SALT LAKE CITY, Feb. 29, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today it will release its fourth quarter and full year 2023 financial results on Thursday, March 14, 2024, after the market close. The Company will also host a conference call and webcast on the same day at 4:30 p.m. ET to discuss its financial results with analysts and institutional investors.  Manage ...

SALT LAKE CITY, Feb. 1, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today the list of events it has chosen to exhibit at or participate in during February, 2024, and which strategically align with the Company's vision. At each event, Co-Dx will discuss its upcoming at-home and point-of-care Co-Dx™ PCR platform technology*, which has been de ...

Co-Diagnostics, Inc. (NASDAQ:CODX) Q3 2023 Earnings Conference Call November 9, 2023 4:30 PM ET Company Participants Andrew Benson - Head of Investor Relations Dwight Egan - Chief Executive Officer Brian Brown - Chief Financial Officer Conference Call Participants Operator Hello. Welcome to the Co-Diagnostics Third Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note today’s event is being recorded. I would now like to turn the conference o ...

At September 30, 2023, we had cash and cash equivalents of $10,239,898. Additionally, we had $53,188,999 of marketable investment securities that could readily be converted into cash if needed. Additionally, our total current assets of September 30, 2023, were $71,310,781 compared to total current liabilities of $5,097,740. Net cash used in operating activities during the nine months ended September 30, 2023 was $17,303,239, compared to cash provided by operating activities of $10,578,544 for the nine month ...

Co-Diagnostics, Inc. (NASDAQ:CODX) Q2 2023 Earnings Call Transcript August 10, 2023 4:30 PM ET Company Participants Andrew Benson - Head, Investor Relations Dwight Egan - Chief Executive Officer Brian Brown - Chief Financial Officer Conference Call Participants Operator Welcome to the Co-Diagnostics Second Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructio ...

Financial Performance - Revenue for Q2 2023 was $197,806, a significant decrease of 96.1% compared to $5,023,226 in Q2 2022[37] - Gross profit for Q2 2023 was $(261,289), compared to a gross profit of $4,107,794 in Q2 2022[37] - Net loss for Q2 2023 was $(8,918,825), compared to a net loss of $(2,686,303) in Q2 2022[37] - The company reported a comprehensive loss of $(8,811,459) for Q2 2023, compared to $(2,686,303) in Q2 2022[37] - Net loss for the six months ended June 30, 2023, was $(14,674,216), compared to a net income of $9,028,292 for the same period in 2022[38] - For the six months ended June 30, 2023, the company generated revenues of $799,763, a decrease of $26,922,507 compared to $27,722,270 for the same period in 2022, primarily due to lower sales of the Logix Smart COVID-19 test[169] Operating Expenses - Total operating expenses for Q2 2023 were $11,733,150, an increase of 42.5% from $8,254,832 in Q2 2022[37] - Total operating expenses for the six months ended June 30, 2023, were $21,783,516, an increase from $17,847,766 in the same period of 2022, mainly due to higher personnel expenses and increased investment in research and development[171] - General and administrative expenses increased from $5,390,616 for the six months ended June 30, 2022, to $6,727,860 for the same period in 2023, primarily due to increased insurance and professional fees[172] Cash and Liquidity - Cash and cash equivalents as of June 30, 2023, were $13,830,846, down from $22,973,803 at the end of 2022[36] - Cash used in operating activities was $(10,708,797) for the six months ended June 30, 2023, compared to cash provided of $9,460,222 in the prior year[38] - Cash and cash equivalents at the end of the period were $13,830,846, down from $86,045,405 at the end of June 30, 2022[38] - Net cash provided by investing activities was $2,603,770 for the six months ended June 30, 2023, compared to $(9,600,444) in the same period of 2022[38] Research and Development - Research and development expenses for Q2 2023 were $5,981,043, up from $3,889,844 in Q2 2022[37] - The Company expensed $5,981,043 and $10,995,103 in research and development costs for the three and six months ended June 30, 2023, respectively, compared to $3,889,844 and $7,661,171 for the same periods in 2022, representing increases of 54% and 44%[89] - Research and development expenses rose from $3,889,844 for the three months ended June 30, 2022, to $5,981,043 for the same period in 2023, reflecting increased personnel and clinical trial expenses[186] - Research and development expenses increased from $7,661,171 for the six months ended June 30, 2022, to $10,995,103 for the six months ended June 30, 2023, reflecting a significant rise in personnel-related expenses and clinical trials[208] Assets and Liabilities - Total assets decreased to $112,801,186 as of June 30, 2023, from $123,086,281 at the end of 2022[36] - Total current liabilities increased to $5,115,655 as of June 30, 2023, compared to $3,873,423 at the end of 2022[36] - Total accounts receivable as of June 30, 2023, was $4,510,545, with an allowance for uncollectible accounts of $3,413,152, resulting in a net amount of $1,097,393[65] - The Company recorded a liability for contingent consideration related to acquisitions, with a fair value of $1,335,279 as of June 30, 2023, down from $2,732,356 at December 31, 2022, reflecting a decrease of approximately 51%[101] Taxation - The Company recognized a benefit from income taxes of $2,238,320 for the three months ended June 30, 2023, representing an effective tax rate of 20.1%[144] - The Company’s effective tax rate for the six months ended June 30, 2023, was 23.5%, differing from the U.S. Federal statutory rate of 21.0% due to various factors[144] - The effective tax rate and potential tax exposure items require significant judgment and expertise, with uncertain income tax positions noted in the financial statements[112] Shareholder Activities - The company repurchased 4,559,479 outstanding common shares for a total of $15.2 million under a repurchase program authorized for up to $30 million[175] - The Company has approximately $13.8 million of unrecognized stock-based compensation expense related to outstanding RSUs, expected to be recognized over a weighted-average period of 2.0 years[141] - The Company has a share repurchase program authorized for up to $30.0 million, allowing flexibility in timing and amount of repurchases based on market conditions[147] Legal and Regulatory Matters - The company is involved in ongoing legal proceedings, with a claim against it for $2,860,809.79 related to an alleged breach of contract[219] - The company filed a shelf registration statement with the SEC to register the sale of up to $150 million of its securities, including an equity distribution agreement for up to $50 million of common stock[212] - The company has no off-balance sheet arrangements, ensuring transparency in its financial reporting[214] Product Development - The company is developing a groundbreaking portable PCR device, the Co-Dx PCR Home™ platform, which is currently under FDA review[32] - The Company is developing a groundbreaking portable PCR device and proprietary test cups, which are currently under FDA review and not yet available for sale[164] - The proprietary test design system and reagents have received regulatory approval for various PCR diagnostic tests, including COVID-19, in multiple countries[180] - The Company has developed three multiplexed tests for identifying diseases carried by mosquitoes, aiding municipalities in managing mosquito populations[157]

Co-Diagnostics, Inc. (NASDAQ:CODX) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants Andrew Benson - Head, Investor Relations Dwight Egan - Chief Executive Officer Brian Brown - Chief Financial Officer Conference Call Participants Chait G - H.C. Wainwright Theodore O'Neill - Litchfield Hills Research Operator Good afternoon and welcome to the Co-Diagnostics’ First Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After to ...

[PART I FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The unaudited consolidated financial statements for Q1 2023 reflect a significant revenue decrease, a shift to net loss, and declines in total assets and stockholders' equity, with negative operating cash flow [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2023, total assets decreased to $117.0 million, driven by reduced cash and cash equivalents, while total liabilities and stockholders' equity also declined Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $6,359 | $22,974 | | Marketable investment securities | $68,921 | $58,289 | | Total Assets | $116,997 | $123,086 | | Total Liabilities | $6,367 | $8,566 | | Total Stockholders' Equity | $110,630 | $114,520 | [Consolidated Statements of Operations and Comprehensive Income (Loss)](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) For Q1 2023, the company experienced a substantial revenue decline, leading to a significant gross profit reduction, increased operating expenses, and a shift from net income to a net loss year-over-year Q1 2023 vs. Q1 2022 Performance (in thousands) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Revenue | $602 | $22,699 | | Gross Profit | $100 | $19,417 | | Total Operating Expenses | $10,050 | $9,593 | | Net (Loss) Income | $(5,755) | $11,715 | | Basic EPS | $(0.20) | $0.35 | [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For Q1 2023, the company reported net cash used in operating, investing, and financing activities, resulting in a significant net decrease in cash and cash equivalents compared to the prior year Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net Cash (Used in) Provided by Operating Activities | $(5,499) | $7,806 | | Net Cash (Used in) Provided by Investing Activities | $(10,633) | $859 | | Net Cash (Used in) Provided by Financing Activities | $(482) | $150 | | Net (Decrease) Increase in Cash | $(16,614) | $8,815 | [Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity declined in Q1 2023, primarily due to the net loss and common stock repurchases, partially offset by stock-based compensation and other comprehensive income - Key changes in stockholders' equity for Q1 2023 included a net loss of **$5,755,391** and common stock repurchases totaling **$482,196**, which were partially offset by stock-based compensation of **$2,168,742**[4](index=4&type=chunk) [Notes to Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, geographic revenue declines, increased stock-based compensation, and updates on ongoing litigation and the share repurchase program - The company develops, manufactures, and sells reagents for diagnostic tests, including for infectious diseases It is also developing a portable PCR device, the Co-Dx PCR Home™ platform, which is subject to FDA review and not yet for sale[16](index=16&type=chunk) Revenue by Geographic Area (in thousands) | Region | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | United States | $393 | $14,218 | | Rest of World | $209 | $8,481 | | **Total** | **$602** | **$22,699** | - The company is a defendant in two class-action claims and three derivative actions alleging false and misleading press releases The company believes these lawsuits are without merit and is unable to estimate a range of potential loss[105](index=105&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the Q1 2023 revenue decline to lower COVID-19 test sales, notes increased operating expenses from R&D, and confirms sufficient liquidity for the next 12 months - The decrease in revenue of **$22.1 million** was primarily due to lower sales of the Logix Smart COVID-19 test[208](index=208&type=chunk) - R&D expenses increased from **$3.8 million** to **$5.0 million** year-over-year, mainly due to increased personnel, materials, and stock-based compensation related to the Co-Dx PCR Home platform development[210](index=210&type=chunk) - As of March 31, 2023, the company had **$6.4 million** in cash and cash equivalents, plus **$68.9 million** in marketable investment securities Management believes these resources are sufficient for the next 12 months[184](index=184&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not required for smaller reporting companies, thus no information is provided - Disclosure is not required for "smaller reporting companies" under Regulation S-K[140](index=140&type=chunk)[214](index=214&type=chunk) [Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes in internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[227](index=227&type=chunk) - No changes occurred in the company's internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[214](index=214&type=chunk) [PART II OTHER INFORMATION](index=30&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material developments in previously disclosed legal proceedings and continues to defend against class action and derivative lawsuits - There have been no material developments to the legal proceedings previously disclosed in the 2022 Annual Report on Form 10-K[128](index=128&type=chunk) [Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) No material changes are reported from the risk factors previously disclosed in the company's 2022 Annual Report on Form 10-K - The report indicates no material changes from the risk factors previously disclosed in the company's 2022 Form 10-K[215](index=215&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company details Q1 2023 share repurchase activity under its $30.0 million program, with approximately $15.3 million remaining for future repurchases Share Repurchase Activity (Q1 2023) | Period | Total Shares Purchased | Average Price Paid per Share | Approx. Dollar Value Remaining | | :--- | :--- | :--- | :--- | | Jan 2023 | - | - | $15,788,134 | | Feb 2023 | - | - | $15,788,134 | | Mar 2023 | 309,012 | $1.56 | $15,305,938 | | **Total** | **309,012** | **$1.56** | **$15,305,938** | - The Board of Directors authorized a share repurchase program of up to **$30.0 million** in March 2022 The program has no expiration date and does not obligate the company to acquire any specific number of shares[114](index=114&type=chunk)[231](index=231&type=chunk) [Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None reported[218](index=218&type=chunk) [Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[232](index=232&type=chunk) [Other Information](index=31&type=section&id=Item%205.%20Other%20Information) The company reported no other information - None reported[219](index=219&type=chunk) [Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and Inline XBRL documents - Exhibits filed include CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002, along with various Inline XBRL files[233](index=233&type=chunk)

Financial Data and Key Metrics Changes - For fiscal year 2022, revenue decreased by 65.0% to $34.2 million compared to $97.9 million in fiscal 2021, primarily due to the global decline in COVID testing [22][25] - Total operating expenses increased to $55.7 million from $40.2 million in fiscal 2021, attributed to a goodwill impairment charge of $15.4 million [23][25] - Net loss for fiscal 2022 was $14.2 million, or a loss of $0.45 per fully diluted share, compared to net income of $36.7 million, or $1.23 per fully diluted share in the prior year [25][32] - Gross profit decreased to $28.7 million from $86.3 million in fiscal 2021, with a gross margin percentage of 84.0%, down from 88.2% [32] Business Line Data and Key Metrics Changes - The company is focusing on the Co-Dx PCR Home platform, which is expected to support multiple tests for respiratory diseases, STIs, and tuberculosis [3][11] - The centralized laboratory business channel continues to drive most sales, providing cash flow for R&D efforts [16][31] Market Data and Key Metrics Changes - The market for COVID testing is expected to persist, but the demand is not anticipated to return to pandemic levels [6][35] - The company is exploring collaborations with NGOs for increased access to diagnostics for diseases like tuberculosis, which remains a significant health concern [83] Company Strategy and Development Direction - The company aims to leverage its patented Co-Primers technology to enhance multiplex testing capabilities and expand its product pipeline [15][18] - The commercialization strategy is guided by market research to identify high-throughput locations for the initial launch of the Co-Dx PCR Home platform [20][31] - The company is committed to maintaining a strong balance sheet and investing in R&D to support long-term growth initiatives [34][47] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the ongoing challenges in the COVID testing market but remains optimistic about the potential of the Co-Dx PCR Home platform [35][48] - The company believes that 2023 will be a pivotal year for positioning itself for long-term success [48] Other Important Information - The company has made significant investments in R&D, with increased expenses offset by a decrease in sales and marketing costs [45] - The company has a solid cash position of $81.3 million as of December 31, 2022, down from $89.9 million the previous year [34] Q&A Session Summary Question: Can you comment on the current enrollment speed of the ongoing clinical trial of the Co-Dx PCR Home device? - Management stated that enrollment is consistent with expectations, but specific numbers cannot be disclosed due to the nature of the clinical trial [36][50] Question: How many sales reps will it take to successfully market this product when approved by the FDA? - Management indicated that they are adequately staffed for the launch and may add personnel as needed [38][66] Question: Will you be able to secure reimbursement from CMS and private payers for tests conducted on this platform? - Management confirmed that they are actively monitoring reimbursement processes and will pursue opportunities for securing coverage [53]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549. Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 Number 001-38148 CO-DIAGNOSTICS, INC. (Exact Name of Registrant as Specified in Its Charter) (State or other jurisdiction of incor ...