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 4, 2022
 
graphic

CHEMBIO DIAGNOSTICS, INC.

Nevada
0-30379
88-0425691
(State or Other Jurisdiction of Incorporation or Organization)
(Commission File Number)
(I.R.S. Employer Identification No.)

555 Wireless Blvd. Hauppauge, NY 11788
(Address of principal executive offices) (Zip code)
 
Registrant’s telephone number, including area code:  (631) 924-1135
 
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
 
Name of each exchange on which registered
Common Stock, $0.01 par value
 
CEMI
 
The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934. 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 August 4, 2022, we issued a press release announcing financial results for the quarter ended June 30, 2022. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8‑K and is incorporated herein by reference.
 
The information contained in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of Section 11 or Section 12(a)(2) of the Securities Act of 1933. The information contained in this Item 2.02 and in the press release furnished as Exhibit 99.1 to this report shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by us whether made before or after the date hereof, regardless of any general incorporation language in such filing.
 
Item 9.01
Financial Statements and Exhibits.
 
(d)          Exhibits.
 
Exhibit No.
 
Description
 
Press Release of Chembio Diagnostics, Inc., dated August 4, 2022
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 filed on its behalf by the undersigned hereunto duly authorized.

 
Chembio Diagnostics, Inc.
   
Dated: August 4, 2022
By:
/s/ Richard L. Eberly
   
Chief Executive Officer and President




Exhibit 99.1

Chembio Diagnostics Reports Second Quarter 2022 Financial Results

HAUPPAUGE, NY, August 4, 2022 -- Chembio Diagnostics, Inc. (“Chembio” or the “Company”) (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today reported financial results for the quarter ended June 30, 2022.

Recent Highlights

Achieved second quarter 2022 total revenue of $9.2 million including product revenue of $8.9 million, representing growth of 42% and 125%, respectively, compared to the prior year period:

o
U.S. product revenue of $3.4 million, representing growth of 208% compared to the prior year period

o
Africa product revenue of $3.1 million, representing growth of 114% compared to the prior year period

Completed manufacturing and most of the shipments under the $4 million HIV test purchase order supported by The Global Fund

Broadened relationship with Reszon Diagnostics International to manufacture HIV1/2 STAT-PAK in the Chembio Diagnostics Malaysia facility and to increase commercial presence in the Asia-Pacific region

Expanded Direct-to-Consumer channel for the commercialization of the Sure Check HIV Self-test in Brazil and the United Kingdom, and the third-party SCoV-2 Ag Detect Self-Test in the United States

Improved cash usage in the second quarter of 2022 to $1.6 million, from $8.8 million in the prior year period and $4.4 million in the preceding quarter, with a cash and cash equivalents balance as of June 30, 2022 of $22.8 million

“We are pleased with our performance in the second quarter including strong sales growth driven by contributions from our core products and a significant improvement in cash burn,” said Richard Eberly, Chembio’s President and Chief Executive Officer. “During the quarter we made continued progress with our Global Competitiveness Program – positioning the team to drive adoption of our core higher margin products in high-growth markets, and expanding manufacturing capabilities through automation and a contract manufacturing agreement leveraging our facility in Malaysia. Additionally, we are excited to advance key new product development and regulatory initiatives, all of which help define a path to more profitable growth.”

Second Quarter 2022 Financial Results
Total revenue for the second quarter of 2022 was $9.2 million, an increase of 42% compared to the prior year period. Net product sales for the second quarter of 2022 were $8.9 million, an increase of 125% compared to the prior year period. Government grant, license and royalty, and R&D revenue for the second quarter of 2022 totaled $0.3 million, a decrease of 88% compared to the prior year period.

Gross product margin for the second quarter of 2022 was $0.8 million, compared to negative $0.1 million for the prior year period. Gross product margin percentage for the second quarter of 2022 was 9%, compared to negative 3% for the prior year period. Gross product margin improvement in the second quarter of 2022 was driven by product mix and operational productivity.

Research and development expenses decreased by $0.8 million, or 27%, compared to the prior year period to $2.0 million in the second quarter of 2022.

Selling, general and administrative expenses decreased by $0.8 million, or 13%, compared to the prior year period to $5.2 million in the second quarter of 2022.

Net loss for the second quarter of 2022 was ($6.9) million, or ($0.23) per diluted share, compared to a net loss of ($9.1) million, or ($0.45) per diluted share, for the prior year period.

Cash and cash equivalents as of June 30, 2022 totaled $22.8 million, compared to $24.4 million at March 31, 2022.


Conference Call
Chembio will host a conference call today beginning at 4:30 pm ET to discuss its financial results and recent business highlights. Investors interested in listening to the call may do so by dialing 888-506-0062 from the United States or 973-528-0011 from outside the United States and providing entry code 558147. To listen to a live webcast of the call, please visit the Investor Relations section of Chembio's website at www.chembio.com. Following the call, a replay will be available on the Investor Relations section of Chembio’s website. A telephone replay will be available until 4:30 pm ET on August 18, 2022 by dialing 877-481-4010 from the United States or 919-882-2331 from outside the United States and using passcode 45932.

About Chembio Diagnostics
Chembio is a leading diagnostics company focused on developing and commercializing point-of-care tests used for the rapid detection and diagnosis of infectious diseases, including sexually transmitted disease, insect vector and tropical disease, COVID-19 and other viral and bacterial infections, enabling expedited treatment. Coupled with Chembio’s extensive scientific expertise, its novel DPP technology offers broad market applications beyond infectious disease. Chembio’s products are sold globally, directly and through distributors, to hospitals and clinics, physician offices, clinical laboratories, public health organizations, government agencies, and consumers. Learn more at www.chembio.com.

Going Concern Considerations
The Company continued to experience market, clinical trial and regulatory complications in seeking to develop and commercialize a portfolio of COVID-19 test systems during the continuing, but evolving, uncertainty resulting from COVID‑19. For the three and six months ended June 30, 2022, the Company also continued to incur significant expenses in connection with pending legal matters.

The Company performed an assessment to determine whether there were conditions or events that, considered in the aggregate, raised substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are being issued. Initially, this assessment did not consider the potential mitigating effect of management’s plans that had not been fully implemented. Because, as described below, substantial doubt was determined to exist as the result of this initial assessment, management then assessed the mitigating effect of its plans to determine if it is probable that the plans (1) would be effectively implemented within one year after the date the accompanying unaudited condensed consolidated financial statements are issued and (2) when implemented, would mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern.

The Company achieved significant revenue growth in recent years while profitability has not been at levels as expected. It has taken steps including investments in automation to mitigate headwinds such as labor availability, volatile capacity planning and implementation of operational efficiency targets to proactively monitor production with the overarching goal of profitable growth. The Company undertook measures to increase its total revenues and improve its liquidity position by continuing to develop the Global Competitiveness Program. The main pillars of the Global Competitiveness Program include the following:

Focus on higher margin business in growth markets
Lower manufacturing costs
Reduce infrastructure costs
Strategic review of non-core businesses and assets


In addition, the Company will continue to focus on regulatory approvals for its DPP SARS-CoV-2 Antigen test system, DPP Respiratory Antigen Panel, and DPP HIV-Syphilis test system. These measures and other plans and initiatives have been designed to provide the Company with adequate liquidity to meet its obligations for at least the twelve-month period following the date the accompanying unaudited condensed consolidated financial statements are being issued. The Company’s execution of its plans continue to depend, however, on factors and uncertainties that are beyond the Company’s control, or that may not be addressable on terms acceptable to the Company or at all. The Company considered in particular how:

The ongoing healthcare and economic impacts of COVID-19 on the global customer base for the Company’s non‑COVID-19 products continue to negatively affect the timing and rate of recovery of the Company’s revenues from those products.

Although the Company has entered into agreements to distribute third-party COVID-19 products in the United States, its ability to sell those products could be constrained because of staffing and supply chain limitations affecting the suppliers of those products.

The Company further considered how these factors and uncertainties could impact its ability over the next year to meet the obligations specified in its Credit Agreement with the Perceptive Credit Holdings II, LP. Those obligations include covenants requiring: i) minimum cash balance of $3.0 million and ii) minimum total revenue amounts for the twelve months preceding each quarter end. For the next four quarters, the minimum total revenue requirements range from $45.6 million for the twelve months ending September 30, 2022 to $50.1 million for the twelve months ending June 30, 2023.   Upon an event of default under the Credit Agreement, Perceptive Credit Holdings II, LP could elect to declare all amounts outstanding thereunder, together with accrued interest, to be immediately due and payable. In such an event, there can be no assurance that the Company would have sufficient liquidity to fund payment of the amounts that would be due under the Credit Agreement or that, if such liquidity were not available, the Company would be successful in raising additional capital on acceptable terms, or at all, or in completing any other endeavor to continue to be financially viable and continue as a going concern. The Company’s inability to raise additional capital on acceptable terms in the near future, whether for purposes of funding payments required under the Credit Agreement or providing additional liquidity needed for its operations, could have a material adverse effect on its business, prospects, results of operations, liquidity and financial condition.

Accordingly, management determined the Company could not be certain that the Company’s plans and initiatives would be effectively implemented within one year after the date on which the accompanying unaudited condensed consolidated financial statements are being issued. Without giving effect to the prospect of raising additional capital, increasing product revenue in the near future or executing other mitigating plans, many of which are beyond the Company’s control, it is unlikely that the Company will be able to generate sufficient cash flows to meet its required financial obligations, including its debt service and other obligations due to third parties. The existence of these conditions raises substantial doubt about the Company’s ability to continue as a going concern for the twelve-month period following the date on which the accompanying unaudited condensed consolidated financial statements are being issued.

The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the date the accompanying unaudited condensed consolidated financial statements are issued. As such, the accompanying unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amount and classification of liabilities that may result should the Company be unable to continue as a going concern.


Forward-Looking Statements
Certain statements contained in the third and fourth bulleted items under “Recent Highlights” above and in the paragraph following the bulleted items under “Recent Highlights” above are not historical facts and may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the intent, belief or current expectations with respect to Reszon Diagnostics International’s manufacturing products and Chembio’s increasing its commercial presence in the Asia-Pacific region; Chembio’s expanding the Direct-to-Consumer channel for the commercialization of the Sure Check HIV Self-test in Brazil and the United Kingdom, and the third-party SCoV-2 Ag Detect Self-Test in the United States; Chembio’s continued progress with its Global Competitiveness Program, positioning it to drive adoption of its core higher margin products in high-growth markets, and expanding manufacturing capabilities through automation and a contract manufacturing agreement leveraging its facility in Malaysia; and Chembio’s advance key new product development and regulatory initiatives, all of which help define a path to more profitable growth. Such statements, which are expectations only, reflect management's current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events or performance may differ materially from forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the following, any of which could be exacerbated even further by the continuing COVID-19 outbreak in the United States and globally: the ability of Chembio to continue to generate revenue from the HIV test purchase order supported by The Global Fund or other product orders, and the margins it can realize from that revenue, or its ability to develop new products, will depend on the availability and cost of human, material and other resources required to build and deliver the tests, which factors are largely outside Chembio’s control; the ability of Chembio to maintain existing, and timely obtain additional, regulatory approvals, which approvals are subject to processes that can change on a recurrent basis without notice; the highly competitive and rapidly developing diagnostics market, which includes a number of competing companies with strong relationships with current and potential customers, including governmental authorities, and with significantly greater financial and other resources that are available to Chembio; and the risks of doing business with foreign governmental entities, including geopolitical, international and other challenges as well as potential material adverse effects of tariffs and other changes in U.S. trade policy. Chembio undertakes no obligation to publicly update forward-looking statements in this release to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio's expectations with regard to the forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio's success are more fully disclosed in Chembio's periodic public filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, its Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022 and in subsequent filings, particularly under the headings “Risk Factors.”

DPP is Chembio’s registered trademark, and the Chembio logo is Chembio’s trademark. For convenience, these trademarks appear in this release without ® or ™ symbols, but that practice does not mean that Chembio will not assert, to the fullest extent under applicable law, its rights to the trademarks. All other trademarks appearing in this release are the property of their respective owners.

Investor Relations Contact
Philip Taylor
Gilmartin Group
(415) 937-5406
investor@chembio.com


CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
 
   
For the three months ended
(Unaudited)
   
For the six months ended
(Unaudited)
 
   
June 30, 2022
   
June 30, 2021
   
June 30, 2022
   
June 30, 2021
 
REVENUES:
                       
Product revenue
 
$
8,858,146
   
$
3,931,383
   
$
27,385,602
   
$
7,956,045
 
R&D revenue
   
8,046
     
727
     
26,219
     
1,107,366
 
Government grant income
   
-
     
2,280,000
     
-
     
5,630,000
 
License and royalty revenue
   
295,238
     
250,000
     
566,220
     
493,058
 
TOTAL REVENUES
   
9,161,430
     
6,462,110
     
27,978,041
     
15,186,469
 
                                 
COSTS AND EXPENSES:
                               
Cost of product revenue
   
8,086,849
     
4,039,696
     
23,310,710
     
7,588,137
 
Research and development expenses
   
2,042,351
     
2,796,981
     
3,696,057
     
5,660,319
 
Selling, general and administrative expenses
   
5,249,980
     
6,001,353
     
12,196,250
     
12,086,422
 
Impairment, restructuring, severance and related costs
   
-
     
1,961,156
     
3,043,179
     
2,044,243
 
TOTAL COSTS AND EXPENSES
   
15,379,180
     
14,799,186
     
42,246,196
     
27,379,121
 
                                 
LOSS FROM OPERATIONS
   
(6,217,750
)
   
(8,337,076
)
   
(14,268,155
)
   
(12,192,652
)
                                 
OTHER EXPENSE:
                               
Interest expense, net
   
(728,414
)
   
(727,374
)
   
(1,461,976
)
   
(1,439,851
)
                                 
LOSS BEFORE INCOME TAXES
   
(6,946,164
)
   
(9,064,450
)
   
(15,730,131
)
   
(13,632,503
)
                                 
Income tax (provision) benefit
   
(279
)
   
65
     
(6,606
)
   
67,955
 
                                 
NET LOSS
 
$
(6,946,443
)
 
$
(9,064,385
)
 
$
(15,736,737
)
 
$
(13,564,548
)
                                 
Basic and diluted loss per share
 
$
(0.23
)
 
$
(0.45
)
 
$
(0.52
)
 
$
(0.67
)
                                 
Weighted average number of shares outstanding, basic and diluted
   
30,222,758
     
20,219,617
     
30,156,768
     
20,191,657
 


CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
AS OF

   
(Unaudited)
June 30, 2022
   
December 31, 2021
 
             
- ASSETS -
           
CURRENT ASSETS:
           
Cash and cash equivalents
 
$
22,837,453
   
$
28,772,892
 
Accounts receivable, net of allowance for doubtful accounts of $242,671 and $243,042 as of June 30, 2022 and December 31, 2021, respectively
   
4,255,944
     
11,441,107
 
Inventories, net
   
11,308,660
     
12,920,451
 
Prepaid expenses and other current assets
   
2,498,447
     
2,096,399
 
TOTAL CURRENT ASSETS
   
40,900,504
     
55,230,849
 
                 
FIXED ASSETS:
               
Property, Plant and Equipment, net
   
8,843,954
     
8,556,773
 
Finance lease right-of-use asset, net
   
172,676
     
191,870
 
TOTAL FIXED ASSETS, net
   
9,016,630
     
8,748,643
 
                 
OTHER ASSETS:
               
Operating lease right-of-use assets, net
   
5,841,382
     
5,891,906
 
Intangible assets, net
               
Goodwill
           
3,022,787
 
Deposits and other assets
   
297,024
     
358,010
 
TOTAL ASSETS
 
$
56,055,540
   
$
73,252,195
 
                 
- LIABILITIES AND STOCKHOLDERS’ EQUITY -
               
CURRENT LIABILITIES:
               
Accounts payable and accrued liabilities
 
$
10,051,649
   
$
13,127,993
 
Deferred revenue
               
Operating lease liabilities
   
905,516
     
886,294
 
Finance lease liabilities
   
73,724
     
68,176
 
Current portion of  long-term debt
   
3,000,000
     
1,200,000
 
TOTAL CURRENT LIABILITIES
   
14,030,889
     
15,282,463
 
                 
OTHER LIABILITIES:
               
Long-term operating lease liabilities
   
5,877,063
     
5,976,151
 
Long-term finance lease liabilities
   
115,943
     
139,678
 
Long-term debt, net
   
16,126,833
     
17,589,003
 
TOTAL LIABILITIES
   
36,150,728
     
38,987,295
 
                 
STOCKHOLDERS’ EQUITY:
               
Preferred stock – 10,000,000 shares authorized, none issued or outstanding
   
-
     
-
 
Common stock - $0.01 par value; 100,000,000 shares authorized; 30,086,283 shares and 20,223,498  shares issued at June 30, 2022 and December 31, 2021, respectively
   
302,727
     
301,050
 
Additional paid-in capital
   
167,041,203
     
165,772,636
 
Accumulated deficit
   
(146,746,597
)
   
(131,009,860
)
Treasury stock 41,141 shares at cost as of June 30, 2022 and December 31, 2021, respectively
   
(206,554
)
   
(206,554
)
Accumulated other comprehensive loss
   
(485,967
)
   
(592,372
)
TOTAL STOCKHOLDERS’ EQUITY
   
19,904,812
     
34,264,900
 
                 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
 
$
56,055,540
   
$
73,252,195
 


CHEMBIO DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS ENDED
(Unaudited)

   
June 30
2022
   
June 30
2021
 
Net cash used in operating activities
   
(4,802,145
)
   
(15,908,660
)
Net cash used in investing activities
   
(1,135,332
)
   
(1,299,012
)
Net cash provided by financing activities
   
(74,089
)
   
(69,488
)
Effect of exchange rate changes on cash
   
76,127

   
(144,947
)
DECREASE IN CASH AND CASH EQUIVALENTS
   
(5,935,439
)
   
(17,422,107
)
Cash and cash equivalents - beginning of the period
   
28,772,892
     
23,066,301
 
Cash and cash equivalents - end of the period
 
$
22,837,453
   
$
5,644,194