Co-Diagnostics (CODX) Q1 2026 Earnings Transcript

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DATE

May 14, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Dwight Egan
• Chief Financial Officer — Brian Brown

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TAKEAWAYS

• Total Revenue -- $146,000, up from $50,000, reflecting higher activity but still limited commercial traction.
• Net Loss -- $9.1 million, compared to $7.5 million, driven by higher operating expenses and reduced other income.
• Adjusted EBITDA (non-GAAP) -- Loss of $8.7 million, compared to a loss of $7.4 million; management reported increased R&D investment.
• Research and Development Expenses -- $5.9 million, up from $4.9 million, largely due to spending on upper respiratory test clinical studies.
• Operating Expenses -- $9.2 million, compared to $8.6 million, primarily reflecting higher R&D.
• Cash and Equivalents -- $8.2 million at period end, down from $11.9 million, due to ongoing investment in clinical and platform development.
• FDA Submission Timeline -- Management expects to file for FDA clearance for the upper respiratory multiplex test in the third quarter, targeting CLIA-waived point-of-care use.
• India CDSCO Milestone -- CoSara joint venture received a CDSCO license to manufacture the PCR Pro instrument, advancing local manufacturing.
• Total Addressable Market (South Asia) -- Expanded to approximately $13 billion through CoSara's distribution growth.
• Potential SPAC Transaction -- Evaluation of a SPAC or similar options for CoSara is ongoing, with parties under NDA but no deal finalized.
• TB Program Progress -- Clinical performance studies for TB are scheduled to begin before month-end, with commercialization in India targeted as early as the end of the third quarter.
• Saudi Arabia Initiative -- CoMira joint venture secured industrial land in Sudair Industrial City, supporting localized manufacturing and participation in Vision 2030 health sector goals.
• Automated Manufacturing -- Management stated the Utah facility’s automated test cup line is expected to improve efficiency by about 4x; deployment is pending but demonstrated capability exists.
• Regulatory Pathways -- Company positioned for potentially faster Saudi market entry upon receiving FDA clearance, preceding full local manufacturing build-out.
• Capital Needs -- CFO Brian Brown said, "We expect that additional capital will likely be required to fully execute our commercialization and development plans."

SUMMARY

Co-Diagnostics (NASDAQ:CODX) management confirmed they completed patient enrollment for their upper respiratory multiplex test clinical study, but lower-than-expected COVID-19 prevalence led to a revised initial focus on Flu A, Flu B, and RSV. The company is finalizing analytical studies and documentation, with an FDA submission planned for the coming quarter. Internationally, the CoSara joint venture achieved a key regulatory milestone by obtaining a CDSCO license for PCR Pro manufacturing, and announced an expanded commercial scope in South Asia amounting to a $13 billion addressable market. In addition, the launch timeline for TB clinical studies in India is imminent, which aligns with evolving WHO guidance and could position commercial introduction by the end of the third quarter. Sequential progress continues in Saudi Arabia, with the CoMira joint venture advancing through the land allocation and facility development phases, anchoring regional growth objectives under Vision 2030.

• The CFO emphasized ongoing and future operating losses as the company advances clinical submissions and moves toward initial commercialization.
• CoSara’s maturation is being actively evaluated for separate public listing through possible SPAC or alternative transactions, with diligence ongoing but outcomes still uncertain.
• The transcript highlighted management’s use of automation and digital platform enhancements, including cloud-connected real-time monitoring and AI-focused product differentiation.
• Upper respiratory and TB test opportunities may extend into U.S. point-of-care settings, according to CEO Dwight Egan’s remarks on "additional domestic commercialization opportunities."

INDUSTRY GLOSSARY

• CDSCO: Central Drugs Standard Control Organization, the primary regulatory authority for pharmaceuticals and medical devices in India.
• SPAC: Special Purpose Acquisition Company, a corporate structure enabling companies to go public through a merger rather than a traditional IPO.
• CLIA-waived: Refers to diagnostic tests that meet criteria under the Clinical Laboratory Improvement Amendments for minimal complexity and risk, allowing use in non-laboratory settings.
• MENA region: Geographic designation for Middle East and North Africa, relevant to CoMira joint venture expansion.
• MODON: Saudi Authority for Industrial Cities and Technology Zones, imparting approvals for industrial development in the Kingdom of Saudi Arabia.

Full Conference Call Transcript

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, 2026. 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 analysts for 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 Co-Dx 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. 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 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?

Dwight Egan: Thank you, everyone, for joining us today and for your continued support of Co-Diagnostics. This continues to be an active and important period for our business as we execute on the opportunities ahead and remain focused on positioning the company for its next phase of growth. The work we are doing across the organization is connected. And together, it reflects the progress we are making towards commercialization as well as the broader strategy we have put in place to create long-term value.

As we look ahead, our efforts remain centered on a few key areas: advancing our clinical and commercialization pipeline, continuing to build out our strategy in India through CoSara, progressing our CoMira joint venture in Saudi Arabia and the broader MENA region, and further enhancing our platform through connectivity, automation and AI-driven capabilities. Taken together, these priorities reflect a business that is increasingly focused on execution, scalability and market readiness. Let me start with our clinical and commercialization pipeline. Our upper respiratory multiplex test remains a key step toward market readiness. As a reminder, this test was originally designed to detect Flu A, Flu B, COVID-19 and RSV on a single platform.

We have now completed enrollment in the clinical study, with more than 1,400 patients enrolled. Based on current epidemiological conditions, COVID prevalence was lower than expected. And as we have shared previously, we are planning an initial submission focused on Flu A, Flu B and RSV. This approach allows us to advance time lines while maintaining the ability to incorporate COVID at a later stage, if appropriate. And it reflects market dynamics rather than any limitation of the platform itself. Based on the company's assessment, management believes the study has generated the data intended to support a 510(k) submission with the FDA.

At the same time, we have maintained the clinical study infrastructure in a paused state to preserve flexibility in the event additional data is requested. Our immediate focus is now on finalizing the analytical studies and documentation for submission to the FDA. We are preparing the submission to obtain clearance for CLIA-waived point-of-care use. And based on our current progress, we anticipate filing in the third quarter of this year, subject to completion of internal validation, submission preparation activities and ongoing regulatory assessment. Turning to India. This has been a core part of our strategy for nearly 9 years.

And over that time, we have built a meaningful foundation through our CoSara joint venture in one of the largest health care markets in the world. Today, CoSara has a nationwide commercial presence, has served hundreds of laboratory customers and has 15 clinical laboratory PCR tests cleared by the CDSCO, India's regulatory body. We are now preparing to manufacture the PCR Pro instrument and associated consumables locally in India, which represents an important step towards commercialization. CoSara has also now received a CDSCO license to manufacture the PCR Pro instrument, an important regulatory milestone that supports this transition. In addition, we have expanded CoSara's commercial and distribution territory across South Asia, increasing our total addressable market to approximately $13 billion.

As CoSara continues to mature, we believe it has reached a stage where it can stand on its own as a public entity, which could provide an alternative path to access capital and support future growth while also creating additional value for Co-Dx shareholders. We continue to evaluate the strategic alternatives, including a potential SPAC transaction, to support the capital needs required to fully execute on this opportunity. This process remains active with ongoing engagement from advisers and potential counterparties, including parties now under NDA with access to the data room. While discussions remain ongoing, no transaction has been agreed to, and there can be no assurance that any transaction will result from these discussions.

Beyond any potential transaction, CoSara is also central to the advancement of our TB program. Clinical performance studies for TB are scheduled to begin before the end of the month, and we are continuing to make operational progress toward that start. The time and place of this program is particularly compelling as India has the highest global burden of tuberculosis and represents the single largest country market for TB testing in the world by testing volume. Recent WHO guidance recommending near point-of-care molecular testing for TB diagnosis, along with the use of tongue swab samples, aligns well with the design of our platform and MTB test.

We specifically designed our test to accommodate these types of sample approaches, and we believe this reflects a convergence between our development strategy, supported in part by the Gates Foundation, and the evolving standards now being adopted by major global health organizations. As clinical studies begin in support of a submission to the CDSCO, we expect them to represent an important validation point for the program and a meaningful step toward commercialization in India, which we believe we will be positioned to commence as early as the end of the third quarter. Turning to the Kingdom of Saudi Arabia. Our CoMira joint venture continues to progress and remains an important part of our international expansion strategy.

Saudi Arabia has historically been our largest international market, and this initiative is designed to build on that position by localizing our platform within the Kingdom and across the broader MENA region. The CoMira model builds on the same localization approach we have used in India, with the goal of establishing manufacturing and distribution capabilities closer to end markets. Last month, CoMira secured approval for an industrial land allocation in Sudair Industrial City following approval by MODON, marking an important step forward as Sudair plays a central role in Saudi Arabia's Vision 2030 initiative. We have also progressed to the next phase of execution, including moving forward with the facility lease and development of the site.

We have completed our initial required funding contributions under the joint venture agreement and the broader project continues to advance. Once operational, CoMira has the potential to be among the early domestic manufacturers of molecular diagnostics in Saudi Arabia, which could provide a meaningful advantage in a market that prioritizes local production. Domestically, manufactured medical products are typically given preference in government procurement processes, and we expect that to extend to molecular diagnostics. While certain operational steps are still in progress, the broader strategic opportunity remains intact.

Importantly, as Co-Dx tests received FDA clearance in the U.S., the path into Saudi Arabia may be more direct than in some other markets, which could allow for commercial activity ahead of full manufacturing build-out. Looking more broadly at the pipeline, we continue to make progress across several important programs as we assess the needs of our target markets and plan for upcoming commercialization. This includes seeing increasing overlapping use cases across certain channels, particularly where the need for upper respiratory testing and TB testing coexist within the same settings, such as skilled nursing and assisted living facilities within the U.S., potentially opening additional domestic commercialization opportunities for the MTB test.

In addition to TB, our HPV program continues to advance through preclinical development and qualification work. We are encouraged by the pace of progress and continue to believe it will become an important part of our test menu. Our Vector program also continues to expand with additional system placements and increasing adoption across public health applications. From a technology perspective, we have been leveraging machine learning and algorithmic analysis within our platform for many years, and we continue to expand those capabilities. A key component of this strategy is our cloud-connected architecture, which allows us to capture and monitor testing activity in real time across deployed systems. These capabilities support improved operational efficiency, remote system management and broader situational awareness.

And over time, we believe they may support enhanced analytical capabilities relating to testing trends and operational insights. We are also continuing to make progress in automation within our manufacturing processes, particularly around consumable production, where advances could become increasingly important as we scale. Taken together, these efforts demonstrate the versatility of our platform and its ability to address multiple high-need markets. In closing, the initiatives we have discussed today reflect the continued progress Co-Diagnostics has made over the past several months. Each of these areas strengthens a different part of the business, from international expansion and manufacturing readiness to clinical advancement and platform development.

Overall they demonstrate that we are continuing to move the business forward and position the platform for commercialization. We believe we are entering the next phase of growth with a stronger foundation, increasing visibility and a clear path toward key milestones. With that, I'll now turn the call over to Brian Brown, our Chief Financial Officer, to review our financial results and outlook.

Brian Brown: Thanks, Dwight, and thank you to everyone who joined today's call. For the first quarter of 2026, total revenue was $146,000, compared to $50,000 in the same period last year. Cost of revenue for the quarter was $194,000, resulting in a loss of approximately $48,000, compared to a gross profit of $29,000 in the prior year period. As we have discussed previously, our current revenue levels remain limited and cost variability can impact gross margin performance at this stage as we continue to scale. Total operating expenses for the quarter were $9.2 million, compared to $8.6 million in the same period last year. This increase was primarily driven by higher research and development spending.

Research and development expenses were $5.9 million, compared to $4.9 million in the prior year period, with the increase largely driven by spending on the upper respiratory test clinical studies. Sales and marketing expenses were $0.5 million, compared to $0.7 million in the prior year. And general and administrative expenses were $2.5 million, compared to $2.8 million in Q1 2025. These decreases were primarily driven by lower consulting and personnel-related costs. Net loss for the quarter was $9.1 million or $4.06 per fully diluted share, compared to a net loss of $7.5 million or $7.05 per fully diluted share in the same period last year.

The increase in net loss was primarily driven by higher operating expenses and lower other income, including the absence of certain onetime remeasurement gains recognized in the prior year period. Adjusted EBITDA for the quarter was a loss of $8.7 million, compared to a loss of $7.4 million in the prior year period. Turning to the balance sheet. We ended the quarter with $8.2 million in cash and cash equivalents, compared to $11.9 million at the end of 2025. The change reflects continued investment in our clinical programs and platform development.

While we expect to continue generating operating losses in the near term, our focus remains on advancing our clinical pipeline, completing regulatory submissions and positioning the business for future revenue growth. At the same time, we remain disciplined in managing our cost structure and prioritizing investments to support key clinical and regulatory milestones. We expect that additional capital will likely be required to fully execute our commercialization and development plans. We will also continue to evaluate financing alternatives, including equity, debt and strategic partnerships to support these objectives, while remaining mindful of dilution and overall capital efficiency. In parallel, we remain focused on securing nondilutive funding opportunities, including grants, where appropriate.

Looking ahead, we remain focused on disciplined capital allocation as we move towards several key inflection points, including clinical submissions and the initial stages of commercialization. With that, I will now turn the call back over to Dwight.

Dwight Egan: Thank you, Brian. To close, I want to reiterate that the progress we are making across the business is beginning to translate into broader recognition of the value of what we have built. Over the past several weeks, we have had the opportunity to engage with a growing number of important stakeholders, including global health organizations, government agencies and other decision-makers. We believe those conversations are a clear indication of increasing interest in both our platform and the opportunities ahead of us. What is especially encouraging is that interest in TB testing is not limited to international markets.

We are also seeing signs that the Co-Dx PCR platform and TB test may have meaningful relevance and broader point-of-care applications here in the United States. We believe that position is the result of years of focused development, deliberate investment and a willingness to act on opportunities that align with our long-term vision. We did not arrive at this point by accident. We made intentional decisions to build a platform designed to address important unmet needs across multiple markets. And we believe those efforts are now beginning to open new opportunities for the company. I also want to thank our shareholders for their continued support and patience, and our employees for their dedication and hard work.

Their commitment continues to be one of the company's greatest strengths. We are encouraged by the momentum we are seeing and remain focused on execution. With that, let's open the line for questions. Operator?

Operator: [Operator Instructions] Your first question comes from Michael Okunewitch with Maxim Group.

Michael Okunewitch: It looks like there's a lot of exciting stuff going on, great progress. I guess to start off, my question lies around scalability and your scale-up plans, since these are pretty big markets and you're approaching them fast. What's your current capacity for producing the test kits? And then what steps are you taking to enhance those capabilities?

Dwight Egan: We believe that we are very well positioned to scale for initial commercial demand. Our Utah facility has already produced hundreds of thousands of test cups for clinical studies and in-house R&D. And we've been manufacturing and have manufacturing plans already designed and ready to implement in both the U.S., Saudi Arabia and also in India. As you may recall, CoSara, our India joint venture, inaugurated its oligo synthesis manufacturing facility in India at the end of 2024, and that will support Co-Primers' oligonucleotides manufacturing and commercialization in India. And over time, we think that the facility in India will also drive efficiency in our manufacturing process.

I'd point out that in the initial launch phase, the CoSara facility will be completing the final assembly of TB, HPV and upper respiratory test kits and instruments that are principally manufactured in Utah. The plan is over time to replicate portions of the Utah manufacturing process locally in India. As you know, India represents one of the largest TB markets globally with high testing demand, strong alignment with WHO guidance. And our approach is simply to deliver the quality of PCR to significantly lower cost, and with greater accessibility, which we believe positions us competitively versus incumbent centralized solutions.

One other very interesting element of our preparation for scaling is that the Utah facility has been preparing an automated test cup manufacturing line that we expect will improve efficiency by approximately 4x in terms of time and overhead. So this is a very exciting development, and it not only increases our throughput capabilities by 4x, but it also gets rid of a lot of the potential human error factors that would happen along a line that would typically involve maybe 14 different human beings, which will now require the assistance of 1 or 2 on an automated line. So we're very excited about the prospects of the automated test cup.

And it's not ready to go right now, but I've seen it demonstrated. And we expect that by the time we get to a certain point of deployment in Asia and in Saudi Arabia, that we'll be able to deploy the automated line.

Michael Okunewitch: And then I do want to follow up on that because it seems like a large portion of your global strategy here is setting up specifically local manufacturing and local sales infrastructure. So can you talk a little bit about the advantages that you're seeking to leverage by going after these local regional manufacturing facilities?

Dwight Egan: Well, we originally picked India as a joint venture partner basically 9 years ago when we identified India as what was going to be, if not the biggest, certainly one of the biggest health care markets in the world. And that was a very good decision. And now we have a mature business entity that's been operating for 9 years. And we're ready now to transfer technology so they can locally manufacture the product and distribute it throughout the country. We've already serviced hundreds of laboratories in India. And so it's well prepped.

There's a lot of expectation, we believe, for the initiation of our new wonderful platform, which emphasizes accessibility in terms of being able to get down to the end of the row. There are 650,000 villages roughly in India that have no access or very little access to these types of diagnostics. And so we're going to be taking it to them and filling a huge gap. And it's not only accessibility. It's affordability. Our tests are competitively priced, of course.

But our platform, the box that is used to actually perform the test, is a fraction of the cost of the competitive elements which are -- competitors, which are mainly targeted towards centralized hospitals and district hospitals in places like India. So we fill a huge gap. We're very excited to take it on.

Michael Okunewitch: All right. And then one more for me before I hop back into the queue. I wanted to see if you could expand a little bit on the actual go-to-market strategy in India. I imagine the clinical trial is largely going to be done in some of those larger medical centers rather than the smaller distributed microscopy centers that are the primary initial market here. So I'd like to see if you could talk a little bit about how you plan to bridge that gap, build those relationships with the smaller centers, and if you have some of those relationships already established based on your existing work in India.

Dwight Egan: Well, let me address the clinical trial first, which will begin shortly. We actually get assigned institutions that will perform the clinical trial. That is the locations, hospitals, district hospitals that will participate in the generation of the data and the testing that goes on there. Then once that finishes and we do the analytical studies, it's submitted to the CDSCO. I would point out that we've already been through this process a lot in India. We've got 15 tests that have been cleared through the CDSCO and that are molecular diagnostic tests. So we're very comfortable with the way that's done and have an excellent track record in executing on it.

So with respect to the kind of places where this is going to go, to fill the aforementioned gap that I referenced of 650,000 villages, and the primary health care facilities or PHCs where we intend these to land, this is an area where if you go into them, and I've been in these in my trips to India and looked at the actual types of facilities that we intend to be going into, and these are places where you go into them, there's a bunch of materials that are being used for smear microscopy, which is a 125-year-old technology.

It's only accurate 20% to 80% of the time, call it, a 50-50 gamble if you take one of those tests. It takes a lot of time. It takes time to get results. And this is what has to be replaced. The key opinion leaders around the world have designated going from smear microscopy to the kind of testing that we're doing, that is molecular diagnostics, as being the key driver in helping India overcome the epidemic of tuberculosis, which results in nearly 1,000 deaths every day. That's not 1,000 people who get TB, it's 1,000 people who die from it. And so we're very excited about our ability to go there.

We've spent a ton of time and have a fully-staffed group over there that has already been selling throughout the country. And I think we're very ready to go as soon as we get the clearance.

Operator: [Operator Instructions] That concludes the Q&A session and our webcast. Thank you for your participation. You may now disconnect, and have a wonderful rest of your day.

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