Co-Diagnostics anticipates India TB test commercialization by Q3 '26 while exploring CoSara SPAC options

Earnings Call Insights: Co-Diagnostics (CODX) Q4 2025

MANAGEMENT VIEW

* “We were pleased to successfully complete the appeal and have our shares relisted, and we are now firmly focused on moving forward,” said Chairman & CEO Dwight Egan.
* Egan said the company’s “4 primary growth pillars” are progressing the clinical pipeline (including upper respiratory, TB, and HPV), advancing CoSara in India (including “evaluating potential strategic alternatives, such as a SPAC transaction”), executing the CoMira JV with Arabian Eagle in Saudi Arabia/MENA, and expanding AI-driven capabilities.
* On India, Egan described CoSara as having “a nationwide commercial presence,” “hundreds of laboratory customers,” and “15 PCR tests cleared through India's regulatory pathway,” and said “CoSara has received the CDSCO license to manufacture the PCR Pro instrument.”
* Egan said CoSara expanded distribution to “Bangladesh, Pakistan, Nepal and Sri Lanka,” calling the resulting addressable market “approximately $13 billion,” and added: “We have engaged a financial adviser and are actively exploring strategic alternatives, including a potential SPAC transaction.”
* On clinical strategy, Egan said that due to low COVID prevalence in study sites, “we are planning to pursue an initial regulatory submission focused on flu A, flu B and RSV,” and emphasized: “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.”
* “For the full year 2025, total revenue was $0.6 million compared to $3.9 million in 2024,” said CFO Brian Brown, adding: “Total operating expenses for 2025 were $50.6 million compared to $43.0 million in 2024,” driven primarily by “a noncash impairment charge of approximately $18.9 million.”

OUTLOOK

* The prepared remarks did not provide EPS or revenue guidance for 2026.
* Egan said the company is “planning to pursue an initial regulatory submission focused on flu A, flu B and RSV,” positioning the change as a timeline accelerator: “This approach allows us to accelerate time lines while maintaining the flexibility to incorporate COVID at a later stage if conditions change.”
* In Q&A, Egan provided a commercialization expectation for India TB: “we actually expect to have commercialization of the TB test in India, let's say, by the third quarter of '26.”
* Brown reiterated financing posture rather than numeric guidance: “we have an active ATM facility in place,” and “We will also continue to evaluate financing alternatives, including equity, debt and strategic partnerships.”

FINANCIAL RESULTS

* Brown reported full-year 2025 product and grant trends: “total revenue was $0.6 million,” “Product revenue for the year was $0.4 million,” and said the decline vs. 2024 was “primarily driven by lower grant revenue.”
* Brown detailed the expense bridge: “Total operating expenses for 2025 were $50.6 million,” with the year’s increase “primarily driven by a noncash impairment charge of approximately $18.9 million,” and added: “Excluding this noncash charge, operating expenses declined year-over-year.”
* Brown reported profitability and non-GAAP measures: “Net loss for the full year 2025 was $46.9 million or a loss of $35.25 per share,” “Excluding the impact of the noncash impairment charge of $18.9 million, full year 2025 net loss would have been $28.0 million,” and “Adjusted EBITDA was a loss of $28.0 million.”
* On liquidity, Brown said: “We ended the year with $11.9 million in cash, cash equivalents and marketable investment securities,” and “Net cash used in operating activities was $29.0 million for 2025.”

Q&A

* Katie on for Yi Chen, H.C. Wainwright: asked about sample accrual and timing after moving to a 3-target panel and how quickly COVID could be added back; Chairman & CEO Egan said COVID was removed because “COVID just simply did not show up over a several month period,” and added that re-adding COVID would depend on “a negotiation with the FDA,” but “We don't view it as being a very difficult thing to do” and “it won't be onerous on the company.”
* Michael Okunewitch, Maxim Group: asked whether South Asia distribution expansion supports existing tests or PCR Pro/TB; Egan said the “disease burden… is very similar to the disease burden in India,” and framed it as expanding TAM “from about $11 billion… to more like $13 billion,” with CoSara as “a mature business.”
* Okunewitch, Maxim Group: asked about sample needs for the U.S. FDA study; Egan said the study is “very structured,” and that enrollment was “in excess of 1,200 different patients,” adding the company is “nearing conclusion… and getting ready… [for] our submission to the FDA.”
* Okunewitch, Maxim Group: asked about next steps after clearance to sell PCR Pro in India and TB commercialization timing; Egan described tech transfer and interim manufacturing in Utah, said India TB sampling availability will be high, and stated: “we actually expect to have commercialization of the TB test in India, let's say, by the third quarter of '26.”

SENTIMENT ANALYSIS

* Analysts’ tone was slightly positive and execution-focused, with Maxim’s Okunewitch saying: “Congrats on the speedy resolution of the listing challenges,” while pressing for specifics on commercialization steps, sample counts, and geographic expansion rationale.
* Management’s tone in prepared remarks was positive and forward-leaning, with Egan saying, “Our execution is on track,” while Q&A responses were pragmatic and explanatory, including “let me emphasize” around dropping COVID from the initial submission and framing it as a sample-availability issue.
* Versus Q3 2025, the current call maintained a similar confident posture on “growth pillars,” but added a resolved NASDAQ listing issue and more concrete operational detail (CDSCO manufacturing license; “in excess of 1,200” enrolled; and an India TB commercialization timing expectation).

QUARTER-OVER-QUARTER COMPARISON

* Strategic pillars remained consistent quarter to quarter (CoSara strategic alternatives, CoMira expansion, AI platform, and respiratory multiplex clinical work), but Q4 added a specific regulatory/tactical change: moving initial respiratory submission to flu A/flu B/RSV due to COVID sample scarcity.
* The CoSara SPAC discussion shifted from Q3’s framing of a “planned CoSara SPAC transaction with Maxim Group” to Q4’s broader language of “exploring strategic alternatives, including a potential SPAC transaction,” with Egan noting the process is “active and ongoing” and that “There can be no assurance that any transaction will be completed.”
* Q4 introduced a specific near-term commercialization expectation for TB in India (“by the third quarter of '26”), while Q3 spoke more generally about “multiple commercial launches expected in 2026.”
* Analyst questioning in Q4 centered on trial execution details (sample counts, timing, adding COVID back) and geographic expansion logic, while Q3 questions leaned more toward JV performance and structure around a potential CoSara transaction.

RISKS AND CONCERNS

* Egan highlighted clinical execution risk tied to epidemiology and enrollment mix: “lower-than-expected COVID prevalence… across our multiple study locations,” driving the decision to exclude COVID from the initial respiratory submission.
* On strategic alternatives for CoSara, Egan cautioned transaction uncertainty: “There can be no assurance that any transaction will be completed or on what terms.”
* Brown emphasized funding and dilution-related considerations through financing needs: “we expect to continue generating operating losses in the near term,” and said the company will evaluate “equity, debt and strategic partnerships,” alongside “non-dilutive funding opportunities, including grant funding.”

FINAL TAKEAWAY

Management presented Q4 2025 as a transition period focused on moving the Co-Dx PCR platform toward commercialization through CoSara in India and CoMira in Saudi Arabia/MENA, while managing liquidity and financing options. Dwight Egan emphasized NASDAQ relisting resolution, highlighted the CDSCO license to manufacture PCR Pro in India, and said the initial U.S. respiratory submission will target flu A/flu B/RSV due to limited COVID-positive samples, with flexibility to add COVID later. In Q&A, Egan stated an expectation for TB test commercialization in India “by the third quarter of '26,” while CFO Brian Brown reported $11.9 million in year-end cash and noted the company expects continued near-term operating losses as it advances regulatory and clinical milestones.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/codx/earnings/transcripts]

MORE ON CO-DIAGNOSTICS

* Co-Diagnostics, Inc. (CODX) Q4 2025 Earnings Call Transcript [https://seekingalpha.com/article/4887616-co-diagnostics-inc-codx-q4-2025-earnings-call-transcript]
* Seeking Alpha’s Quant Rating on Co-Diagnostics [https://seekingalpha.com/symbol/CODX/ratings/quant-ratings]
* Historical earnings data for Co-Diagnostics [https://seekingalpha.com/symbol/CODX/earnings]
* Financial information for Co-Diagnostics [https://seekingalpha.com/symbol/CODX/income-statement]