Co-Diagnostics Q2 2025 Earnings Report

Co-Diagnostics EPS Results

• Actual EPS: -$0.23
• Consensus EPS: -$0.25
• Beat/Miss: Beat by +$0.02
• One Year Ago EPS: N/A

Co-Diagnostics Revenue Results

• Actual Revenue: $0.16 million
• Expected Revenue: $0.30 million
• Beat/Miss: Missed by -$137.00 thousand
• YoY Revenue Growth: N/A

Co-Diagnostics Announcement Details

• Quarter: Q2 2025
• Date: 8/14/2025
• Time: After Market Closes
• Conference Call Date: Thursday, August 14, 2025
• Conference Call Time: 4:30PM ET

Co-Diagnostics (NASDAQ:CODX), a molecular diagnostics company, develops, manufactures, and sells reagents used for diagnostic tests that function through the detection and/or analysis of nucleic acid molecules in the United States and internationally. The company offers Co-Dx PCR platform, a polymerase chain reaction (PCR) testing to patients in point-of-care and at-home setting. It also provides PCR diagnostic tests for COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the zika virus. In addition, the company offers three multiplexed tests to test mosquitos for the identification of diseases carried by the mosquitos; molecular tools for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications; tests that identify genetic traits in plant and animal genomes; and portable diagnostic device designed to bring PCR to patients in point-of-care and at-home settings. The company was incorporated in 2013 and is headquartered in Salt Lake City, Utah.

Co-Diagnostics Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: CoDiagnostics remains on track to initiate clinical evaluations for its four Kodiak PCR tests—COVID-19, a four-plex flu A/B/COVID-19/RSV panel, tuberculosis, and an 8-type HPV panel—during 2025.
• Positive Sentiment: The TB assay has demonstrated strong preclinical performance, with planned clinical trials in India and South Africa targeting a disease responsible for 1.25 million deaths in 2023 according to WHO.
• Negative Sentiment: In Q2 2025, revenue fell to $0.2 million from $2.7 million a year ago, while net loss widened slightly to $7.7 million and adjusted EBITDA loss increased to $7.2 million, reflecting ongoing development investments.
• Negative Sentiment: The company ended Q2 with $13.4 million in cash and equivalents but plans to tap its ATM, seek debt and equity financing, and pursue additional grants to fund commercialization.
• Positive Sentiment: CoDiagnostics expects FDA 510(k) submissions and potential clearances for its COVID-19 and respiratory panel tests by mid-2026, aiming for initial market launches in physician offices, nursing facilities, pharmacies, and home settings.

Presentation

[Operator]

Thank you. I'd like to turn the conference over to Andrew Benson, Head of Investor Relations. Andrew, please go ahead.

[Andrew Benson, Head - IR at Co-Diagnostics Inc]

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 second quarter ended 06/30/2025. A copy of the press release is available on the company's website.

[Andrew Benson, Head - IR at Co-Diagnostics Inc]

We will begin with management's prepared remarks and then open up the call to analyst Q and A. Before we begin, we would like to inform 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 Kodiak 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 CoDiagnostics' filings with the SEC.

[Andrew Benson, Head - IR at Co-Diagnostics Inc]

CoDiagnostics 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 reconciliations of the non GAAP financial measures presented to their most comparable GAAP results. At this time, I would like to turn the call over to CoDiagnostics' Chief Executive Officer, Dwight Egan. Dwight?

[Dwight Egan, CEO at Co-Diagnostics Inc]

Thank you, Andrew, and good afternoon, everyone. Thank you for joining CoDiagnostics second quarter twenty twenty five earnings call. The second quarter of this year continued to bring steady advancements of our Kodiak's PCR point of care platform, And thanks to the diligent efforts of our team working towards our goal to bring the instrument and test to market. We remain on track to initiate clinical evaluations for all tests in our pipeline during 2025. In addition to the Kodiak's PCR COVID-nineteen test, which is expected to imminently begin enrolling participants for its clinical evaluations, the test pipeline for the new platform includes real time PCR tests for flu, a and e, covid and RSV in a four plex respiratory panel supported by a grant from the National Institute of Health Radix Tech program, as well as tests for tuberculosis or TB and an HPV eight type multiplex panel, both of which are supported by grants from the Bill and Melinda Gates Foundation.

[Dwight Egan, CEO at Co-Diagnostics Inc]

These indications were identified as amongst the best opportunities in the near term to bring our unique technology and platform to market and to help advance the co diagnostics vision of increasing the accessibility of affordable, high quality diagnostics in The United States, India, and around the world. Our focus remains on bringing the Kodiak's PCR platform to the point of care market, which has included incorporating ongoing advancements developed by our scientific engineering, and software development teams as we prepare for our upcoming regulatory submissions in the appropriate jurisdictions for each indication. As mentioned in our previous call, the augmented Kodiak PCR COVID-nineteen test underwent extensive verification testing, and we are pleased to report that the clinical evaluation sites for this updated test are currently being trained with testing of trial participants expected to begin imminently. Our plans continue to be to submit a five ten application to the FDA for this updated version of our COVID-nineteen test after the completion of the clinical evaluations. We look forward to the platform's initial introduction to the market next year and to the disruptive potential of this new diagnostic solution.

[Dwight Egan, CEO at Co-Diagnostics Inc]

Perhaps the greatest opportunity for the platform to disrupt the current testing paradigm is through tuberculosis. TB caused an estimated one point two five million deaths in 2023, according to the World Health Organization, making it the number one infectious disease killer globally. Several preliminary analytical and preclinical studies for the Kodiak PCR MTB tests have been completed or are currently in process and testing on clinical samples have demonstrated the high performance properties of the test. We believe that the efficient affordable workflow process supported by the straightforward mobile app will help to speed adoption at the point of care in areas across India and Africa that have previously had little to no access to gold standard PCR diagnostic technology for a disease that is highly treatable if diagnosed early and accurately. The company remains on track to begin clinical evaluations for our TB tests in both India and South Africa before the 2025, which will gather data to support regulatory submissions to the South Africa Health Products Regulatory Agency or SAFRA and the Central Drug Standard Control Organization or CDSCO in India, helping to increase the accessibility of high quality real time PCR diagnostics in India has been a focus of the company since the early days of its founding.

[Dwight Egan, CEO at Co-Diagnostics Inc]

Twenty seven percent of global TB cases and twenty six percent of global TB deaths were found in India alone in 2023. And the country continues to be our top priority market for TB testing. Our footprint in India is significantly strengthened by our joint venture Kocera Diagnostics, who provides substantial experience and regulatory, commercial, and manufacturing infrastructure in India. Principal manufacturing for tests and instruments will take place in our domestic manufacturing facility in South Salt Lake inaugurated a little over a year ago before being completed in the upgraded COSERA manufacturing campus prior to distribution and commercialization in India. As we proceed with the preparations for the clinical evaluations, we continue to engage with local health officials and potential customers in both India and Africa to evaluate the most effective and efficient commercialization strategy in specific target markets.

[Dwight Egan, CEO at Co-Diagnostics Inc]

We are pleased to report that the Kodiak's PCR ABCR four plex respiratory panel is nearly prepared for clinical evaluations expected to begin concurrent with the 2025 North American fall and winter flu season. The test has been designed to deliver simultaneous differentiated real time PCR test results for patients suspected of having flu A and B, COVID-nineteen, or RSV. It remains the test with the highest domestic demand in our pipeline, driven by the burden these diseases place on everyday life in The United States and around the world. Once complete, the data collected by the clinical evaluations will be used in a five ten application to the FDA. Five ten clearance will not only allow the test to be commercialized as an infectious disease in vitro diagnostic in The United States, but also in other countries around the world to accept US FDA clearance as valid regulatory approval following a straightforward registration process in those countries.

[Dwight Egan, CEO at Co-Diagnostics Inc]

This international personalization model allowed Kodiak to achieve significant growth during the pandemic. Thanks to the sales of our centralized lab COVID-nineteen PCR tests, and we believe we will be able to follow a similar pathway for this new platform. Finally, the Kodiak's PCR HPV eight type multiplex panel is also on track to initiate clinical evaluations before year end. HPV is the most widespread and common sexually transmitted infection worldwide. And despite the widespread availability of an HPV vaccine, there remains a vast need for HPV testing around the world.

[Dwight Egan, CEO at Co-Diagnostics Inc]

Human papillomavirus has many subtypes, several of which are linked to cervical cancer, which causes hundreds of thousands of deaths annually. We believe the code XPCR platform can have a significant impact on testing accessibility and efficiency, which remain key constraints to mitigating the impact of HPV on global health. Supported by a grant from the Bill and Melinda Gates Foundation and powered by our Primers technology. This HPV assay is designed to simultaneously detect eight different high risk HPV subtypes from a single self collective vaginal swab sample and differentiate between HPV sixteen, HPV eighteen and HPV forty five. These are considered to be the three most carcinogenic HPV variations collectively responsible for roughly seventy five percent of cervical cancers worldwide.

[Dwight Egan, CEO at Co-Diagnostics Inc]

Early detection of HPV can improve intervention and treatment of precancerous cells and lesions before they develop into cervical or other types of cancer. And we believe that a test with these performance characteristics has the potential to dramatically increase the availability of HPV PCR diagnostics around the world. Like TB, the regulatory pathway for this test will follow areas of greatest need in India and Africa, and clinical evaluations to support submissions to the CDSCO and SAFR are anticipated to begin this year. We look forward to initiation and completion of the upcoming clinical evaluations, regulatory submissions, and commercialization of this test on the Kodiak PCR Pro. One of the most original and inventive features of the Kodiak PCR platform is the cloud based analysis of tests performed on the Kodiak PCR Pro, which allows de identified epidemiological data to be made available to help departments at the local, regional, national, or international level.

[Dwight Egan, CEO at Co-Diagnostics Inc]

The ability to track the spread of infectious diseases in real time is often compartmentalized in other testing paradigms or even absent outright. And we anticipate this situational awareness can provide health officials with key data and insights that could save lives and limit outbreaks. We believe that this feature was a key factor in receiving the support of several leading organizations who share in our passion for improving the global health infrastructure, including the Bill and Melinda Gates Foundation, Smart for TB, and the National Institute of Health's RADx Tech program. As we near the initiation of clinical evaluations for all four tests currently in our Kodiak PCR product pipeline and firm up our pathway to commercialization, we anticipate increasing activity at trade shows and other events to continue engaging with local and international potential customers and key stakeholders. Over the past couple of years, we have developed solid relationships with local trade and commerce organizations, some of which support the growth of Utah's businesses by offering grants for their travel and participation in trade shows and conferences.

[Dwight Egan, CEO at Co-Diagnostics Inc]

We have been successful in securing grants to help offset the cost of some recent and upcoming events, and we will continue to pursue these and other opportunities to be mindful of our spend while we prepare for our expansion. To conclude, I want to emphasize our commitment to achieving our clinical evaluations and regulatory submission objectives as the next critical steps to successfully launching the Kodiak's PCR Pro instrument and test kits to the world. This pathway remains the most expeditious way to return value to our shareholders and the foundation we have built for near and long term success is possible. Thanks to the investments in infrastructure, technology, and people that we have made along the way. We believe this framework will allow us to replicate the process more quickly and efficiently for other critical infectious disease test panels in the future and can be applied to other areas of interest, such as veterinary, agricultural, and livestock applications.

[Dwight Egan, CEO at Co-Diagnostics Inc]

The company remains on schedule to reach the critical milestones discussed here, as well as to expand our manufacturing capacity domestically and in India to be able to scale to meet market demand upon platform launch. We believe the Kodiak PCR platform can revolutionize and set a new bar for the affordability, accessibility, and decentralization of accurate gold standard PCR infectious disease testing. I'm 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 Inc]

Thanks Dwight, and thanks to everyone who joined today's call.

[Brian Brown, CFO at Co-Diagnostics Inc]

For the 2025, total revenue decreased to $200,000 as compared to $2,700,000 in the prior year same period. In the prior year same period, revenue from grants represented $2,500,000 while all revenue recognized during the 2025 came from product sales. Total operating expenses for the 2025 decreased to $8,200,000 from $10,100,000 in the 2024. This decrease continues to reflect our efforts to become operationally efficient. Research and development expenses in the 2025 were $4,700,000 compared to $5,600,000 during the prior year comparable period.

[Brian Brown, CFO at Co-Diagnostics Inc]

Net loss for the 2025 was $7,700,000 or a loss of $0.23 per fully diluted share compared to a net loss of $7,600,000 or a loss of $0.25 per fully diluted share in the prior year comparable period. Adjusted EBITDA was a loss of $7,200,000 compared to an adjusted EBITDA loss of $5,900,000 in the 2024. We ended the second quarter with $13,400,000 in cash, cash equivalents and marketable investment securities. As always, we are managing our spend to maintain a healthy balance sheet as we position ourselves for commercialization. Throughout the year, we will continue to make improvements to our operating footprint that will drive efficiency gains and cost savings.

[Brian Brown, CFO at Co-Diagnostics Inc]

We plan to provide for the company's capital requirements through equity and or debt financing, additional grant funding, and operational efficiencies. More specifically, we're using our ATM to generate capital when appropriate. We are evaluating various debt and equity financing structures, and we'll continue to press forward with seeking grant support for our Kodiak's PCR platform. In the near term, we are focused on progressing our development pipeline towards completing clinical evaluations and preparations for regulatory submission and are managing our allocation of time and resources accordingly. We're very excited about our continued progress and remain optimistic about 2025, multiple commercial launches in 2026, and future developments within our test pipeline.

[Brian Brown, CFO at Co-Diagnostics Inc]

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 Inc]

Thank you, Brian. To close, we want to extend our gratitude to co diagnostics shareholders and to our employees whose consistent dedication and hard work is one of our most valuable assets to achieving the codex vision. We will now take questions from our analysts. Operator?

[Operator]

Thank you. We will now begin the question and answer Your first question comes from Yi Chen with H. C. Wainwright. Please go ahead.

[Eduardo Martinez-Montes, Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC]

Hi. This is Eduardo on for you. I was hoping if you could just kinda repeat your expected timeline. You mentioned that all sites are are being trained, and you're gonna start recruitment imminently. I was just wondering if I could get a timeline for the specific tests in order, which one you expect to have earlier completion of those trials, and then the consequent five ten applications?

[Eduardo Martinez-Montes, Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC]

Just trying to get a feel for the progression and cadence of things.

[Dwight Egan, CEO at Co-Diagnostics Inc]

Yes. Thank you for the question. Our clinical trials for all four of the indications that we cited with our COVID-nineteen, our multiplex flu AV COVID-nineteen and RSV test, our MTB or tuberculosis test, and then our HPV or human papillomavirus test. We expect all of those indications to be into clinical trials during the remainder of this calendar year. We anticipate to begin with the COVID-nineteen test, which has already begun its site visits and training prior to putting customers through the trial, applicants through the trial.

[Dwight Egan, CEO at Co-Diagnostics Inc]

We believe that the next test up will be our ABCR or multiplex AB over the RSV test. And probably the next one after that will be our tuberculosis test followed by HPV. That order could change with respect to the final treatment we expect for all of them to commence clinical trials during the remainder of this calendar year.

[Eduardo Martinez-Montes, Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC]

Got it. That's really helpful. And you expect applications, are you going to prioritize them in that order as they finish as well? Or do you think you'd prioritize TB or multiplex given the acute need both internationally and domestically for those two respectively?

[Dwight Egan, CEO at Co-Diagnostics Inc]

Well, we believe that there is a solid need for all four of those panels. The MGB and HPV tests are targeted mainly to India and the African nations, including South Africa. We also believe that COVID still has a vibrant market, including in The US and we're seeking FDA approval for a five ten application for both the COVID-nineteen test and for the multiplex ABCR test. Again, flu AB, COVID and RSV. So, we know that COVID is there was a lot of COVID fatigue out there, but it's still the number two killer in terms of infectious disease pathogens out there.

[Dwight Egan, CEO at Co-Diagnostics Inc]

So, we think there's still a robust market for COVID and we anticipate that that will be the first one up.

[Eduardo Martinez-Montes, Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC]

Got it. So COVID first. Got it. Thanks for the clarity there. And curious if you have some visibility towards commercial launch.

[Eduardo Martinez-Montes, Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC]

I know maybe that might be a ways down. But if you have any visibility there and how you plan on deploying your marketing strategy, you're planning on point of care or over the counter, are you in conversations with distributors at this point in time or how you plan on executing in regard to commercial launch?

[Dwight Egan, CEO at Co-Diagnostics Inc]

Well, with respect to getting into commercialization, we plan to do that as soon as we have a clearance from the FDA in case of COVID-nineteen. We don't expect that the clinical trial submission to the FDA will be protracted. The FDA generally has about a one hundred and twenty day period in which they endeavor to clear a test. It doesn't always happen that way, but we believe that that is a reasonable timeframe after we get the submission done. As to the clinical trial, depends largely on how many people that come to the testing sites actually have COVID, because we will need to have a certain number of positive and negative applicants in order to conclude the clinical trial. The other part of your test, of your question with respect to where we will deploy it from a commercialization standpoint is really as follows. In The United States, we are targeting physician offices and clinics. This is a point of care application.

[Dwight Egan, CEO at Co-Diagnostics Inc]

We're also targeting skilled nursing facilities, restrooms, so they have a vulnerable population that has a need for extensive testing. We also anticipate doing marketing into the home market. We are seeking clearance for a home use.

[Dwight Egan, CEO at Co-Diagnostics Inc]

And finally, we are expecting to have activity in the pharmacy market. There's tens of thousands of pharmacies in The United States, many of which are set up to test and treat. And we believe that will also be a fertile market for us. So, areas are in The United States where we're targeting for the COVID and for the ABCR test. In India, we're mainly targeting the primary healthcare facilities where there's almost 30,000 primary care centers, primarily hair microscopy.

[Dwight Egan, CEO at Co-Diagnostics Inc]

It really needs to be replaced with all types of technology that is a molecular technology. We have the gold standard technology for that type of application, including its accessibility, its affordability and its accuracy.

[Eduardo Martinez-Montes, Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC]

Got it. And would you expect just trying to add the timelines together. So, obviously there's some variability in the readout for the COVID trial like you mentioned. I'm curious, so would this be commercial launch potentially 2026, early twenty twenty seven?

[Dwight Egan, CEO at Co-Diagnostics Inc]

I hope we have a commercialization before the 2026. I would think that we'll be, because we're imminently beginning the clinical trial in COVID, I believe we'll be wrapping that up near year end and that sometime in that by the end of the second quarter, we have at least a reasonable possibility of having it cleared through the FDA. That's not something we can guarantee, of course. But I would be surprised if it takes us clear out until the end of the year to get something into the market. I'd look more to mid year.

[Eduardo Martinez-Montes, Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC]

Got it. Thanks so much for the clarity and for taking the questions.

[Dwight Egan, CEO at Co-Diagnostics Inc]

Thank you.

[Operator]

And that concludes our question and answer session. And that does conclude today's conference call. Thank you for your participation and you may now disconnect.

Participants

Executives

• Andrew Benson, Head - IR
• Dwight Egan, CEO
• Brian Brown, CFO

Analysts

• Eduardo Martinez-Montes, Biotechnology Equity Research Associate at H.C. Wainwright & Co., LLC