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): August 12, 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 ☒
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 August 12, 2021, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended June 30, 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 June 30, 2021 with the U.S. Securities and Exchange Commission on or before August 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 August 12, 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: August 12, 2021 | By: | /s/ Brian Brown |
| Name: | Brian Brown | |
| Title: | Chief Financial Officer (Principal Financial and Accounting Officer) | |
Exhibit 99.1
Co-Diagnostics Reports Strong Second Quarter 2021 Financial Results
Solid quarterly results highlighted by revenue of $27.4 million, pre-tax income of $11.9 million and diluted EPS of $0.33
SALT LAKE CITY, August 12, 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 second quarter ended June 30, 2021.
Second Quarter 2021 Financial Results:
| ● | Revenue of $27.4 million, primarily due to sales of the Logix Smart™ COVID-19 Test, representing an increase of 13.8% as compared to the prior year period. | |
| ● | Gross profit increased 37.6% to $24.9 million, representing 90.8% of consolidated revenue due to reduced production costs and improved product mix as compared to the prior-year period. | |
| ● | Operating income totaled $11.8 million, representing a 19.8% decrease from the prior year period due to increased sales and marketing expenses as a result of increased third-party sales commissions, as well as increased research and development expenses related to the Eikon point of care technology platform. | |
| ● | Income before taxes of $11.9 million. | |
| ● | Net income of $9.8 million, compared to a net income of $15.0 million in the prior-year first quarter, representing $0.33 per fully diluted share, as compared to $0.51 per fully diluted share in the second quarter of 2020. | |
| ● | Cash, cash equivalents, and marketable securities totaled $72.4 million as of June 30, 2021, an increase of $12.3 million from March 31, 2021. | |
| ● | Operating cash flows totaled $24.7 million for the year-to-date period ending June 30, 2021, as compared to cash used in operations of $0.3 million during the prior year period. |
“We are proud to continue the momentum, delivering another strong quarter following our record results in 2020,” said Dwight Egan, Co-Diagnostics’ Chief Executive Officer. “Our team has done an excellent job of cultivating distributor relationships throughout the United States and abroad, which is evident in the record sales results this quarter. As new variants of COVID-19 continue to emerge and affect the global population, we remain steadfast in our mission to deliver high-quality diagnostic testing kits to customers throughout the world.”
“Looking to the back half of 2021, we are well positioned to maintain our trajectory of growth as our significant investments in talent and R&D continue to yield positive results,” continued Egan. “Our Eikon point of care technology platform has experienced several breakthrough technological advancements, including our direct saliva extraction-free PCR protocol, and a groundbreaking instrument designed to be inexpensive, easy to use, and to deliver rapid results while maintaining the superior performance of PCR. The result is a low-cost, small-footprint PCR device that we anticipate could be deployed widely in nearly every setting. We have strong cash reserves with no debt, and despite the substantial R&D investment and impact on EPS, the Eikon platform is the surest way for the Company to position itself for future growth and profitability.”
A video animation illustrating the Eikon platform can be seen here https://codiagnostics.com/yourtest-animation/.
Second Quarter 2021 Business Highlights:
| ● | New international CoPrimer™ patent strengthened the Company’s intellectual property protection for the technology underpinning the millions of molecular diagnostic test products that have been deployed in laboratories and hospitals in over 50 countries and across the United States. | |
| ● | Over 20 million tests sold to-date as of Q3 2021 | |
| ● | The Logix Smart™ SARS-CoV-2 DS (Direct Saliva) obtained regulatory authorization to be sold as an in vitro diagnostic for the diagnosis of COVID-19 in markets that accept CE markings. | |
| ● | CoSara Diagnostics was recognized for its work combating the COVID-19 surge in India and its tireless efforts to increase manufacturing of COVID-19 tests in response to the deadly wave of infections. |
Third Quarter 2021 Outlook:
Co-Diagnostics is offering the following guidance for its third quarter of 2021:
| ● | Revenue to be in the range of $23.0 million to $25.0 million | |
| ● | Increased development expenses for our Eikon point of care technology platform | |
| ● | Diluted earnings per share forecasted to be in the $0.19 to $0.22 range, with shares outstanding expected to be approximately 30 million and a corporate effective tax rate of approximately 19.0 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 | Zach Mizener |
| Head of Investor Relations | Lambert & Co. |
| +1 801-438-1036 | +1 616-233-0500 |
| [email protected] | [email protected] |
CO-DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| June 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 70,274,078 | $ | 42,976,713 | ||||
| Marketable investment securities | 2,109,675 | 4,335,446 | ||||||
| Accounts receivable, net | 12,755,952 | 12,136,833 | ||||||
| Inventory | 4,120,704 | 7,995,189 | ||||||
| Prepaid expenses | 1,039,506 | 369,028 | ||||||
| Deferred tax asset | 20,443 | 547,224 | ||||||
| Total current assets | 90,320,358 | 68,360,433 | ||||||
| Property and equipment, net | 1,192,901 | 949,639 | ||||||
| Investment in joint venture | 1,276,202 | 1,927,125 | ||||||
| Total assets | $ | 92,789,461 | $ | 71,237,197 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 427,144 | $ | 598,318 | ||||
| Accrued expenses, current | 4,001,445 | 2,849,503 | ||||||
| Accrued expenses (related party), current | 90,000 | 120,000 | ||||||
| Income taxes payable | 47,180 | 637,560 | ||||||
| Deferred revenue | 163,134 | 305,307 | ||||||
| Total current liabilities | 4,728,903 | 4,510,688 | ||||||
| Long-term liabilities | ||||||||
| Accrued expenses, noncurrent | 794,615 | - | ||||||
| Accrued expenses (related party), noncurrent | - | 30,000 | ||||||
| Total long-term liabilities | 794,615 | 30,000 | ||||||
| Total liabilities | 5,523,518 | 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 June 30, 2021 and December 31, 2020 | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 28,889,890 and 28,558,033 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 28,890 | 28,558 | ||||||
| Additional paid-in capital | 52,042,150 | 49,157,236 | ||||||
| Accumulated earnings | 35,194,903 | 17,510,715 | ||||||
| Total stockholders’ equity | 87,265,943 | 66,696,509 | ||||||
| Total liabilities and stockholders’ equity | $ | 92,789,461 | $ | 71,237,197 | ||||
CO-DIAGNOSTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenue | $ | 27,358,140 | $ | 24,040,274 | $ | 47,382,909 | $ | 25,588,802 | ||||||||
| Cost of revenue | 2,504,355 | 5,975,305 | 5,776,920 | 6,457,045 | ||||||||||||
| Gross profit | 24,853,785 | 18,064,969 | 41,605,989 | 19,131,757 | ||||||||||||
| Operating expenses | 90.8 | % | ||||||||||||||
| Sales and marketing | 5,853,313 | 390,191 | 7,050,859 | 658,674 | ||||||||||||
| General and administrative | 2,468,433 | 2,191,034 | 5,404,122 | 3,650,518 | ||||||||||||
| Research and development | 4,669,160 | 750,249 | 6,886,223 | 1,150,271 | ||||||||||||
| Depreciation and amortization | 71,714 | 25,218 | 138,719 | 45,966 | ||||||||||||
| Total operating expenses | 13,062,620 | 3,356,692 | 19,479,923 | 5,505,429 | ||||||||||||
| Income from operations | 11,791,165 | 14,708,277 | 22,126,066 | 13,626,328 | ||||||||||||
| Other income (expense) | ||||||||||||||||
| Interest income | 10,529 | 38,173 | 25,186 | 45,748 | ||||||||||||
| Gain (loss) on equity method investment in joint venture | 128,595 | 258,559 | (336,348 | ) | 267,740 | |||||||||||
| Total other income (expense) | 139,124 | 296,732 | (311,162 | ) | 313,488 | |||||||||||
| Income before income taxes | 11,930,289 | 15,005,009 | 21,814,904 | 13,939,816 | ||||||||||||
| Income tax provision | 2,145,076 | - | 4,130,716 | - | ||||||||||||
| Net income | $ | 9,785,213 | $ | 15,005,009 | $ | 17,684,188 | $ | 13,939,816 | ||||||||
| Earnings per common share: | ||||||||||||||||
| Basic | $ | 0.34 | $ | 0.54 | $ | 0.62 | $ | 0.50 | ||||||||
| Diluted | $ | 0.33 | $ | 0.51 | $ | 0.59 | $ | 0.48 | ||||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic | 28,794,047 | 27,582,229 | 28,728,828 | 27,605,137 | ||||||||||||
| Diluted | 29,741,265 | 29,152,222 | 29,833,955 | 29,094,475 | ||||||||||||