UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549. Form 10-K (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_______to_______ | --- | --- | --- | --- | |---------------------------------------------------|--------------------------------------------------------------- ...

Co-Diagnostics, Inc. (NASDAQ:CODX) Q3 2020 Earnings Conference Call November 16, 2020 4:30 PM ET Company Participants Dwight Egan - Chairman, CEO & President Reed Benson - CFO & Secretary Conference Call Participants Theodore O'Neill - Litchfield Hills Research Yi Chen - H.C. Wainwright & Co. Operator Good afternoon, and welcome to the Co-Diagnostics Third Quarter 2020 Earnings Conference Call. [Operator Instructions]. Please note, this event is being recorded. I would now like to turn the conference over ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share CODX NASDAQ-CM Large accelerated filer [ ] Accelerated filer [ ] Non-accelerated filer [X] Smaller reporting company [X] Emerging growth company [X] FORM 10-Q [X] Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2020 OR [ ] Transition re ...

Co-Diagnostics Inc. (NASDAQ:CODX) Q2 2020 Earnings Conference Call August 13, 2020 4:30 PM ET Company Participants Andrew Benson - IR Dwight H Egan - CEO Reed Benson - CFO Conference Call Participants Yi Chen - HC Wainwright Michael Okunewitch - Maxim Group Theodore O'Neill - Litchfield Hills Research Operator Good afternoon, everyone, and welcome to the Co-Diagnostics Q2 2020 Earnings Conference Call. All participants are currently in a listen only mode. [Operator instructions] Please also note today's eve ...

[FORM 10-Q Filing Details](index=1&type=section&id=FORM%2010-Q%20Filing%20Details) This section provides key administrative and identification details for the company's quarterly report filing FORM 10-Q Filing Information | Detail | Value | | :----- | :---- | | Registrant Name | CO-DIAGNOSTICS, INC. | | Trading Symbol | CODX | | Exchange | NASDAQ-CM | | Filing Type | Quarterly report pursuant to Section 13 or 15(d) | | Period Ended | June 30, 2020 | | Commission File No. | 001-38148 | | Filer Status | Non-accelerated filer, Smaller reporting company, Emerging growth company | | Common Stock Outstanding (as of Aug 12, 2020) | 28,082,709 shares | [PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the company's financial statements and management's analysis of its financial condition and operations [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements, including balance sheets, operations, cash flows, and equity, with detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position at specific dates, detailing assets, liabilities, and equity Condensed Consolidated Balance Sheets Highlights | Metric | June 30, 2020 | December 31, 2019 | Change | | :------------------------------ | :------------ | :---------------- | :----- | | Cash and cash equivalents | $18,550,437 | $893,138 | +1977.0% | | Accounts receivables, net | $5,349,876 | $131,382 | +3969.0% | | Inventory | $10,110,786 | $197,168 | +5030.0% | | Total current assets | $34,532,279 | $1,584,254 | +2079.0% | | Total assets | $36,422,135 | $2,215,326 | +1544.0% | | Total current liabilities | $2,984,642 | $328,070 | +809.0% | | Total liabilities | $3,064,642 | $478,070 | +541.0% | | Total stockholders' equity | $33,357,493 | $1,737,256 | +1820.0% | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's revenues, expenses, and net income or loss over specific periods, reflecting operational performance Condensed Consolidated Statements of Operations Highlights (Three Months Ended June 30) | Metric | 2020 | 2019 | Change | | :-------------------------- | :----------- | :----------- | :----- | | Net revenue | $24,040,274 | $61,574 | +39090.0% | | Cost of revenue | $8,344,674 | $38,809 | +21410.0% | | Gross profit | $15,695,600 | $22,765 | +68840.0% | | Total operating expenses | $3,356,692 | $1,388,529 | +141.7% | | Income (loss) from operations | $12,338,908 | $(1,365,764) | N/A | | Net income (loss) | $12,635,640 | $(1,344,396) | N/A | | Basic income (loss) per common share | $0.46 | $(0.08) | N/A | | Diluted income (loss) per common share | $0.43 | $(0.08) | N/A | Condensed Consolidated Statements of Operations Highlights (Six Months Ended June 30) | Metric | 2020 | 2019 | Change | | :-------------------------- | :----------- | :----------- | :----- | | Net revenue | $25,588,802 | $64,974 | +39280.0% | | Cost of revenue | $8,826,414 | $39,261 | +22380.0% | | Gross profit | $16,762,388 | $25,713 | +65090.0% | | Total operating expenses | $5,505,429 | $2,645,969 | +108.1% | | Income (loss) from operations | $11,256,959 | $(2,620,256) | N/A | | Net income (loss) | $11,570,447 | $(2,712,785) | N/A | | Basic income (loss) per common share | $0.42 | $(0.16) | N/A | | Diluted income (loss) per common share | $0.40 | $(0.16) | N/A | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section reports the cash generated and used by operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows Highlights (Six Months Ended June 30) | Metric | 2020 | 2019 | Change | | :---------------------------------- | :----------- | :----------- | :----- | | Net cash used in operating activities | $(348,459) | $(2,697,691) | +87.1% | | Net cash used in investing activities | $(919,790) | $(299,775) | +206.8% | | Net cash provided by financing activities | $18,925,548 | $5,903,238 | +220.6% | | Net increase in cash | $17,657,299 | $2,905,772 | +507.7% | | Cash and cash equivalents end of period | $18,550,437 | $3,856,009 | +380.0% | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%27%20Equity) This section outlines changes in the company's equity accounts, including stock issuances, net income, and accumulated deficit Stockholders' Equity Changes (Six Months Ended June 30, 2020) | Item | Amount | | :------------------------------------ | :----------- | | Balance as of December 31, 2019 | $1,737,256 | | Public offering, net of costs | $18,012,083 | | Issuance of Common Stock for warrant exercises | $50,000 | | Stock-based compensation expense | $432,823 | | Conversion of Preferred Stock to Common | $0 | | Net Income | $12,635,640 | | Balance as of June 30, 2020 | $33,357,493 | - The company's accumulated deficit decreased significantly from **$(24,967,814)** at December 31, 2019, to **$(13,397,367)** at June 30, 2020, primarily due to the net income generated[18](index=18&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the financial statements, clarifying accounting policies and significant transactions [NOTE 1 – OVERVIEW AND BASIS OF PRESENTATION](index=8&type=section&id=NOTE%201%20%E2%80%93%20OVERVIEW%20AND%20BASIS%20OF%20PRESENTATION) This note describes the company's business and the foundational principles used in preparing the financial statements - CDI develops, manufactures, and sells reagents for diagnostic tests detecting nucleic acid molecules (DNA or RNA), and may also sell diagnostic equipment (MDx Device)[22](index=22&type=chunk) - The company's core technical advance is a novel Polymerase Chain Reaction (PCR) test design using 'CoPrimers' that eliminates primer-dimer issues, improving accuracy and reducing false positives/negatives[23](index=23&type=chunk) [NOTE 2 – SUMMARY of SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=NOTE%202%20%E2%80%93%20SUMMARY%20of%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the key accounting principles and methods applied in the preparation of the financial statements - Accounts receivable, net of allowance for doubtful accounts, totaled **$5,349,876** at June 30, 2020, with an allowance of **$535,389**[26](index=26&type=chunk) - Inventory is valued at the lower of cost or net-realizable value (FIFO basis), with **$10,110,786** in inventory at June 30, 2020, comprising **$3,763,472** in finished goods and **$6,347,314** in raw materials[28](index=28&type=chunk) - Research and development costs are expensed as incurred, totaling **$750,249** for the three months and **$1,150,271** for the six months ended June 30, 2020[33](index=33&type=chunk) - As an emerging growth company (EGC), the company has elected to defer adoption of certain new accounting standards, including ASU 2016-02 (Leases) until after December 15, 2020, and ASU 2016-13 (Credit Losses) until after December 15, 2021[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk) [NOTE 3 – EQUITY](index=12&type=section&id=NOTE%203%20%E2%80%93%20EQUITY) This note details changes in the company's equity structure, including stock issuances, conversions, and warrant exercises Equity Issuances and Proceeds (Six Months Ended June 30, 2020) | Transaction | Shares Issued | Gross Proceeds | Net Proceeds (after costs) | | :------------------------------------ | :------------ | :------------- | :------------------------- | | Registered Direct Offering (Jan 28) | 3,448,278 | $5,000,003 | $4,517,102 | | Registered Direct Offering (Feb 13) | 3,324,676 | $10,240,002 | $9,612,561 | | Registered Direct Offering (Mar 2) | 470,000 | $4,230,000 | $3,882,420 | | Warrant Exercises (Mar 5) | 25,000 | $50,000 | $50,000 | | Conversion of Series A Preferred Stock | 2,133,333 | N/A | N/A | | Cashless Warrant Exercises (Mar 31) | 694,492 | N/A | N/A | | Warrant Exercises (Jun 30) | 110,000 | $220,000 | $220,000 | | Option Exercises (Jun 30) | 420,289 | $643,465 | $643,465 | - During the three months ended March 31, 2020, **2,560,000** shares of Series A Preferred Stock were converted into **2,133,333** shares of common stock[46](index=46&type=chunk) [NOTE 4 – STOCK-BASED COMPENSATION](index=14&type=section&id=NOTE%204%20%E2%80%93%20STOCK-BASED%20COMPENSATION) This note describes the company's stock option and warrant activity, along with related compensation expenses Stock-Based Compensation Expense | Period | 2020 | 2019 | | :------------------------------------ | :----------- | :----------- | | Three months ended June 30 (options) | $301,568 | $126,483 | | Six months ended June 30 (options) | $703,198 | $214,278 | Stock Option Activity (Six Months Ended June 30, 2020) | Metric | Options Outstanding | Weighted Average Exercise Price | | :-------------------------- | :------------------ | :------------------------------ | | Outstanding at Jan 1, 2019 | 1,172,707 | $2.23 | | Outstanding at Dec 31, 2019 | 2,021,817 | $1.69 | | Options granted (2020) | 150,000 | $8.14 | | Exercised (2020) | (420,289) | $1.53 | | Outstanding at June 30, 2020 | 1,751,528 | $2.28 | Warrant Activity (Six Months Ended June 30, 2020) | Metric | Warrants Outstanding | Weighted Average Exercise Price | | :-------------------------- | :------------------- | :------------------------------ | | Outstanding at Jan 1, 2019 | 483,535 | $4.92 | | Outstanding at Dec 31, 2019 | 983,535 | $1.44 | | Warrants issued (2020) | 20,000 | $16.49 | | Exercised (2020) | (894,445) | $1.37 | | Outstanding at June 30, 2020 | 109,090 | $2.06 | - Total unrecognized stock-based compensation was **$468,295** at June 30, 2020, expected to be recognized over the next few years[61](index=61&type=chunk) [NOTE 5 – RELATED PARTY TRANSACTIONS](index=15&type=section&id=NOTE%205%20%E2%80%93%20RELATED%20PARTY%20TRANSACTIONS) This note discloses transactions and liabilities involving parties with a close relationship to the company - The company pays Dr. Brent Satterfield **$10,000** per month for accrued royalties under an exclusive license agreement for the CoPrimer technology[62](index=62&type=chunk) - The aggregate balance of this related party liability was **$200,000** at June 30, 2020[62](index=62&type=chunk) [NOTE 6 – LEASE OBLIGATIONS](index=15&type=section&id=NOTE%206%20%E2%80%93%20LEASE%20OBLIGATIONS) This note details the company's lease agreements, including new leases, rent expenses, and total ongoing obligations - In February 2020, the company signed a new 4-year lease for approximately **13,687 square feet** of office space at **$28,825** per month, expiring in February 2024[63](index=63&type=chunk) Rent Expense | Period | 2020 | 2019 | | :-------------------------- | :----------- | :----------- | | Three months ended June 30 | $86,969 | $45,040 | | Six months ended June 30 | $138,787 | $90,621 | - The total ongoing lease obligation as of June 30, 2020, is **$1,268,303**[63](index=63&type=chunk) [NOTE 7 – SUBSEQUENT EVENTS](index=16&type=section&id=NOTE%207%20%E2%80%93%20SUBSEQUENT%20EVENTS) This note reports significant events that occurred after the balance sheet date but before the financial statements were issued - In August 2020, approximately **$1,200,000** of finished goods inventory became unsaleable due to a freezer failure and will be written off[65](index=65&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, condition, and operational changes, highlighting COVID-19 impact, strategic developments, and liquidity [Cautionary Note Regarding Forward-Looking Statements](index=17&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This note advises readers that future-oriented statements involve risks and uncertainties, and actual results may differ materially - Forward-looking statements are identified by terms such as 'anticipates,' 'believes,' 'expects,' and 'plans,' and are based on current expectations and projections[67](index=67&type=chunk)[68](index=68&type=chunk) - Important factors that could cause actual results to differ include clinical trial results, market acceptance, intellectual property rights, litigation, competition, regulatory changes, and the ability to develop new products[71](index=71&type=chunk) [Critical Accounting Policies](index=18&type=section&id=Critical%20Accounting%20Policies) This section outlines the accounting policies requiring significant judgment and estimates, which are crucial to financial reporting - Key estimates and judgments include revenue recognition, valuation of investments and inventory, stock-based compensation expense, and litigation[72](index=72&type=chunk) - As an emerging growth company, the company has opted for the extended transition period for new or revised accounting standards, which may affect comparability with other public companies[73](index=73&type=chunk) [Executive Overview](index=18&type=section&id=Executive%20Overview) This overview provides a high-level summary of the company's financial and operational highlights for the reporting period - The discussion should be read with the unaudited financial statements and notes, and the 'Cautionary Note Regarding Forward-Looking Statements' for risks[74](index=74&type=chunk) [Overview (Business Description)](index=19&type=section&id=Overview%20(Business%20Description)) This section describes the company's core business, proprietary technology, and competitive advantages in diagnostic test development - CDI develops and manufactures reagents for diagnostic tests using its proprietary CoPrimer technology, which enhances detection of genetic material by eliminating primer-dimer issues in PCR amplification[76](index=76&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk) - The company's technology is protected by seven granted or pending US and foreign patents, trade secrets, and copyrights, allowing it to avoid patent royalties and maintain profit margins while being a low-cost provider[80](index=80&type=chunk) - CDI's tests are designed to be rapid, low-cost, and highly specific, suitable for various applications including multiplexing and enhanced SNP detection[77](index=77&type=chunk)[79](index=79&type=chunk) [Recent Developments](index=20&type=section&id=Recent%20Developments) This section highlights key recent events, including COVID-19 test development, regulatory clearances, and market authorizations - On January 23, 2020, the company announced the completion of the principle design work for a PCR screening test for COVID-19[86](index=86&type=chunk) - By February 24, 2020, the Logix Smart™ COVID-19 Test obtained regulatory clearance (CE marking) for sale as an in vitro diagnostic (IVD) in markets accepting it[87](index=87&type=chunk) - On April 6, 2020, the company received an Emergency Use Authorization (EUA) from the FDA, allowing sales of its COVID-19 test to CLIA-certified laboratories in the United States[89](index=89&type=chunk) [Infectious Disease Product Offering](index=20&type=section&id=Infectious%20Disease%20Product%20Offering) This section details the company's range of PCR diagnostic tests for various infectious diseases and their regulatory approvals - CDI offers PCR diagnostic tests for COVID-19, tuberculosis, hepatitis B and C, human papilloma virus, malaria, chikungunya, dengue, and zika virus[90](index=90&type=chunk) - The company has received CE Marks for its COVID-19, tuberculosis, Zika, and a triplex test for zika, dengue, and chikungunya[90](index=90&type=chunk) - The Logix Smart COVID-19 test received approval for manufacture and sale in India (CDSCO) and Mexico (INDRE) in April 2020, and in Australia in August 2020[90](index=90&type=chunk) [Caribbean and Central and South America](index=20&type=section&id=Caribbean%20and%20Central%20and%20South%20America) This section discusses the company's sales and market penetration strategies within the Caribbean, Central, and South American regions - Initial sales in this region focused on zika tests, followed by tuberculosis, triplex tests (zika, chikungunya, dengue), and hepatitis B and C[95](index=95&type=chunk) - Significant sales in this region commenced after the Logix Smart COVID-19 test received its CE Mark[95](index=95&type=chunk) [India](index=21&type=section&id=India) This section outlines the operations and performance of the Indian joint venture, including COVID-19 test manufacturing and market activities - CoSara Diagnostics, Pvt., the Indian joint venture, received authorization to begin manufacture and sale of COVID-19 tests (branded SaraGene COVID-19) in India on March 19, 2020[98](index=98&type=chunk) - CoSara became profitable for the quarter ending June 30, 2020, despite commercial activity restrictions until May 2020[98](index=98&type=chunk) - The joint venture has placed twenty-one MDx Devices with labs in India under a reagent rental program, requiring a minimum purchase of **250 tests** per month[97](index=97&type=chunk) [Europe](index=21&type=section&id=Europe) This section details the company's certifications and CE Mark approvals, enabling product sales in European and other accepting markets - The company has received ISO 13485 and ISO 9001 certifications for the design and manufacture of its medical device products[101](index=101&type=chunk) - CDI has obtained CE Marks for its COVID-19, tuberculosis, Zika, and zika/dengue/chikungunya triplex tests, allowing sales in the European Community and other countries that accept CE marking[100](index=100&type=chunk) [United States](index=22&type=section&id=United%20States) This section covers the company's regulatory approvals and market access for its diagnostic products within the United States - The FDA granted Emergency Use Authorization (EUA) for the LogixSmart COVID-19 test, permitting sales to qualified CLIA labs in the United States[103](index=103&type=chunk) - The company's other IVD products are approved for export under Section 801(e) of the FDC Act but have not yet undergone Premarket Approval steps with the FDA for U.S. sales[103](index=103&type=chunk) [Market Opportunity](index=22&type=section&id=Market%20Opportunity) This section assesses the global market for molecular diagnostics, highlighting the company's distribution network and growth potential - The COVID-19 pandemic enabled the company to establish a distribution network in over **80 countries** with more than **50 active distributors**[105](index=105&type=chunk) - The molecular diagnostics market is a fast-growing segment, offering advantages such as higher specificity, sensitivity, multiplex testing, and the ability to test for drug resistance[106](index=106&type=chunk) Estimated Global Annual Demand for Diagnostic Tests | Disease | Estimated Annual Tests | | :------------------------------ | :------------- | | Tuberculosis | 10,400,000 | | Multi-drug resistant Tuberculosis | 580,000 | | Zika | 324,000,000 | | Hepatitis B | 240,000,000 | | Hepatitis C | 130,000,000 | | HIV | 36,700,000 | | Malaria | 214,000,000 | | Sexually Transmitted Illnesses | 357,000,000 | | Human papilloma virus | 291,000,000 | | Dengue | 390,000,000 | | **Total Annual Tests** | **1,993,680,000** | [Mosquito Vector Control Services](index=22&type=section&id=Mosquito%20Vector%20Control%20Services) This section describes the company's diagnostic tests for mosquito-borne pathogens and their application in vector control - The company introduced diagnostics tests for mosquito-borne pathogens in June 2019, including triplex tests for West Nile, Western Equine, St. Louis encephalitis, and another for Zika, Chikungunya, and Dengue[107](index=107&type=chunk)[108](index=108&type=chunk) - These tests allow for rapid results (hours instead of weeks), enabling more effective and cost-efficient mosquito spraying operations for abatement districts[110](index=110&type=chunk) [Competitive Advantages of Co-Diagnostics](index=23&type=section&id=Competitive%20Advantages%20of%20Co-Diagnostics) This section highlights the company's key competitive strengths, including affordability, flexibility, speed, and proprietary technology - Key advantages include affordability (low-cost test kits and MDx Device), flexibility (tests run on many DNA diagnostic machines), and speed (rapid assay design system software, e.g., **30 days** for COVID-19 test)[112](index=112&type=chunk)[113](index=113&type=chunk) - The company claims higher accuracy (more sensitive and specific tests, detecting more virus strains) and exclusivity due to owning all patents and intellectual property for its tests[114](index=114&type=chunk)[115](index=115&type=chunk) - CDI operates as a low-cost provider by avoiding patent royalties required by competitors, and its technology is well-suited for multiplexing and new generation point-of-care devices[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk) [Liquid Biopsy for Cancer Screening](index=24&type=section&id=Liquid%20Biopsy%20for%20Cancer%20Screening) This section explores the application of the company's technology in liquid biopsy for cancer detection, prognosis, and treatment monitoring - The company's technology, by eliminating primer-dimers, is uniquely suited for liquid biopsy in cancer detection, allowing for multiplexed testing of several DNA targets in a single blood sample[121](index=121&type=chunk)[122](index=122&type=chunk) - The liquid biopsy test aims to identify specific mutations in genes linked to cancer, determine prognosis, guide effective treatment, and allow for frequent, affordable monitoring of treatment efficacy[121](index=121&type=chunk) [Agricultural Applications](index=24&type=section&id=Agricultural%20Applications) This section details the use of the company's SNP detection technology in agriculture for crop improvement and licensing arrangements - SNP detection technology is used in agriculture to identify crop genome variations for improved seed viability and resistance to drought, disease, and pests[122](index=122&type=chunk) - An exclusive worldwide licensing arrangement for CoPrimers in the agricultural industry was completed in October 2018, with the licensee paying royalties for CoPrimers sold[123](index=123&type=chunk) [Additional Licensing and Assay Development](index=25&type=section&id=Additional%20Licensing%20and%20Assay%20Development) This section discusses expanded licensing agreements and custom diagnostic design services for various gene sequence applications - The license agreement for agricultural testing was amended in July 2019 to include test design services for customers in both infectious disease and agriculture, generating license fees[125](index=125&type=chunk) - Research companies and institutions are requesting custom diagnostic designs to locate and identify uncommon gene sequences and SNPs in multiplexed reactions, indicating potential for future revenue-producing licensing arrangements[125](index=125&type=chunk) [Intellectual Property Protection](index=25&type=section&id=Intellectual%20Property%20Protection) This section outlines the company's granted and pending patents, copyrights, and strategy for intellectual property portfolio expansion - Five U.S. patents related to the company's technology have been granted, including the CoPrimer technology patent, with one patent issued in Great Britain and two additional patents pending in the U.S[126](index=126&type=chunk) - The company has copyrighted its development software used for diagnostic test development and intends to build its intellectual property portfolio further[128](index=128&type=chunk) [Major Customers](index=25&type=section&id=Major%20Customers) This section identifies the company's significant customers and the potential impact of their loss on financial condition - Three customers generated approximately **58%** of total revenue for the three months ended June 30, 2020, and **55%** for the six months ended June 30, 2020[129](index=129&type=chunk) - The loss of these major customers could have a material adverse effect on the company's financial condition[129](index=129&type=chunk) [Competition](index=25&type=section&id=Competition) This section describes the highly competitive molecular diagnostics industry and the intense competition in the COVID-19 test market - The molecular diagnostics industry is extremely competitive, with larger competitors like BioMerieux, Siemens, Qiagen, Cepheid, Abbott Laboratories, Becton Dickinson, and Johnson and Johnson[130](index=130&type=chunk) - Competition in the COVID-19 diagnostic test market is intense, with many established and emerging companies, some supported by government funding, developing new products and technologies[133](index=133&type=chunk)[134](index=134&type=chunk) [Employees](index=26&type=section&id=Employees) This section provides information on the company's full-time personnel and independent contractors across various locations - The company employs **37 full-time personnel** in Salt Lake City, Utah, and two outside Utah, along with independent contractors in India and sales representatives[135](index=135&type=chunk) [Government Regulation](index=26&type=section&id=Government%20Regulation) This section details the regulatory approvals and authorizations for the company's diagnostic products in various global markets - In the U.S., the company's Logix Smart COVID-19 test has an Emergency Use Authorization (EUA) from the FDA for sales to CLIA labs[136](index=136&type=chunk) - The company has CE Marks for its COVID-19, tuberculosis, Zika, and triplex tests, allowing sales in most countries in Europe, South America, and Asia[136](index=136&type=chunk) - The Logix Smart COVID-19 test is licensed for manufacture and sale in India (CDSCO) and approved for sale in Mexico (INDRE)[136](index=136&type=chunk) [Organizational History and Corporate Information](index=26&type=section&id=Organizational%20History%20and%20Corporate%20Information) This section provides the company's incorporation details and the location of its principal executive office - Co-Diagnostics, Inc. was incorporated in Utah on April 18, 2013[137](index=137&type=chunk) - The principal executive office is located at 2401 S. Foothill Drive, Suite D, Salt Lake City, Utah 84109[137](index=137&type=chunk) [RESULTS OF OPERATIONS](index=26&type=section&id=RESULTS%20OF%20OPERATIONS) This section analyzes the company's financial performance, detailing revenue, cost of sales, and operating expenses [Results of Operations for the Six Months ended June 30, 2020 and 2019](index=26&type=section&id=Results%20of%20Operations%20for%20the%20Six%20Months%20ended%20June%2030,%202020%20and%202019) This section compares the company's financial results for the six-month periods ended June 30, 2020, and 2019 [Net Sales](index=26&type=section&id=Net%20Sales%20(Six%20Months)) This section analyzes the company's total revenue generated from product sales for the six-month period Net Sales (Six Months Ended June 30) | Metric | 2020 | 2019 | Change | | :------- | :----------- | :------- | :----- | | Net Sales | $25,588,802 | $64,974 | +39280.0% | - The increase of **$25,523,828** was primarily due to sales of the LogixSmart COVID-19 test. Of the total sales in 2020, **$1,782,312** was from third-party manufactured equipment[138](index=138&type=chunk) [Cost of Sales](index=26&type=section&id=Cost%20of%20Sales%20(Six%20Months)) This section details the direct costs associated with the goods sold, including reagents and equipment, for the six-month period Cost of Sales (Six Months Ended June 30) | Metric | 2020 | 2019 | Change | | :---------- | :----------- | :------- | :----- | | Cost of Sales | $8,826,414 | $39,261 | +22380.0% | - In 2020, cost of sales included **$7,175,019** for test reagents and **$1,651,395** for equipment sold, reflecting the significant increase in sales volume[139](index=139&type=chunk) [Operating Expenses](index=27&type=section&id=Operating%20Expenses%20(Six%20Months)) This section provides an overview of the total operating expenses incurred during the six-month period Total Operating Expenses (Six Months Ended June 30) | Metric | 2020 | 2019 | Change | | :------------------- | :----------- | :----------- | :----- | | Total Operating Expenses | $5,505,429 | $2,645,969 | +108.1% | - The increase was due to higher business activities driven by COVID-19 test sales[141](index=141&type=chunk) [General and administrative expenses](index=27&type=section&id=General%20and%20administrative%20expenses%20(Six%20Months)) This section details the non-production related expenses, including professional services, bad debt, and stock-based compensation General and Administrative Expenses (Six Months Ended June 30) | Metric | 2020 | 2019 | Change | | :-------------------------------- | :----------- | :----------- | :----- | | General and administrative expenses | $3,650,518 | $1,448,132 | +152.1% | - Increases were driven by **$888,572** in professional services, **$514,266** in bad debt expense, **$488,920** in stock-based compensation, and **$112,935** in salaries and benefits[142](index=142&type=chunk) [Sales and marketing](index=27&type=section&id=Sales%20and%20marketing%20expenses%20(Six%20Months)) This section analyzes expenses related to promoting and selling products, including salaries, advertising, and travel Sales and Marketing Expenses (Six Months Ended June 30) | Metric | 2020 | 2019 | Change | | :-------------------- | :----------- | :----------- | :----- | | Sales and marketing expenses | $658,674 | $508,179 | +29.6% | - The increase was due to higher salaries and benefits (**$131,903**) and advertising (**$23,966**), partially offset by reduced travel (**$43,462**) due to the pandemic[143](index=143&type=chunk) [Research and development](index=27&type=section&id=Research%20and%20development%20expenses%20(Six%20Months)) This section details expenses incurred for developing new products and improving existing ones, including professional services and lab supplies Research and Development Expenses (Six Months Ended June 30) | Metric | 2020 | 2019 | Change | | :-------------------------- | :----------- | :----------- | :----- | | Research and development expenses | $1,150,271 | $659,896 | +74.3% | - The increase was primarily due to **$193,117** in professional services for freeze-drying COVID-19 tests, **$113,946** in salaries for lab personnel, and **$89,252** in lab supplies[144](index=144&type=chunk) [Interest Expense](index=27&type=section&id=Interest%20Expense%20(Six%20Months)) This section reports the company's interest income and expense, reflecting changes in debt obligations and cash balances Interest Expense and Income (Six Months Ended June 30) | Metric | 2020 | 2019 | Change | | :------------- | :------- | :------- | :----- | | Interest Expense | $0 | $28,187 | -100.0% | | Interest Income | $45,748 | $20,049 | +128.2% | - The decrease in interest expense was due to the payoff of a **$2,000,000** loan in January 2019[145](index=145&type=chunk) [Net Income](index=27&type=section&id=Net%20Income%20(Six%20Months)) This section presents the company's overall profitability, driven by COVID-19 test sales and joint venture income Net Income (Loss) (Six Months Ended June 30) | Metric | 2020 | 2019 | Change | | :----------- | :----------- | :----------- | :----- | | Net Income (Loss) | $11,570,447 | $(2,712,785) | N/A | - The **$14,283,232** increase in net income was primarily due to sales of the LogixSmart COVID-19 test and resulting margins, along with income from the Indian joint venture (**$267,740** vs. **$7,000** loss in 2019)[146](index=146&type=chunk) [The three months ended June 30, 2020 compared to the three months ended June 30, 2019](index=27&type=section&id=The%20three%20months%20ended%20June%2030,%202020%20compared%20to%20the%20three%20months%20ended%20June%2030,%202019) This section compares the company's financial results for the three-month periods ended June 30, 2020, and 2019 [Revenues](index=27&type=section&id=Revenues%20(Three%20Months)) This section analyzes the company's total revenue generated from product sales for the three-month period Revenues (Three Months Ended June 30) | Metric | 2020 | 2019 | Change | | :------- | :----------- | :------- | :----- | | Revenues | $24,040,274 | $61,574 | +39090.0% | - The revenue primarily represented sales of the LogixSmart COVID-19 test, with **$1,676,820** from third-party manufactured equipment sales[147](index=147&type=chunk) [Cost of Revenues](index=28&type=section&id=Cost%20of%20Revenues%20(Three%20Months)) This section details the direct costs associated with the goods sold, including equipment, for the three-month period Cost of Revenues (Three Months Ended June 30) | Metric | 2020 | 2019 | Change | | :------------- | :----------- | :------- | :----- | | Cost of Revenues | $8,344,674 | $38,809 | +21410.0% | - The increase was directly linked to the surge in LogixSmart COVID-19 test sales, with **$1,580,968** attributed to equipment sold[148](index=148&type=chunk) [Expenses](index=28&type=section&id=Expenses%20(Three%20Months)) This section provides an overview of the total operating expenses incurred during the three-month period Total Operating Expenses (Three Months Ended June 30) | Metric | 2020 | 2019 | Change | | :------------------- | :----------- | :----------- | :----- | | Total Operating Expenses | $3,356,692 | $1,388,529 | +141.7% | - The increase of **$1,968,163** was primarily due to increased general and administrative costs (**$1,383,264**) and research and development expenses (**$437,659**)[150](index=150&type=chunk) [General and administrative expenses](index=28&type=section&id=General%20and%20administrative%20expenses%20(Three%20Months)) This section details the non-production related expenses, including professional services, bad debt, and stock-based compensation General and Administrative Expenses (Three Months Ended June 30) | Metric | 2020 | 2019 | Change | | :-------------------------------- | :----------- | :----------- | :----- | | General and administrative expenses | $2,191,034 | $807,769 | +171.3% | - Increases were mainly from professional services (**$511,607**), bad debt expense reserves (**$483,266**), and option/warrant expense (**$175,085**)[151](index=151&type=chunk) [Sales and marketing expenses](index=28&type=section&id=Sales%20and%20marketing%20expenses%20(Three%20Months)) This section analyzes expenses related to promoting and selling products, including salaries, 401K contributions, and travel Sales and Marketing Expenses (Three Months Ended June 30) | Metric | 2020 | 2019 | Change | | :-------------------- | :----------- | :----------- | :----- | | Sales and marketing expenses | $390,191 | $252,076 | +54.8% | - The increase was due to higher salaries and benefits (**$114,394**) and 401K contributions (**$21,600**), partially offset by reduced travel (**$30,004**) due to the pandemic[152](index=152&type=chunk) [Research and development expenses](index=28&type=section&id=Research%20and%20development%20expenses%20(Three%20Months)) This section details expenses incurred for developing new products and improving existing ones, including payroll and professional services Research and Development Expenses (Three Months Ended June 30) | Metric | 2020 | 2019 | Change | | :-------------------------- | :----------- | :----------- | :----- | | Research and development expenses | $750,249 | $312,590 | +140.0% | - Increases were primarily from payroll and employee-related expenses (**$191,292**) and professional services for freeze-drying tests (**$196,226**)[153](index=153&type=chunk) [Other Income/Expense](index=28&type=section&id=Other%20Income/Expense%20(Three%20Months)) This section reports non-operating income and expenses, including gains from the India joint venture and interest income Total Other Income (Three Months Ended June 30) | Metric | 2020 | 2019 | Change | | :----------------- | :----------- | :----------- | :----- | | Total Other Income | $296,732 | $21,368 | +1288.0% | - The increase was due to a gain of **$258,559** from the India joint venture (compared to **$1,728** in 2019) and an increase of **$18,533** in interest income[154](index=154&type=chunk) [Net Income](index=28&type=section&id=Net%20Income%20(Three%20Months)) This section presents the company's overall profitability, driven by increased gross profit from COVID-19 test sales Net Income (Loss) (Three Months Ended June 30) | Metric | 2020 | 2019 | Change | | :---------------- | :----------- | :----------- | :----- | | Net Income (Loss) | $12,635,640 | $(1,344,396) | N/A | - The income was driven by increased gross profit from LogixSmart COVID-19 test sales, partially offset by higher operating expenses[155](index=155&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet short-term obligations and fund operations, detailing cash, assets, and financing activities Liquidity Position (June 30, 2020) | Metric | Amount | | :-------------------------- | :----------- | | Cash and cash equivalents | $18,550,437 | | Total current assets | $34,532,279 | | Total current liabilities | $2,984,642 | | Total stockholders' equity | $33,357,493 | - Net cash used in operations for the six months ended June 30, 2020, was **$(348,459)**, a significant improvement from **$(2,697,691)** in the prior year[158](index=158&type=chunk) - Financing activities provided **$18,062,083** in net proceeds from registered direct offerings and **$913,465** from warrant/option exercises, funding operations and investments[158](index=158&type=chunk) - The company believes it has sufficient capital to fund operations for the next **12 months** and does not expect to require additional capital in the foreseeable future, absent significant acquisitions or capital expansion[157](index=157&type=chunk)[170](index=170&type=chunk) [Off-Balance Sheet Arrangements](index=29&type=section&id=Off-Balance%20Sheet%20Arrangements) This section discloses any financial arrangements not recorded on the balance sheet that could impact the company's financial condition - The company has no off-balance sheet arrangements[172](index=172&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not required for smaller reporting companies under Regulation S-K - Not required under Regulation S-K for 'smaller reporting companies'[174](index=174&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of June 30, 2020, due to a material weakness in accounting and tax expertise [Evaluation of Disclosure Controls and Procedures](index=30&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section details the assessment of the company's disclosure controls and procedures, identifying material weaknesses - As of June 30, 2020, disclosure controls and procedures were deemed not effective due to material weaknesses in internal control over financial reporting[175](index=175&type=chunk) - The material weakness identified was a lack of sufficient technical expertise on certain accounting and tax requirements for new and unusual transactions[177](index=177&type=chunk) - Remediation efforts include increasing consultant involvement and hiring additional accounting staff, but the weakness is not considered remediated until controls operate effectively for a sufficient period[177](index=177&type=chunk) [Changes in Internal Control over Financial Reporting](index=30&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports any material changes in internal control over financial reporting during the quarter, including remediation efforts - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2020, other than remediation efforts for previously reported material weaknesses[178](index=178&type=chunk) [PART II. OTHER INFORMATION](index=30&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part includes legal proceedings, risk factors, equity sales, and other significant disclosures not covered in financial statements [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company faces a lawsuit alleging false press releases to inflate stock price and a threatened suit from former consultants - On July 16, 2020, a lawsuit was filed alleging the company promulgated false and misleading press releases to improperly benefit officers and directors, seeking compensatory damages[180](index=180&type=chunk) - A threatened lawsuit from former consultants claims compensation for services rendered in 2015[181](index=181&type=chunk) - The company intends to vigorously defend both actions, believing they lack merit[180](index=180&type=chunk)[181](index=181&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant business risks, including limited commercial history and COVID-19 market dependence, and common stock ownership risks [Risks Related to Our Business and Industry](index=31&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) This section details risks associated with the company's limited operating history and reliance on the volatile COVID-19 test market - The company has a limited operating history and, despite recent profitability, cannot guarantee sustained future profitability, especially given the unpredictable duration of demand for its COVID-19 test[184](index=184&type=chunk)[185](index=185&type=chunk) - Future success is highly dependent on continued demand for the COVID-19 test and the ability to develop and market other commercially accepted diagnostic tests, which faces challenges like customer acceptance, competition, and manufacturing capacity[186](index=186&type=chunk)[187](index=187&type=chunk) [Risks Related to Owning our Common Stock and Other Securities](index=32&type=section&id=Risks%20Related%20to%20Owning%20our%20Common%20Stock%20and%20Other%20Securities) This section outlines risks for common stock owners, including price fluctuations, future sales, anti-takeover provisions, and potential delisting - The price of common stock may fluctuate substantially due to factors like sales by shareholders, market acceptance of products, financing needs, regulatory approvals, competition, and general economic conditions[189](index=189&type=chunk) - Future sales of common stock by existing shareholders or upon exercise of options/warrants could cause the stock price to decline and impair the ability to raise future capital[191](index=191&type=chunk)[193](index=193&type=chunk) - Anti-takeover provisions in charter documents and Utah law, such as 'blank check' preferred stock and limitations on calling special meetings, could discourage or prevent a change of control[194](index=194&type=chunk)[195](index=195&type=chunk) - Potential NASDAQ delisting due to failure to meet listing requirements could negatively impact stock price, liquidity, and future financing capabilities[196](index=196&type=chunk)[198](index=198&type=chunk) - The company does not currently intend to pay dividends on its common stock, and future payments are at the discretion of the board[201](index=201&type=chunk) - As an 'emerging growth company,' the company avails itself of reduced disclosure requirements, which might make its common stock less attractive to some investors and potentially increase stock price volatility[202](index=202&type=chunk)[203](index=203&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued unregistered equity securities, including warrants and common stock for services and exercises, relying on Section 4(a)(2) - On April 1, 2020, a warrant to acquire up to **20,000 shares** of common stock at **$1.40** was issued to a consultant[207](index=207&type=chunk) - On June 30, 2020, **9,689 shares** of common stock were issued for services rendered under consulting agreements[207](index=207&type=chunk) - In June 2020, **110,000 shares** of stock were issued upon the exercise of warrants at **$2.00** per share[208](index=208&type=chunk) [Item 3. Defaults Upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[210](index=210&type=chunk) [Item 4. Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[211](index=211&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) This section includes disclosures of subsequent events not previously reported [Subsequent Events](index=35&type=section&id=Subsequent%20Events) This section reports significant events that occurred after the balance sheet date but before the financial statements were issued - In August 2020, a freezer failure resulted in approximately **$1,200,000** of finished goods inventory becoming unsaleable and will be written off[212](index=212&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications from the CEO and CFO, and XBRL interactive data files Exhibit Index Highlights | Exhibit Number | Description | | :------------- | :---------- | | 31.1* | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | 31.2* | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | | 32.1* | Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | 32.2* | Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | 104 | Cover Page Interactive Data File | [Signatures](index=36&type=section&id=Signatures) The report is duly signed by Dwight H. Egan, President and CEO, and Reed L. Benson, CFO, on August 13, 2020 - The report was signed by Dwight H. Egan, President and CEO, and Reed L. Benson, CFO, on August 13, 2020[217](index=217&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share CODX NASDAQ-CM FORM 10-Q [X] Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2020 OR [ ] Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to __________ Commis ...

PART I [Business Overview](index=5&type=section&id=Item%201.%20Business%2E) Co-Diagnostics, Inc. develops molecular diagnostic tools using proprietary Co-Primer PCR technology for rapid, accurate, and low-cost testing - Co-Diagnostics, Inc. develops, manufactures, and sells reagents and diagnostic equipment for molecular diagnostic tests, covering infectious diseases, liquid biopsy for cancer screening, and agricultural applications[17](index=17&type=chunk)[81](index=81&type=chunk) - The company's proprietary Co-Primer PCR test design eliminates primer-dimer pairs, enabling **rapid, low-cost, and accurate molecular testing**, protected by **seven granted or pending US and foreign patents**[18](index=18&type=chunk)[21](index=21&type=chunk)[24](index=24&type=chunk)[82](index=82&type=chunk)[85](index=85&type=chunk)[89](index=89&type=chunk) - In January 2020, the company completed the design for a **COVID-19 PCR screening test** and obtained **CE-marking regulatory clearance by February 24, 2020**, enabling sales in Europe and other markets[28](index=28&type=chunk)[29](index=29&type=chunk)[31](index=31&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) - CDI has obtained regulatory approval in Europe and India for PCR diagnostic tests covering **COVID-19, tuberculosis, hepatitis B and C, human papilloma virus, Malaria, chikungunya, dengue, and Zika virus**[26](index=26&type=chunk)[30](index=30&type=chunk)[39](index=39&type=chunk)[90](index=90&type=chunk) - The company formed an Indian joint venture, CoSara Diagnostics, Pvt., to manufacture and sell diagnostic tests in India, receiving a license for **five tests in December 2019** and submitting for COVID-19 approval[36](index=36&type=chunk)[37](index=37&type=chunk)[94](index=94&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk) - In June 2019, the company introduced diagnostics tests for mosquito DNA, including triplex tests for West Nile/Western Equine/St. Louis encephalitis and Zika/chikungunya/dengue, offering **rapid results** at competitive costs of **$10-$15 per triplex test**[45](index=45&type=chunk)[46](index=46&type=chunk) Estimated Global Annual Demand for Diagnostic Tests | Disease | Estimated Annual Tests | | :-------------------------------- | :------------------- | | Tuberculosis | 10,400,000 | | Multi-drug resistant Tuberculosis | 580,000 | | Zika | 324,000,000 | | Hepatitis B | 240,000,000 | | Hepatitis C | 130,000,000 | | HIV | 36,700,000 | | Malaria | 214,000,000 | | Sexually Transmitted Illnesses | 357,000,000 | | Human papilloma virus | 291,000,000 | | Dengue | 390,000,000 | | **Total Annual Tests** | **1,993,680,000** | - Key competitive advantages include **affordability, flexibility, speed** (e.g., 30 days for COVID-19 assay design), **accuracy, intellectual property exclusivity, and multiplexing capabilities**[48](index=48&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) - The company is developing liquid biopsy tests for cancer screening, expected in **2020**, and holds an exclusive worldwide licensing arrangement for CoPrimers in agriculture, generating royalties[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk) - Co-Diagnostics is an **'emerging growth company'** and **'smaller reporting company,'** benefiting from exemptions from certain SEC disclosure requirements and an extended transition period for new accounting standards[62](index=62&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) [Risk Factors](index=12&type=section&id=Item%201A.%20Risk%20Factors%2E) As a smaller reporting company, the registrant is exempt from providing specific risk factor disclosures in this annual report section - This section is not applicable to smaller reporting companies[66](index=66&type=chunk) [Unresolved Staff Comments](index=12&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments%2E) The company has no unresolved staff comments from the Securities and Exchange Commission - There are no unresolved staff comments[67](index=67&type=chunk) [Properties](index=13&type=section&id=Item%202.%20Properties%2E) The company's primary operational facilities in Salt Lake City, Utah, are under a month-to-month lease, with longer-term negotiations underway - Executive offices and lab facilities are located at **2401 S. Foothill Drive, Salt Lake City, Utah 84109**[69](index=69&type=chunk) - The company occupies approximately **10,273 square feet** under a month-to-month lease at **$14,831 per month**, with negotiations for a longer-term lease underway[69](index=69&type=chunk) - The company has no other properties[69](index=69&type=chunk) [Legal Proceedings](index=13&type=section&id=Item%203.%20Legal%20Proceedings%2E) The company is defending a libel lawsuit in Florida and has responded to FINRA and NASDAQ inquiries regarding stock price fluctuations - One lawsuit alleging libel is pending in Florida, which the company believes is groundless and will be vigorously defended[70](index=70&type=chunk) - The company has received and responded to inquiries from FINRA and NASDAQ concerning a sudden rise in its stock price[70](index=70&type=chunk) - To management's knowledge, no governmental authority is contemplating any proceeding likely to have a material adverse effect on the company[70](index=70&type=chunk) [Mine Safety Disclosures](index=13&type=section&id=Item%204.%20Mine%20Safety%20Disclosures%2E) This item is not applicable to the company's operations - This item is not applicable[71](index=71&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=13&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities%2E) The company's common stock trades on NASDAQ under 'CODX', experienced significant volatility, with **27 million shares outstanding** as of March 2020, and no dividends paid or equity repurchases made - The company's common stock has been quoted on the NASDAQ market under the symbol **'CODX' since July 12, 2017**[73](index=73&type=chunk) Common Stock High and Low Prices | Period | High ($) | Low ($) | | :-------------------------------- | :------- | :------ | | **2020 (through March 15)** | 21.75 | 0.88 | | **2019** | | | | First Quarter | 3.77 | 0.90 | | Second Quarter | 1.20 | 0.69 | | Third Quarter | 2.00 | 0.79 | | Fourth Quarter | 1.20 | 0.85 | | **2018** | | | | First Quarter | 3.27 | 1.45 | | Second Quarter | 6.66 | 1.57 | | Third Quarter | 4.30 | 2.60 | | Fourth Quarter | 3.10 | 1.15 | - As of March 22, 2020, **27,438,701 shares of common stock** were outstanding, held by approximately **336 record holders** as of March 13, 2020[6](index=6&type=chunk)[75](index=75&type=chunk) - The company has never declared or paid cash dividends and plans to retain all available funds for future business development and expansion[76](index=76&type=chunk) - The company relied on the exemption from registration under **Section 4(2) of the Securities Act** for recent issuances of unregistered securities[78](index=78&type=chunk) - There were no purchases of equity securities by the issuer or affiliated purchasers[79](index=79&type=chunk) [Selected Financial Data](index=14&type=section&id=Item%206.%20Selected%20Financial%20Data%2E) As a smaller reporting company, Co-Diagnostics is not required to provide selected financial data in this annual report - Selected financial data is not required for the company[80](index=80&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%2E) This section analyzes Co-Diagnostics' 2019 and 2018 financial condition and operations, highlighting molecular diagnostics, recent product developments, market expansions, and liquidity maintained through significant early 2020 capital raises [Overview](index=14&type=section&id=Overview) This overview details Co-Diagnostics' molecular diagnostic business, proprietary Co-Primer PCR technology, recent COVID-19 test development, Indian joint venture, intellectual property, competitive landscape, and regulatory compliance - Co-Diagnostics, Inc. develops and sells molecular tools for infectious disease detection, cancer screening, and agricultural applications, utilizing proprietary Co-Primer PCR technology to automate and simplify testing[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk)[88](index=88&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk) - The company completed the design for a **COVID-19 PCR screening test on January 23, 2020**, and obtained **CE-marking regulatory clearance by February 24, 2020**, for sales in Europe and other markets[92](index=92&type=chunk)[93](index=93&type=chunk) - The Indian joint venture, CoSara Diagnostics, obtained regulatory clearance for **five IVD tests in December 2019**, with additional tests (including COVID-19) submitted or planned for 2020[94](index=94&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk) - The company's intellectual property includes **four granted U.S. patents** (including CoPrimer technology) and **three additional pending patents**, along with copyrighted development software[100](index=100&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) - The molecular diagnostics industry is highly competitive, with larger firms posing a challenge due to greater financial resources and established customer bases[104](index=104&type=chunk)[106](index=106&type=chunk) - The company employs **23 full-time personnel** in Utah and two outside, supplemented by independent contractors and sales representatives[107](index=107&type=chunk) - Co-Diagnostics is regulated by the **U.S. FDA**, holds **CE Marks** for several tests (including COVID-19), and its Indian joint venture is regulated by the **CDSCO**[108](index=108&type=chunk) - The company's executive offices and lab facilities in Salt Lake City, Utah, are leased month-to-month, covering approximately **10,273 square feet** at **$14,831 per month**[109](index=109&type=chunk) - A libel lawsuit is pending in Florida, which the company believes is groundless, and inquiries from FINRA and NASDAQ regarding stock price fluctuations have been addressed[110](index=110&type=chunk) [RESULTS OF OPERATIONS](index=17&type=section&id=RESULTS%20OF%20OPERATIONS) This section analyzes Co-Diagnostics' 2019 versus 2018 financial performance, detailing increased net sales and gross profit, decreased operating expenses, and a slight reduction in net loss Consolidated Statements of Operations (2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | Change ($) | Change (%) | | :-------------------------------- | :--------- | :--------- | :--------- | :--------- | | Net sales | 214,974 | 39,911 | 175,063 | 438.6% | | Cost of sales | 112,431 | 9,391 | 103,040 | 1097.2% | | Gross profit | 102,543 | 30,520 | 72,023 | 236.0% | | Total operating expenses | 5,996,284 | 6,148,336 | (152,052) | (2.5%) | | Total operating loss | (5,893,741) | (6,117,816) | 224,075 | (3.7%) | | Total other expense | (301,816) | (153,907) | (147,909) | 96.1% | | Loss before income taxes | (6,195,557) | (6,271,723) | 76,166 | (1.2%) | | Net loss | (6,195,557) | (6,271,723) | 76,166 | (1.2%) | | Net loss per share – basic and diluted | (0.36) | (0.50) | 0.14 | (28.0%) | | Weighted average shares – basic and diluted | 16,756,912 | 12,484,617 | 4,272,295 | 34.2% | Revenue Breakdown (2019 vs. 2018) | Revenue Source | 2019 ($) | 2018 ($) | | :----------------------- | :--------- | :--------- | | Testing equipment sales | 128,124 | 10,123 | | Agriculture license sales | 50,000 | 29,088 | | Diagnostic test sales | 36,850 | 700 | | **Total Net Sales** | **214,974** | **39,911** | - Cost of sales increased by **$103,040** in 2019, primarily due to higher equipment sales, resulting in a gross profit of **$102,543**, up from **$30,520 in 2018**[114](index=114&type=chunk) - Total operating expenses decreased by **$152,052** in 2019, driven by a **$73,513 decrease in general and administrative expenses** and a **$103,955 decrease in sales and marketing expenses**, partially offset by a **$10,279 increase in research and development expenses**[115](index=115&type=chunk)[116](index=116&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk) - Interest and other expense increased by **$147,909** in 2019, mainly due to an increased loss from the India joint venture (**$194,117**) and a **$78,241 loss on debt extinguishment**[119](index=119&type=chunk) - The net loss decreased by **$76,166** to **$6,195,557 in 2019**, compared to **$6,271,723 in 2018**[120](index=120&type=chunk) [LIQUIDITY AND CAPITAL RESOURCES](index=20&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) This section details Co-Diagnostics' liquidity and capital resources, highlighting cash flow changes, significant capital raises in 2019 and early 2020, and sufficient cash for the next twelve months Key Financial Position (December 31, 2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | Change ($) | | :-------------------------- | :--------- | :--------- | :--------- | | Cash and cash equivalents | 893,138 | 950,237 | (57,099) | | Total current assets | 1,584,254 | 1,051,913 | 532,341 | | Total current liabilities | 328,070 | 2,351,983 | (2,023,913) | | Total stockholders' equity (deficit) | 1,737,256 | (1,058,811) | 2,796,067 | - Net cash used in operating activities increased to **$5,525,091 in 2019** from **$4,080,036 in 2018**[124](index=124&type=chunk)[155](index=155&type=chunk) - In 2019, the company received net proceeds of **$5,000,000** from a registered direct offering and approximately **$1,000,000** from preferred stock sales, and converted **$2,000,000 of debt to preferred stock**[124](index=124&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk)[155](index=155&type=chunk) - In early 2020, the company raised approximately **$19.2 million in gross proceeds** from three registered direct offerings of common stock (**January 23: $5.0 million; February 10: $10.2 million; February 28: $4.0 million**)[126](index=126&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk)[232](index=232&type=chunk)[233](index=233&type=chunk)[235](index=235&type=chunk) - Additional financing in early 2020 included **$50,000 from warrant exercises**, the cashless exercise of **759,445 warrants for 694,492 common shares**, and the conversion of all **25,600 preferred shares to 2,133,333 common shares**[129](index=129&type=chunk)[236](index=236&type=chunk) - At current operating expenditures (approximately **$460,000 per month in 2019**), the company has sufficient cash to fund operations for the next **twelve months** and does not expect to raise additional capital without significant acquisitions or capital expansion[125](index=125&type=chunk)[133](index=133&type=chunk) - Long-term capital needs for commercialization and future development of diagnostic tests are estimated at approximately **$1,350,000 annually**[134](index=134&type=chunk) - As of December 31, 2019, the company had no off-balance sheet arrangements[135](index=135&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk%2E) This section is not required for Co-Diagnostics as it qualifies as a smaller reporting company under SEC regulations - This disclosure is not required for the company[136](index=136&type=chunk) [Financial Statements and Supplementary Data](index=22&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data%2E) This section presents Co-Diagnostics' audited consolidated financial statements for 2019 and 2018, including balance sheets, statements of operations, equity changes, cash flows, and notes, with an unqualified audit opinion [Report of Independent Registered Public Accounting Firm](index=23&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Haynie & Company issued an unqualified audit opinion on Co-Diagnostics' 2019 and 2018 consolidated financial statements, affirming fair presentation in accordance with GAAP - Haynie & Company issued an **unqualified opinion** on the consolidated financial statements for **December 31, 2019 and 2018**, affirming fair presentation of financial position, results of operations, and cash flows in conformity with GAAP[141](index=141&type=chunk) - Haynie & Company is registered with the **PCAOB** and has served as the company's auditor since **2016**[142](index=142&type=chunk)[145](index=145&type=chunk) - The audit did not include an audit of internal control over financial reporting, as the company is not required to have one[143](index=143&type=chunk) [Consolidated Balance Sheets](index=24&type=section&id=Consolidated%20Balance%20Sheets) This section presents Co-Diagnostics' consolidated balance sheets for 2019 and 2018, highlighting a significant improvement from stockholders' deficit to positive equity and a dramatic decrease in current liabilities Consolidated Balance Sheet Highlights (December 31, 2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | Change ($) | Change (%) | | :-------------------------------- | :--------- | :--------- | :--------- | :--------- | | Cash and cash equivalents | 893,138 | 950,237 | (57,099) | (6.0%) | | Total current assets | 1,584,254 | 1,051,913 | 532,341 | 50.6% | | Total current liabilities | 328,070 | 2,351,983 | (2,023,913) | (86.1%) | | Total liabilities | 478,070 | 2,611,983 | (2,133,913) | (81.7%) | | Total stockholders' equity (deficit) | 1,737,256 | (1,058,811) | 2,796,067 | 264.1% | - The company transitioned from a stockholders' deficit of **$(1,058,811) in 2018** to positive equity of **$1,737,256 in 2019**, a significant improvement of **$2,796,067**[149](index=149&type=chunk) - Total current liabilities decreased dramatically by **$2,023,913 (86.1%) in 2019**, primarily due to the conversion of **$1,908,572 in current notes payable to preferred stock**[149](index=149&type=chunk) [Consolidated Statements of Operations](index=25&type=section&id=Consolidated%20Statements%20of%20Operations) This section presents Co-Diagnostics' consolidated statements of operations for 2019 and 2018, detailing significant increases in net sales and gross profit, alongside a slight improvement in net loss Consolidated Statements of Operations (2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | Change ($) | Change (%) | | :-------------------------------- | :--------- | :--------- | :--------- | :--------- | | Net sales | 214,974 | 39,911 | 175,063 | 438.6% | | Cost of sales | 112,431 | 9,391 | 103,040 | 1097.2% | | Gross profit | 102,543 | 30,520 | 72,023 | 236.0% | | Total operating expenses | 5,996,284 | 6,148,336 | (152,052) | (2.5%) | | Total operating loss | (5,893,741) | (6,117,816) | 224,075 | (3.7%) | | Net loss | (6,195,557) | (6,271,723) | 76,166 | (1.2%) | | Net loss per share – basic and diluted | (0.36) | (0.50) | 0.14 | (28.0%) | - Net sales increased significantly by **438.6% to $214,974 in 2019**, up from **$39,911 in 2018**[152](index=152&type=chunk) - The net loss improved slightly by **1.2%**, decreasing from **$(6,271,723) in 2018** to **$(6,195,557) in 2019**[152](index=152&type=chunk) [Consolidated Statement of Changes in Stockholders' Equity (Deficit)](index=26&type=section&id=Consolidated%20Statement%20of%20Changes%20in%20Stockholders%27%20Equity%20(Deficit)) This section details changes in Co-Diagnostics' stockholders' equity, showing a transition from deficit in 2018 to positive equity in 2019, driven by public offerings and preferred stock issuances - Total stockholders' equity shifted from a deficit of **$(1,058,811) at December 31, 2018**, to positive equity of **$1,737,256 at December 31, 2019**[153](index=153&type=chunk) - Key contributions to equity in 2019 included **$4,903,238 net proceeds** from a public offering of common stock and **$3,000,000** from preferred stock issuance (including **$2,000,000 from debt conversion**)[153](index=153&type=chunk) - Stock-based compensation recognized in 2019 amounted to **$1,088,386**[153](index=153&type=chunk) [Consolidated Statements of Cash Flows](index=27&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section presents Co-Diagnostics' consolidated statements of cash flows for 2019 and 2018, detailing increased cash usage in operating activities offset by significant financing cash from stock sales Consolidated Statements of Cash Flows (2019 vs. 2018) | Metric | 2019 ($) | 2018 ($) | | :------------------------------------------------------------------------------------------------ | :--------- | :--------- | | Net cash used in operating activities | (5,525,091) | (4,080,036) | | Net cash used by investing activities | (435,246) | (380,336) | | Net cash provided by financing activities | 5,903,238 | 1,876,155 | | Net increase (decrease) in cash | (57,099) | (2,584,217) | | Cash and cash equivalents end of period | 893,138 | 950,237 | - Net cash used in operating activities increased to **$(5,525,091) in 2019**, while net cash provided by financing activities significantly increased to **$5,903,238**, primarily from common and preferred stock sales[155](index=155&type=chunk) - Non-cash investing and financing activities in 2019 included **$379,487 for warrants issued for services**, **$440,000 for conversion of preferred stock to common**, and **$2,000,000 for conversion of debt to preferred stock**[155](index=155&type=chunk) [Notes to Consolidated Financial Statements](index=28&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed notes to the consolidated financial statements, covering joint venture investments, debt conversions, stock-based compensation, royalty payments, preferred stock, NOLs, and significant early 2020 subsequent events - The company invested **$322,000 in 2019** and **$339,000 in 2018** for its **50% interest** in the Indian joint venture, CoSara Diagnostics, accounted for using the equity method[158](index=158&type=chunk) - The **$2,000,000 Robert Salna Promissory Note** from August 2018 was converted to Series A Convertible Preferred Stock on **January 30, 2019**, resulting in no outstanding notes payable at year-end 2019[193](index=193&type=chunk)[194](index=194&type=chunk)[196](index=196&type=chunk) - Stock-based compensation expense was **$589,683 in 2019** and **$468,240 in 2018**, with **2,021,817 options** and **983,535 warrants outstanding** at December 31, 2019[200](index=200&type=chunk)[201](index=201&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk) - A down round feature on **313,779 warrants** led to an exercise price adjustment from **$2.59 to $1.20 in 2019**, resulting in a **$78,090 impact**[206](index=206&type=chunk) - The company paid Dr. Satterfield **$110,000 in 2019** and **$100,000 in 2018** for accrued technology royalties, with **$270,000 in unpaid accrued royalties** remaining at December 31, 2019[216](index=216&type=chunk)[217](index=217&type=chunk) - In January 2019, **30,000 shares of Series A Convertible Preferred Stock** were issued for **$3,000,000** (including **$2,000,000 from debt conversion**), convertible to common stock at **$1.20 per share**[219](index=219&type=chunk) - Net operating loss carry-forwards of approximately **$19,735,000 at December 31, 2019**, are fully offset by a valuation allowance, with no tax benefit reported[227](index=227&type=chunk) - Subsequent events in early 2020 include the completion and regulatory clearance of the **COVID-19 test**, three registered direct offerings raising approximately **$19.2 million in gross proceeds**, and significant warrant and preferred stock conversions[231](index=231&type=chunk)[232](index=232&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=43&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure%2E) The company reported no changes in or disagreements with its independent accountants regarding accounting principles or financial disclosure - There were no changes in or disagreements with accountants on accounting and financial disclosure[240](index=240&type=chunk) [Controls and Procedures](index=43&type=section&id=Item%209A.%20Controls%20and%20Procedures%2E) As of December 31, 2019, disclosure controls and internal control over financial reporting were ineffective due to a material weakness in technical expertise, with remediation efforts underway - As of **December 31, 2019**, the company's disclosure controls and procedures were **not effective** due to a material weakness in internal control over financial reporting[242](index=242&type=chunk)[244](index=244&type=chunk) - The identified material weakness is insufficient technical expertise on complex accounting and tax requirements, potentially leading to undetected material misstatements[245](index=245&type=chunk) - Despite the material weakness, management concluded that the Consolidated Financial Statements fairly present the company's financial position, results of operations, and cash flows in conformity with U.S. GAAP[247](index=247&type=chunk) - Remediation efforts include implementing internal control recommendations and planning to increase consultant involvement or expand accounting staff[246](index=246&type=chunk) - An attestation report by the independent registered public accounting firm regarding internal control over financial reporting is not included, as the company is an emerging growth company[248](index=248&type=chunk) [Other Information](index=43&type=section&id=Item%209B.%20Other%20Information%2E) The company reported no other information required for disclosure under this item - No other information is required to be disclosed[249](index=249&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=45&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance%2E) This section outlines Co-Diagnostics' executive officers, directors, and corporate governance, including independent board committees, a financial expert, conflict of interest policies, a code of ethics, and Section 16(a) compliance - Key executive officers include **Dwight H. Egan** (CEO, President, Chairman), **Reed L. Benson** (CFO, Secretary), and **Brent Satterfield** (Chief Science Officer)[252](index=252&type=chunk)[253](index=253&type=chunk)[254](index=254&type=chunk)[261](index=261&type=chunk) - The Board of Directors includes independent members **Eugene Durenard, James Nelson, Richard S. Serbin, and Edward L. Murphy**, bringing diverse expertise[252](index=252&type=chunk)[255](index=255&type=chunk)[257](index=257&type=chunk)[258](index=258&type=chunk)[259](index=259&type=chunk)[263](index=263&type=chunk) - The company maintains an Audit Committee (chaired by **Mr. Durenard**, an 'audit committee financial expert'), a Compensation Committee (chaired by **Mr. Serbin**), and a Corporate Governance and Nominating Committee (chaired by **Mr. Nelson**), all composed of independent directors[263](index=263&type=chunk)[266](index=266&type=chunk)[267](index=267&type=chunk)[268](index=268&type=chunk)[269](index=269&type=chunk) - The company has a code of ethics for its principal executive, financial, and accounting officers, and a policy requiring disclosure of conflicts of interest[272](index=272&type=chunk)[275](index=275&type=chunk) - All directors, executive officers, and greater than **10% shareholders** complied with **Section 16(a) filing requirements** for the year ended December 31, 2019[274](index=274&type=chunk) [Executive Compensation](index=49&type=section&id=Item%2011.%20Executive%20Compensation%2E) Co-Diagnostics' executive compensation aligns pay with company and individual performance, utilizing base salaries, bonuses, and equity awards from the 2015 Long-term Incentive Plan, with director compensation including fees and stock options - The company's compensation philosophy links total cash compensation to company, department, and individual performance, with increased variability and at-risk compensation for higher responsibility levels[280](index=280&type=chunk) - Executive compensation integrates competitive annual base salaries with performance-based bonuses and equity awards through the **2015 Long-term Incentive Plan**, aligning executive interests with shareholders[281](index=281&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk) - The Compensation Committee evaluates company progress and executive services against development, financial, and sales and marketing milestones, benchmarking compensation against a peer group of diagnostic testing companies[279](index=279&type=chunk)[284](index=284&type=chunk) Summary Compensation Table for Named Executive Officers | Name | Year | Salary ($) | Bonus ($) | Awards ($) | Total ($) | | :-------------------------------- | :--- | :--------- | :-------- | :--------- | :-------- | | **Dwight H. Egan** | 2019 | 275,000 | 20,000 | 165,000 | 460,000 | | President & CEO | 2018 | 275,000 | 12,500 | 186,000 | 463,500 | | | 2017 | 195,000 | 15,000 | 0 | 210,000 | | **Reed L Benson** | 2019 | 200,000 | 15,000 | 137,500 | 352,500 | | CFO & Secretary | 2018 | 200,000 | 10,000 | 155,000 | 365,000 | | | 2017 | 195,000 | 10,000 | 0 | 205,000 | | **Brent Satterfield** | 2019 | 237,500 | 0 | 0 | 237,500 | | Chief Technology Officer | 2018 | 237,500 | 0 | 0 | 237,500 | | | 2017 | 159,300 | 0 | 0 | 159,300 | - Dr. Satterfield also received **$110,000 in 2019**, **$100,000 in 2018**, and **$170,000 in 2017** for accrued royalties under a technology license agreement[290](index=290&type=chunk) - Non-employee directors receive annual fees of **$35,000**, additional fees for committee roles, and initial/annual grants of **25,000 immediately exercisable stock options**[297](index=297&type=chunk) Director Summary Compensation Table (2019) | Name | Fees Paid in Cash ($) | Options/Awards ($) | Total ($) | | :-------------------- | :-------------------- | :----------------- | :-------- | | Frank Kiesner (resigned) | 27,500 | 0 | 27,500 | | Richard Serbin | 55,000 | 17,750 | 72,750 | | Edward J. Borkowski (resigned) | 27,500 | 0 | 27,500 | | James Nelson | 18,333 | 27,500 | 45,833 | | Edward Murphy | 12,000 | 17,750 | 29,750 | | Eugene Durenard | 27,500 | 17,750 | 45,250 | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=54&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters%2E) As of March 19, 2020, Co-Diagnostics had **27,438,701 common shares outstanding**, with directors and executive officers collectively owning **1.4%**, and Reagents, LLC holding **6.3%** as a **5% stockholder** - As of **March 19, 2020**, there were **27,438,701 shares of common stock outstanding**[303](index=303&type=chunk) Beneficial Ownership (March 19, 2020) | Name | Title | Beneficially Owned Shares | Percent of Class | | :-------------------------------- | :-------------------------------- | :------------------------ | :--------------- | | Dwight H. Egan | CEO, President, Chairman | 150,000 | * (<1%) | | Reed L. Benson | CFO, Secretary | 125,000 | * (<1%) | | Edward Murphy | Director | 25,000 | * (<1%) | | Eugene Durenard | Director | 25,000 | * (<1%) | | James Nelson | Director | 25,000 | * (<1%) | | Richard S. Serbin | Director | 45,455 | * (<1%) | | **Officers and Directors as a Group** | (total of 6 persons) | **395,455** | **1.4%** | | **5% Stockholders:** | | | | | Reagents, LLC (Seth Egan) | | 1,746,796 | 6.3% | - Beneficial ownership includes shares over which a person exercises sole or shared voting/investment power, or has a right to acquire within **60 days**[303](index=303&type=chunk) - There are no known voting trusts or similar agreements, and no arrangements that may result in a change in control of the company[304](index=304&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=56&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence%2E) The company engages in related party transactions, primarily involving royalty payments to Dr. Satterfield and consulting fees to a former and current director in 2019 - The company paid Dr. Satterfield **$110,000 in 2019** and **$100,000 in 2018** for accrued royalties under the exclusive license agreement for CoPrimer technology[309](index=309&type=chunk) - The license agreement with Dr. Satterfield was amended in **March 2017** to cease ongoing royalties and pay down **$700,000 of accrued royalties** at a rate of **$10,000 per month**[309](index=309&type=chunk) - In 2019, the company paid a one-time consulting fee of **$35,000** to former director Frank Keisner and **$30,000** to current director Richard Serbin for consulting services[310](index=310&type=chunk) [Principal Accountant Fees and Services](index=56&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services%2E) Co-Diagnostics paid its independent auditors, Haynie & Company, **$72,000 in 2019** and **$69,000 in 2018** for audit and tax services, all pre-approved by the audit committee or Board of Directors Principal Accountant Fees (2019 vs. 2018) | Category | 2019 ($) | 2018 ($) | | :----------------- | :--------- | :--------- | | Audit fees | 69,000 | 66,000 | | Audit-related fees | 0 | 0 | | Tax fees | 3,000 | 3,000 | | All other fees | 0 | 0 | | **Total** | **72,000** | **69,000** | - Audit fees covered the annual audit and reviews of annual and quarterly reports[311](index=311&type=chunk) - Tax fees included services for tax compliance and consultations[312](index=312&type=chunk) - All audit and tax fees incurred in **2019** were pre-approved by the audit committee, and in **2018** by the Board of Directors, with a policy requiring advance approval for services exceeding **$15,000**[311](index=311&type=chunk)[312](index=312&type=chunk)[313](index=313&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=57&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules%2E) This section lists all exhibits and financial statement schedules in the Annual Report on Form 10-K, covering corporate governance, various agreements, and certifications, with many incorporated by reference - The exhibits include corporate documents such as Articles of Incorporation and Bylaws, legal opinions, and various agreements including Underwriting, Subscription, Exclusive License, and Securities Purchase[317](index=317&type=chunk)[318](index=318&type=chunk) - Also included are the **2015 Long-Term Incentive Plan**, Code of Ethics, Subsidiaries of Registrant, Consents of auditors and legal counsel, and certifications by the CEO and Principal Financial Officer under the Sarbanes-Oxley Act[317](index=317&type=chunk)[318](index=318&type=chunk) - Many exhibits are incorporated by reference from previous SEC filings, including Draft Registration Statements and Form S-1/A filings[318](index=318&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q [X] Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2019 OR [ ] Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to __________ Commission File No. 1-38148 CO-DIAGNOSTICS, INC. | --- | --- | --- | |-----------------------------------------------------------|-------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock CODX Nasdaq Capital Market FORM 10-Q [X] Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2019 OR [ ] Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to __________ Commission File No. 1-3 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q [X] Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2019 OR [ ] Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to __________ Commission File No. 1-38148 CO-DIAGNOSTICS, INC. (Exact Name of Registrant as Specified in Its Charter) | --- | --- | --- | --- | --- | --- | ...