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Co-Diagnostics Reports Second Quarter 2023 Financial Results

August 10, 2023 | Last Trade: US$1.11 0.03 -2.63
  • Co-Dx receives grant awards from the Bill & Melinda Gates Foundation; NIH RADx® Tech to develop tests on our new Co-Dx PCR Home™ platform

SALT LAKE CITY, Aug. 10, 2023 /PRNewswire/ -- 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 quarter ended June 30, 2023.

Second Quarter 2023 Financial Results:

  • Revenue of $0.2 million, down from $5.0 million during the prior year primarily due to the anticipated decline in global demand for the Logix Smart® COVID-19 tests
  • Operating expenses of $11.7 million increased by 42.1% from the prior year same period due to our pre-commercialization investments in our Co-Dx PCR Home platform*
  • Operating loss of $12.0 million compared to operating loss of $4.1 million a year ago
  • Net loss of $8.9 million, compared to net loss of $2.7 million in the prior year second quarter, representing EPS loss of $0.31 per fully diluted share, compared to EPS loss of $0.08 in the prior year period
  • Adjusted EBITDA loss of $9.6 million
  • Repurchased 0.4 million shares of common stock at an average price of $1.51 per share for an aggregate purchase price of approximately $0.6 million
  • Cash, cash equivalents, and marketable securities of $69.1 million as of June 30, 2023

2023 Recent Business Highlights:

  • NIH awarded the Company $1.2 million as part of the Rapid Acceleration of Diagnostics (RADx®) Tech program for completion of its upcoming upper respiratory panel on the Company's Co-Dx PCR Home testing platform
  • The company was awarded two grants by the Bill & Melinda Gates Foundation in the amounts of $1.33 million and $987K, to support the development of TB and HPV tests, respectively
  • Signed lease and began build-out of new manufacturing facility with capacity for up to 12 lines of production; first lines expected to be operational by end of 2023
  • Received results from a recent usability and analytical study conducted by PATH, which investigated the limit-of-detection and ease-of-use of the Company's Co-Dx PCR Home platform, running the platform's COVID-19 assay

Dwight Egan, Co-Diagnostics' Chief Executive Officer, said, "While sales of our COVID diagnostic kits declined as expected, we continue to strengthen our position as we seek to expand our advanced PCR technology reach beyond the four walls of the lab to the places of greatest unmet need. We remain on track for FDA submission of our new Co-Dx PCR Home platform and initial testing product by the end of this year."

"We remain steadfast in our strategy and continue to progress toward our mission of making affordable, high-quality real-time PCR diagnostics available to all," said Brian Brown, Co-Diagnostics' Chief Financial Officer. "We are making notable progress toward our goals and move into the second half of this year with strong momentum."

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

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

*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. The Company believes that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company's management uses this non-GAAP measure 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 provides 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 it allows 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 measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes 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 measure 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. A reconciliation table of the net income, the most comparable GAAP financial measure to adjusted EBITDA, is 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. 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) completion of development and FDA submission for approval of the Co-Dx PCR Home platform by end of this year and (ii) 12 lines of production with first lines expected to be operational by end of 2023. 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 16, 2023, 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.

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

 
  
  

June 30, 2023

  

December 31, 2022

 

Assets

      

Current assets

        

Cash and cash equivalents

 

$

13,830,846

  

$

22,973,803

 

Marketable investment securities

  

55,307,146

   

58,289,066

 

Accounts receivable, net

  

1,097,393

   

3,453,723

 

Inventory, net

  

4,691,068

   

5,310,473

 

Income taxes receivable

  

1,439,451

   

1,870,419

 

Prepaid expenses and other current assets

  

981,996

   

761,187

 

Note receivable

  

37,500

   

75,000

 

Total current assets

  

77,385,400

   

92,733,671

 

Property and equipment, net

  

2,795,023

   

2,539,483

 

Deferred tax asset

  

2,012,181

   

-

 

Operating lease right-of-use asset

  

3,228,774

   

372,115

 

Intangible assets, net

  

26,555,000

   

26,768,333

 

Investment in joint venture

  

824,808

   

672,679

 

Total assets

 

$

112,801,186

  

$

123,086,281

 

Liabilities and stockholders' equity

        

Current liabilities

        

Accounts payable

 

$

1,712,204

  

$

952,296

 

Accrued expenses, current

  

1,628,765

   

934,447

 

Operating lease liability, current

  

772,515

   

297,209

 

Contingent consideration liabilities, current

  

744,172

   

1,689,471

 

Deferred revenue

  

257,999

   

-

 

Total current liabilities

  

5,115,655

   

3,873,423

 

Long-term liabilities

        

Income taxes payable

  

1,203,975

   

1,181,284

 

Deferred tax liability

  

-

   

2,417,987

 

Operating lease liability

  

2,458,072

   

50,708

 

Contingent consideration liabilities

  

591,107

   

1,042,885

 

Total long-term liabilities

  

4,253,154

   

4,692,864

 

Total liabilities

  

9,368,810

   

8,566,287

 

Commitments and contingencies (Note 10)

        

Stockholders' equity

        

Convertible preferred stock, $0.001 par value; 5,000,000 shares

authorized; 0 shares issued and outstanding as of June 30, 2023 and

December 31, 2022, respectively

  

-

   

-

 

Common stock, $0.001 par value; 100,000,000 shares authorized;

35,348,350 shares issued and 30,788,871 shares outstanding as of

June 30, 2023 and 34,754,265 shares issued and 30,872,607 shares

outstanding as of December 31, 2022

  

35,348

   

34,754

 

Treasury stock, at cost; 4,559,479 and 3,881,658 shares held as of

June 30, 2023 and December 31, 2022, respectively

  

(15,249,796)

   

(14,211,866)

 

Additional paid-in capital

  

92,810,883

   

88,472,935

 

Accumulated other comprehensive income

  

579,127

   

293,140

 

Accumulated earnings

  

25,256,815

   

39,931,031

 

Total stockholders' equity

  

103,432,377

   

114,519,994

 

Total liabilities and stockholders' equity

 

$

112,801,186

  

$

123,086,281

 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(Unaudited)

 
  

Three Months Ended June 30,

 

Six Months Ended June 30,

  

2023

  

2022

  

2023

  

2022

 

Revenue

 

$

197,806

  

$

5,023,226

  

$

799,763

  

$

27,722,270

 

Cost of revenue

  

459,095

   

915,432

   

961,336

   

4,197,383

 

Gross profit

  

(261,289)

   

4,107,794

   

(161,573)

   

23,524,887

 

Operating expenses

                

Sales and marketing

  

1,732,966

   

1,472,225

   

3,439,297

   

4,124,373

 

General and administrative

  

3,713,895

   

2,468,421

   

6,727,860

   

5,390,616

 

Research and development

  

5,981,043

   

3,889,844

   

10,995,103

   

7,661,171

 

Depreciation and amortization

  

305,246

   

424,342

   

621,256

   

671,606

 

Total operating expenses

  

11,733,150

   

8,254,832

   

21,783,516

   

17,847,766

 

Income (loss) from operations

  

(11,994,439)

   

(4,147,038)

   

(21,945,089)

   

5,677,121

 

Other income

                

Interest income

  

191,892

   

61,671

   

394,264

   

73,064

 

Realized gain on investments

  

411,190

   

-

   

829,272

   

-

 

(Loss) on disposition of assets

  

-

   

(48,740)

   

-

   

(142,161)

 

Gain on remeasurement of acquisition contingencies

  

359,405

   

812,822

   

1,397,077

   

4,192,712

 

Gain (loss) on equity method investment in joint venture

  

(125,193)

   

(106,525)

   

152,129

   

(127,864)

 

Total other income

  

837,294

   

719,228

   

2,772,742

   

3,995,751

 

Income (loss) before income taxes

  

(11,157,145)

   

(3,427,810)

   

(19,172,347)

   

9,672,872

 

Income tax provision (benefit)

  

(2,238,320)

   

(741,507)

   

(4,498,131)

   

644,580

 

Net income (loss)

 

$

(8,918,825)

  

$

(2,686,303)

  

$

(14,674,216)

  

$

9,028,292

 

Other comprehensive income (loss)

                

Change in net unrealized gains on marketable securities, net of tax

 

$

107,366

  

$

-

  

$

285,987

  

$

-

 

Total other comprehensive income

 

$

107,366

  

$

-

  

$

285,987

  

$

-

 

Comprehensive income (loss)

 

$

(8,811,459)

  

$

(2,686,303)

  

$

(14,388,229)

  

$

9,028,292

 
                 

Earnings per common share:

                

Basic

 

$

(0.31)

  

$

(0.08)

  

$

(0.50)

  

$

0.28

 

Diluted

 

$

(0.31)

  

$

(0.08)

  

$

(0.50)

  

$

0.27

 

Weighted average shares outstanding:

                

Basic

  

29,088,159

   

32,472,251

   

29,284,175

   

32,509,664

 

Diluted

  

29,088,159

   

32,472,251

   

29,284,175

   

33,253,612

 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

GAAP AND NON-GAAP MEASURES

(Unaudited)

 
  

Reconciliation of net income to adjusted EBITDA:

            
  

Three Months Ended June 30,

 

 Six Months Ended June 30,

 
  

2023

 

2022

  

2023

  

2022

 

Net income (loss)

 

$

(8,918,825)

  

$

(2,686,303)

  

$

(14,674,216)

  

$

9,028,292

 

Interest income

  

(191,892)

   

(61,671)

   

(394,264)

   

(73,064)

 

Realized gain on investments

  

(411,190)

   

-

   

(829,272)

   

-

 

Depreciation and amortization

  

305,246

   

424,342

   

621,256

   

671,606

 

Transaction costs

  

310

   

47,943

   

310

   

126,171

 

Change in fair value of contingent consideration

  

(359,405)

   

(812,822)

   

(1,397,077)

   

(4,192,712)

 

Stock-based compensation expense

  

2,169,800

   

1,533,286

   

4,338,542

   

2,908,381

 

Income tax provision

  

(2,238,320)

   

(741,507)

   

(4,498,131)

   

644,580

 

Adjusted EBITDA

 

$

(9,644,276)

  

$

(2,296,732)

  

$

(16,832,852)

  

$

9,113,254

 
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