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): May 13, 2021
| 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) |
2401 S. Foothill Drive, Suite D, Salt Lake City, Utah 84109
(Address of principal executive offices)
(801) 438-1036
(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:
| 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 |
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 [X]
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.
Item 7.01. Regulation FD. Disclosure.
On May 13, 2021, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended March 31, 2021. A copy of the press release is included as Exhibit 99.1 and incorporated herein by reference. The Company anticipates filing its Quarterly Report on Form 10-Q for the fiscal quarter ended May 31, 2021 with the U.S. Securities and Exchange Commission on or before May 15, 2021.
The disclosures under Item 2.02 and Item 7.01, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information provided herein shall not be deemed incorporated by reference into any filing made under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No.: | Description: | |
| 99.1 | Press Released, dated May 13, 2021 |
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. | ||
| Date: May 13, 2021 | By: | /s/ Brian Brown |
| Name: | Brian Brown | |
| Title: | Chief Financial Officer (Principal Financial and Accounting Officer) | |
Exhibit 99.1
Co-Diagnostics Reports First Quarter 2021 Financial Results
Strong quarterly results highlighted by revenue of $20.0 million, pre-tax income of $9.9 million and diluted EPS of $0.26
SALT LAKE CITY, May 13, 2021—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 first quarter ended March 31, 2021.
First-Quarter 2021 Financial Results:
| ● | Revenue of $20.0 million, primarily due to sales of the Logix Smart™ COVID-19 Test | |
| ● | Gross profit increased to $16.8 million, representing 83.7% of consolidated revenue due to improved product mix as compared to the prior-year period | |
| ● | Operating income improved to $10.3 million over an operating loss in the prior-year quarter, due to continued strong revenue and gross profit | |
| ● | Income before taxes of $9.9 million | |
| ● | Net income of $7.9 million, compared to a net loss of $1.1 million in the prior-year first quarter, representing $0.26 per fully diluted share | |
| ● | Cash, cash equivalents, and marketable securities totaled $60.1 million as of March 31, 2021, an increase of $12.8 million from December 31, 2020 |
“We are proud to deliver another strong quarter following our record results across 2020,” said Dwight Egan, Co-Diagnostics’ Chief Executive Officer. “We continue to see great progress in the development of our new rapid PCR diagnostic testing and are incredibly thankful to our customers, partners, and employees for their efforts toward combatting COVID-19 and other infectious diseases. We remain well positioned to provide timely, affordable, and high-quality molecular diagnostics solutions to countries around the globe and especially to those with increasing needs and surging crises.
“Looking forward, we continue to anticipate demand for our product portfolio amid strong market conditions,” concluded Egan. “As such, we have maintained solid revenues, earnings, and free cash flow to start the year and are excited to accelerate investments in talent and the breadth of our portfolio to create increased capacity and deliver sustained value to our customers and shareholders.”
Year-to-Date 2021 Business Highlights:
| ● | Continued development of previously announced new rapid PCR point-of-care and at-home diagnostic testing, screening, and surveillance platform, which utilizes its proprietary CoPrimer™ technology, direct saliva, and nasal swab extraction-free protocols, for COVID-19 and other infectious disease testing. | |
| ● | The Company believes its direct saliva technology has the potential to greatly improve COVID-19 testing throughput while delivering lower processing costs and increased accessibility of gold-standard PCR diagnostics worldwide with applications for “Workflow of Life” locations, including businesses, schools, and home settings. | |
| ● | Announced its partner Clinical Reference Lab, which received an FDA EUA for its Rapid Response COVID-19 saliva test that uses Co-Diagnostics CoPrimer™ technology, is now available through Walgreens Find Care®, allowing consumers a convenient, non-invasive option for PCR-based testing from their own homes. | |
| ● | Shipped an emergency supply of raw test materials to its Indian Joint Venture, CoSara Diagnostics, to help combat the surge of cases in India, which comes as the Company marks the two-year anniversary of the inauguration of its CoSara manufacturing facility. CoSara has received significant recognition across India and its media for these efforts. |
Second-Quarter 2021 Outlook:
Co-Diagnostics is offering the following guidance for its second quarter of 2021:
| ● | Revenue to be in the range of $20.0 million to $22.0 million | |
| ● | Diluted earnings per share forecasted to be in the $0.19 to $0.23 range, which includes enhanced R&D spending related to the Company’s new molecular diagnostics platform, with shares outstanding expected to be approximately 30 million and a corporate effective tax rate of approximately 21.0 percent. |
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: ir.codiagnostics.com on the Events & Webcasts page
Conference Call: 877-317-6789 (domestic) or 412-317-6789 (international)
The call will be recorded and later made available on the Company’s website: https://codiagnostics.com.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. The Company’s technology is 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 to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.
Forward-Looking Statements:
This press release contains forward-looking statements. 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 the (i) use of funding proceeds, (ii) expansion of product distribution, (iii) acceleration of initiatives in liquid biopsy and SNP detection, (iv) use of the Company’s liquid biopsy tests by laboratories, (v) capital resources and runway needed to advance the Company’s products and markets, (vi) increased sales in the near-term, (vii) flexibility in managing the Company’s balance sheet, (viii) anticipation of business expansion, (ix) benefits in research and worldwide accessibility of the CoPrimer technology and its cost-saving and scientific advantages, and (x) the impact that known and unknown COVID-19 variants may have on us and our products, our customers and suppliers, including disruptions and inefficiencies in the supply chain. 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. 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: | Investor Relations Contact: |
| Andrew Benson | Tyler Deur |
| Head of Investor Relations | Lambert & Co. |
| +1 801-438-1036 | +1 616-446-6180 |
| investors@codiagnostics.com | tdeur@lambert.com |
CO-DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| March 31, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 57,788,893 | $ | 42,976,713 | ||||
| Marketable investment securities | 2,302,644 | 4,335,446 | ||||||
| Accounts receivable, net | 12,117,127 | 12,136,833 | ||||||
| Inventory | 6,197,608 | 7,995,189 | ||||||
| Prepaid expenses | 483,501 | 369,028 | ||||||
| Deferred tax asset | 244,824 | 547,224 | ||||||
| Total current assets | 79,134,597 | 68,360,433 | ||||||
| Property and equipment, net | 1,022,192 | 949,639 | ||||||
| Investment in joint venture | 962,182 | 1,927,125 | ||||||
| Total assets | $ | 81,118,971 | $ | 71,237,197 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 667,592 | $ | 598,318 | ||||
| Accrued expenses, current | 1,594,312 | 2,849,503 | ||||||
| Accrued expenses (related party), current | 120,000 | 120,000 | ||||||
| Income taxes payable | 1,765,998 | 637,560 | ||||||
| Deferred revenue | 158,791 | 305,307 | ||||||
| Total current liabilities | 4,306,693 | 4,510,688 | ||||||
| Long-term liabilities | ||||||||
| Accrued expenses, noncurrent | 554,802 | - | ||||||
| Accrued expenses (related party), noncurrent | - | 30,000 | ||||||
| Total long-term liabilities | 554,802 | 30,000 | ||||||
| Total liabilities | 4,861,495 | 4,540,688 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Stockholders’ equity | ||||||||
| Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2021 and December 31, 2020 | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 28,665,714 and 28,558,033 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 28,666 | 28,558 | ||||||
| Additional paid-in capital | 50,819,120 | 49,157,236 | ||||||
| Accumulated earnings | 25,409,690 | 17,510,715 | ||||||
| Total stockholders’ equity | 76,257,476 | 66,696,509 | ||||||
| Total liabilities and stockholders’ equity | $ | 81,118,971 | $ | 71,237,197 | ||||
CO-DIAGNOSTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Revenue | $ | 20,024,769 | $ | 1,548,528 | ||||
| Cost of revenue | 3,272,565 | 481,740 | ||||||
| Gross profit | 16,752,204 | 1,066,788 | ||||||
| Operating expenses | ||||||||
| Sales and marketing | 1,197,546 | 268,483 | ||||||
| General and administrative | 2,935,689 | 1,459,484 | ||||||
| Research and development | 2,217,063 | 400,022 | ||||||
| Depreciation and amortization | 67,005 | 20,748 | ||||||
| Total operating expenses | 6,417,303 | 2,148,737 | ||||||
| Income (loss) from operations | 10,334,901 | (1,081,949 | ) | |||||
| Other income (expense) | ||||||||
| Interest income | 14,657 | 7,575 | ||||||
| Gain (loss) on equity method investment in joint venture | (464,943 | ) | 9,181 | |||||
| Total other income (expense) | (450,286 | ) | 16,756 | |||||
| Income (loss) before income taxes | 9,884,615 | (1,065,193 | ) | |||||
| Income tax provision | 1,985,640 | - | ||||||
| Net income (loss) | $ | 7,898,975 | $ | (1,065,193 | ) | |||
| Earnings (loss) per common share: | ||||||||
| Basic | $ | 0.28 | $ | (0.05 | ) | |||
| Diluted | $ | 0.26 | $ | (0.05 | ) | |||
| Weighted average shares outstanding: | ||||||||
| Basic | 28,662,885 | 22,820,450 | ||||||
| Diluted | 30,002,729 | 22,820,450 | ||||||