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) | --- | --- | --- | --- | --- | --- | ...

Technology and Innovation - Co-Diagnostics, Inc. has developed proprietary molecular diagnostics technology that allows for rapid, low-cost testing for infectious diseases and genetic conditions[20]. - Co-Diagnostics' proprietary Co-Primer technology enhances specificity in testing, allowing for multiplexing several targets and improved SNP detection[23][49]. - The company has developed a novel PCR test design technology called "Co-Primers," which aims to reduce false positives and negatives in DNA identification[78]. - Co-Diagnostics has established a licensing agreement in the agricultural sector for its Co-Primer technology, which will generate royalties from sales to the licensee's customers[52]. Market Demand and Growth - The company estimates a global annual demand for its initial diagnostic tests could reach approximately 1.99 billion tests, with specific demands including 10.4 million for tuberculosis and 36.7 million for HIV[40]. - The molecular diagnostics market is identified as a fast-growing segment, with Co-Diagnostics positioned to capitalize on this growth through its innovative testing solutions[40]. - The company is classified as an "emerging growth company" and will maintain this status until total annual gross revenues exceed $1 billion or other specified conditions are met[56]. Regulatory and Certifications - Co-Diagnostics has received CE Marks for its tuberculosis test, Zika test, and a triplex test for Zika, Dengue, and Chikungunya, allowing sales throughout the European community and in most Central and South American countries[27][38]. - The company has received ISO 13485 and ISO 9001 certifications, enabling it to self-certify certain products for CE marking in Europe[38]. - The company is regulated by the U.S. FDA and has obtained CE Marks for its tuberculosis and zika virus tests, allowing sales in various international markets[94]. Financial Performance - Net sales for the year ended December 31, 2018, were $700, with diagnostic equipment sales of $10,123 and licensing revenue of $29,088, compared to no test revenue in 2017[98]. - Net sales for the year ended December 31, 2018, were $39.91 million, a significant increase from $7.66 million in 2017, representing a growth of approximately 420%[133]. - Gross profit for 2018 was $30.52 million, compared to $7.36 million in 2017, indicating a substantial increase in profitability[133]. - The net loss for the year ended December 31, 2018, was $6,271,723, a decrease of $687,509 compared to a net loss of $6,959,232 in 2017, mainly due to the absence of a loss on extinguishment of debt recorded in 2017[105]. - Total operating expenses increased to $6,148,336 in 2018 from $4,571,427 in 2017, an increase of $1,576,909, primarily due to higher general and administrative, sales and marketing, and research and development expenses[101]. Cash Flow and Expenses - Cash and cash equivalents decreased to $950,237 as of December 31, 2018, from $3,534,454 in 2017, with total current liabilities increasing significantly to $2,351,983[107]. - Monthly cash operating expenses were approximately $385,000 during the year ended December 31, 2018, reflecting increased development and sales activities following the initial public offering[112]. - Negative cash flow used in operations was $4,080,036 for the year ended December 31, 2018, compared to $3,211,401 in 2017[111]. - The company expects to require approximately $850,000 annually for the continued commercialization and development of its diagnostic testing technology[116]. Joint Ventures and Collaborations - The company has entered a joint venture with Synbiotics Limited to manufacture diagnostics tests for seven infectious diseases, with profits shared based on performance levels[85]. - The joint venture has already sold approximately $200,000 worth of probes and primers in India, marking the beginning of product sales in that market[85]. - The company invested $339,000 in a joint venture in India in 2018, up from $60,000 in 2017, marking a significant increase of 465%[140]. Stock and Equity - As of March 15, 2019, the last reported sales price of the company's common stock was $1.15 per share, with approximately 429 holders of the stock[69]. - The company executed an 11 to 1 reverse stock split on May 24, 2017, affecting the statements in this report[144]. - The company completed a registered direct offering in February 2019, raising net proceeds of $4,996,322 from the sale of 3,925,716 shares of common stock[114]. - The company completed a registered direct offering in February 2019, selling 3,925,716 shares of common stock at a price of $1.40 per share, raising gross proceeds of $5,496,002[214]. Employee and Compensation - The company currently employs 20 full-time personnel and engages independent contractors in India for product promotion[93]. - The company recognized $468,240 in stock-based compensation for the 850,000 options granted to nine employees for the year ended December 31, 2018[186]. - For the year ended December 31, 2018, the company granted 850,000 options with a weighted average fair value of $1.24, while the options granted in 2017 were 61,335 with a fair value of $1.59[185]. Liabilities and Obligations - Cash and cash equivalents at the end of the period decreased to $950,237 in 2018 from $3,534,454 in 2017, a decline of approximately 73%[1]. - Total current liabilities increased significantly to $2.35 million in 2018, compared to $628,256 in 2017, representing a rise of approximately 273%[130]. - The company reported an accumulated deficit of $18.69 million as of December 31, 2018, compared to $12.42 million in 2017, reflecting an increase in losses[130]. - The company recorded a total of $1,908,572 in notes payable as of December 31, 2018, with a principal amount of $2,000,000 issued to Robert Salna bearing an interest rate of 9%[179]. - The company incurred $71,000 in interest expense related to the notes payable for the 12 months ended December 31, 2018[181].