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Co-Diagnostics Reports First Quarter 2023 Financial Results

May 11, 2023 | Last Trade: US$1.08 0.02 1.89
  • Clinical trials for Co-Dx PCR Home™ platform remain on track;
  • Solid cash position and grant funding support long-term strategy

SALT LAKE CITY, May 11, 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 March 31, 2023.

First Quarter 2023 Financial Results:

  • Revenue of $0.6 million, down from $22.7 million during the prior year primarily due to lower global demand for the Logix Smart™ COVID-19 tests
  • Gross profit of $0.1 million, representing 16.6% of consolidated revenue
  • Operating loss of $10.0 million compared to operating income of $9.8 million a year ago, due to lower revenue and continued investments into research and development for the Co-Dx PCR Home™ Platform
  • Net loss of $5.8 million, compared to net income of $11.7 million in the prior year, representing EPS loss of $0.20 per fully diluted share, compared to EPS of $0.34 in 2022
  • Adjusted EBITDA loss of $7.2 million
  • Repurchased 0.3 million shares of common stock at an average price of $1.56 per share for an aggregate purchase price of approximately $0.5 million
  • Cash, cash equivalents, and marketable securities of $75.3 million as of March 31, 2023

Dwight Egan, Co-Diagnostics' Chief Executive Officer, said, "Our financial performance during the quarter reflects the expected decline in COVID-related sales year-over-year. However, we continue to advance our longer-term strategy, most notably with progress in our clinical evaluations for our Co-Dx PCR Home™ platform. We believe that the innovation of this new platform has been validated after recently receiving notification of various grant awards, which we expect will be the subject of future press releases."

Mr. Egan continued, "Looking ahead, we remain focused in our strategy and will continue to leverage our assets and impressive team to deliver innovative and affordable diagnostic testing solutions. To help guide and measure our progress through the remainder of this year, we have established a set of goals we anticipate achieving. We expect completion of clinical evaluations for our Co-Dx PCR Home™ platform and submission to the FDA by the end of this calendar year. We also anticipate clinical trials for our ABC+RSV tests (both for clinical laboratories and on the new platform) to commence during this upcoming flu season."

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, (ii) completion of clinical evaluations for our Co-Dx PCR Home platform, and (iii) clinical trials for our ABC+RSV tests to commence during this upcoming flu season. 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)

 
  

March 31, 2023

  

December 31,

2022

 

Assets

        

Current assets

        

Cash and cash equivalents

 

$

6,359,380

  

$

22,973,803

 

Marketable investment securities

  

68,920,535

   

58,289,066

 

Accounts receivable, net

  

2,702,196

   

3,453,723

 

Inventory, net

  

5,294,653

   

5,310,473

 

Income taxes receivable

  

1,695,480

   

1,870,419

 

Prepaid expenses and other current assets

  

913,175

   

761,187

 

Note receivable

  

37,500

   

75,000

 

Total current assets

  

85,922,919

   

92,733,671

 

Property and equipment, net

  

2,510,083

   

2,539,483

 

Operating lease right-of-use asset

  

952,176

   

372,115

 

Intangible assets, net

  

26,661,667

   

26,768,333

 

Investment in joint venture

  

950,001

   

672,679

 

Total assets

 

$

116,996,846

  

$

123,086,281

 

Liabilities and stockholders' equity

        

Current liabilities

        

Accounts payable

 

$

829,819

  

$

952,296

 

Accrued expenses, current

  

1,492,611

   

934,447

 

Operating lease liability, current

  

277,290

   

297,209

 

Contingent consideration liabilities, current

  

992,229

   

1,689,471

 

Deferred revenue

  

18,120

   

-

 

Total current liabilities

  

3,610,069

   

3,873,423

 

Long-term liabilities

        

Income taxes payable

  

1,193,080

   

1,181,284

 

Deferred tax liability

  

203,335

   

2,417,987

 

Operating lease liability

  

658,137

   

50,708

 

Contingent consideration liabilities

  

702,455

   

1,042,885

 

Total long-term liabilities

  

2,757,007

   

4,692,864

 

Total liabilities

  

6,367,076

   

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 March 31,

2023 and December 31, 2022, respectively

  

-

   

-

 

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

authorized; 34,823,015 shares issued and 30,632,345 shares

outstanding as of March 31, 2023 and 34,754,265 shares issued

and 30,872,607 shares outstanding as of December 31, 2022

  

34,823

   

34,754

 

Treasury stock, at cost; 4,190,670 and 3,881,658 shares held as

of March 31, 2023 and December 31, 2022, respectively

  

(14,694,062)

   

(14,211,866)

 

Additional paid-in capital

  

90,641,608

   

88,472,935

 

Accumulated other comprehensive income

  

471,761

   

293,140

 

Accumulated earnings

  

34,175,640

   

39,931,031

 

Total stockholders' equity

  

110,629,770

   

114,519,994

 

Total liabilities and stockholders' equity

 

$

116,996,846

  

$

123,086,281

 
 

 See accompanying notes to unaudited condensed consolidated financial statements

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(Unaudited)

 
  

Three Months Ended March 31,

 
  

2023

  

2022

 

Revenue

 

$

601,957

  

$

22,699,044

 

Cost of revenue

  

502,241

   

3,281,951

 

Gross profit

  

99,716

   

19,417,093

 

Operating expenses

        

Sales and marketing

  

1,706,331

   

2,652,148

 

General and administrative

  

3,013,965

   

2,922,195

 

Research and development

  

5,014,060

   

3,771,327

 

Depreciation and amortization

  

316,010

   

247,264

 

Total operating expenses

  

10,050,366

   

9,592,934

 

Income (loss) from operations

  

(9,950,650)

   

9,824,159

 

Other income

        

Interest income

  

202,372

   

11,393

 

Realized gain on investments

  

418,082

   

-

 

(Loss) on disposition of assets

  

-

   

(93,421)

 

Gain on remeasurement of acquisition contingencies

  

1,037,672

   

3,379,890

 

Gain (loss) on equity method investment in joint venture

  

277,322

   

(21,339)

 

Total other income

  

1,935,448

   

3,276,523

 

Income (loss) before income taxes

  

(8,015,202)

   

13,100,682

 

Income tax provision (benefit)

  

(2,259,811)

   

1,386,087

 

Net income (loss)

 

$

(5,755,391)

  

$

11,714,595

 

Other comprehensive income

        

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

 

$

178,621

  

$

-

 

Total other comprehensive income

 

$

178,621

  

$

-

 

Comprehensive income (loss)

 

$

(5,576,770)

  

$

11,714,595

 
         

Earnings per common share:

        

Basic

 

$

(0.20)

  

$

0.35

 

Diluted

 

$

(0.20)

  

$

0.34

 

Weighted average shares outstanding:

        

Basic

  

29,483,540

   

33,935,570

 

Diluted

  

29,483,540

   

34,711,476

 
 

See accompanying notes to unaudited condensed consolidated financial statements

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

GAAP AND NON-GAAP MEASURES

(Unaudited)

 

Reconciliation of net income to adjusted EBITDA:

 
  

Three Months Ended March 31,

 
  

2023

  

2022

 

Net income (loss)

 

$

(5,755,391)

  

$

11,714,595

 

Interest income

  

(202,372)

   

(11,393)

 

Realized gain on investments

  

(418,082)

   

-

 

Depreciation and amortization

  

316,010

   

247,264

 

Transaction costs

  

-

   

133

 

Change in fair value of contingent consideration

  

(1,037,672)

   

-

 

Stock-based compensation expense

  

2,168,742

   

1,375,097

 

Income tax provision

  

(2,259,811)

   

1,386,087

 

Adjusted EBITDA

 

$

(7,188,576)

  

$

14,711,783

 
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