CEO at Co-Diagnostics]

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. Human papillomavirus is probably not as sensitive as TB.

[Brian Brown, CFO at Co-Diagnostics]

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. 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. Using all these past references for those. All right. Really appreciate the answers and thanks for taking the questions.

[Brian Brown, CFO at Co-Diagnostics]

Thanks, Eduardo.

[Operator]

Thank you. I am 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.

[Operator]

Thank you for standing by. My name is Kath, 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 * followed by the number one on your telephone keypad. If you would like to withdraw your question, simply press * one again. I would now like to turn the call over to Andrew Benson, Head of Investor Relations. Please go ahead.

[Andrew Benson, Head of Investor Relations at Co-Diagnostics]

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 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 Co-Diagnostics during this call, which are not historical facts, are forward-looking statements. This includes statements concerning the company's CODEX 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.

[Andrew Benson, Head of Investor Relations at Co-Diagnostics]

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.

[Dwight Egan, CEO at Co-Diagnostics]

Thank you, Andrew. Good afternoon, everyone. Thank you for joining Co-Diagnostics' first quarter 2025 earnings call. During the first quarter, we continued to advance our CODEX 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. 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.

[Dwight Egan, CEO at Co-Diagnostics]

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, SMART for TB, and the National Institutes of Health's RADxTech program. We remain highly focused on bringing our CODEX 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.

[Dwight Egan, CEO at Co-Diagnostics]

The design for the augmented CODEX 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 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.

[Dwight Egan, CEO at Co-Diagnostics]

Moreover, we have identified instruments for the TB sample prep, which takes place prior to samples being added to the CODEX 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.

[Dwight Egan, CEO at Co-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 African Health Products Regulatory Authority, 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 four-plex respiratory panel, which has been developed with grant support from the NIH's RADxTech initiative. The test has been designed to deliver simultaneous real-time PCR test results for flu A and B, COVID-19, and RSV.

[Dwight Egan, CEO at Co-Diagnostics]

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 CODEX 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 CODEX 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.

[Dwight Egan, CEO at Co-Diagnostics]

Rounding out our pipeline, we continue to make good progress in preparing the eight-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 CODEX 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-primer 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.

[Dwight Egan, CEO at Co-Diagnostics]

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 CODEX 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.

[Dwight Egan, CEO at Co-Diagnostics]

This was hosted in collaboration with CoSara Diagnostics, 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 CODEX 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 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.

[Operator]

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 CODEX 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.

[Brian Brown, CFO at Co-Diagnostics]

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.

[Brian Brown, CFO at Co-Diagnostics]

Net loss for the first quarter of 2025 was $7.5 million for a loss of $0.24 per fully diluted share compared to a net loss of $9.3 million for 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.

[Brian Brown, CFO at Co-Diagnostics]

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.

[Dwight Egan, CEO at Co-Diagnostics]

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. Operator.

[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. Your first question comes from the line of Ye Chen with H.C. Wainwright. Your line is open.

[Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright]

Hi there. This is Eduardo on for Ye. Just hoping to get a little bit more clarity on the timeline for resubmission that you guys were planning on doing, as I understand, for the COVID-19 test and the state of that, and if there's anything else that would be required for that resubmission for the 510(k) application.

[Dwight Egan, CEO at Co-Diagnostics]

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.

[Dwight Egan, CEO at Co-Diagnostics]

We're confident that 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. We remain very positive on the functionality and quality of the test. We believe that the revised 510(k) application will increase the probability of a successful clearance. 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.

[Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright]

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

[Dwight Egan, CEO at Co-Diagnostics]

Sort of the governor of that is what the prevalence of COVID is in the world, in the United States in particular. For instance, if we ended up being ready to go to clinical trials, but we were not 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 is 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. We do not know exactly what the timing is because there are some exogenous events and characteristics that we have to pay attention to.

[Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright]

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

[Dwight Egan, CEO at Co-Diagnostics]

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. 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. Then there is 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 remaining part of 2025. As you can appreciate, in places like India, we do not have any problem getting samples. There is not a constraint with respect to the presence of HPV. HPV in India comprises roughly 25% of all HPV cases in the world. We do not have an anticipation that we are going to have any trouble getting samples there.

[Dwight Egan, CEO at Co-Diagnostics]

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. We do not anticipate having any trouble getting those samples. Other than that, from a date standpoint, they will all be entering the clinical trial phase during the rest of this calendar year.

[Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright]

Got it. Got it. That's really helpful. 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?

[Dwight Egan, CEO at Co-Diagnostics]

It is. That is certainly a possibility. Largely, that stems from the ability to get samples at will, basically. 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. There has 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 did not have a problem with 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. The same positive control that is RNA-based is also incorporated into the ABCR test.

[Dwight Egan, CEO at Co-Diagnostics]

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. Then it's on to regulatory submission and our initial commercialization launch.

[Dwight Egan, CEO at Co-Diagnostics]

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.

[Dwight Egan, CEO at Co-Diagnostics]

Yeah. I think we have long talked about the costs of our instrument initially being in the $300-$500 range. Kind of depends on how many people buy. 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. 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. 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 developed world. We've typically used the $15-$20 per cup price in the developed world.

[Dwight Egan, CEO at Co-Diagnostics]

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. Human papillomavirus is probably not as sensitive as TB.

[Brian Brown, CFO at Co-Diagnostics]

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. 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. Using all these past references for those. All right. Really appreciate the answers, and thanks for taking the questions.

[Brian Brown, CFO at Co-Diagnostics]

Thanks, Eduardo.

[Operator]

Thank you. I am 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.

Participants

Executives

• Andrew Benson, Head of Investor Relations
• Dwight Egan, CEO
• Brian Brown, CFO

Analysts

• Eduardo Martinez-Montes, Research Analyst at H.C. Wainwright