Co-Diagnostics, Inc.

Good day, everyone, and thank you all for joining today's CoDiagnostics, Inc. Full Year 2025 Earnings Webcast. As a reminder, all phone participants are in a listen-only mode, but later you will be provided with the opportunity to ask a question during our question and answer session. As a reminder, today's session is being recorded. And it is now my pleasure to turn the floor over to Head of Investor Relations, Mr. Andrew Benson. Please go ahead, sir.

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 fourth quarter and full year ended December 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 listeners that certain statements made by co-diagnostics during this call, which are not historical facts, are forward-looking statements. In addition to diagnostic test developments and timing for commencement of clinical evaluations, this includes statements concerning the company's CODIX PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale. 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, including risks related to our ability to obtain regulatory approvals, successfully complete clinical evaluations, secure adequate financing, and achieve commercial adoption of our products. 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 contained reconciliations to the non-GAAP financial measures presented to their most comparable GAAP results. At this time, I would like to turn the call over to Co-Diagnostics Chief Executive Officer Dwight Egan. Dwight.

Thank you, everyone, for joining us today and for your continued support of Co-Diagnostics. This continues to be one of the most active and strategically important periods in our company's history. as we execute on the significant opportunity ahead of us and continue to implement our multi-pronged growth strategy. Before we begin, I'd like to briefly touch on our NASDAQ listing status. We want to thank our shareholders for their patience and continued support throughout this process. We were pleased to successfully complete the appeal and have our shares relisted, and we are now firmly focused on moving forward. Importantly, despite this temporary disruption, we remained focused on execution and continued to make meaningful progress across the business. During the reporting period, we advanced several key initiatives that are positioning CoDiagnostics for its next phase of growth. Each of these developments support our goal of strengthening the company, both operationally and financially, as we move closer to commercialization. These efforts are not isolated. They represent cumulative progress with each initiative contributing to a broader integrated strategy designed to create long-term shareholder value. As we look ahead, our focus remains centered on four primary growth pillars. First, progressing our clinical pipeline toward key regulatory milestones, including our upper respiratory program, and additional tests such as TB and HPV. Second, advancing COSERA and our broader strategy in India, including regulatory progress, manufacturing readiness, and evaluating potential strategic alternatives such as a SPAC transaction. Third, continuing execution of our Comir joint venture with Arabian Eagle. which is expanding our international footprint across Saudi Arabia and the broader MENA region. And finally, expanding our AI-driven capabilities to enhance innovation, efficiency, and data-driven insights across our platform. Together, these pillars form a cohesive strategy built around global reach, technological innovation, financial discipline, and scalable execution. This is the framework guiding how we are approaching 2026 and laying the foundation for commercialization and long-term growth. With that context, I'll begin with our COSERA strategy and our progress in India. India has been a core component of our business for nearly eight years. And over that time, we have built a meaningful foundation through our COSERA joint venture in one of the largest healthcare markets in the world. Today, COSERA has established a nationwide commercial presence, serves hundreds of laboratory customers, and has 15 PCR tests cleared through India's regulatory pathway. We are now preparing to manufacture the PCR Pro instrument and associated consumables locally in India, which represents an important step towards commercialization. Importantly, COSERA has received the CDSCO license to manufacture the PCR-PRO instrument, a key regulatory milestone that supports this transition. We have also expanded COSERA's commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing our addressable market to approximately 13 billion and strengthening our long-term opportunity in the region. As Coursera continues to mature, we believe it has reached a stage where it can stand on its own as a public entity, which we believe may provide an alternative path to access capital and support future growth. We have engaged a financial advisor and are actively exploring strategic alternatives, including a potential SPAC transaction, to support the capital needs required to fully execute on this opportunity. which we expect will enhance value for our shareholders. While we are not in a position to announce a transition today, we have completed multiple presentations with prospective partners, and the process remains active and ongoing. There can be no assurance that any transaction will be completed or on what terms. Beyond a potential SPAC transaction, Coursera represents a key engine for long-term growth We are also preparing to initiate TB clinical performance studies in India, which is the largest single country market for TB diagnostics. This represents one of the most significant near-term commercial opportunities for our platform. Earlier this month, the World Health Organization issued updated guidance recommending near point of care molecular tests for TB diagnosis. along with the use of tongue swab samples for patients who cannot produce sputum. This is an important development for the field, as we believe both our PCR-Pro instrument and our MTB test are directly aligned with this guidance. The importance of tongue swab sampling has been building over time, including throughout our own development efforts supported by the Bill and Melinda Gates Foundation. We designed our test specifically to accommodate this approach, in addition to traditional sputum samples. We believe our platform is well positioned to address emerging needs in TB diagnostics. Preclinical studies conducted by third parties have shown performance that is comparable to, and in some cases exceeds, other commercially available molecular TB tests. We are confident that upcoming clinical studies will further validate the role our tests can play in supporting these new WHO guidelines. We look forward to providing additional updates as COSERA continues to advance. Turning to our Comira joint venture, this initiative remains a cornerstone of our international expansion strategy. Saudi Arabia has historically been our largest international market, and Comira represents the next step in localizing our technology within the region. This model builds on the same approach we have used in India with the goal of establishing local manufacturing and distribution capabilities so products can be produced closer to end markets. We are currently progressing on execution, including finalizing a lease for a manufacturing facility and progressing toward operational readiness across Saudi Arabia in 18 additional MENA markets. Domestically manufactured medical products are typically prioritized in Saudi Arabia's procurement processes, and we anticipate this to extend to molecular diagnostics. Once operational, Comira is expected to be the first domestic manufacturer of molecular diagnostics in the kingdom, which would provide a meaningful competitive advantage. This initiative aligns with Saudi Arabia's broader goals around healthcare innovation. local manufacturing, and supply chain resilience. It also positions CoDiagnostics as a strategic partner in the region's healthcare infrastructure. More broadly, Comira reinforces the scalability of our platform and our ability to deploy it globally in a capital-efficient way. In parallel with our operational progress, we continue to strengthen the intellectual property foundation that supports our platform. Over the past several months, we have received international patents covering key components of the Kodi X PCR platform, including recent patent grants in Australia and Japan. These patents cover core systems, methods, and technologies underlying our PCR Pro instrument and proprietary test cups. The Japanese patent was granted by one of the most rigorous patent offices in the world, further validating the strength and uniqueness of our platform. Expanding our IP portfolio is critical as we move toward commercialization, particularly as we scale internationally through initiatives like COSERA and Comira. These protections help secure our competitive positioning and support our long-term strategy of building a differentiated, globally deployable diagnostics platform. Turning to our clinical pipeline, our upper respiratory multiplex test represents a critical step in advancing our platform toward market readiness. This test was originally designed to detect flu A, flu B, COVID-19, and RSV, and clinical evaluations are progressing well. Based on current epidemiological trends, including lower than expected COVID prevalence across our multiple study locations, we are planning to pursue an initial regulatory submission focused on flu A, flu B, and RSV. Importantly, this decision is driven by limited availability of COVID-positive samples rather than any limitation of the platform or performance of the COVID-19 target. This approach allows us to accelerate timelines while maintaining the flexibility to incorporate COVID at a later stage if conditions change and to prioritize speed to market while remaining adaptable demonstrating our ability to execute in a disciplined and pragmatic way. Beyond this program, our broader pipeline continues to advance. Our TB and HPV programs remain key areas of focus, with TB representing a significant global opportunity, particularly in India. The global TB diagnostics market is expected to grow meaningfully over the coming years, and we believe our platform is well positioned to participate in that growth Our HPV program is progressing through preclinical development and process qualification with additional updates to come as timelines are further defined. In addition, our vector program continues to expand with increased adoption across public health applications. Collectively, these programs highlight the versatility of our technology and its relevance across multiple high-need markets. Finally, Our AI business unit represents one of the most forward-looking aspects of our strategy. We have been leveraging machine learning and algorithmic analysis within our platform for many years, and we are now expanding these capabilities more broadly. The Codex Primer AI platform is designed to unify our efforts across diagnostics, data analytics, and operational efficiency. Integrating AI enhances our ability to design assays, interpret results, and improve system performance. Over time, we believe these capabilities may support predictive insights, including identifying emerging outbreaks and improving real-time situational awareness. We already have multiple AI models in place with additional development underway, and we believe this represents a significant long-term opportunity This initiative strengthens our competitive position while complementing the scientific progress we are making across our clinical programs. In closing, the initiatives we've discussed today reflect the continued progress CoDiagnostics has made over the past year. From international expansion and manufacturing readiness to clinical advancement and technological innovation, each milestone strengthens a different aspect of our business taken together They demonstrate that our strategy is working, our execution is on track, and we are building a scalable platform with global relevance. We are entering the next phase of growth with a strong foundation, expanding opportunities, and a clear path toward commercialization. With that, I'll now turn the call over to Brian Brown, our Chief Financial Officer, to review our financial results and outlook.

Thanks, Dwight, and thank you to everyone who joined today's call. For the full year 2025, total revenue was $0.6 million compared to $3.9 million in 2024. The year-over-year decrease was primarily driven by lower grant revenue, as most of the previously awarded grant funding was recognized in the prior year. Product revenue for the year was $0.4 million compared to $0.8 million in 2024, reflecting our continued focus on platform development and limited commercial activity during the period. Total operating expenses for 2025 were $50.6 million compared to $43.0 million in 2024. This increase was primarily driven by a non-cash impairment charge of approximately $18.9 million related to in-process research and development intangible assets. Excluding this non-cash charge, operating expenses declined year over year, reflecting our continued focus on cost discipline. Research and development expenses were $19.1 million compared to $21.0 million in the prior year, reflecting discipline investment in the CODI-X PCR platform, partially offset by increased clinical trial activity. Sales and marketing expenses were $2.4 million compared to $4.5 million in 2024, primarily driven by lower personnel, consulting, and travel-related expenses. General and administrative expenses were $9.1 million compared to $16.2 million in the prior year, with the decrease primarily driven by lower legal, consulting, and stock-based compensation expenses. Net loss for the full year 2025 was $46.9 million, or a loss of $35.25 per share, compared to a net loss of $37.6 million, or $37.22 per share in 2024. The increase in net loss was primarily driven by the non-cash impairment charge and lower grant revenue, partially offset by reduced operating expenses and a tax benefit recognized during the year. Excluding the impact of the non-cash impairment charge of $18.9 million, full year 2025 net loss would have been $28.0 million. Adjusted EBITDA was a loss of $28.0 million for the full 2025 compared to a loss of $33.5 million in 2024. Turning to the balance sheet, we ended the year with $11.9 million in cash, cash equivalents, and marketable investment securities compared to $29.7 million at the end of 2024. Net cash used in operating the activities was $29.0 million for 2025, consistent with the prior year as we continue to invest in platform development and clinical programs. Net cash provided by investing activities was $26.3 million, primarily driven by the maturity of marketable securities. Net cash provided by financing activities was $11.7 million, reflecting capital raised through our at-the-market program and registered direct offerings. As discussed previously, we have an active ATM facility in place, which provides additional flexibility to support our capital needs. We continue to carefully manage our liquidity and cost structure as we progress towards commercialization. While we expect to continue generating operating losses in the near term, our focus remains on advancing our clinical pipeline, achieving regulatory milestones, and positioning the business for future revenue growth. We will also continue to evaluate financing alternatives, including equity, debt, and strategic partnerships to support these objectives. In parallel, we remain focused on securing additional non-dilutive funding opportunities, including grant funding, to support continued development of our CODI-X PCR platform. Looking ahead, we remain focused on disciplined capital allocation as we advance towards key inflection points, including clinical submissions and potential commercialization milestones. I look forward to sharing additional updates as we progress through 2026. With that, I will now turn the call back over to Dwight.

Thank you, Brian. To close, I want to extend our sincere gratitude to our shareholders for their continued support and to our employees, whose dedication and hard work remain one of our most important assets as we execute on the COTIX vision. We are focused on delivering against our strategy and advancing the company toward its next phase. With that, we'll now open the line for questions. Operator?

gentlemen thank you and to our phone audience joining today at this time if you would like to ask a question simply press the star followed by the digit one on your telephone keypad pressing star and one will place your line into a queue and we will open your lines one at a time and you will be invited to share your questions once again ladies and gentlemen that is star and one on your telephone keypad and we'll pause for just a few seconds to allow our audience the opportunity to signal Thank you, ladies and gentlemen. We'll take our first question today from Yi Chen at HC Wainwright. Please go ahead. Your line is open.

Hi, thank you. This is Katie on for Yi. Looking at your now three target tests, dropping COVID seems like a great idea. Where does the sample accrual stand for the three target panel? Is first half of 26 still the target? And how quickly could you add COVID back? if for some reason conditions change and it makes sense to add it back.

Thank you for your question.

First of all, let me emphasize that the taking away the COVID out of the mix of the multiplex test was not, was a decision based on the availability of COVID in what is a very powered clinical trial. in about eight different locations across the United States, COVID just simply did not show up over a several-month period. And so, rather than wait to do a submission after a protracted clinical trial, we decided to move forward with the flu A, flu B, and RSV components of the test and to leave ourselves the flexibility of putting COVID in later when it shows up with more samples. In the meantime, it doesn't get in the way of us getting a more expeditious submission into the FDA. So, you just want to make that logic clear as to why we made that decision. It is a little bit surprising, of course, that COVID doesn't show up the way we would have expected it to show up in terms of its, you know, broader, characteristics across the country when we just came through a pandemic where there were so many hundreds of millions of tests done on COVID. But that's what reality was during our clinical trial. And, you know, if we waited, for instance, until the summer to do the get more COVID, there's no assurance that it would show up then, even though it might be. So we have the flexibility to continue to do test for COVID when and if that becomes a viable direction for the company. Was there another part of your question?

So I guess my question is more what would it look like to add it back? Is it like a quick approval or is it you're going to have to put it through another trial? What does it look like to put it back should that time ever come?

Well, first of all, we would not anticipate that it requires any redesign, for example. And so a lot of that would be a negotiation with the FDA in terms of what they would require. You know, will they require 30 positive samples? Will they require it to be dispersed over demographics and so on and so forth in terms of age? So a lot of that will be defined in our consultation with the FDA as to what they would want us to do to light that up. We don't view it as being a very difficult thing to do. Like I say, it doesn't require that we re-engineer or work on the chemistry or those sorts of things. It's just getting it up and going. How many sites would we have to put in? Arguably not as many as we did with the eight sites or so that we did during our normal clinical trial. I think it's a change that we can add and that it won't be onerous on the company to do that.

Perfect. Thank you.

And a reminder to our audience that is star and one. We will hear next from the line of Michael Okunowicz at Maxim Group.

All right. Thank you for taking my questions and congrats on the speedy resolution of the listing challenges.

Good to see you back on the NASDAQ. Thank you.

So I guess just to kick off, I want to see if you could talk a little bit about the South Asia distribution expansion to the other countries like Nepal, Pakistan, and Bangladesh. Is this more for supporting the existing commercial tests, or would this be to expand the opportunity for PCR-pro, particularly on TB? Is that a similar issue in those countries as it is in India?

I think the kind of disease burden that you have in those other countries is very similar to the disease burden in India. Altogether, our motive is driven by the fact that we go from about 11 billion in total addressable market to more like 13 billion by adding those countries. And it just made geographical sense for us to have all of that handled through the COSERA joint venture. Coursera Joint Venture is a mature business at this point. You know, we've been doing it for almost eight years. And so we have manufacturing capabilities there. We have a number of employees. We have salespeople covering pretty much the entire continent, subcontinent of India. And it's just a natural progression to go into these others as we then also move into the Comira Joint Venture in the Kingdom of Saudi Arabia. So it's it's just a sort of strategic move to let the COSERA group do everything they could do on that subcontinent. And we think it makes a lot of sense for the company.

Thank you for the additional clarity on that. And then for the US FDA study in particular, can you just comment on how many samples you're expecting to need to support that study?

Well, you know, when we do a study like that, this is something that we hire a CRO to do, and it's a very structured sort of clinical trial. The FDA knows what we're doing. They know how many samples that we're going to collect, and I would represent to you that it's in excess of 1,200 different patients that have already been through the enrollment. We're nearing conclusion here of the entire test and getting ready to do analytical studies and do our submission to the FDA. Now, that's one of the reasons that we are waiting to add COVID to the mix when there is COVID, when COVID shows up with enough force that we can get the kind of samples we need to satisfy the FDA.

All right, thank you. And then one last one for me, and I'll hop back into the queue. I saw that you've gained the clearance to sell the PCR pro device now in India. You started shipping devices over there. Could you talk about what are the immediate next steps and timelines for getting that study up and running and then moving on to commercialization?

Yeah, our expectation in India, and as I mentioned, it's a mature joint venture at this point, having spent about eight years doing it. And we have 15 tests that are already cleared through the CDSEO there. We have a very good track record. with the regulatory bodies there in India. We have, you know, manufacturing facilities. We have sales and marketing. And we have a very, very good group of individuals that support that business. And so, you know, when we look at taking this new Codex PCR Pro box there, it has, it's a technology transfer operation. We have already established a oligonucleotide lab there where we were making our own oligonucleotides. And that's not, that's rocket science. That's pretty sophisticated molecular science. And that's already in process. We put that in last, a year ago, December actually. So it's a matter of getting the technology over there and set up and trained. We will be manufacturing product here in Utah while we're doing that at a measured pace. because we've already gone through all the processes in Utah of making it so that we can produce cups that are the consumables with integrity and we can do it at scale. So we have a lot of capacity here in Utah. We'll continue to use that capacity as we start what's going on in India and begin the clinical trials. As you can imagine, since India is the hotspot for tuberculosis worldwide, we will not have any trouble whatsoever getting the type of clinical samples that we need to do the clinical trial for tuberculosis since such a high percentage of the country is infected already with latent TB and a certain percentage of those erupt into full-blown TB on an active basis every year. So we believe that this clinical trial will proceed quickly and then that the study will go before the CDSCO in pretty short order. We actually expect to have commercialization of the TB tests in India, let's say by the third quarter of 26.

All right, thank you. I really appreciate the update.

And we would like to thank each of our analysts who had signaled for a question today. Ladies and gentlemen, this does conclude the Co-Diagnostics, Inc. full-year 2025 earnings call. We thank you all for your participation, and you may now disconnect your lines. Enjoy the rest of your day.