Co-Diagnostics (NASDAQ:CODX) executives highlighted progress on international expansion, clinical development plans, and financing flexibility while reviewing a year of lower revenue and a wider GAAP net loss, driven in part by a large non-cash impairment charge.
On the company’s fourth-quarter and full-year 2025 earnings call, Chief Executive Officer Dwight Egan said the period was “one of the most active and strategically important” in the company’s history as it advances its Kodiak PCR platform toward commercialization. Egan also noted the company “successfully complete[d] the appeal” related to its Nasdaq listing and that shares have been relisted.
Four growth pillars: pipeline, India, MENA expansion, and AI
- Progressing the clinical pipeline toward regulatory milestones, including an upper respiratory program and additional tests such as tuberculosis (TB) and HPV.
- Advancing the CoSara joint venture and broader India strategy, including regulatory progress and manufacturing readiness, while evaluating strategic alternatives including a potential SPAC transaction.
- Executing the CoMira joint venture with Arabian Eagle to expand across Saudi Arabia and additional MENA markets.
- Expanding AI-driven capabilities to support assay design, analytics, and operational efficiency.
India: CoSara regulatory progress and potential strategic alternatives
Egan called India a core market for nearly eight years and said CoSara has a nationwide commercial presence, serves “hundreds of laboratory customers,” and has “15 PCR tests cleared through India’s regulatory pathway.” He added that CoSara received a CDSCO license to manufacture the PCR Pro instrument locally, which he described as a key step toward commercialization.
Co-Diagnostics also expanded CoSara’s commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka. Egan said the move increased the addressable market from “about $11 billion…to more like $13 billion.” In response to a question from Maxim Group’s Michael Okunewitch, Egan said the expansion was a “natural progression” given CoSara’s maturity and regional disease burden.
Egan also said the company engaged a financial advisor and is “actively exploring strategic alternatives, including a potential SPAC transaction,” to support CoSara’s capital needs. He noted that the company had completed “multiple presentations with prospective partners” and that the process remains active, while cautioning there can be no assurance a transaction will be completed or on what terms.
TB opportunity and WHO guidance
Management emphasized TB as a near-term opportunity in India, where Egan said Co-Diagnostics is preparing to initiate TB clinical performance studies. He referenced updated World Health Organization guidance recommending near point-of-care molecular tests for TB diagnosis and the use of tongue swab samples for patients unable to produce sputum. Egan said Co-Diagnostics believes its PCR Pro instrument and MTB test align with that guidance, adding that the company’s work on tongue swab sampling has been supported through development efforts backed by the Bill and Melinda Gates Foundation.
Egan also said third-party preclinical studies have shown performance comparable to, and in some cases exceeding, other commercial molecular TB tests, and he expressed confidence that upcoming clinical studies will further validate its approach.
In the Q&A, Egan provided a more specific commercialization expectation for India: “We actually expect to have commercialization of the TB tests in India, let’s say, by the third quarter of 2026.” He said the company expects strong access to clinical samples in India given TB prevalence, which he believes will allow the clinical trial to proceed quickly.
CoMira in Saudi Arabia and IP updates
On the CoMira joint venture, Egan said Saudi Arabia has historically been the company’s largest international market and described CoMira as the next step in localizing manufacturing and distribution in the region. He said the company is finalizing a lease for a manufacturing facility and progressing toward operational readiness across Saudi Arabia and “18 additional MENA markets.”
Egan also said domestically manufactured medical products are typically prioritized in Saudi procurement processes, and he expects this to extend to molecular diagnostics. Once operational, he said CoMira is expected to be the “first domestic manufacturer of molecular diagnostics in the kingdom,” which management believes would be a competitive advantage.
Separately, Egan said the company has received international patents covering components of the Kodiak PCR platform, including patent grants in Australia and Japan. He highlighted the Japanese patent as having been granted by “one of the most rigorous patent offices in the world,” which he said supports the platform’s differentiation as the company prepares for commercialization.
Upper respiratory submission strategy shifts as COVID samples lag
Egan said clinical evaluations are progressing for the company’s upper respiratory multiplex test, originally designed to detect flu A, flu B, COVID-19, and RSV. However, due to “lower than expected COVID prevalence” across study locations, management plans an initial regulatory submission focused on flu A, flu B, and RSV.
In response to an H.C. Wainwright question, Egan emphasized the decision was driven by sample availability rather than any platform limitation, saying COVID “just simply did not show up over a several-month period.” He said the shift is intended to avoid delaying an FDA submission.
Okunewitch asked about study size, and Egan said the enrollment was “in excess of 1,200 different patients” across the structured trial being conducted with a CRO and with FDA visibility into the design. He added that the company is “nearing conclusion” of the trial and preparing for analytical studies and its FDA submission.
On re-adding COVID later, Egan said he would not anticipate redesign and that requirements would depend on discussions with the FDA, including how many positive samples would be needed and demographic distribution. “We don’t view it as being a very difficult thing to do,” he said, adding it should not be onerous for the company.
Financial results: revenue decline, impairment charge, and liquidity
Chief Financial Officer Brian Brown reported full-year 2025 revenue of $0.6 million, down from $3.9 million in 2024, primarily due to lower grant revenue as previously awarded funding was recognized in the prior year. Product revenue was $0.4 million versus $0.8 million in 2024, which Brown attributed to continued platform development and limited commercial activity.
Total operating expenses were $50.6 million in 2025 compared to $43.0 million in 2024. Brown said the increase was primarily due to a non-cash impairment charge of approximately $18.9 million tied to in-process R&D intangible assets. Excluding that charge, Brown said operating expenses declined year over year as the company focused on cost discipline.
By category, Brown reported:
- R&D expense of $19.1 million versus $21.0 million in 2024, reflecting disciplined investment partially offset by increased clinical trial activity.
- Sales and marketing expense of $2.4 million versus $4.5 million in 2024, driven by lower personnel, consulting, and travel.
- General and administrative expense of $9.1 million versus $16.2 million in 2024, reflecting lower legal, consulting, and stock-based compensation.
Net loss for 2025 was $46.9 million, or $35.25 per share, compared with a net loss of $37.6 million, or $37.22 per share, in 2024. Brown attributed the change primarily to the impairment charge and lower grant revenue, partially offset by reduced operating expenses and a tax benefit recognized during the year. Excluding the impairment charge, Brown said net loss would have been $28.0 million. Adjusted EBITDA was a loss of $28.0 million, compared with a loss of $33.5 million in 2024.
Co-Diagnostics ended 2025 with $11.9 million in cash equivalents and marketable investment securities, down from $29.7 million at the end of 2024. Net cash used in operating activities was $29.0 million, consistent with the prior year, as the company invested in platform development and clinical programs. Net cash provided by investing activities was $26.3 million, primarily from the maturity of marketable securities, while net cash provided by financing activities was $11.7 million, reflecting capital raised through its at-the-market program and registered direct offerings.
Brown said the company has an active ATM facility and plans to continue evaluating financing alternatives, including equity, debt, and strategic partnerships, as well as additional non-dilutive opportunities such as grants. Management said it expects continued operating losses in the near term while it advances clinical and regulatory milestones in pursuit of commercialization.
About Co-Diagnostics (NASDAQ:CODX)
Co-Diagnostics, Inc is a molecular diagnostics company headquartered in Salt Lake City, Utah, known for its proprietary CoPrimer™ technology. Founded in 2016, the company focuses on the design, development and distribution of molecular diagnostic test kits for the detection of infectious diseases, genetic mutations and other health-relevant biomarkers. Its core platform leverages patented cooperative primers, which are engineered to enhance specificity, sensitivity and cost-effectiveness compared to conventional PCR-based assays.
Through its in-house manufacturing and global supply chain partnerships, Co-Diagnostics produces a range of real-time polymerase chain reaction (qPCR) kits, reagents and customized assay development services.
