# EDGAR Filing Document

**Accession Number:** 0001692415
**File Stem:** 0001493152-23-007900
**Filing Date:** 2023-3
**Character Count:** 21248
**Document Hash:** 6e99469bfc8219469d7f7a1a2f27f2f3
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-23-007900.hdr.sgml**: 20230316

**ACCESSION NUMBER**: 0001493152-23-007900

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20230316

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230316

**DATE AS OF CHANGE**: 20230316

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Co-Diagnostics, Inc.
- **CENTRAL INDEX KEY:** 0001692415
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **IRS NUMBER:** 462609396
- **STATE OF INCORPORATION:** UT
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38148
- **FILM NUMBER:** 23738751

**BUSINESS ADDRESS:**
- **STREET 1:** 4049 SOUTH HIGHLAND DRIVE
- **CITY:** SALT LAKE CITY
- **STATE:** UT
- **ZIP:** 84124
- **BUSINESS PHONE:** 8012789769

**MAIL ADDRESS:**
- **STREET 1:** 4049 SOUTH HIGHLAND DRIVE
- **CITY:** SALT LAKE CITY
- **STATE:** UT
- **ZIP:** 84124

?xml version="1.0" encoding="utf-8"?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the**

**Securities Exchange Act of 1934**

Date of report (Date of earliest event reported): **March 16, 2023**

**CO-DIAGNOSTICS, INC.**

(Exact name of small business issuer as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Utah** | **1-38148** | **46-2609363** |
| (State or other jurisdiction of | (Commission | (IRS Employer |
| incorporation or organization) | File Number) | Identification Number) |

---

**<u>2401 S. Foothill Drive, Suite D, Salt Lake City, Utah 84109</u>**

(Address of principal executive offices)

**<u>(801) 438-1036</u>**

(Issuer's telephone number)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, par value $0.001 per share | CODX | The Nasdaq Capital Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 2.02. Results of Operations and Financial Condition.**

On March 16, 2023, Co-Diagnostics, Inc. (the "Company") issued a press release announcing financial results for its fourth quarter and year ended December 31, 2022. The full text of the press release, which includes information regarding the Company's use of a non-GAAP financial measure, is furnished as Exhibit 99.1 to this Form 8-K.

The information contained in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. Furthermore, the information contained in this Item 2.02 or Exhibit 99.1 shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

**Item 7.01. Regulation FD. Disclosure.**

The information set forth under Item 2.02 is incorporated by reference as if fully set forth herein.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits

---

| | |
|:---|:---|
| **Exhibit No.:** | **Description:** |
| 99.1 | [Press Release, dated March 16, 2023](ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

**SIGNATURE**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **CO-DIAGNOSTICS, INC.** | **CO-DIAGNOSTICS, INC.** |
| Date: March 16, 2023 | By: | */s/ Brian Brown* |
|  | Name: | Brian Brown |
|  | Title: | Chief Financial Officer<br> (Principal Financial and Accounting Officer) |

---

## Exhibit 99.1

**Exhibit 99.1**

**Co-Diagnostics, Inc. Reports Full Year 2022 Financial Results**

 ****

*Full-year Results Impacted by Lower Demand for COVID-19 Testing*

*Announced Initiation of Clinical Evaluations for Co-Dx PCR Home™ Platform*

**SALT LAKE CITY, March 16, 2023—** Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today financial results for the full year ended December 31, 2022.

**<u>Full Year 2022 Financial Results:</u>**

● Revenue of $34.2 million, down from $97.9 million during the prior year primarily due to lower global demand for the Logix Smart™ COVID-19 tests

● Gross profit of $28.7 million, representing 84.0% of consolidated revenue

● Operating loss of $27.0 million compared to operating income of $46.1 million a year ago, due to lower revenue, goodwill impairment charges, and continued investments into research and development for the Co-Dx PCR Home Platform

● Net loss of $14.2 million, compared to net income of $36.7 million in the prior year, representing loss of $0.45 per fully diluted share, compared to $1.23 in 2021

● Adjusted net income, net of goodwill impairment charges, of $1.2 million, compared to adjusted net income of $36.7 million in the prior year, representing adjusted income of $0.04 per fully diluted share, compared to $1.23 in 2021

● Adjusted EBITDA loss of $3.1 million

● Repurchased 3.9 million shares of common stock at an average price of $3.66 per share for an aggregate purchase price of approximately $14.2 million

● Cash, cash equivalents, and marketable securities of $81.3 million as of December 31, 2022

● Cash flow from operations of $6.6 million for the twelve months ended December 31, 2022

Dwight Egan, Co-Diagnostics' Chief Executive Officer, said, "The impact of COVID-19 on society decreased considerably during the second half of the year, and resulted in lower demand for high-throughput testing at the centralized lab level. While our overall financial performance has been impacted by these trends, we are pleased with the progress we made against our strategic priorities which support our Co-Dx PCR Home™ platform as we continue to see an emphasis on diagnostics shifting out of the centralized lab settings and towards at-home and point-of-care (POC). The commencement of clinical evaluations announced in February of this year marks an important step toward detection of infectious diseases in at-home and POC settings, with anticipated multiplex panels to follow."

Mr. Egan continued, "Looking ahead, we remain focused on executing the clinical evaluations for our Co-Dx PCR Home platform, including the clinical trials themselves and the analytical studies required to support regulatory submissions. Our mission of creating a new standard for real-time PCR at-home and POC technology continues to be validated. We firmly believe our patented Co-Primers™ technology and patent-pending design of the new Co-Dx PCR Home platform extend our capabilities, aspirations, and potential far beyond COVID-19, and we continue our focus on managing the business and being deliberate in our actions."

**<u>Full Year 2022 and Recent Business Highlights:</u>**

● Expanded the OEM agreement with Bio Molecular Systems for the Co-Dx Box™ magnetic induction PCR cycler to encompass 193 countries worldwide

● Designed and verified two testing products for mpox in response to urgent global health concern generated by that virus

● Received clearance from Indian regulators for JV CoSara hepatitis B and hepatitis C viral load tests, as well as a high-risk HPV multiplex test

● Authorized a $30.0 million share repurchase program

● Recently initiated clinical evaluations for Co-Dx PCR Home platform and initial COVID-19 test

● Completed strategic additions to the Scientific Advisory Board appointing Carl Wittwer, M.D., Ph.D. as Chairman, as well as Karen C. Carroll, M.D, Noriko Kusukawa, Ph.D., and Anne Wyllie, Ph.D.

***Conference Call and Webcast***

Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors. The conference call and webcast will be available via:

Webcast: <u>ir.codiagnostics.com</u> on the Events & Webcasts page

Conference Call: 844-481-2661 (domestic) or 412-317-0652 (international)

The call will be recorded and later made available on the Company's website: <u>https://codiagnostics.com.</u>

\*The Co-Dx PCR Home platform is subject to FDA review and is not currently for sale.

**About Co-Diagnostics, Inc.:**

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR Home™ platform and to locate genetic markers for use in applications other than infectious disease.

***Non-GAAP Financial Measures:***

 ****

*This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, and one-time transaction related costs. Additionally, this press release contains adjusted net income (loss), which is a non-GAAP measure defined as net income excluding goodwill impairment charges. The Company believes that adjusted EBITDA and adjusted net income (loss) provide useful information to management and investors relating to its results of operations. The Company's management uses these non-GAAP measures to compare the Company's performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA and adjusted net income (loss) provide an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company's financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making.*

 

*Management does not consider the non-GAAP measures in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measures is that they exclude significant expenses that are required by GAAP to be recorded in the Company's financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measures together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Reconciliation tables of the net income, the most comparable GAAP financial measure, to adjusted EBITDA and adjusted net income (loss) are included at the end of this release. The Company urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company's business.*

 ****

***Forward-Looking Statements:***

*This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) that are subject to a number of risks and uncertainties. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include statements regarding (i) that we continue to see an emphasis on diagnostics shifting out of the centralized lab settings and towards at-home and point-of-care settings, (ii)anticipated development of multiplex panels, and (iii) that we will successfully complete the clinical trials required to support regulatory submissions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 24, 2022, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.* 

---

| | |
|:---|:---|
| **Company Contact:** <br> Andrew Benson | **Investor Relations Contact:** <br> Zachary Mizener |
| Head of Investor Relations<br> +1 801-438-1036 | Lambert & Co.<br> +1 616-258-5804 |
| <u>investors@codiagnostics.com</u> | <u>zmizener@lambert.com</u> |

---

**CO-DIAGNOSTICS, INC. AND SUBSIDIARIES** 

**CONSOLIDATED BALANCE SHEETS** 

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| | | |
|:---|:---|:---|
|  | **December 31, 2022** | **December 31, 2021** |
| **Assets** |  |  |
| Current assets |  |  |
| &nbsp;&nbsp;&nbsp;Cash and cash equivalents | $22973803 | $88607234 |
| &nbsp;&nbsp;&nbsp;Marketable investment securities | 58289066 | 1255266 |
| &nbsp;&nbsp;&nbsp;Accounts receivable, net | 3453723 | 20839182 |
| &nbsp;&nbsp;&nbsp;Inventory | 5310473 | 2004169 |
| &nbsp;&nbsp;&nbsp;Income taxes receivable | 1870419 |  |
| &nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 761186 | 2338444 |
| &nbsp;&nbsp;&nbsp;Note receivable | 75000 | 75000 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 92733670 | 115119295 |
| &nbsp;&nbsp;&nbsp;Property and equipment, net | 2539483 | 1933216 |
| &nbsp;&nbsp;&nbsp;Operating lease right-of-use asset | 372115 |  |
| &nbsp;&nbsp;&nbsp;Goodwill |  | 14706818 |
| &nbsp;&nbsp;&nbsp;Intangible assets, net | 26768333 | 27195000 |
| &nbsp;&nbsp;&nbsp;Investment in joint venture | 672679 | 1004953 |
| &nbsp;&nbsp;&nbsp;Note receivable | - | 75000 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $123086280 | $160034282 |
| **Liabilities and stockholders' equity** |  |  |
| Current liabilities |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable | $952297 | $607506 |
| &nbsp;&nbsp;&nbsp;Accrued expenses, current | 934447 | 3859652 |
| &nbsp;&nbsp;&nbsp;Operating lease liability, current | 297209 |  |
| &nbsp;&nbsp;&nbsp;Contingent consideration liabilities, current | 1689471 | 5767304 |
| &nbsp;&nbsp;&nbsp;Income taxes payable |  | 2213088 |
| &nbsp;&nbsp;&nbsp;Deferred revenue | - | 150000 |
| &nbsp;&nbsp;&nbsp;Total current liabilities | 3873424 | 12597550 |
| Long-term liabilities |  |  |
| &nbsp;&nbsp;&nbsp;Income taxes payable | 1181284 | 1067853 |
| &nbsp;&nbsp;&nbsp;Deferred tax liability | 2417987 | 7228444 |
| &nbsp;&nbsp;&nbsp;Operating lease liability | 50708 |  |
| &nbsp;&nbsp;&nbsp;Contingent consideration liabilities | 1042885 | 4665337 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total long-term liabilities | 4692864 | 12961634 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 8566288 | 25559184 |
| **Commitments and contingencies (Note 13)** |  |  |
| **Stockholders' equity** |  |  |
| &nbsp;&nbsp;&nbsp;Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively |  |  |
| &nbsp;&nbsp;&nbsp;Common stock, $0.001 par value; 100,000,000 shares authorized; 34,754,265 shares issued and 30,872,607 shares outstanding as of December 31, 2022 and 33,819,862 shares issued and outstanding as of December 31, 2021 | 34754 | 33820 |
| &nbsp;&nbsp;&nbsp;Treasury stock, at cost; 3,881,658 and 0 shares held as of December 31, 2022 and December 31, 2021, respectively | (14211866) |  |
| &nbsp;&nbsp;&nbsp;Additional paid-in capital | 88472934 | 80271999 |
| &nbsp;&nbsp;&nbsp;Accumulated other comprehensive income | 293140 |  |
| &nbsp;&nbsp;&nbsp;Accumulated earnings | 39931030 | 54169279 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' equity | 114519992 | 134475098 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities and stockholders' equity | $123086280 | $160034282 |

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**CO-DIAGNOSTICS, INC. AND SUBSIDIARIES**

**CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)**

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| | | |
|:---|:---|:---|
|  | **Years Ended December 31,** | **Years Ended December 31,** |
|  | **2022** | **2021** |
| Revenue | $34218209 | $97885603 |
| Cost of revenue | 5481092 | 11574944 |
| &nbsp;&nbsp;&nbsp;Gross profit | 28737117 | 86310659 |
| Operating expenses |  |  |
| &nbsp;&nbsp;&nbsp;Sales and marketing | 7344628 | 13397813 |
| &nbsp;&nbsp;&nbsp;General and administrative | 14262963 | 11550615 |
| &nbsp;&nbsp;&nbsp;Research and development | 17438098 | 14961916 |
| &nbsp;&nbsp;&nbsp;Depreciation and amortization | 1282718 | 335363 |
| &nbsp;&nbsp;&nbsp;Goodwill impairment charges | 15388546 | - |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 55716953 | 40245707 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Income (loss) from operations | (26979836) | 46064952 |
| Other income (expense) |  |  |
| &nbsp;&nbsp;&nbsp;Interest income | 704044 | 45631 |
| &nbsp;&nbsp;&nbsp;Loss on disposition of assets | (138117) | (44355) |
| &nbsp;&nbsp;&nbsp;Gain on remeasurement of acquisition contingencies | 7899644 |  |
| &nbsp;&nbsp;&nbsp;Loss on equity method investment in joint venture | (332969) | (430433) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total other income (expense) | 8132602 | (429157) |
| Income (loss) before income taxes | (18847234) | 45635795 |
| Income tax provision (benefit) | (4608985) | 8977231 |
| Net income (loss) | $(14238249) | $36658564 |
| Other comprehensive income |  |  |
| &nbsp;&nbsp;&nbsp;Change in net unrealized gains on marketable securities, net of tax | $293140 | $- |
| Total other comprehensive income | $293140 | $- |
| Comprehensive income (loss) | $(13945109) | $36658564 |
| Earnings per common share: |  |  |
| &nbsp;&nbsp;&nbsp;Basic | $(0.45) | $1.27 |
| &nbsp;&nbsp;&nbsp;Diluted | $(0.45) | $1.23 |
| Weighted average shares outstanding: |  |  |
| &nbsp;&nbsp;&nbsp;Basic | 31479028 | 28874555 |
| &nbsp;&nbsp;&nbsp;Diluted | 31479028 | 29903686 |

---

**CO-DIAGNOSTICS, INC. AND SUBSIDIARIES** 

**GAAP AND NON-GAAP MEASURES** 

**Reconciliation of net income to adjusted EBITDA:**

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| | | |
|:---|:---|:---|
|  | **Years Ended December 31,** | **Years Ended December 31,** |
|  | **2022** | **2021** |
| Net income (loss) | $(14238249) | $36658564 |
| Interest income | (704044) | (45631) |
| Depreciation and amortization | 1282718 | 335363 |
| Transaction costs | 139342 | 151305 |
| Change in fair value of contingent consideration | (7899644) |  |
| Stock-based compensation expense | 7543223 | 5509404 |
| Income tax provision | (4608985) | 8977231 |
| Goodwill impairment charges | 15388546 | - |
| &nbsp;&nbsp;&nbsp;Adjusted EBITDA | $(3097093) | $51586236 |

---

**Reconciliation of net income (loss) to adjusted net income (loss):**

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| | | |
|:---|:---|:---|
|  | **Years Ended December 31,** | **Years Ended December 31,** |
|  | **2022** | **2021** |
| Net income (loss) | $(14238249) | $36658564 |
| Goodwill impairment charges | 15388546 | - |
| &nbsp;&nbsp;&nbsp;Adjusted net income (loss) | $1150297 | $36658564 |

---