C

Co-Diagnostics Inc.

1.42-1.39 %$CODX
NASDAQ
Healthcare
Medical Devices

Price History

-13.68%

Company Overview

Business Model: Co-Diagnostics, Inc. develops, manufactures, and sells reagents for diagnostic tests that detect and analyze nucleic acid molecules (DNA or RNA), primarily focusing on molecular tools for infectious diseases. The Company's proprietary Co-Primers technology is designed to enable dependable, low-cost molecular testing by simplifying PCR amplification and reducing false positives. Co-Diagnostics, Inc. offers PCR diagnostic tests for various infectious diseases, including COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus, which are currently cleared for use in clinical laboratories. The Company is also developing a portable diagnostic device and test system, the Co-Dx PCR platform, for point-of-care and at-home use. Additionally, Co-Diagnostics, Inc. designs tests for genetic traits in plant and animal genomes and multiplexed tests for mosquito-borne pathogens.

Market Position: Co-Diagnostics, Inc. leverages its proprietary and patented molecular diagnostics technology, including its Co-Primers technology, which it believes allows for faster and more economical innovation in disease detection. The Company aims to be a low-cost provider of molecular diagnostics while maintaining significant margins, partly by avoiding patent royalties associated with other PCR test systems. Co-Diagnostics, Inc. was the first US-based company to receive a CE-marking for a COVID-19 test in early 2020, demonstrating rapid assay design capabilities. The Company has built a worldwide distribution network covering clinical labs in over 50 countries. Its technologies are protected by over 20 granted or pending US and foreign patents, as well as trade secrets and copyrights. Co-Diagnostics, Inc. faces intense competition from larger, well-established companies such as BioMerieux, Siemens, Qiagen, Roche Diagnostics, Cepheid, Abbott Laboratories, Becton Dickinson, and Johnson and Johnson, which possess greater financial resources, broader product offerings, and established customer bases.

Recent Strategic Developments:

  • Co-Dx PCR Platform Development: Co-Diagnostics, Inc. voluntarily withdrew its 510(k) submission for the Co-Dx PCR COVID-19 Test in June 2024 to focus capital and time on developing and clinically validating the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test ("ABCR") for point-of-care settings, with clinical performance studies underway as of November 2025. The Company received $1.2 million in funding from the National Institutes of Health (NIH) in July 2023 for upper respiratory panel diagnostic test development. It also secured grants totaling $6.8 million for a TB test and $987,000 for an HPV test from the Bill & Melinda Gates Foundation to support Co-Dx PCR platform development. In December 2025, the Company received its first patent for the Co-Dx PCR platform from Australia, followed by a Japan Patent Office grant in March 2026 for "Systems, Methods, and Apparatus for Automated Self-Contained Biological Analysis," covering the Co-Dx PCR Pro instrument and test cups.
  • Joint Ventures & Market Expansion: In October 2025, Co-Diagnostics, Inc. formed CoMira Diagnostics, a joint venture with Arabian Eagle Manufacturing in the Kingdom of Saudi Arabia, to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies, including the Co-Dx PCR platform, in KSA and 18 other Middle East and North Africa (MENA) countries. Co-Diagnostics, Inc. invested an initial $102,566 for a 50% ownership interest. CoSara Diagnostics Pvt Ltd, the Company's joint venture in India, received CDSCO clearance in 2024 for the SARAPLEX™ Influenza Multiplex (IFM) Test Kit and a license in 2026 to manufacture the CoSara PCR Pro real-time PCR point-of-care instrument.
  • Workforce Reduction: In March 2026, Co-Diagnostics, Inc. approved and initiated a workforce reduction impacting approximately 26% of its employees to align its cost structure with current business conditions and strategic priorities, expecting reduced operating expenses from Q2 2026.
  • Nasdaq Listing Status: Following a 1-for-30 reverse stock split on January 1, 2026, Co-Diagnostics, Inc. regained compliance with Nasdaq's minimum bid price requirement in March 2026. The Company is subject to a Discretionary Panel Monitor through March 9, 2027.

Geographic Footprint: Co-Diagnostics, Inc. maintains its headquarters and lab facilities in Salt Lake City, Utah. The Company has a global presence, selling PCR diagnostic tests to entities in the Caribbean, Central and South America, and the European Community (where it holds CE markings for several tests). Its joint venture, CoSara Diagnostics Pvt Ltd, operates a manufacturing plant in Ranoli, India, and sells SaraGene brand tests in the Indian market. The newly formed CoMira Diagnostics joint venture targets the Kingdom of Saudi Arabia and 18 other MENA countries. In the United States, the Company sells its Logix Smart COVID-19 test under Emergency Use Authorization to CLIA certified laboratories.

Financial Performance

Revenue Analysis

MetricCurrent Year (2025)Prior Year (2024)Change
Total Revenue$0.6 million$3.9 million-84.1%
Gross Profit$0.4 million$2.9 million-86.3%
Operating Income($50.2 million)($40.1 million)+25.2%
Net Income($46.9 million)($37.6 million)+24.6%

Profitability Metrics:

  • Gross Margin: 64.3% (2025)
  • Operating Margin: -8059.0% (2025)
  • Net Margin: -7533.0% (2025)

Investment in Growth:

  • R&D Expenditure: $19.1 million (3074.3% of revenue)
  • Capital Expenditures: $0.7 million
  • Strategic Investments: Co-Diagnostics, Inc. made an initial investment of $102,566 in the CoMira Diagnostics joint venture in October 2025. The Company also received $1.2 million in NIH RADx Tech funding in July 2023 and grants totaling $6.8 million for a TB test and $987,000 for an HPV test from the Bill & Melinda Gates Foundation to support Co-Dx PCR platform development.

Business Segment Analysis

Co-Diagnostics, Inc. operates as one operating segment. The Chief Executive Officer, as the chief operating decision maker, evaluates financial information and resources and assesses performance on a consolidated basis. Therefore, detailed segment-specific financial and operational metrics are not separately reported in the filing.

Capital Allocation Strategy

Shareholder Returns:

  • Share Repurchases: No shares were repurchased under the Company's $30.0 million authorized share repurchase program during the year ended December 31, 2025.
  • Dividend Payments: Co-Diagnostics, Inc. has never declared or paid cash dividends on its common stock and does not anticipate doing so in the foreseeable future, expecting to use available funds to finance business development and expansion.
  • Dividend Yield: Not applicable.
  • Future Capital Return Commitments: The share repurchase program is discretionary and does not obligate the Company to acquire any specific number of shares.

Balance Sheet Position:

  • Cash and Equivalents: $11.9 million as of December 31, 2025.
  • Total Debt: No significant long-term debt is disclosed in the balance sheet.
  • Net Cash Position: $11.9 million.
  • Credit Rating: Not disclosed.
  • Debt Maturity Profile: Not applicable due to the absence of significant debt.

Cash Flow Generation:

  • Operating Cash Flow: ($29.1 million) for the year ended December 31, 2025, compared to ($29.2 million) for the prior year.
  • Free Cash Flow: Approximately ($29.8 million) for the year ended December 31, 2025 (Operating Cash Flow less Capital Expenditures).
  • Cash Conversion Metrics: Not explicitly detailed in the filing.

Operational Excellence

Production & Service Model: Co-Diagnostics, Inc. develops, manufactures, and sells reagents for diagnostic tests, utilizing its proprietary Co-Primers technology for PCR test design to reduce false positives. The Company employs a rapid assay design system, exemplified by the development of its Logix Smart COVID-19 test in approximately 30 days. Its test design process involves identifying optimal target gene locations and pairing them with optimized primer and probe structures, followed by rigorous verification and validation. Manufacturing operations adhere to an ISO 13485:2016 certified quality management system. The Co-Dx PCR platform, designed for point-of-care and at-home use, features a compact Co-Dx PCR Pro instrument, diagnostic test cups with lyophilized reagents for room temperature storage, and a mobile application that delivers PCR test results in about 30 minutes. This platform utilizes a saliva or nasal swab-based PCR test that does not require RNA/DNA extraction.

Supply Chain Architecture: Key Suppliers & Partners:

  • Raw Materials: Co-Diagnostics, Inc. relies on a limited number of third-party suppliers for key raw materials required for its diagnostic products and candidates. The Company does not have formal supply agreements in place with these suppliers.
  • Manufacturing Partners: CoSara Diagnostics Pvt Ltd, a joint venture in India, manufactures approved tests for the Indian market. CoMira Diagnostics, a new joint venture with Arabian Eagle Manufacturing, is dedicated to manufacturing and assembly in KSA and the MENA region.
  • Diagnostic Equipment: The Company sells diagnostic equipment from other manufacturers, including an OEM's PCR instrument referred to as the "Co-Dx Box."

Facility Network:

  • Headquarters & Lab Facilities: Co-Diagnostics, Inc.'s headquarters in Salt Lake City, Utah, encompass approximately 50,000 square feet of laboratory, manufacturing, storage, and office space under leases expiring between 2026 and 2028, with the corporate headquarters lease extended to December 31, 2028.
  • Manufacturing (India): A manufacturing plant in Ranoli, India, operated by CoSara Diagnostics Pvt Ltd, is licensed for manufacturing approved tests for the Indian market.
  • Manufacturing (KSA/MENA): The CoMira Diagnostics joint venture will establish manufacturing and assembly capabilities in KSA and the MENA region.
  • Research & Development: R&D activities are conducted at the Salt Lake City facilities and through its joint ventures.

Operational Metrics: Co-Diagnostics, Inc. maintains an ISO 13485:2016 certified quality management system, indicating adherence to medical device product design and manufacturing standards. Specific quantitative operational metrics such as capacity utilization or efficiency measures are not explicitly disclosed in the filing.

Market Access & Customer Relationships

Go-to-Market Strategy: Distribution Channels:

  • Direct Sales: Co-Diagnostics, Inc. sells its Logix Smart COVID-19 test directly to CLIA certified laboratories in the United States.
  • Channel Partners: The Company utilizes a global network of distributors to reach clinical labs in over 50 countries. Arabian Eagle Manufacturing, a former primary distributor in the Middle East, is now a joint venture partner in CoMira Diagnostics.
  • Joint Ventures: CoSara Diagnostics Pvt Ltd handles sales and marketing for SaraGene brand tests in India. CoMira Diagnostics is responsible for distribution and commercialization in KSA and 18 other MENA countries.
  • Digital Platforms: The Co-Dx PCR platform incorporates a mobile application for user interaction and result delivery, with anonymized data analyzed in the cloud, potentially providing valuable insights for governmental health agencies and the World Health Organization.
  • Trade Shows & Solicitations: Vector Smart test products are marketed through trade shows, electronic, and regular mail solicitations.

Customer Portfolio: Enterprise Customers:

  • Tier 1 Clients: One customer accounted for approximately 31% of product revenue for the year ended December 31, 2024. Two customers collectively accounted for approximately 82% of accounts receivable at December 31, 2025, and 94% at December 31, 2024, indicating significant customer concentration.
  • Strategic Partnerships: Key partnerships include joint ventures with CoSara Diagnostics Pvt Ltd in India and CoMira Diagnostics with Arabian Eagle Manufacturing in the KSA/MENA region.
  • Customer Concentration: The Company faces concentration risk, as the loss of major customers could materially adversely affect its financial condition.

Geographic Revenue Distribution:

  • United States: Accounted for 93% of total revenue in 2025 ($581,549) and 90% in 2024 ($3,523,324). This includes product revenue of $377,265 (2025) and $378,212 (2024), and grant revenue of $204,284 (2025) and $3,145,112 (2024).
  • Rest of World: Accounted for 7% of total revenue in 2025 ($40,940) and 10% in 2024 ($391,836), primarily from product revenue.
  • Growth Markets: India and the KSA/MENA region are identified as strategic growth markets for both existing diagnostic tests and the upcoming Co-Dx PCR platform.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The molecular diagnostics market is a rapidly growing segment of the in vitro diagnostics industry, characterized by intense competition. PCR tests offer advantages such as higher specificity and sensitivity, multiplex testing capabilities, and the ability to detect drug resistance or specific genes. The market environment is highly dynamic, with continuous emergence of new risks and evolving customer requirements. The COVID-19 pandemic significantly altered the market landscape, enabling Co-Diagnostics, Inc. to establish a global distribution network. Ongoing demand for comprehensive upper respiratory and other infectious disease testing is expected to persist.

Competitive Positioning Matrix:

Competitive FactorCompany PositionKey Differentiators
Technology LeadershipStrongProprietary Co-Primers technology significantly reduces primer-dimer amplification (false positives); rapid assay design system (e.g., 30-day COVID-19 test development); enhanced Single Nucleotide Polymorphism (SNP) detection and enrichment for next generation sequencing; patented molecular structure and predictive mathematical algorithms.
Market ShareCompetitive/NicheEstablished global distribution network in over 50 countries; first US-based company to receive CE-marking for a COVID-19 test; strategic joint ventures in India (CoSara Diagnostics Pvt Ltd) and KSA/MENA (CoMira Diagnostics) for localized market penetration.
Cost PositionAdvantagedOwnership of proprietary platform eliminates patent royalties, allowing for lower diagnostic PCR test pricing while maintaining profit margins; development of a low-cost, portable Co-Dx PCR platform.
Customer RelationshipsDevelopingBuilt a worldwide distribution network over six years; utilizes trade shows, electronic, and regular mail solicitations; implements a reagent rental program in India to facilitate sales.

Direct Competitors

Primary Competitors: Co-Diagnostics, Inc. competes with major players in the diagnostic testing and point-of-care testing (POCT) industries, including BioMerieux, Siemens, Qiagen, Roche Diagnostics, and Cepheid. Pharmaceutical companies such as Abbott Laboratories, Becton Dickinson, and Johnson and Johnson also pose significant competition. Many of these competitors are larger, possess greater financial and human resources, have broader product offerings, extensive intellectual property portfolios, and established customer bases. Emerging Competitive Threats: The Company anticipates increasing competition from new entrants, disruptive technologies, and alternative solutions. Competitors, particularly those with strong relationships with governmental authorities, may be able to respond more quickly to new regulatory requirements, emerging technologies, and changes in customer demands. Companies from Asia also exert competitive price pressure in certain markets, notably Asia and Latin America.

Competitive Response Strategy: Co-Diagnostics, Inc.'s strategy to maintain competitive advantage includes focusing on its proprietary Co-Primers technology for superior detection and specificity, and the development of the Co-Dx PCR platform for affordable and reliable point-of-care and at-home testing. The Company emphasizes its rapid assay design capabilities and plans to expand its product lines, including the ABCR multiplex test and TB/HPV tests for the Co-Dx PCR platform. Strategic joint ventures like CoSara Diagnostics Pvt Ltd and CoMira Diagnostics are crucial for expanding its global footprint and localizing manufacturing and distribution, leveraging its low-cost provider advantage.

Risk Assessment Framework

Strategic & Market Risks

Market Dynamics: Co-Diagnostics, Inc.'s future success is highly dependent on the demand for infectious disease diagnostics and its ability to develop and commercialize new diagnostic tests for its Co-Dx PCR platform. Market acceptance and commercial success are subject to various factors, including regulatory clearance, customer adoption, the breadth of its test menu, changes in healthcare policies, marketing effectiveness, and manufacturing capacity. The Company is also exposed to technology disruption risks, as competitors may develop alternative solutions or design around its patents. Customer Concentration: A significant risk is customer concentration, with one customer accounting for approximately 31% of product revenue in 2024, and two customers representing approximately 82% of accounts receivable at December 31, 2025. The loss of these key customers could have a material adverse effect on the Company's financial condition.

Operational & Execution Risks

Supply Chain Vulnerabilities: Co-Diagnostics, Inc. relies on a limited number of third-party suppliers for key raw materials without formal supply agreements. Any interruption in this supply chain could materially harm the Company's ability to manufacture products and delay commercialization efforts. Capacity Constraints: The ability to manufacture products in sufficient quantities is a critical factor for market acceptance and commercial success.

Financial & Regulatory Risks

Market & Financial Risks: Co-Diagnostics, Inc. faces substantial doubt about its ability to continue as a going concern due to recurring operating losses and negative operating cash flows, necessitating additional financing. The Company's cash and cash equivalents were $11.9 million as of December 31, 2025. Failure to secure timely and adequate funding could lead to delays or termination of product development and commercialization efforts. Any additional equity financing would likely be dilutive to existing stockholders, and debt financing may impose restrictive covenants. The Company's stock price is subject to wide fluctuations due to various factors, including regulatory approvals, financial performance, and competitive landscape. Regulatory & Compliance Risks: In the United States, products require FDA approval, clearance, or authorization. The Emergency Use Authorization (EUA) for the Logix Smart COVID-19 test could be revoked, impacting market access. The Company's 510(k) submission for its Co-Dx PCR COVID-19 Test was voluntarily withdrawn, and the ABCR multiplex test is now pursuing 510(k) clearance. Internationally, compliance with regulations like Europe's IVDR, India's CDSCO, and KSA's SFDA is required, with no guarantee of timely approvals. Co-Diagnostics, Inc. is also subject to complex and evolving healthcare laws and regulations (e.g., federal Anti-Kickback Statute, False Claims Act, HIPAA, GDPR), with non-compliance potentially leading to significant penalties, litigation, and reputational damage. The Company's reliance on third-party vendors for data processing and storage also exposes it to data privacy and security risks.

Innovation & Technology Leadership

Research & Development Focus: Core Technology Areas: Co-Diagnostics, Inc.'s R&D is centered on its proprietary Co-Primers technology, a novel approach to PCR test design that significantly reduces primer-dimer amplification (false positives). The Company utilizes complex mathematical algorithms and automated systems to engineer and optimize PCR tests, rapidly screening millions of design options. Its technology is also suited for multiplexing several targets, enhanced Single Nucleotide Polymorphism (SNP) detection, and enrichment for next generation sequencing. A key innovation for the Co-Dx PCR platform is the development of saliva or nasal swab-based PCR tests that do not require RNA/DNA extraction. Innovation Pipeline: The Company is actively engaged in clinical performance studies for its Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test ("ABCR"), aiming for 510(k) clearance. It is also developing TB and HPV diagnostic tests for its Co-Dx PCR platform, supported by grants from the Bill & Melinda Gates Foundation. Co-Diagnostics, Inc. has commercialized three Vector Smart PCR tests for mosquito-borne pathogens, enabling municipalities to target mosquito abatement efforts.

Intellectual Property Portfolio:

  • Patent Strategy: Co-Diagnostics, Inc. protects its technology with over 20 granted or pending US and foreign patents. This includes two U.S. patents for its foundational "Cooperative primers, probes, and applications thereof" (Co-Primers technology) and three U.S. patents for earlier primer and assay designs. More recent patent applications cover "Methods and Compositions for Next Generation Sequencing (NGS) Library Preparation," "Allele-Specific Design of Cooperative Primers for Improved Nucleic Acid Variant Genotyping," "Methods and Compositions Related to Cooperative Primers and Reverse Transcription," and "Systems, Methods, and Apparatus for Automated Self-Contained Biological Analysis" for the Co-Dx PCR platform. The first patent for the Co-Dx PCR platform was granted by Australia in December 2025, and Japan granted Patent No. 7797537 in March 2026, covering the fundamental systems, methods, and apparatus of the Co-Dx PCR Pro instrument and proprietary test cups.
  • Licensing Programs: The Company grants exclusive licenses to its joint ventures, CoSara Diagnostics Pvt Ltd and CoMira Diagnostics, to use, manufacture, and commercialize its licensed intellectual property.
  • Trade Secrets & Copyrights: Co-Diagnostics, Inc. also protects certain technology and know-how as trade secrets and copyrights.
  • IP Litigation: The Company acknowledges the risk of intellectual property litigation, which could be costly and divert management resources.

Technology Partnerships: Co-Diagnostics, Inc. collaborates with strategic partners and receives funding from key organizations. It was awarded $1.2 million from the National Institutes of Health (NIH) as part of the Rapid Acceleration of Diagnostics (RADx) Tech program. The Bill & Melinda Gates Foundation has provided grants totaling $6.8 million for TB test development and $987,000 for HPV test development for the Co-Dx PCR platform. The Company's joint ventures, CoSara Diagnostics Pvt Ltd in India and CoMira Diagnostics in KSA/MENA, also serve as strategic alliances for technology development and commercialization.

Leadership & Governance

Executive Leadership Team

PositionExecutiveTenurePrior Experience
Chief Executive Officer, President and Chairman of the BoardDwight EganSince April 2013Engaged in private investment business since February 1999; Senior executive at Data Broadcasting Corporation (1995-1999); Co-founded, CEO, and Chairman of Broadcast International, Inc. (1984-1995).
Chief Financial Officer and SecretaryBrian BrownSince Feb 2021CFO of A-Core Concrete Cutting, Inc. (July 2020-February 2021); Independent consultant (January 2020-July 2020); VP of Accounting, Treasury and Investor Relations at Sportsman’s Warehouse Holdings, Inc. (August 2019-December 2019); Director of Finance at Sportsman’s Warehouse Holdings, Inc. (October 2009-August 2019); Corporate Controller of Franklin Covey Products (May 2005-October 2009); Assurance Senior at KPMG, LLP (July 2001-May 2005).
PresidentRichard AbbottSince March 2024President of Advanced Conceptions, Inc. (January 2021-March 2024); Partner in SaltRidge, LLC (September 2018-January 2021); Chief Technology Officer for Vilicus (August 2017-August 2018); Chief Technology Officer for Fenome (October 2016-July 2017).

Leadership Continuity: Co-Diagnostics, Inc. has a Change in Control Severance Plan that provides severance benefits to designated management, including the CEO and CFO, in the event of termination without "cause" or for "good reason" following a change in control. The Nominating Committee is responsible for evaluating and providing succession planning for the Chief Executive Officer and other executive officers.

Board Composition: The Board of Directors consists of five members, with four independent directors (Eugene Durenard, James Nelson, Richard Serbin, and Edward Murphy) constituting a majority. The Board met eleven times during 2025. Key committees include the Audit Committee (chaired by Eugene Durenard, who is an "audit committee financial expert"), Compensation Committee (chaired by Richard S. Serbin), Corporate Governance Committee (chaired by James Nelson), and Nominating Committee (chaired by Edward Murphy). All members of these committees are independent directors. The Board considers various factors for director candidates, including experience, education, employment history, special talents, anticipated participation, and geographic and diversity factors.

Human Capital Strategy

Workforce Composition: As of December 31, 2025, Co-Diagnostics, Inc. had 115 full-time and part-time employees located at its executive offices and lab facilities in Salt Lake City, Utah. The Company also engages independent contractors and sales representatives as needed. In March 2026, the Company initiated a workforce reduction impacting approximately 26% of its employees.

Talent Management: Acquisition & Retention: Co-Diagnostics, Inc. focuses on maintaining a strong and collaborative company culture, increasing diversity, inclusion, and belonging, and offering fair and competitive compensation and benefits. The Company invests in people and organizational development and aims to protect and enrich employee health and wellness, fostering a culture of respectful and effective communications. Diversity & Development: While specific diversity metrics are not disclosed, increasing diversity, inclusion, and belonging is a stated objective. The Company invests in development programs, including training and leadership development, to support career advancement.

Environmental & Social Impact

No material information explicitly stated in the filing regarding environmental commitments or social impact initiatives.

Business Cyclicality & Seasonality

No material information explicitly stated in the filing regarding business cyclicality or seasonality.

Regulatory Environment & Compliance

Regulatory Framework: Industry-Specific Regulations: Co-Diagnostics, Inc. operates under a complex regulatory framework. In the United States, its products are subject to FDA approval, clearance, or authorization. The Logix Smart COVID-19 test holds an Emergency Use Authorization (EUA). The Company voluntarily withdrew a 510(k) submission for its Co-Dx PCR COVID-19 Test and is now pursuing 510(k) clearance for its Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test ("ABCR"). Internationally, the Company's products have received CE markings for sale in the European Community and registrations in various countries, including India (CDSCO clearances for 15 PCR tests and a license for the CoSara PCR Pro instrument), Mexico (INDRE approval), and Australia. The new CoMira Diagnostics joint venture will pursue regulatory clearance with the Saudi Food & Drug Administration (SFDA). Co-Diagnostics, Inc. maintains an ISO 13485:2016 certified quality management system, which aids in regulatory clearance applications. Trade & Export Controls: Section 801(e) of the Federal Food, Drug, and Cosmetic Act permits the export of IVD products that are acceptable to the importing country and manufactured under FDA's Good Manufacturing Practices.

Legal Proceedings: Co-Diagnostics, Inc. is currently involved in several legal proceedings. It is a defendant in two securities class action claims (consolidated into Stadium Capital LLC v. Co-Diagnostics, Inc., et al.), alleging that the Company overstated demand for its Logix Smart COVID-19 test, with a trial set for October 5, 2026. The Company was also a party to three shareholder derivative lawsuits, which were voluntarily dismissed. In commercial litigation, the Company successfully defended against counterclaims in Co-Diagnostics, Inc. v. Hukui Technology, Inc., et al., with a trial court ruling in its favor in March 2026, though an appeal is possible. Co-Diagnostics, Inc. settled a dispute with Pantheon International Advisors Ltd. for $140,000 in March 2026. The Company is also defending against Robert Salna v. Co-Diagnostics, Inc., et al., a suit alleging entitlement to equity-based compensation and seeking not less than $10 million, with a motion to dismiss hearing scheduled for May 2026. Management believes it has established appropriate legal reserves and does not anticipate an unfavorable outcome in these cases, but acknowledges that an adverse resolution could be material.

Tax Strategy & Considerations

Tax Profile: Co-Diagnostics, Inc. reported an effective tax rate of -3.3% for 2025 and -0.2% for 2024. The Company's tax profile was impacted by the One Big Beautiful Bill Act (OBBBA) signed into law in 2025, which led to the filing of amended federal income tax returns for 2022 and 2023 and a subsequent refund of $870,633 from the IRS.

  • Deferred Tax Assets/Liabilities: As of December 31, 2025, and 2024, the Company had a net deferred tax asset (liability) of $0, primarily due to a full valuation allowance.
  • Valuation Allowance: A valuation allowance of $24.9 million was recorded at December 31, 2025 ($14.9 million at December 31, 2024), reflecting management's conclusion that it is more likely than not that the Company's U.S. deferred tax assets will not be realized, given cumulative losses in recent years.
  • Net Operating Loss (NOL) Carryforwards: The Company holds federal NOL carryforwards of $92.9 million with an indefinite carryforward period. State NOL carryforwards total $59.5 million, including $43.8 million from Utah with an indefinite carryforward, and others expiring from 2044.
  • Research and Development (R&D) Credit Carryforwards: Federal R&D credit carryforwards amount to $3.0 million, expiring from 2042. State R&D credit carryforwards are $1.1 million, expiring in 2036.
  • Unrecognized Tax Benefits: Unrecognized tax benefits were $618,749 at December 31, 2025, and $1,200,035 at December 31, 2024. No material change is anticipated in the next 12 months.
  • Tax Examinations: Tax years from December 31, 2022, through December 31, 2025, remain open for federal and state income tax examination, though the Company is not currently under examination.

Insurance & Risk Transfer

Risk Management Framework: Co-Diagnostics, Inc. manages its risks through a framework that includes various insurance coverages.

  • Insurance Coverage: The Company maintains general liability and cyber insurance coverage. It also obtains executive and corporate securities liability insurance to mitigate risks associated with potential claims and litigation.
  • Cybersecurity Risk Insurance: Co-Diagnostics, Inc. carries cybersecurity risk insurance to provide coverage for certain cybersecurity incidents, complementing its cybersecurity policies and incident response plan.