UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

Mark one

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended April 30, 2022January 31, 2023

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ___________________ to ___________________

 

Commission File Number 001-09974

 

ENZO BIOCHEM, INC.INC.
(Exact name of registrant as specified in its charter)

 

New York 13-2866202
(State or Other Jurisdiction of (IRS. Employer
Incorporation or Organization) Identification No.)
   
527 Madison Ave,81 Executive Blvd. Suite 3 Farmingdale, New York New York 1002211735
(Address of Principal Executive office) (Zip Code)

 

212-583-0100
(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant has required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

Yes No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and posted pursuant to Rule 45 of Regulation S-T (§232.405 of that chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit and post such files).

 

Yes No

 

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 ENZ New York Stock Exchange

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer a smaller reporting company, or an emerging growth company (as defined in Rule 12b-2 of the Exchange Act).

 

Large accelerated filer Accelerated filer
Non-accelerated filer Smaller reporting company
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.

 

Yes No

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.)

 

Yes No

 

As of June 6, 2022,March 17, 2023, the Registrant had 48,720,45449,662,821 shares of common stock outstandingoutstanding. 

 

 

 

 

 

 

ENZO BIOCHEM, INC.

FORM 10-Q

April 30, 2022January 31, 2023

 

INDEX

 

PART I - FINANCIAL INFORMATION
 
Item 1.Financial Statements1
   
 Consolidated Balance Sheets – April 30, 2022January 31, 2023 (unaudited) and July 31, 202120221
   
 Consolidated Statements of Operations for the three and ninesix months ended April 30,January 31, 2023 and 2022 and 2021 (unaudited)2
   
 Consolidated Statements of Comprehensive Income (Loss)Loss for the three and ninesix months ended April 30,January 31, 2023 and 2022 and 2021 (unaudited)3
   
 Consolidated StatementStatements of Stockholders’ Equity for the three and ninesix months ended April 30,January 31, 2023 and 2022 and 2021 (unaudited)4
   
 Consolidated Statements of Cash Flows for the ninesix months ended April 30,January 31, 2023 and 2022 and 2021 (unaudited)6
   
 Notes to the Consolidated Financial Statements7
   
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations2427
   
Item 3.Quantitative and Qualitative Disclosures About Market Risk3640
   
Item 4.Controls and Procedures3641
   
Part II - OTHER INFORMATION
 
Item 1.Legal Proceedings3742
   
Item 1A. Risk Factors3742
   
Item 6.Exhibits3743
   
Signatures3844

 

i

 

 

Part 1 Financial InformationPART I FINANCIAL INFORMATION

ItemITEM 1 Financial StatementsFINANCIAL STATEMENTS

 

ENZO BIOCHEM, INC.

CONSOLIDATED BALANCE SHEETS
(UNAUDITED)

(in thousands, except share and per share data)

 

 April 30,
2022
(unaudited)
  July 31,
2021
  January 31,
2023
  

July 31,

2022

 
ASSETS          
Current assets:          
Cash and cash equivalents $31,130  $13,524  $5,054  $21,603 
Marketable securities     29,978 
Accounts receivable, net  11,761   10,198   10,866   11,516 
Inventories  14,934   12,652 
Prepaid expenses  4,474   4,230 
Inventories, net  15,723   15,411 
Prepaid expenses and other current assets  4,738   5,824 
Total current assets  62,299   70,582   36,381   54,354 
                
Property, plant, and equipment, net  17,545   16,585   17,425   17,259 
Right-of-use assets  14,962   17,020 
Right-of-use assets, net  13,569   15,174 
Goodwill  7,452   7,452   7,452   7,452 
Intangible assets, net  29   244 
Other, including restricted cash of $1,000 at April 30, 2022 and $750 at July 31, 2021  1,617   1,808 
Other, including restricted cash of $1,000 at January 31, 2023 and July 21, 2022  1,625   1,618 
Total assets $103,904  $113,691  $76,452  $95,857 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                
Current liabilities:                
Accounts payable – trade  7,664   8,123  $13,189  $8,508 
Accrued liabilities  13,629   14,301   11,590   12,300 
Current portion of operating lease liabilities  3,171   3,419   3,425   3,432 
Mortgage debt  3,684    
Other current liabilities and finance leases short term  238   233   313   310 
Total current liabilities  24,702   26,076   32,201   24,550 
                
Finance leases long term and other liabilities  59   115 
Operating lease liabilities, non-current  12,779   14,558 
Long term debt – net  4,177   4,356 
Other liabilities and finance leases long term     39 
Operating lease liabilities, non-current, net  11,132   12,729 
Long term debt, net  289   4,077 
Total liabilities $41,717  $45,105  $43,622  $41,395 
                
Commitments and contingencies – see Note 12        
Contingencies – see Note 12        
                
Stockholders’ equity:                
Preferred Stock, $.01 par value; authorized 25,000,000 shares; no shares issued or outstanding            
Common Stock, $.01 par value; authorized 75,000,000 shares; shares issued and outstanding: 48,720,454 at April 30, 2022 and 48,471,771 at July 31, 2021  487   485 
Common Stock, $.01 par value; authorized 75,000,000 shares; shares issued and outstanding: 48,733,054
at January 31, 2023 and 48,720,454 at July 31, 2022
  487   487 
Additional paid-in capital  339,023   337,126   340,407   339,462 
Accumulated deficit  (280,205)  (270,377)  (310,593)  (288,638)
Accumulated other comprehensive income  2,882   1,352   2,529   3,151 
Total stockholders’ equity  62,187   68,586   32,830   54,462 
                
Total liabilities and stockholders’ equity $103,904  $113,691  $76,452  $95,857 

 

The accompanying notes are an integral part of these consolidated financial statements.

  


 

 

ENZO BIOCHEM, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(in thousands, except per share data)

 

 Three Months Ended
April 30,
  Nine Months Ended
April 30,
  Three Months Ended
January 31,
  Six Months Ended
January 31,
 
 2022  2021  2022  2021  2023  2022  2023  2022 
Revenues $26,222  $32,797  $86,787  $92,918  $16,338  $34,046  $34,614  $60,565 
                                
Operating costs and expenses:                                
Cost of revenues  16,049   16,751   49,160   49,154   15,079   17,838   29,750   33,111 
Research and development  1,133   836   2,697   2,388   1,431   820   2,427   1,564 
Selling, general and administrative  11,442   12,082   36,960   33,109   11,812   14,466   23,263   25,518 
Legal and related expense, net  734   1,061   4,861   3,993   995   2,845   2,066   4,127 
Total operating costs and expenses  29,358   30,730   93,678   88,644   29,317   35,969   57,506   64,320 
                                
Operating (loss) income  (3,136)  2,067   (6,891)  4,274 
Operating loss  (12,979)  (1,923)  (22,892)  (3,755)
                                
Other income (expense):                                
Interest, net  54   60   161   (40)  62   68   132   107 
Other  (716)  (88)  (1,211)  (55)  125   (350)  130   (495)
Foreign exchange (loss) gain  (1,056)  (33)  (1,887)  428   1,472   (450)  675   (831)
Total other (expense) income  (1,718)  (61)  (2,937)  333 
Total other income (expense)  1,659   (732)  937   (1,219)
                                
(Loss) income before income taxes  (4,854)  2,006   (9,828)  4,607 
Loss before income taxes  (11,320)  (2,655)  (21,955)  (4,974)
Income taxes                        
Net (loss) income $(4,854) $2,006  $(9,828) $4,607 
Net loss $(11,320) $(2,655) $(21,955) $(4,974)
                                
Net (loss) income per common share:                
Basic $(0.10) $0.04  $(0.20) $0.10 
Diluted $(0.10) $0.04  $(0.20) $0.10 
Net loss per common share:                
Basic and diluted $(0.23) $(0.05) $(0.45) $(0.10)
                                
Weighted average common shares outstanding:                                
Basic  48,713   48,391   48,552   48,097 
Diluted  48,713   48,788   48,552   48,201 
Basic and diluted  48,729   48,472   48,725   48,472 

 

The accompanying notes are an integral part of these consolidated financial statements.

 


 

 

ENZO BIOCHEM, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)LOSS
(UNAUDITED)
(in thousands)

 

 Three Months Ended
April 30,
  Nine Months Ended
April 30,
  Three Months Ended
January 31,
  Six Months Ended
January 31,
 
 2022  2021  2022  2021  2023  2022  2023  2022 
Net (loss) income $(4,854) $2,006  $(9,828) $4,607 
Net loss $(11,320) $(2,655) $(21,955) $(4,974)
Other comprehensive (loss) income:                                
Foreign currency translation adjustments  911   (2)  1,530   (413)  (1,355)  342   (622)  619 
Comprehensive (loss) income $(3,943) $2,004  $(8,298) $4,194 
Comprehensive loss $(12,675) $(2,313) $(22,577) $(4,355)

 

The accompanying notes are an integral part of these consolidated financial statements.

 


 

 

ENZO BIOCHEM, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
Three Months Ended April 30,January 31, 2023 and 2022 and 2021
(unaudited)(UNAUDITED)
(in thousands, except share data)

 

  Common
Stock
Shares
Issued
  Common
Stock
Amount
  Additional
Paid-in
Capital
  Accumulated Deficit  Accumulated
Other
Comprehensive
Income
  Total
Stockholders’
Equity
 
Balance at January 31, 2022  48,471,771  $485  $338,021  $(275,351) $1,971  $65,126 
Net loss for the period ended
April 30, 2022
           (4,854)     (4,854)
Share-based compensation
charges
        162         162 
Exercise of stock options  11,300      28         28 
Issuance of common stock for employee 401(k) plan match  237,383   2   812         814 
Foreign currency translation adjustments              911   911 
Balance at April 30, 2022  48,720,454  $487  $339,023  $(280,205) $2,882  $62,187 
  Common
Stock
Shares
Issued
  Common
Stock
Amount
  Additional
Paid-in
Capital
  Accumulated
Deficit
  Accumulated
Other
Comprehensive
Income
  Total
Stockholders’
Equity
 
Balance at October 31, 2022  48,720,454  $487  $339,892  $(299,273) $3,884  $44,990 
Net loss for the period ended January 31, 2023           (11,320)     (11,320)
Share-based compensation charges        515         515 
Vesting of performance stock units  12,600                
Foreign currency translation adjustments              (1,355)  (1,355)
Balance at January 31, 2023  48,733,054  $487  $340,407  $(310,593) $2,529  $32,830 

 

  Common
Stock
Shares
Issued
  Common Stock
Amount
  Additional Paid-in Capital  Accumulated Deficit  Accumulated Other Comprehensive Income  Total
Stockholders’
Equity
 
Balance at January 31, 2021  48,227,750  $482  $335,688  $(275,651) $1,270  $61,789 
Net income for the period ended April 30, 2021           2,006      2,006 
Share-based compensation
charges
        297         297 
Exercise of stock options  34,667   1   96         97 
Vesting of restricted stock  817                
Issuance of common stock for employee 401(k) plan match  208,537   2   778         780 
Foreign currency translation adjustments              (2)  (2)
Balance at April 30, 2021  48,471,771  $485  $336,859  $(273,645) $1,268  $64,967 
  Common
Stock
Shares
Issued
  Common
Stock
Amount
  Additional
Paid-in
Capital
  Accumulated
Deficit
  Accumulated
Other
Comprehensive
Income
  Total
Stockholders’ Equity
 
Balance at October 31, 2021  48,471,771  $485  $337,342  $(272,696) $1,629  $66,760 
Net loss for the period ended January 31, 2022           (2,655)     (2,655)
Share-based compensation charges        679         679 
Foreign currency translation adjustments              342   342 
Balance at January 31, 2022  48,471,771  $485  $338,021  $(275,351) $1,971  $65,126 

 

The accompanying notes are an integral part of these consolidated financial statements.

 


 

 

ENZO BIOCHEM, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
NineSix Months Ended April 30,January 31, 2023 and 2022 and 2021
(unaudited)(UNAUDITED)
(in thousands, except share data)

 

  Common
Stock
Shares
Issued
  Common Stock
Amount
  Additional Paid-in Capital  Accumulated Deficit  Accumulated Other Comprehensive Income  Total
Stockholders’ Equity
 
Balance at July 31, 2021  48,471,771  $485  $337,126  $(270,377) $1,352  $68,586 
Net loss for the period ended
April 30, 2022
           (9,828)     (9,828)
Share-based compensation
charges
        1,057         1,057 
Exercise of stock options  11,300      28         28 
Issuance of common stock for employee 401(k) plan match  237,383   2   812         814 
Foreign currency translation adjustments              1,530   1,530 
Balance at April 30, 2022  48,720,454  $487  $339,023  $(280,205) $2,882  $62,187 
  Common
Stock
Shares
Issued
  Common
Stock
Amount
  Additional
Paid-in
Capital
  Accumulated
Deficit
  Accumulated
Other
Comprehensive
Income
  Total
Stockholders’
Equity
 
Balance at July 31, 2022  48,720,454  $487  $339,462  $(288,638) $3,151  $54,462 
Net loss for the period ended January 31, 2023           (21,955)     (21,955)
Share-based compensation charges        945         945 
Vesting of performance stock units  12,600                
Foreign currency translation adjustments              (622)  (622)
Balance at January 31, 2023  48,733,054  $487  $340,407  $(310,593) $2,529  $32,830 

 

  Common
Stock
Shares
Issued
  Common Stock
Amount
  Additional
Paid-in
Capital
  Accumulated Deficit  Accumulated
Other
Comprehensive Income
  Total
Stockholders’
Equity
 
Balance at July 31, 2020  47,895,050  $479  $334,473  $(278,252) $1,681  $58,381 
Net income for the period ended April 30, 2021           4,607      4,607 
Exercise of stock options  34,667   1   96         97 
Share-based compensation
charges
        640         640 
Vesting of restricted stock  817                
Issuance of common stock for bonus payments  332,700   3   872         875 
Issuance of common stock for employee 401(k) plan match  208,537   2   778         780 
Foreign currency translation adjustments              (413)  (413)
Balance at April 30, 2021  48,471,771  $485  $336,859  $(273,645) $1,268  $64,967 
  Common Stock Shares Issued  Common Stock
Amount
  Additional Paid-in Capital  Accumulated Deficit  Accumulated Other Comprehensive Income  Total
Stockholders’ Equity
 
Balance at July 31, 2021  48,471,771  $485  $337,126  $(270,377) $1,352  $68,586 
Net loss for the period ended January 31, 2022           (4,974)     (4,974)
Share-based compensation charges        895         895 
Foreign currency translation adjustments              619   619 
Balance at January 31, 2022  48,471,771  $485  $338,021  $(275,351) $1,971  $65,126 

 

The accompanying notes are an integral part of these consolidated financial statements.

 


 

 

ENZO BIOCHEM, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)

 

 Nine Months Ended
April 30,
  Six Months Ended
January 31,
 
 2022  2021  2023 2022 
Cash flows from operating activities:          
Net (loss) income $(9,828) $4,607 
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities:        
Net loss $(21,955) $(4,974
Adjustments to reconcile net loss to net cash used in operating activities:     
Depreciation and amortization of property, plant and equipment  1,910   1,724  1,428 1,253 
Amortization of intangible assets  228   244   153 
Share-based compensation charges  1,057   640  945 895 
Share-based 401(k) employer match expense  645   559  396 358 
Foreign exchange loss (gain)  1,788   (494)
Realized loss on marketable securities  1,283    
Foreign exchange (gain) loss (707 773 
Unrealized loss on marketable securities     91   553 
             
Changes in operating assets and liabilities:             
Accounts receivable  (1,556)  (2,292) 653 (5,127)
Inventories  (2,273)  (3,159) (310) (1,211)
Prepaid expenses and other assets  179   29  1,080 743 
Accounts payable – trade  (458)  (2,473) 4,678 (1,272)
Accrued liabilities, other current liabilities and other liabilities  (495)  803   (1,099  1,183 
Total adjustments  2,308   (4,328)  7,064   (1,699)
             
Net cash (used in) provided by operating activities  (7,520)  279 
Net cash used in operating activities  (14,891)  (6,673)
             
Cash flows from investing activities:             
Sales of marketable securities  28,695    
Purchases of marketable securities     (30,023)  (55
Capital expenditures  (3,103)  (2,870)  (1,521)  (2,247)
Net cash provided by (used in) investing activities  25,592   (32,893)
Net cash used in investing activities  (1,521)  (2,302)
             
Cash flows from financing activities:             
Repayments under mortgage agreement and finance leases  (173)  (283)  (157)  (114)
Proceeds from exercise of stock options  28   97 
Net cash used in financing activities  (145)  (186)  (157)  (114)
             
Effect of exchange rate changes on cash and cash equivalents  (71)  24   20   (26
             
Increase (decrease) in cash and cash equivalents and restricted cash  17,856   (32,776)
Decrease in cash and cash equivalents and restricted cash (16,549) (9,115)
Cash and cash equivalents and restricted cash - beginning of period  14,274   48,615   22,603  14,274 
Total cash and cash equivalents and restricted cash - end of period $32,130  $15,839  $6,054 $5,159 
             
The composition of total cash and cash equivalents and restricted cash is as follows:             
Cash and cash equivalents  31,130   15,089  5,054 4,159 
Restricted cash included in other assets  1,000   750   1,000  1,000 
Total cash and cash equivalents and restricted cash $32,130  $15,839  $6,054 $5,159 

 

The accompanying notes are an integral part of these consolidated financial statements.


 

 

ENZO BIOCHEM, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

As of April 30, 2022January 31, 2023
(Unaudited)(UNAUDITED)
(Dollars in thousands, except share data)

 

Note 1 – Basis of Presentation

 

The accompanying consolidated financial statements include the accounts of Enzo Biochem, Inc. and its wholly-owned subsidiaries, Enzo Life Sciences, Enzo Clinical Labs, Enzo Therapeutics, Enzo Realty LLC and Enzo Realty II LLC, collectively or with one or more of its subsidiaries referred to as the “Company” or “Companies”. The Company has threetwo reportable segments: Clinical Services Products, and Therapeutics.Products. The consolidated balance sheet as of April 30, 2022,January 31, 2023, the consolidated statements of operations, comprehensive (loss) incomeloss and stockholders’ equity for the three and ninesix months ended April 30,January 31, 2023 and 2022, and 2021, and the consolidated statements of cash flows for the ninesix months ended April 30,January 31, 2023 and 2022 and 2021 (the “interim statements”) are unaudited. In the opinion of management, all adjustments (which include normal recurring adjustments) necessary to present fairly the financial position and operating results for the interim periods have been made. Certain information and footnote disclosure, normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), have been condensed or omitted. The interim statements should be read in conjunction with the consolidated financial statements for the year ended July 31, 20212022 and notes thereto contained in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission. The consolidated balance sheet at July 31, 20212022 has been derived from the audited financial statements at that date. The results of operations for the three and ninesix months ended April 30, 2022January 31, 2023 are not necessarily indicative of the results that may be expected for the fiscal year ending July 31, 2022.2023.

Change in segment reporting

Historically, we engaged in the research and development of therapeutic candidates through Enzo Therapeutics, a biopharmaceutical venture that was developing multiple novel approaches in the areas of gastrointestinal, infectious, ophthalmic and metabolic diseases, many of which were derived from the researching work of Enzo Life Sciences. Enzo Therapeutics focused its efforts on researching treatment regimens for diseases and conditions for which treatment options were ineffective, costly, and/or caused unwanted side effects. This focus generated a clinical and preclinical pipeline, as well as numerous patents and patent applications with Enzo Therapeutics as the assignee. At the beginning of fiscal 2023, we determined we would redirect our research resources and efforts to our two operating segments, Enzo Life Sciences and Enzo Clinical Labs, and no longer consider Enzo Therapeutics a segment. The operating results of Enzo Therapeutics are now included in the “Other” segment. The prior period segment information for the three and six months ended January 31, 2022 reported in Note 11 has been restated to be included in the “Other” segment. The operating expenses of Enzo Therapeutics for the three and six months ended January 31, 2023 now included in the “Other” segment were $12 and $21, respectively. The operating expenses of Enzo Therapeutics for the three and six months ended January 31, 2022 now included in the “Other” segment were $20 and $25, respectively.

Liquidity and Going Concern

During the six months ended January 31, 2023, the Company incurred a net loss of $21,955 and used cash in operating activities of $14,891. The Company believes that based on its fiscal 2023 forecast, its current cash and cash equivalents level is not sufficient for its foreseeable liquidity and capital resource needs over at least the next twelve (12) months, which conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date that the unaudited interim financial statements are issued.

 

While


In response to these conditions, the Company is evaluating various financing strategies to obtain sufficient additional liquidity to meet its operating and capital requirements for the next twelve months following the date of issuance of these unaudited interim consolidated financial statements. Specifically, on March 10, 2023, the Company signed a commitment letter providing for up to $8,000 of a revolving line of credit subject to closing, and as previously disclosed is exploring various strategic alternatives including the sale of segment operating assets. On March 16, 2023, the Company entered into an Asset Purchase Agreement with respect to the sale to Labcorp of substantially all the operating assets and assignment of certain liabilities which are necessary for Labcorp to operate the business of the Clinical Labs division. See Note 13 Subsequent Events. However, there can be no assurance that either of these capital raising strategies will be successful, and the Company may need to raise additional capital during the current fiscal year. The Company also believes it has the ability to raise additional funds, either through additional debt secured by real property owned, private debt, selling preferred stock, reactivating its Sales Agreement with Cantor, or through other sources, but there can be no assurances that the Company will be able to raise capital pursuant to the foregoing on favorable terms or at all. The Registration Statement on Form S-3 filed in connection with the Sales Agreement expired in October 2020 but a new Registration Statement could be filed at any time at the discretion of the Company, as disclosed in Note 10 in the Notes to the Consolidated Financial Statements. Our liquidity plans are subject to a number of risks and uncertainties, some of which are outside our control. Macroeconomic conditions could limit our ability to successfully execute our business plans and therefore adversely affect our liquidity plans. The unaudited interim financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.

Revolving Line of Credit commitment

On March 10, 2023, the Company entered into a commitment for a one-year credit facility with an asset based lender specializing in direct lending to middle-market companies in the healthcare sector. The facility is an $8 million revolving line of credit based on the Company’s eligible accounts receivable. The annual interest rate is equal to the 90 day term SOFR rate plus 5.5%. The line of credit would terminate one year from closing and unused line fees and early prepayment penalties apply.

Closing and initial funding are conditioned on the absence of any material adverse change in the operations or financial condition of the Company prior to the closing date. The Company and the lender are using their best efforts to close on the line of credit as soon as possible. The expected closing time period is the end of March 2023.

Impact of COVID-19

We made substantial investments to expand and maintain the amount of COVID-19 testing available in the communities we serve since the start of the pandemic in March 2020. We applied our technical expertise in molecular diagnostics to develop next generation COVID-19 diagnostic and antibody testing options which were approved under the FDA Emergency Use Authorization (EUA). During the fiscal year ended July 31, 2022, the Company generated substantial COVID-19 related services revenues, representing 44% of all services revenues. This testing had a significantly positive impact on the profitability and cash flow of our Clinical services segment for most of fiscal 2022. Revenues from COVID-19 testing during the three and six months ended January 31, 2022 represented 56% and 52%, respectively of all services revenues. The rate of transmission of COVID-19 and the severity of its variants is on the declinehave dramatically declined in the USUS. Revenues from COVID-19 testing during the three and six months ended January 31, 2023 represented approximately 4% and 6%, respectively, of all services revenues.

In March 2022, the economy has begunU.S. Health Resources and Services Administration (“HRSA”) informed providers that, after March 22, 2022, it would stop accepting claims for testing and treatment for uninsured individuals under the HRSA COVID-19 Uninsured Program and that claims submitted prior to open,that date would be subject to eligibility and availability of funds. Although we believe that our estimates for contractual allowances and patient price concessions are appropriate, actual results could differ from those estimates. If the HRSA receives additional funding, it continues to spread in other parts ofmight again accept claims under the world and negatively impacts the world economy. Uninsured Program.


Federal, state and local governmental policies and initiatives designed to reduce the transmission of COVID-19 resulted in, among other things, a significant reduction in physician office visits, the cancellation of elective medical procedures, customers of our products remaining closed or continuing to curtail their operations (voluntarily or in response to government orders), and the continuation of work-from-home policies. The COVID-19 impact on the Company’s operations is consistent with the overall industry and our competitors, partners, and vendors.

While the Company anticipateswe anticipate that COVID-19 will continue to impact itsour business forinto the rest of fiscal 2022 and potentially beyond, the Company expects thatfuture, increases in vaccination rates and booster shots, the development of new therapeutics and greater availability of rapid COVID-19 tests will likely resulthas resulted in a continued, significant decline in demand for itsour COVID-19 testing. As a result, volume, revenues, profitability, and cash flow from COVID-19 testing volume in fiscalduring the current periods were all substantially and materially lower than the prior year 2022 has not and likely will not match 2021period levels. Global supply chain issues due to the pandemic continue to hamper both the manufacturingCOVID-19 testing is no longer a material part of products within the life science segment as well as testing capabilities in the clinical laboratory.our Services business.

 

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally acceptedWe expect volume and revenues from COVID-19 testing will remain less significant in the United States (“U.S. GAAP”) requires management to make estimates and assumptions that affectperiods ahead as the reported amountspercentage of assets and liabilities and disclosureAmericans who are vaccinated increases, the severity of contingent assets and liabilities at the date of the financial statementsits variants declines, and the reported amountsgeneral increase in the use of revenues“at home” testing. However, the emergence and expenses during the reporting periods. Actual results could differ from those estimates.


spread of potentially more serious variants may cause our COVID-19

The extent testing volume to whichincrease again. With respect to our non-COVID-19 operations, even after the COVID-19 pandemic impacts the Company’s business andimpact has greatly moderated, we may continue to experience similar adverse effects to our businesses, consolidated results of operations, financial position and cash flows will depend on numerous evolving factorsresulting from a recessionary economic environment, including but not limited to:inflation and actions by the magnitude and duration of the COVID-19 pandemic, the extentFederal Reserve to which it will impact worldwide macroeconomic conditions including, but not limited to, employment rates and health insurance coverage, the speed of the anticipated recovery, and governmental and business reactions to the pandemic. These factors are beyond the Company’s knowledge and control, and as a result, at this time the Company cannot reasonably estimate the impact the COVID-19 pandemic will have on its businesses but the impact could be material. increase interest rates.

The Company assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 and the recessionary economic environment, including inflation and actions by the Federal Reserve to increase interest rates as of April 30, 2022January 31, 2023 and through the date of this report.Quarterly Report. The accounting matters assessed included, but were not limited to, the Company’s patient self-pay revenue concessions and credit losses in the Clinical Services segment, accounts receivable, inventories and the carrying value of goodwill and other long-lived assets. The Company’s future assessment of the magnitude and duration of COVID-19, as well as other economic factors, could result in additional material adverse impacts to the Company’s consolidated financial statements in future reporting periods. We expect COVID-19 testing volume will continue to decline in the quarters ahead as the percentage of Americans who are vaccinated increases, the severity of its variants declines, and the general use of at home testing. However, the emergence and spread of more serious variants may cause our COVID-19 testing volume to increase again. Even after the COVID-19 pandemic has moderated and the business and social distancing restrictions have eased, we may continue to experience similar adverse effects to our businesses, consolidated results of operations, financial position and cash flows resulting from a recessionary economic environment that may persist.

 

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates.

Effect of New Accounting Pronouncements

Recently Adopted Accounting Pronouncements

In December 2019, the FASB issued ASU No. 2019-12 Income Taxes (Topic 740) Simplifying the Accounting for Income Taxes. The amendments in the ASU simplify the accounting for income taxes by removing certain exceptions to the general principles of Topic 740. The amendments also improve consistent application of and simplify U.S. GAAP for other areas of Topic 740 by clarifying and amending existing guidance. We adopted the amendments in this ASU beginning August 1, 2021. The adoption of the amendments in this ASU did not have a material impact on our consolidated results of operations, financial position or cash flows.

 

Pronouncements Issued but Not Yet Adopted

 

In June 2016, FASB issued ASU No. 2016-13 Financial Instruments – Credit Losses (Topic 326). This standard changes the impairment model for most financial instruments, including trade receivables, from an incurred loss method to a new forward-looking approach, based on expected losses.

 

The estimate of expected credit losses will require entities to incorporate considerations of historical information, current information and reasonable and supportable forecasts. Adoption of this standard is required for our annual and interim periods beginning August 1, 2023, providedas we qualifyqualified as a smaller reporting company at the end of fiscal 2022 and must be adopted using a modified retrospective transition approach. We are currently assessing the impact of the adoption of this standard on our results of operations, financial position and cash flows.

 

We reviewed all other recently issued accounting pronouncements and have concluded they are not applicable or not expected to be significant to the accounting for our operations.

 


Concentration Risk

Other than the Medicare program, two providers whose programs are included in the “Third-party payers” and “Health Maintenance Organizations” (“HMOs”) categories represent approximately 30% and 35% of Clinical Services net revenue for the three months ended April 30, 2022 and 2021 respectively, and 34% of Clinical Services net revenue for both the nine months ended April 30, 2022 and 2021.

 

Other than the Medicare program, one provider whose programs are included in the “Third-party payers” and “Health Maintenance Organizations” (“HMOs”HMO’s”) categories represents 20%approximately 16% and 17% of Clinical Services net revenue for the three and six months ended January 31, 2023, respectively and 16% of the Clinical Services net accounts receivable as of April 30, 2022.January 31, 2023. Other than the Medicare program, two providers whose programs are included in the “Third-party payers” and “Health Maintenance Organizations” (“HMO’s”) categories represent approximately 36% and 35% of Clinical Services net revenue for the three and six months ended January 31, 2022, respectively.

 

For the nine months ended April 30, 2022, the Life Sciences segment’s revenue includes $2,800 from one customer, representing 11% of its revenues for the nine month period.


Income Taxes

 

The Company accounts for income taxes under the liability method of accounting for income taxes. Under the liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The liability method requires that any tax benefits recognized for net operating loss carry forwards and other items be reduced by a valuation allowance wherewhen it is not more likely than not that the benefits willmay not be realized in the foreseeable future.realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

Under the liability method, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. It is the Company’s policy to provide for uncertain tax positions, if any, and the related interest and penalties based upon management’s assessment of whether a tax benefit is more likely than not to be sustained upon examination by tax authorities. To the extent the Company prevails in matters for which a liability for an unrecognized tax benefit is established or is required to pay amounts in excess of the liability, the Company’s effective tax rate in a given financial statement period may be affected.

We maintain a full valuation allowance on all tax assets and, as a consequence, do not provide any tax benefit for the fiscal 2022 period loss or any tax provision for the fiscal 2021 period pre-tax income.

Fair Value Measurements

The Company determines fair value measurements used in its consolidated financial statements based upon the exit price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants exclusive of any transaction costs, as determined by either the principal market or the most advantageous market.

Inputs used in the valuation techniques to derive fair values are classified based on a three-level hierarchy. The basis for fair value measurements for each level within the hierarchy is described below with Level 1 having the highest priority and Level 3 having the lowest.

Level 1:Quoted prices in active markets for identical assets or liabilities.
Level 2:Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs are observable in active markets.
Level 3:Valuations derived from valuation techniques in which one or more significant inputs are unobservable.

Marketable securities

The Company limits its credit risk associated with investments by investing in a mutual fund and an exchange traded fund (ETF) which hold highly rated corporate bonds, asset backed securities, municipal bonds, mortgage obligations and government obligations. These investments are classified as trading securities and are Level 1 fair value investments. During the three months ended of April 30, 2022, the Company sold all of its marketable securities, resulting in proceeds of $28,695, which is included in cash and cash equivalents. The Company recognized a realized loss - net on the sale of the marketable securities of $1,283 for the nine months ended April 30, 2022. The Company earned interest of $447 on the marketable securities over the holding period of the marketable securities.

 

Note 2 – Net income (loss) per share

 

Basic net income (loss) per share represents net income (loss) divided by the weighted average number of common shares outstanding during the period. As a result of the net loss for the three and ninesix months ended April 30,January 31, 2023 and 2022, diluted weighted average shares outstanding are the same as basic weighted average shares outstanding, and do not include the potential common shares from stock options, restricted stock units, andor unearned performance stock units because to do so would be antidilutive.

For the three and ninesix months ended April 30, 2022,January 31, 2023, approximately 438,00060,000 and 510,00083,000, respectively, of potential common shares (“infrom “in the money options”), and unvested restricted stock units, and unearned performance stock units were excluded from the calculation of diluted (loss) per share. share because their effect would be antidilutive.

For the three and ninesix months ended April 30, 2021,January 31, 2022, approximately 47,000499,000 and 23,000 weighted average stock options527,000, respectively, of potential common shares from “in the money options” and unvested performance stock units were included inexcluded from the calculation of diluted weighted average shares outstanding.(loss) per share because their effect would be antidilutive.

 


 

 

For the three and ninesix months ended April 30, 2022,January 31, 2023, the effect of approximately 1,319,0004,189,000 and 1,068,0003,392,000, respectively, of outstanding “out of the money” options to purchase common shares were excluded from the calculation of diluted net loss(loss) income per share because their effect would be anti-dilutive. For the three and ninesix months ended April 30, 2021,January 31, 2022, the effect of approximately 2,264,0001,091,000 and 2,122,000942,000, respectively, of outstanding “out of the money” options to purchase common shares were excluded from the calculation of diluted net (loss) income per share because their effect would be anti-dilutive.

  

Note 3 – Revenue Recognition

 

Clinical Services Revenue

 

The Company accounts for revenue pursuant to Accounting Standards Codification Topic 606. Service revenues in the Company’s clinical services business accounted for 71%54% and 70% of the Company’s total revenues for the three and nine months ended April 30,January 31, 2023 and 2022, respectively and 76% of the Company’s total revenues58% and 72% for the three and ninesix months ended April 30, 2021January 31, 2023 and 2022, respectively and are primarily comprised of a high volume of relatively low-dollar transactions. The services business, which provides clinical testing services, satisfies its performance obligation and recognizes revenues upon completion of the testing process for a specific patient and reporting to the ordering physician. The Company may also perform clinical testing services for other laboratories and will recognize revenue from those services when reported to the ordering laboratory. The Company estimates the amount of consideration it expects to receive from customer groups using the portfolio approach. These estimates of the expected consideration include the impact of contractual allowances and price concessions on our customer group portfolios consisting of healthcare insurers, government payers, client payers and patients as described below. Contracts with customers in our laboratory services business do not contain a financing component, based on the typically limited period of time between performance of services and collection of consideration. The transaction price includes variable consideration in the form of the contractual allowance and price concessions as well as the collectability of the transaction based on patient intent and ability to pay. The Company uses the expected value method in estimating the amount of the variability included in the transaction price.

 

The following are descriptions of our laboratory services business portfolios:

 

Third party payers and Health Maintenance Organizations (HMOs)(HMO’s)

 

Reimbursements from third party payers, primarily healthcare insurers and HMOsHMO’s are based on negotiated fee-for-service schedules and on capitated payment rates. Revenues consist of amounts billed net of contractual allowances for differences between amounts billed and the estimated consideration the Company expects to receive from such payers, which considers historical collection and denial experience and the terms of the Company’s contractual arrangements. Adjustments to the allowances, based on actual receipts from the third-party payers, are recorded upon settlement.

 

Collection of the consideration the Company expects to receive is normally a function of providing complete and correct billing information to these third-partythird party payers within the various filing deadlines, and typically occurs within 30 to 90 days of billing. Provided the Company has billed healthcare insurers accurately with complete information prior to the established filing deadline, there has historically been little to no collection risk. If there has been a delay in billing, the Company determines if the amounts in question will likely go past the filing deadline, and if so, will reserve accordingly for the billing.

 

Third-party payers, including government programs, may decide to deny payment or recoup payments for testing that they contend was improperly billed or not medically necessary, against their coverage determinations, or for which they believe they have otherwise overpaid (including as a result of their own error), and we may be required to refund payments already received. Our revenues may be subject to adjustment as a result of these factors among others, including without limitation, differing interpretations of billing and coding guidance and changes by government agencies and payers in interpretations, requirements, and “conditions of participation” in various programs.

 


 

 

Government Payer - Medicare

 

Reimbursements from Medicare are based on fee-for-service schedules set by Medicare, which is funded by the government. Revenues consist of amounts billed net of contractual allowances for differences between amounts billed and the estimated consideration the Company expects to receive from Medicare, which considers historical collection and denial experience and other factors. Adjustments to the allowances, based on actual receipts from the government payers, are recorded upon settlement.

 

Collection of consideration the Company expects to receive is normally a function of providing the complete and correct billing information within the various filing deadlines and typically occurs within 60 days of billing. Provided the Company has billed the government payer accurately with complete information prior to the established filing deadline, there has historically been little to no collection risk. If there has been a delay in billing, the Company determines if the amounts in question will likely go past the filing deadline, and, if so, it will reserve accordingly for the billing.

 

Patient self-pay

 

Uninsured patients are billed based on established patient fee schedules or fees negotiated with physicians on behalf of their patients. Coinsurance and deductible responsibilities based on fees negotiated with healthcare insurers are also billed to insured patients and included in this portfolio. Collection of billings from patients is subject to credit risk and ability of the patients to pay. Revenues consist of amounts billed net of discounts provided to uninsured patients in accordance with the Company’s policies and implicit price concessions. Implicit price concessions represent differences between amounts billed and the estimated consideration the Company expects to receive from patients, which considers historical collection experience and other factors including current market conditions. Adjustments to the estimated allowances, based on actual receipts from the patients, are recorded upon settlement. Patient responsibility is invoiced and if it reaches 91 days outstanding, the account is sent to a collection agency for further processing. After the account has been with the collection agency for at least 105 days, and is determined to be uncollectable it is written off.

 

The following table represents clinical services net revenues and percentages by type of customer:

 

 Three months ended
April 30, 2022
  Three months ended
April 30, 2021
  Three months ended
January 31, 2023
  Three months ended
January 31, 2022
 
Revenue category                  
Third-party payer $10,817   58% $16,135   64% $5,163   58% $14,256   60%
Medicare  2,436   13   2,952   12   1,374   16   2,784   12 
Patient self-pay  2,177   12   2,468   10   974   11   2,605   11 
HMOs  3,200   17   3,463   14   1,313   15   4,029   17 
Total $18,360   100% $25,018   100% $8,824   100% $23,674   100%

 

 Nine months ended
April 30, 2022
  Nine months ended
April 30, 2021
  Six months ended
January 31, 2023
  Six months ended
January 31, 2022
 
Revenue category                  
Third-party payer $36,962   60% $44,138   63% $11,186   56% $26,145   60%
Medicare  7,949   13   10,265   15   3,670   18   5,514   13 
Patient self-pay  6,727   11   6,524   9   2,212   11   4,550   10 
HMOs  10,407   16   9,302   13   2,929   15   7,206   17 
Total $62,045   100% $70,229   100% $19,997   100% $43,415   100%

 

For the three and ninesix months ended April 30,January 31, 2023 and 2022, and 2021, all of the Company’s clinical services revenues were generated within the United States.

 


 

 

Products Revenue

 

Products revenues consist ofIn accordance with ASC 606, the Company generates product revenue from the sale of our single-use products used in the identification of genomic informationinformation. Revenue is recorded net of sales tax. The Company considers revenue to be earned when all of the following criteria are met: the Company has a contract with a customer that creates enforceable rights and obligations; promised products are identified; the transaction price is determinable; and the Company has transferred control of the promised items to the customer. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer, and is the unit of account in the contract. The transaction price for the contract is measured as the amount of consideration the Company expects to receive in exchange for the goods expected to be transferred. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, control of the distinct good or service is transferred. Transfer of control for the Company’s products is generally at shipment or delivery, depending on contractual terms, but occurs when title and risk of loss transfers to the customer which represents the point in time when the customer obtains the use of and substantially all of the remaining benefit of the product. As such, the Company’s performance obligation related to product sales is satisfied at a point in time followingtime. The Company recognizes a receivable when it has an unconditional right to payment, which represents the transfer of control of such productsamount the Company expects to collect in a transaction and is most often equal to the customer, which generally occurs upon shipment.transaction price in the contract. Payment terms for shipments to end-user and distributor customers may range from 30 to 90 days. Any claims for credit or return of goods may be made generally within 30 days of receipt. Revenues are reduced to reflect estimated credits and returns, although historically these adjustments have not been material. Taxes collected from customers relating to product sales and remitted to governmental authorities are excluded from revenue. Amounts billed to customers for shipping and handling are included in revenue, while the related shipping and handling costs are reflected in cost of products.

 

Products revenue by geography is as follows:

 

 

Three Months Ended
April 30

 

Nine Months Ended
April 30

  

Three Months Ended

January 31

 

Six Months Ended

January 31

 
 2022  2021  2022  2021  2023  2022  2023  2022 
United States $4,422  $3,941  $15,039  $11,410  $4,144  $6,754  $8,239  $10,617 
Europe  2,169   2,732   6,576   7,798   2,277   2,401   4,181   4,407 
Asia Pacific  1,001   1,106   3,127   3,481   1,093   1,217   2,197   2,126 
Products revenue $7,592  $7,779  $24,742  $22,689  $7,514  $10,372  $14,617  $17,150 

 

Note 4 - Supplemental disclosure for statement of cash flows

 

DuringIn the ninesix months ended April 30,January 31, 2023 and 2022, and 2021, interest paid by the Company was $167$106 and $177,$112, respectively.

 

For the ninesix months ended April 30,January 31, 2023 and 2022, and 2021, the net reductions in the measurement of right of use assets and liabilities included in cash flows from operating activities was $29$2 and $67,$20, respectively. The changes are included in changes in accrued liabilities, other current liabilities, and other liabilities in the statement of cash flows.

 

For the ninesix months ended April 30,January 31, 2023 and 2022, and 2021, tax on capital paid by the Company was $120$9 and $145,$116, respectively.

In January 2021, the Company issued 332,700 restricted shares of common stock to two senior executives in settlement of their accrued bonuses totaling $875.

 

Note 5 – Inventories

 

Inventories consist of the following:

 

 April 30,
2022
  July 31,
2021
  January 31,
2023
  July 31,
2022
 
Raw materials $1,480  $1,062  $1,962  $1,524 
Work in process  2,598   2,534   2,748   2,459 
Finished products  10,856   9,056   11,013   11,428 
 $14,934  $12,652  $15,723  $15,411 

 


Note 6 – Goodwill and intangible assetsLong-Lived Assets

Goodwill

 

The Company’s net carrying amount of goodwill is in the Clinical Laboratory Services segment and is $7,452 as of April 30, 2022January 31, 2023 and July 31, 2021.


Intangible assets2022.

 

The Company’s changeCompany tests goodwill annually as of the first day of the fourth quarter, or more frequently if indicators of potential impairment exist. In assessing goodwill for impairment, the Company has the option to first perform a qualitative assessment to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the Company determines that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, the Company is not required to perform any additional tests in assessing goodwill for impairment. However, if the netCompany concludes otherwise or elects not to perform the qualitative assessment, then it will perform a quantitative assessment as it identifies the reporting units and compares the fair value of each of these reporting units to their respective carrying amount. If the carrying amount of intangible assets, all in the Life Sciences Products segmentreporting unit is as follows:less than its fair value, no impairment exists. If the carrying amount of the reporting unit is higher than its fair value, the impairment charge is the amount by which the carrying amount exceeds its fair value, not to exceed the total amount of goodwill allocated to the reporting unit.

 

  Gross  Accumulated
Amortization
  Net 
July 31, 2021 $27,775  $(27,531) $244 
Amortization expense     (210)  (210)
Foreign currency translation  (534)  529   (5)
April 30, 2022 $27,241  $(27,212) $29 

IntangibleThe Company reviews the recoverability of the carrying value of long-lived assets (including its intangible assets, all finite-lived, consistof which have finite lives) of an asset or asset group for impairment annually as of the following:

  April 30, 2022  July 31, 2021 
  Gross  Accumulated
Amortization
  Net  Gross  Accumulated
Amortization
  Net 
Patents $11,027  $(11,027) $  $11,027   (11,027) $ 
Customer relationships  11,768   (11,739)  29   12,059   (11,815)  244 
Website and acquired content  1,008   (1,008)     1,025   (1,025)   
Licensed technology and other  476   (476)     494   (494)   
Trademarks  2,962   (2,962)     3,170   (3,170)   
Total $27,241  $(27,212) $29  $27,775   (27,531) $244 

At April 30, 2022, information with respectend of the fiscal year, or more frequently if indicators of potential impairment exist. Should indicators of impairment exist, the carrying values of the assets are evaluated in relation to acquired intangiblesthe operating performance and future undiscounted cash flows of an asset or asset group. The net book value of the long-lived asset is as follows:

Useful life
assigned
Weighted
average
remaining
useful life
Customer relationships8 -15 years0.25 years

At April 30, 2022, the weighted average remaining useful life of all intangible assets wasadjusted to fair value if its expected future undiscounted cash flow is less than three months.its book value. The Company has determined that there is no impairment of goodwill or long-lived assets at January 31, 2023.

 

Note 7 – Mortgage debt and Long term debt, net

 

In connection with the purchase of our new facilitya building in Farmingdale, NY in November 2018, a wholly-owned subsidiary (the “mortgagor subsidiary”) of the Company entered into a Fee Mortgage and Security Agreement (the “mortgage agreement”) with Citibank, N.A. (the “mortgagee”). The mortgage agreement provides for a loan of $4,500 for a term of 10 years, bears a fixed interest rate of 5.09% per annum and requires monthly mortgage payments of principal and interest of $30. Debt issuance costs of $72 are being amortized over the life of the mortgage agreement. The balance of unamortized debt issuance cost was $48$42 at April 30, 2022.January 31, 2023. At April 30, 2022,January 31, 2023, the balance owed by the subsidiary under the mortgage agreement was $4.0 million.$3,902. The Company’s obligations under the mortgage agreement are secured by the new facilitybuilding and by a $1,000 cash collateral deposit with the mortgagee as additional security. This restricted cash is included in other assets as of April 30, 2022.January 31, 2023.

 

The mortgage agreement includes affirmative and negative covenants and events of default, as defined. Events of default include non-payment of principal and interest on debt outstanding, non-performance of covenants, material changes in business, breach of representations, bankruptcy or insolvency, and changes in control. The mortgage includes certain financial covenants. Effective October 2020, the Company and the mortgagee agreed to a covenant restructure whereby the mortgagee waived the Company’s financial ratio covenant for the fiscal period ended July 31, 2020 and modified the mortgage to replace a financial ratiothat covenant with a liquidity covenant. ThatThe liquidity covenant requiredrequires that we own and maintain at all times and throughout the remaining term of the loan at least $25,000 of liquid assets, defined as time deposits, money market accounts and obligations issued by the U.S. government or any of its agencies. The cash collateral agreement was also modified to require compliance with the liquidity covenant for two consecutive fiscal years before the collateral is released back to us. Effective September 29, 2021, the Company and the mortgagee agreed to further covenant restructuring whereby (a) the liquidity covenant was reduced to 150% (or approximately $6 million at April 30, 2022) of the loan principal (or approximately $5,911 as of January 31, 2023) from $25 million$25,000 previously, and (b) the collateral requirement would bewas increased from $0.75 million$750 to $1.0 million. The$1,000. As of January 31, 2023, the Company increasedwas not in compliance with the collateral deposit to $1.0 million in November 2021 andliquidity covenant, but was in compliance aswith the other financial covenants related to this mortgage. Effective March 20, 2023, the Company and the mortgagee agreed to a waiver of the liquidity covenant default as of April 30, 2022.January 31, 2023. While the Company believes it will be able to either achieve compliance or obtain further waivers going forward, as there can be no assurances, all of the mortgage debt has been classified as current in the consolidated balance sheet as of January 31, 2023.

 


 

 

In April 2020, our subsidiary in Switzerland received a loan of CHF 400 ($400,(or $400, based on the foreign exchange rate as of April 30, 2022)at that time) from the Swiss government under the “Corona Krise” emergency loan program in response to the pandemic. This loan is uncollateralized and bears 0% interest, is due in 5interest. In January 2022, the bank agent of the Swiss government informed our subsidiary that the loan had to be fully amortized within a maximum of eight years and maythat the first of semi-annual amortization payments of CHF 33 would begin in March 2022. In September 2022, the subsidiary made its second semi-annual principal repayment of CHF 33 (or $35 based on exchange rates). Based on this amortization schedule, the loan will be repaid at any time. Thisby September 2027. The current portion of this loan is included in other current liabilities and the long term portion in long term debt – net as of January 31, 2023.

The CARES Act expanded the U.S. Small Business Administration’s (SBA) business loan program to create the Paycheck Protection Program (PPP), which provided employers with uncollateralized loans whose primary purpose was to retain or maintain workforce and salaries for a twenty-four week period (“covered period”) following receipt of the loan. We applied for the PPP loan based on the eligibility and need requirements established when the program was announced and in April 30, 2022.2020 received $7,000 through Citibank N.A., the Company’s existing lender, pursuant to the PPP (the “PPP Loan”). In June 2021, the SBA approved in full our request for loan forgiveness and in the fiscal year 2021 the Company recognized the forgiveness of the $7,000 loan in Other income. The SBA announced its intention to audit loans in excess of $2,000 and in June 2022 requested through Citibank N.A. the production of documents and information related to our loan and our request for forgiveness. We provided that information to the SBA via Citibank N.A. In October 2022 the SBA requested through Citibank N.A. that we complete a new version of their loan necessity questionnaire with respect our forgiven loan, which we provided. The SBA subsequently requested additional information with respect to wages paid which has been provided.

  

Minimum future annual principal payments under these agreements as of April 30, 2022January 31, 2023 are as follows:

 

July 31, Total  Total 
2022 $39 
2023  160  $118 
2024  167   239 
2025  541   249 
2026  186   259 
2027  269 
Thereafter  3,290   3,117 
Total principal payments  4,383   4,251 
Less: current portion, included in other current liabilities and finance leases short term  (158)  (236)
Unamortized mortgage cost  (48)
Long term debt - net $4,177 
unamortized mortgage cost  (42)
Mortgage debt - current and long term debt – net $3,973 

 

Note 8 - Leases

 

The Company determines if an arrangement is or contains a lease at contract inception. The Company leases buildings, office space, patient service centers, and equipment primarily through operating leases, and equipment through a limited number of finance leases. Generally, a right-of-use asset, representing the right to use the underlying asset during the lease term, and a lease liability, representing the payment obligation arising from the lease, are recognized on the balance sheet at lease commencement based on the present value of the payment obligation. For operating leases, expense is recognized on a straight-line basis over the lease term. For finance leases, interest expense on the lease liability is recognized using the effective interest method and amortization of the right-of-use asset is recognized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet; the Company recognizes lease expense for these leases on a straight-line basis over the lease term. The Company primarily uses its incremental borrowing rate in determining the present value of lease payments as the Company’s leases generally do not provide an implicit rate.

 


The Company has lease agreements with (i) right-of-use asset payments and (ii) non-lease components (i.e. payments related to maintenance fees, utilities, etc.,), which have generally been combined and accounted for as a single lease component. The Company’s leases have remaining terms of less than 1 year to 6 years, some of which include options to extend the leases for up to 5 years. The Company’s lease terms may include renewal options that are reasonably certain to be exercised and early termination options that are reasonably certain not to be exercised.

Certain of the Company’s lease agreements include rental payments adjusted periodically for inflation or a market rate which are included in the lease liabilities.

 


Leases Balance Sheet Classification April 30,
2022
 July 31,
2021
  Balance Sheet Classification January 31,
2023
  July 31,
2022
 
Assets          
Operating Right-of-use assets $14,962 $17,020  Right-of-use assets $13,569  $15,174 
Finance Property, plant and equipment, net (a)  191  248  Property, plant and equipment, net (a)  134   172 
Total lease assets $15,153 $17,268  $13,703  $15,346 
             
Liabilities             
Current:             
Operating Current portion of operating lease liabilities $3,171 $3,419  Current portion of operating lease liabilities $3,425  $3,432 
Finance Finance leases short term 81 88  Finance leases short term  78   81 
             
Non-current:             
Operating Operating lease liabilities, non-current 12,779 14,558  Operating lease liabilities, non-current  11,132   12,729 
Finance Finance leases long term and other liabilities  59  110  Other liabilities and finance leases long term     39 
Total lease liabilities $16,090 $18,175  $14,635  $16,281 

 

(a)Accumulated amortization of finance lease assets was approximately $190$248 and $1,100$210 as of April 30, 2022January 31, 2023 and July 31, 2021,2022, respectively.

 

Components of lease cost were as follows:

 

 Three months ended
April 30,
  Nine months ended
April 30,
  Three months ended
January 31,
  Six months ended
January 31,
 
 2022  2021  2022  2021  2023  2022  2023  2022 
Operating lease cost $1,085  $1,271  $3,372  $4,265 
Operating lease cost – net (a) $912  $1,129  $1,960  $2,287 
Finance lease cost:                                
Amortization of leased assets  19   19   57   118   19   19   38   38 
Interest on lease liabilities  3   3   8   12   1   2   3   5 
Total lease cost $1,107  $1,293  $3,437  $4,395  $932  $1,150  $2,001  $2,330 

 

(a)Net of $114 sublease income for the three and six months ended January 31, 2023.


The maturity of the Company’s lease liabilities as of April 30, 2022January 31, 2023 is as follows:

 

Maturity of lease liabilities, years ending July 31, Operating
leases
  Finance
leases
  Total  Operating
leases
  Finance
leases
  Total 
2022 $1,064  $22  $1,086 
2023  3,735   88   3,823  $2,080  $44  $2,124 
2024  3,561   37   3,598   3,874   36   3,910 
2025  3,299      3,299   3,541      3,541 
2026  3,150      3,150   3,351      3,351 
2027  2,507      2,507 
Thereafter  3,224      3,224   808      808 
Total lease payments  18,033   147   18,180   16,161   80   16,241 
Less: Interest (a)  (2,083)  (7)  (2,090)  (1,604)  (2)  (1,576)
Present value of lease liabilities $15,950  $140  $16,090  $14,557  $78  $14,665 

 

(a)Primarily calculated using the Company’s incremental borrowing rate.

 

Lease term and discount rate for the ninesix months ended April 30January 31 were as follows: 

 

Lease term and discount rate 2022  2021  2023  2022 
Weighted-average remaining lease term (years):          
Operating leases  5.0 years   5.8 years   4.3 years   5.2 years 
Finance leases  1.7 years   2.7 years   0.9 years   2.0 years 
                
Weighted-average discount rate:                
Operating leases  4.97%  4.97%  4.96%  4.98%
Finance leases  5.20%  8.25%  2.95%  5.96%

 

See Note 4 for cash flow information on cash paid for amounts included in the measurement of lease liabilities for the three and six months ended April 30, 2022January 31, 2023 and 2021.2022.

 


Note 9 – Accrued Liabilities

 

Accrued liabilities consist of:

  April 30,
2022
  July 31,
2021
 
Payroll, benefits, and commissions $6,445  $5,856 
Professional fees  638   628 
Legal  4,561   2,554 
Deferred revenue     2,675 
Other  1,985   2,588 
  $13,629  $14,301 

Deferred revenue

In order to increase cash flow to providers of services and suppliers impacted by the pandemic, the Centers for Medicare and Medicaid Services (CMS) expanded its Accelerated and Advance Payment Program to a broader group of Medicare providers. We applied for and received a $2,526 payment advance from this program in April 2020. Since the Company had the right to repay the advance at any time, the entire balance was considered current. The recoupment of the advance by CMS started April 2021 and was completed by April 2022. As of July 31, 2021, the deferred revenue related to the CMS payment advance was $1,847.

Accrued liabilities consist of: January 31,
2023
  July 31,
2022
 
Payroll, benefits, and commissions $5,312  $4,912 
Professional fees  1,090   801 
Legal  3,099   4,523 
Other  2,089   2,064 
  $11,590  $12,300 

 

Self-Insured Medical Plan

 

The Company self-funds medical insurance coverage for certain of its U.S. based employees. The risk to the Company is believed to be limited through the use of individual and aggregate stop loss insurance. As of April 30, 2022January 31, 2023 and July 31, 2021,2022, the Company has established a reserve of $300$340 and $347$260, respectively which is included in accrued liabilities for payroll, benefits and commissions, for claims that have been reported but not paid and for claims that have been incurred but not reported. The reserve is based upon the Company’s historical payment trends, claim history and current estimates.

 


Note 10 - Stockholders’ Equityequity

 

Controlled Equity Offering

The Company has a Controlled Equity OfferingSMSales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”). Under the Sales Agreement, the Company may offer and sell, from time to time, through Cantor, shares of the Company’s common stock, par value $0.01 per share (the “Common Stock”). The Company pays Cantor a commission of 3%3.0% of the aggregate gross proceeds received under the Sale Agreement. The Company is not obligated to make any sales of the Shares under the Sales Agreement. The offering of Shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the sale of all of the Shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by Cantor or the Company, as permitted therein. The initial agreement contemplated the sale of shares of the Company’s common stock having an aggregate offering price of up to $20.0 million.

In December 2014, the Sales Agreement was amended in order for the Company to offer and sell additional shares of Common Stock having an aggregate offering price of $20.0 million.

 

In September 2017, the Company filed with the SEC a Form S-3 “shelf” registration statement and sales agreement prospectus (the “Registration Statement”) covering the offering, issuance and sale of our Common Stock that may becould have been issued and sold under the existing Sales Agreement in an aggregate amount of up to $19.2 million. A total of $150 million of securities could have been sold under this shelf registration, which was declared effective September 15, 2017. The Registration Statement on Form S-3 filed in connection with the Sales Agreement expired in October 2020 but maya new Registration Statement could be refiled at any time at the discretion of the Company. During the nine months ended April 30, 2021, the Company did not sell any shares of Common Stock under the Sales Agreement. 

 


Share-basedShare based awards and share based compensation

In January 2011, the Company’s stockholders approved the adoption of the 2011 Incentive Plan (the “2011 Plan”) for the issuance of equity awards, including, among others, options, restricted stock, restricted stock units and performance stock units for up to 3,000,000 shares of common stock. In January 2018, the Company’s stockholders approved the amendment and restatement of the 2011 Plan (the “Amended and Restated 2011 Plan”) to increase the number of shares of common stock available for grant under the 2011 Plan by 2,000,000 shares of common stock bringing the total number of shares available for grant to 5,000,000 shares of common stock. On October 7, 2020, the Company’s Board of Directors approved the amendment and restatement of the Amended and Restated 2011 Plan, with an effective date of October 7, 2020 and subject to approval by the Company’s stockholders at the 2020 annual meeting of stockholders of the Company. The amendment and restatement of the Amended and Restated 2011 Plan was for purposes of, among other things, (i) increasing the shares of common stock available for grant under the Amended and Restated 2011 Plan by an additional 4,000,000 shares of common stock bringing the total number of shares available for grant to 9,000,000 shares of common stock and (ii) extending the term of the Amended and Restated 2011 Plan until October 7, 2030. In January 2021, the Company’s stockholders approved the amendment and restatement of the Amended and Restated 2011 Plan.

The exercise price of options granted under the Amended and Restated 2011 Plan, as amended and restated, is equal to or greater than fair market value of the common stock on the date of grant. The Amended and Restated 2011 Plan, as amended and restated, will terminate at the earliest of (a) such time as no shares of common stock remain available for issuance under the plan, (b) termination of the plan by the Company’s Board of Directors, or (c) October 7, 2030. Awards outstanding upon expiration of the Amended and Restated 2011 Plan, as amended and restated, will remain in effect until they have been exercised or terminated, or have expired. As of April 30, 2022,January 31, 2023, there were approximately 4,955,0003,874,000 shares of common stock available for grant under the Amended and Restated 2011 Plan, as amended and restated.

The Company estimates the fair value of each stock option award on the measurement date using a Black-Scholes option pricing model. The fair value of awards is amortized to expense on a straight-line basis over the requisite service period. The Company expenses restricted stock awards based on vesting requirements, primarily time elapsed. Performance stock awards are not recognized until it is probable they will be earned. At such time, their expense is then recognized over the requisite service period, including that portion of the service period already elapsed.

Options granted pursuant to the plans may be either incentive stock options or non-statutory options. The 2011 Plan provides for the issuance of stock options, restricted stock and restricted stock unit awards which generally vest over a two or three year period.

The amounts of share-based compensation expense recognized in the periods presented are as follows:

  Three months ended
April 30,
  Nine months ended
April 30,
 
  2022  2021  2022  2021 
Stock options $181  $297  $841  $638 
Performance stock units  (105)     57    
Restricted stock units  86      159   2 
  $162  $297  $1,057  $640 
  Three months ended
January 31,
  Six months ended
January 31,
 
  2023  2022  2023  2022 
Stock options and performance stock units $313  $606  $557  $822 
Restricted stock units  202   73   388   73 
  $515  $679  $945  $895 


The following table sets forth the amount of expense related to share-based payment arrangements included in specific line items in the accompanying statements of operations:

 Three months ended
April 30,
  Nine months ended
April 30,
  Three months ended
January 31,
  Six months ended
January 31,
 
 2022  2021  2022  2021  2023  2022  2023  2022 
Selling, general and administrative $158  $258  $1,037  $574  $494  $667  $904  $879 
Cost of revenues  4   39   20   66   21   12   41   16 
 $162  $297  $1,057  $640  $515  $679  $945  $895 

During the nine months ended April 30, 2022, the Company recognized additional share-based compensation expense of $225 included in Selling, general and administrative expenses, for the modification of options awards affecting 2 members of the board of directors who resigned in January 2022. During the three and nine months ended April 30, 2022, the Company reversed $124 of share based compensation expense related to performance stock units awarded to a former executive officer, as vesting in the units is not probable.

No excess tax benefits were recognized during the three and ninesix month periods ended April 30, 2022January 31, 2023 and 2021.2022.


Stock Option Plans

 

The following table summarizes stock option activity during the ninethree month period ended April 30, 2022:January 31, 2023:

 Options   Weighted
Average
Exercise
Price
 Weighted
Average
Remaining
Contractual
Term
 Aggregate
Intrinsic
Value (000s)
  Options  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Contractual
Term
  Aggregate
Intrinsic
Value
(000s)
 
Outstanding at July 31, 2021  2,504,563 $3.74     
Outstanding at July 31, 2022  3,941,783  $3.00                        
Awarded 1,100,750 $3.32       615,000  $2.00        
Exercised (11,300 2.49   $             $  
Cancelled or expired (406,396) $7.05        (368,216) $4.33        
Outstanding at end of period 3,187,617 $3.18 2.4 years   $179   4,188,567  $2.73   2.6 years  $ 
Exercisable at end of period 1,794,399 $  0.9 years   $139    1,734,109  $    0.4 years  $  

As of April 30, 2022,January 31, 2023, the total future compensation cost related to non-vested options, not yet recognized in the statements of operations, was $1,954$2,344 and the weighted average period over which the remaining expense of these awards is expected to be recognized is approximately twenty six months.two years.

The intrinsic value of in the money stock option awards at the end of the period represents the Company’s closing stock price on the last trading day of the period in excess of the exercise price multiplied by the number of outstanding options.

Performance Stock Units

To better align the long-term interest of executives with growing U.S. practices, beginningBeginning in fiscal 2018, the Company granted long-term incentive awards in the form of time-basedtime based stock options and performance-based restricted stock units (“Performance Stock Units” or “PSUs”). The PSUs earned will beis determined over a three-year performance period. The primary performance metrics will be revenue and Adjusted EBITDA growth.growth, as defined. Payouts are based on revenue and adjusted EBITDA goals will bemet at threshold, target or maximum levels and are modified based on Total Shareholder Return (“TSR”) performance relative to Enzo’s peer group. The PSU’s awardPSUs awarded to executive officers in fiscal 2018, net of forfeitures, expired in fiscal 2021 as the 3 year growth goals were not achieved.

During the fiscal years ended 2020 and 2019, the Company awarded additional PSUs to its executive officers. These awards provide for the grant of shares of our common stock at the end of a three–yearthree-year period based on the achievement of average revenue growth and adjusted EBITDA growth goals met at threshold, target or maximum levels over the respective period. ForThe PSUs awarded to executive officers in fiscal 2019, net of forfeitures, were earned as of the three and nine months ended April 30,three-year period ending July 31, 2022 the Company reversed cumulative accruals of $124 for a former officer whose vesting in the PSU is not considered probable, resulting in net PSU compensation (credit) expense of ($105) and $57, respectively. For the three and nine months ended April 30, 2021, the Company did not accrue any compensation expense for these PSUs as the achievement of the growth goals was deemed not probable at that time. As of April 30, 2022, two former officers forfeitedthe maximum level were achieved. After TSR modification, a total of 14,50025,200 PSUs awardedwere earned equally by two officers. As of January 31, 2023, 12,600 shares had been issued and the balance of the shares are expected to be issued in the third quarter of fiscal 2019.2023.

The following table summarizes PSU’s granted and outstanding as of April 30, 2022:

Grant Date Performance
period
end date
 Total Grant  Forfeitures  Outstanding  Fair
Market
Value
At Grant
Date (000s)
 
10/15/2019 7/31/2022  80,500   (14,500)  66,000  $222 
10/19/2020 7/31/2023  98,600      98,600  $207 

Restricted Stock Units

The Company awarded restricted stock units (“RSUs”) to our CEO who was appointed in November 2021. The award was for 260,000 RSUs which vest over three years on the anniversary of his hiring. The fair market value of these RSUs at the date of grant was $881. The Company also awarded 117,189 RSUs to its 3 independent directors in April 2022 whose fair market value was $300. During the three and nine months ended April 30, 2022, the Company recognized shared based compensation expense of $86 and $159, respectively for these RSUs.


 

During the six months ended January 31, 2023 a former officer forfeited 15,000 PSUs awarded in fiscal 2020. The Company recorded PSU compensation expense of $7 during the three months ended January 31, 2023 and ($48) during the six months ended January 31, 2023. For the three and six months ended January 31, 2022, the Company recorded PSU compensation expense of $96 and $162, respectively.

The following table summarizes RSUPSU’s granted and outstanding through January 31, 2023:

Grant Date Total Grant  Forfeitures  Outstanding  Fair Market
Value At
Grant Date
(000s)
 
10/19/2020  98,600   (40,300)  58,300  $122 
                 

Restricted Stock Units

The following table summarizes Restricted Stock Unit (“RSU”) activity duringfor the ninesix month period ended April 30, 2022:January 31, 2023:

 Number of RSUs
outstanding
  Weighted
Average Fair
Value per Unit at
Date of Grant
or Vesting
 Weighted
Average
Remaining
Contractual  
Term
 Aggregate
Intrinsic
Value (000s)
  Number of 
RSUs 
outstanding
  Weighted
Average Fair
Value per
Unit at
Date of
Grant or
Vesting
  Weighted
Average
Remaining
Contractual
Term
  Aggregate
Intrinsic
Value (000s)
 
Outstanding at July 31, 2022  502,187  $2.95                    
Granted  377,189  $3.13           100,000   1.97        
Vested                (86,667)  3.39        
Cancelled    $             $         
Outstanding at end of period  377,189  $3.18   2.36 years    $1,181   515,520  $2.69  1.5 years  $807 
Expected to vest at end of period  377,189    $       2.36 years      $1,181   515,520  $   1.5 years  $     

See Note 13During the three and six months ended January 31, 2023, the Company recognized shared based compensation expense for more information with respectthese RSUs of $202 and $388, respectively for these RSUs. During the three and six months ended January 31, 2022, the Company recognized shared-based compensation expense for these RSUs of $73.

As of January 31, 2023, the total future compensation cost related to non-vested RSUs, not yet recognized in the appointmentstatements of operations, was $995 and the CEO.weighted average period over which the remaining expense of these awards is expected to be recognized is approximately one and a half years.

Note 11 - Segment reporting

The Company has 3two reportable segments: Products, Clinical Services and Therapeutics.Products. The Clinical Services segment provides diagnostic services to the health care community. The Company’s Products segment develops, manufactures, and markets products to research and pharmaceutical customers. The Clinical Services segment provides diagnostic services to the health care community. The Company’s Therapeutics segment conducts research and development activities for therapeutic drug candidates. The Company evaluates segment performance based on segment income (loss) before taxes. Costs excluded from segment income (loss) before taxes and reported as “Other” consist of corporate general and administrative costs which are not allocable to the 3two reportable segments. All intersegment activities are eliminated.

Legal and related expenses incurred to defend the Company’s intellectual property, which may result in settlements recognized in another segment and other general corporate matters are considered a component of the Other segment. Legal and related expenses specific to other segments’ activities are allocated to those segments. Management of the Company assesses assets on a consolidated basis only and therefore, assets by reportable segment have not been included in the reportable segments below. The accounting policies of the reportable segments are the same as those described in the summary of significant accounting policies.


At the beginning of fiscal 2023, we determined we would redirect our research resources and efforts to our two operating segments, Enzo Life Sciences and Enzo Clinical Labs, and as a result, Enzo Therapeutics no longer meets the criteria for being a reportable segment. The operating expenses of Enzo Therapeutics are included in the “Other” segment for all periods presented.

The following financial information represents the operating results of the reportable segments of the Company:

Three months ended April 30, 2022 Clinical
Services
  Products  Therapeutics  Other  Consolidated 
Three months ended January 31, 2023 Clinical
Services
  Products  Other  Consolidated 
Revenues $18,630  $7,592        $26,222  $8,824  $7,514     $16,338 
                                    
Operating costs and expenses:                                    
Cost of revenues  11,180   4,869         16,049   10,463   4,616      15,079 
Research and development  666   458   9      1,133   306   1,113   12   1,431 
Selling, general and administrative  6,756   2,786      1,900   11,442   6,943   2,556   2,313   11,812 
Legal fee expense  12   10      712   734   107   11   877   995 
Total operating costs and expenses  18,614   8,123   9   2,612   29,358   17,819   8,296   3,202   29,317 
                                    
Operating income (loss)  16   (531)  (9)  (2,612)  (3,136)
Operating loss  (8,995)  (782)  (3,202)  (12,979)
                                    
Other income (expense):                                    
Interest, net  (2)  10      46   54   (1)  29   34   62 
Other  15   (2)     (729)  (716)  7   2   116   125 
Foreign exchange loss     (1,056)        (1,056)     1,472      1,472 
Net income (loss) $29  $(1,579) $(9) $(3,295) $(4,854)
(Loss) income before income taxes $(8,989) $721  $(3,052) $(11,320)
                                    
Depreciation and amortization included above $430   224      78   732  $386   171   91   648 
                                    
Share-based compensation included in above:                                    
Selling, general and administrative  38   1      119   158   65   20   409   494 
Cost of revenues  4            4   15   6      21 
Total $42   1      119   162  $80   26   409   515 
                                    
Capital expenditures $202   572      82   856  $196   632   41   869 


 

Three months ended January 31, 2022

 Clinical
Services
  Products  Other  Consolidated 
Revenues $23,674  $10,372     $34,046 
                 
Operating costs and expenses:                
Cost of revenues  12,586   5,252      17,838 
Research and development  89   711   20   820 
Selling, general and administrative  6,811   3,039   4,616   14,466 
Legal fee expense  148      2,697   2,845 
Total operating costs and expenses  19,634   9,002   7,333   35,969 
                 
Operating income (loss)  4,040   1,370   (7,333)  (1,923)
                 
Other income (expense):                
Interest, net  (3)  9   62   68 
Other  5   3   (358)  (350)
Foreign exchange loss     (450)     (450)
Income (loss) before income taxes $4,042  $932  $(7,629) $(2,655)
                 
Depreciation and amortization included above $438   190   77   705 
                 
Share-based compensation included in above:                
Selling, general and administrative  16   1   650   667 
Cost of revenues  12         12 
Total $28   1   650   679 
                 
Capital expenditures $283   730   201   1,214 


 

Six months ended January 31, 2023

 Clinical
Services
  Products  Other  Consolidated 
Revenues $19,997  $14,617     $34,614 
                 
Operating costs and expenses:                
Cost of revenues  20,545   9,205      29,750 
Research and development  603   1,803   21   2,427 
Selling, general and administrative  13,493   4,986   4,784   23,263 
Legal fee expense  171   36   1,859   2,066 
Total operating costs and expenses  34,812   16,030   6,664   57,506 
                 
Operating loss  (14,815)  (1,413)  (6,664)  (22,892)
                 
Other income (expense):                
Interest, net  (3)  54   81   132 
Other  12   4   114   130 
Foreign exchange loss     675      675 
Loss before income taxes $(14,806) $(680) $(6,469) $(21,955)
                 
Depreciation and amortization included above $918   336   174   1,428 
                 
Share-based compensation included in above:                
Selling, general and administrative  114   40   749   903 
Cost of revenues  31   11      42 
Total $145   51   749   945 
                 
Capital expenditures $359   938   224   1,521 

Six months ended January 31, 2022 Clinical
Services
  Products  Other  Consolidated 
Revenues $43,415  $17,150     $60,565 
                 
Operating costs and expenses:                
Cost of revenues  23,789   9,322      33,111 
Research and development  96   1,443   25   1,564 
Selling, general and administrative  12,812   6,134   6,572   25,518 
Legal fee expense  205   13   3,909   4,127 
Total operating costs and expenses  36,902   16,912   10,506   64,320 
                 
Operating income (loss)  6,513   238   (10,506)  (3,755)
                 
Other income (expense):                
Interest, net  (5)  18   94   107 
Other  54   5   (554)  (495)
Foreign exchange loss      (831)     (831)
Income (loss) before income taxes $6,562  $(570) $(10,966) $(4,974)
                 
Depreciation and amortization included above $856   402   148   1,406 
                 
Share-based compensation included in above:                
Selling, general and administrative  36   1   842   879 
Cost of revenues  16         16 
Total $52   1   842   895 
                 
Capital expenditures $593   1,216   438   2,247 


 

Three months ended April 30, 2021 Clinical
Services
  Products  Therapeutics  Other  Consolidated 
Revenues $25,018  $7,779        $32,797 
                     
Operating costs and expenses:                    
Cost of revenues  12,733   4,018         16,751 
Research and development  173   643  $20      836 
Selling, general and administrative  7,029   2,810   17  $2,226   12,082 
Legal fee expenses  95   10      956   1,061 
Total operating costs and expenses  20,030   7,481   37   3,182   30,730 
                     
Operating income (loss)  4,988   298   (37)  (3,182)  2,067 
                     
Other income (expense):                    
Interest, net  (4)  11      53   60 
Other  1   2      (91)  (88)
Foreign exchange loss     (33)        (33)
Net income (loss) $4,985  $278  $(37) $(3,220) $2,006 
                     
Depreciation and amortization included above $399  $208  $  $66  $673 
                     
Share-based compensation included in above:                    
Selling, general and administrative  9   41      208   258 
Cost of revenues  39            39 
Total $48  $41  $  $208  $297 
                     
Capital expenditures $1,544  $180  $  $23  $1,747 

Note 12 – Contingencies

Nine months ended April 30, 2022 Clinical
Services
  Products  Therapeutics  Other  Consolidated 
Revenues – Services and Products $62,045  $24,742        $86,787 
                     
Operating costs and expenses:                    
Cost of revenues  34,969   14,191         49,160 
Research and development  762   1,901  $34      2,697 
Selling, general and administrative  19,568   8,920     $8,472   36,960 
Legal and related expenses  217   23      4,621   4,861 
Total operating costs and expenses  55,516   25,035   34   13,093   93,678 
                     
Operating income (loss)  6,529   (293)  (34)  (13,093)  (6,891)
                     
Other income (expense):                    
Interest, net  (7)  28      140   161 
Other  69   3      (1,283)  (1,211)
Foreign exchange (loss)      (1,887)        (1,887)
Net income (loss) $6,591  $(2,149) $(34) $(14,236) $(9,828)
                     
Depreciation and amortization included above $1,286  $626  $  $226  $2,138 
                     
Share-based compensation included in above:                    
Selling, general and administrative  74   2      961   1,037 
Cost of revenues  20            20 
Total $94  $2  $  $961  $1,057 
                     
Capital expenditures $795  $1,788  $  $520  $3,103 


Nine months ended April 30, 2021 Clinical
Services
  Products  Therapeutics  Other  Consolidated 
Revenues – Services and Products $70,229  $22,689        $92,918 
                     
Operating costs and expenses:                    
Cost of revenues  37,436   11,718         49,154 
Research and development  454   1,868  $66      2,388 
Selling, general and administrative  19,552   7,848   50  $5,659   33,109 
Legal and related expenses  191   16      3,786   3,993 
Total operating costs and expenses  57,633   21,450   116   9,445   88,644 
                     
Operating income (loss)  12,596   1,239   (116)  (9,445)  4,274 
                     
Other income (expense):                    
Interest  (14)  29      (55)  (40)
Other  30   6      (91)  (55)
Foreign exchange gain      428         428 
Net income (loss) $12,612  $1,702  $(116) $(9,591) $4,607 
                     
Depreciation and amortization included above $1,189  $581  $  $198  $1,968 
                     
Share-based compensation included in above:                    
Selling, general and administrative  28   73      473   574 
Cost of revenues  66            66 
Total $94  $73  $  $473  $640 
                     
Capital expenditures $2,425  $378  $  $67  $2,870 

Note 12 ContingenciesOn or about March 2, 2023, a verified complaint was filed in the Supreme Court of the State of New York, New York County captioned Elazar Rabbani v. Mary Tagliaferri, et al., Index No. 651120/2023.  The verified complaint purports to assert causes of action for breach of fiduciary duty and corporate waste under N.Y.B.C.L. § 720, and also seeks an accounting and certain injunctive relief.  Plaintiff served a copy of the verified complaint on Enzo’s agent for service in New York on or about March 13, 2023.  The Company cannot predict the outcome of this matter; however, no inference whatsoever should be drawn from the absence of such prediction that the Company will not prevail.

The Company has brought cases in the United States District Court for the District of Delaware (“the Court”), alleging patent infringement against various companies. In 2017, the Court ruled that the asserted claims of the ’180 and ’405 Patents are invalid for nonenablement in cases involving Abbott, Becton Dickinson, Gen-Probe, Hologic, and Roche. That ruling was affirmed by the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) in June 2019. Enzo subsequently filed a petition for certiorari regarding the invalidity ruling for the ’180 and ’405 Patents in February 2020; the Supreme Court denied Enzo’s petition on March 30, 2020.

The Company, along with its subsidiary Enzo Life Sciences, Inc., resolved its claims against Roche regarding the ’197 Patent before the Court (civil action No. 12 cv-00106) in July 2022. There areis currently two casesone case that werewas originally brought by the Company that is still pending in the Court. In those two cases,that case, Enzo alleges patent infringement of the ’197 patent against Becton Dickinson Defendants and Roche Defendants, respectively.Defendants. The claims in those cases involve the ’197 Patent. Both casesthat case are stayed.


In separate inter partes review proceedings before the U.S. Patent and Trademark Office (PTO) involving, among others, Becton Dickinson, certain claims of the ’197 Patent were found unpatentable as anticipated or obvious and cancelled by the Patent Trial and Appeals Board (“Board”). Enzo appealed that decision to the Federal Circuit. On August 16, 2019, the Federal Circuit affirmed the Board’s decision, finding that each of the challenged claims is unpatentable. The Company filed a petition for rehearing and rehearing en banc on October 30, 2019, which the Federal Circuit denied on December 4, 2019. The Company filed a petition for certiorari with the Supreme Court on March 3, 2020, which was denied.

In April 2019, the Company entered into an agreement with Hologic and Grifols, resolving litigation resulting from four cases originally brought by the Company in the Court.  As a result, Enzo dismissed (1) a stayed patent litigation regarding the ’180 and ’197 Patent against Hologic in the Court; (2) the Consolidated Appeals against Gen-Probe and Hologic resulting from two cases filed in the Court, and (3) the Company’s appeal in the litigation involving the ’581 Patent that involved both Hologic and Grifols. As a result of the agreement with Hologic, Hologic withdrew from Enzo’s Federal Circuit appeal of the Board’s adverse rulings in the inter partes review proceedings regarding the ’197 Patent filed by Hologic and joined by Becton Dickinson mentioned above.

On September 2, 2021, the PTO issued a non-final office action in an ex parte reexamination concerning the ’197 Patent. In the office action, the PTO rejected certain claims of the ’197 Patent under 35 U.S.C. §§§ 102 and 103, and for nonstatutory double-patenting. Enzo responded to the office action on January 3, 2022, and the proceeding remains pending. Becton Dickinson requested another ex parte reexamination concerning the ’197 patent on July 26, 2022. On September 16, 2022, the PTO ordered that ex parte reexamination as to certain claims of the ’197 patent and has not yet issued an office action. Enzo filed a petition to terminate that second reexamination proceeding on November 16, 2022.

On February 5, 2020, Harbert Discovery Fund, LP and Harbert Discovery Co-Investment Fund I, LP (“HDF”) brought an action in the United States District Court for the Southern District of New York against the Company and five of its present or former Directors, Dr. Elazar Rabbani, Barry W. Weiner, Dr. Bruce A. Hanna, Dov Perlysky and Rebecca Fischer. On March 26, 2020, HDF filed an amended complaint against the same defendants. Count I asserted the Company violated Section 14(a) of the Securities and Exchange Act of 1934 and Rule 14a-9 thereunder by disseminating proxy materials that made purportedly false statements. Count II asserted a claim against the individual defendants under Section 20(a) of the Exchange Act premised on Enzo’s purported violation of Section 14(a) and Rule 14a-9. Count III asserted the individual defendants breached their fiduciary duty, based on the same conduct and by seeking to entrench themselves. Finally, Count IV purported to assert a derivative claim for a declaration that any amendment to Article II, Section 2 requires the approval of 80% of Enzo’s shareholders. On July 16, 2020, the day before the defendants’ motion to dismiss was due, HDF asked the Court to dismiss their claims without prejudice. Defendants asked HDF to dismiss the claims with prejudice, but they refused. On July 17, 2020, the Court dismissed the claims without prejudice.


On November 27, 2020, the Company brought an action in the United States District Court for the Southern District of New York against Harbert Discovery Fund, LP, Harbert Discovery Co-Investment Fund I, LP, Harbert Fund Advisors, Inc., Harbert Management Corp. and Kenan Lucas (together, “Harbert”). The Company allegesalleged Harbert made false and misleading representations, or omitted to state material facts necessary to make their statements not misleading, in proxy materials they disseminated seeking the election to the Company’s Board of Directors at its 2019 Annual Meeting of two candidates they nominated, in violation of Section 14(a) of the 1934 Exchange Act and Rule 14a-9 thereunder. The Company seekssought damages and injunctive relief. On October 12, 2021, HDF filed ninefive counterclaims against the Company and present and former directors Dr. Elazar Rabbani, Barry W. Weiner, Dr. Bruce A. Hanna, Dov Perlysky, Rebeca Fischer, Dr. Mary Tagliaferri and Dr. Ian B. Walters. HDF claimsclaimed the Company made false and misleading representations in proxy materials it disseminated in connection with its 2019 Annual Meeting, in violation of Section 14(a) of the 1934 Exchange Act and Rule 14a-9 thereunder, and that the Company’s directors at that time arewere liable under Section 20(a) of the Exchange Act for the Company’s purported misstatements. HDF also claimsclaimed that current and former Company directors breached their fiduciary duties by taking four corporate actions: (a) adjourning the 2019 meeting for 25 days; (b) purportedly causing the two Harbert candidates for director, who were elected at the 2019 Meeting, to resign in November 2020; (c) authorizing the November 27, 2020 Lawsuit; and (d) not accepting Dr. Rabbani’s resignation as a director in March 2021. On November 10, 2021, the Company and the other counterclaim defendants moved to dismiss HDF’s counterclaims. On December 9, 2021, the Courtcourt granted the motion to dismiss HDF’s counterclaims except with respect toHDF’s Section 14(a) claim against the counterclaim that Enzo violated the securities law by announcing on January 20, 2020Company concerning its statement that it had decidedintended to “delay” the 2019 annual meeting when it intended to conveneAnnual Meeting, and adjourn the meeting (the “Delay Statement”) and the counterclaims that the Company’s directors at that time violatedHDF’s Section 20(a) and breach of the Exchange Actfiduciary duty counterclaims against Dr. Elazar Rabbani, Barry W. Weiner, Dr. Bruce Hanna, Dov Perlysky and breached their fiduciary duties in connectionRebecca Fischer with the Delay Statement.respect to that statement. The Court allowed HDF to move for leave to replead with respect to its counterclaims that were dismissed.

dismissed counterclaims. On June 7, 2022, the Company, Drs. Hanna, Tagliaferri, and Walters, Ms. Fischer, Mr. Perlysky and Harbert executedCourt “so ordered” a settlement agreement. A stipulation of dismissal with prejudice was so ordered by the Court on June 7, 2022.   Pursuant to the terms of the Order: (i) allCompany’s claims asserted byagainst Harbert Discovery Fund, LP, Harbert Discovery Co-Investment Fund I, LP, Harbert Fund Advisors, Inc., Harbert Management Corp., and Kenan Lucas, and HDF’s counterclaims against the Company, Drs.Dr. Bruce Hanna, Tagliaferri,Dov Perlysky, Rebecca Fischer, Dr. Ian B. Walters and Walter, Ms. Fischer,Dr. Mary Tagliaferri. The only remaining claims were HDF’s counterclaims against Dr. Rabbani and Mr. Perlysky shall be dismissedWeiner. HDF asked the Court to dismiss those claims without prejudice. Dr. Rabbani and Mr. Weiner asked the Court to dismiss those counterclaims with prejudice and (ii) all claims asserted byto allow them to take discovery from HDF, the Company, against Harbert shall be dismissed with prejudice.  Messrs.and possibly others. On December 1, 2022, the court granted HDF’s motion for voluntary dismissal without prejudice, denied Dr. Rabbani and Weiner did not executeMr. Weiner’s motion to compel discovery, and directed the settlement agreement.Clerk of the Court to close this case.


There can be no assurance that the Company will be successful in any of these litigations. Even if the Company is not successful, management does not believe that there will be a significant adverse monetary impact on the Company. The Company is party to other claims, legal actions, complaints, and contractual disputes that arise in the ordinary course of business. The Company believes that any liability that may ultimately result from the resolution of these matters will not, individually or in the aggregate, have a material adverse effect on its financial position or results of operations.

As described in Note 3, third-party payers, including government programs, may decide to deny payment or recoup payments for testing that they contend was improperly billed or not medically necessary, against their coverage determinations, or for which they believe they have otherwise overpaid (including as a result of their own error), and we may be required to refund payments already received.

Note 13 – Appointment and Departure of Certain Officers

Effective November 8, 2021, Enzo appointed Hamid Erfanian as Chief Executive Officer and granted equity awards to him comprised of restricted stock units (RSUs) for 260,000 shares of the common stock of the Company and options to purchase 700,000 shares of common stock of the Company.


Former executives arbitration

On January 21, 2022,The Company terminated the employment of Elazar Rabbani, Ph.D., the Company’s co-founder andformer Chief Executive Officer, was provided a notice of termination of his employment by the Company. His termination became effective April 21, 2022, which was 90 days from the date of notice.2022.  Dr. Rabbani remains a board director of the Company. Dr. Rabbani is a party to an employment agreement with the Company, which entitles him to certain termination benefits, including severance pay, acceleration of vesting of share-based compensation, and continuation of benefits and tax gross up certain of these termination benefits. Based on the terms of his employment agreement, the Company estimated and accrued a charge of $2,600 for the three and nine months ended April 30,in fiscal 2022 which is included in Selling, general and administrative expenses. The charge was partially offset by the reversal of bonus accruals. In May 2022, the Company paid Dr. Rabbani $2,123 in accordanceseverance (the payment constituted taxable income but the Company did not withhold taxes from the payment). In July 2022, the Company paid Dr. Rabbani’s income and other withholding taxes of $1,024 related to that payment on Dr. Rabbani’s behalf, which is included in “prepaid expense and other current assets” as of July 31, 2022, as the payment is reimbursable from Dr. Rabbani. Dr. Rabbani disputed, among other things, the Company’s decision to not award him a bonus for fiscal year 2021 and the amount of severance that was owed to him under his employment agreement.  On July 8, 2022, the Company filed a demand for arbitration with terms of the employment contract.American Arbitration Association (the “AAA”) seeking, among other things, a declaration that the Company has fully satisfied its contractual obligations to Dr. Rabbani and seeking the tax withholding reimbursement referenced above.  On August 4, 2022, Dr. Rabbani filed counterclaims in the arbitration seeking, among other things, a bonus for fiscal year 2021 and additional severance that he asserts is owed to him.  The parties have chosen an arbitrator from the AAA’s panel and a hearing is scheduled for June 8-16, 2023.

On February 25, 2022, Barry Weiner, the Company’s co-founder and President, notified the Company that he was terminating his employment as President of the Company for “Good Reason” as defined in his employment agreement. The Company accepted Mr. Weiner’s termination, effective April 19, 2022, but disagreesdisagreed with Mr. Weiner’s assertion regarding “Good Reason.” On July 20, 2022, Mr. Weiner filed a demand for arbitration with the AAA asserting, among other things, that his annual bonus for fiscal year 2021 was too low and that his resignation (effective April 19, 2022) was for “Good Reason” under the terms of his employment agreement. He seeks, among other things, payment of a higher 2021 bonus, and severance payments and benefits. The parties have chosen an arbitrator from the AAA’s panel and a hearing is scheduled for July 18-21, and 24, 2023. As of April 30, 2022,January 31, 2023, the Company has not accrued any charges related to Mr. Weiner’s termination.

Note 13 – Subsequent Events – Agreement to sell assets of Clinical Labs division to Labcorp

On March 16, 2023, the Company filed a Form 8-K indicating that it and Enzo Clinical Labs, Inc. (the “Subsidiary” and, together with the Company, the “Seller”) entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Laboratory Corporation of America Holdings, a Delaware corporation (the “Buyer”). Pursuant to the Purchase Agreement, the Seller has agreed to sell substantially all operating assets and assign certain liabilities of its clinical labs business (the “Business”) to the Buyer which are necessary to operate the Business in exchange for approximately $146,000,000 in cash (subject to certain adjustments), on and subject to the terms and conditions set forth therein (such transaction, the “Transaction”).

The Purchase Agreement contains customary representations, warranties, covenants and termination rights for a transaction of this nature, including, among other things, customary covenants: (i) relating to the conduct of the Business between the signing of the Purchase Agreement and the closing of the Transaction and (ii) regarding the efforts of the parties to cause the Transaction to be consummated, including obtaining certain consents and approvals. The consummation of the Transaction is subject to the satisfaction or waiver of customary closing conditions, including the expiration or termination of any required waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. In addition, closing under the Purchase Agreement is contingent on the Company obtaining approval of the Transaction by shareholders of the Company holding a majority of the shares of its common stock outstanding. Certain officers and directors of the Company have agreed with Buyer to vote the shares they beneficially own, totaling up to approximately 11% of the shares outstanding, in favor of the Transaction.

The Purchase Agreement also includes customary termination provisions for both the Company and Buyer and provides that, in connection with the termination of the Purchase Agreement under specified circumstances, including termination by the Company to accept and enter into a definitive agreement with respect to an unsolicited Superior Proposal, the Company will be required to pay Buyer a termination fee of $5,000,000 or reimbursement of Buyer’s expenses of up to $5,000,000.


 

Subject to the terms and conditions stated in the Purchase Agreement, after shareholder approval of the Transaction, Buyer will be obligated to pay a fee to the Company for each day after the date of such approval until the closing of the Transaction.  At the closing of the Transaction, such fee will be wholly or partially credited against the purchase price.

There can be no assurances that the Purchase Agreement will close and if it does close, the exact proceeds to be received by the Company.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes and other information included elsewhere in this Quarterly Report on Form 10-Q.

Forward-Looking Statements

Our disclosure and analysis in this report, including but not limited to the information discussed in this Item 2, contain forward-looking information about our Company’s financial results and estimates, business prospects and products in research and development that involve substantial risks and uncertainties. From time to time, we also may provide oral or written forward-looking statements in other materials we release to the public. Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historic or current facts. They use words such as “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “will”, and other words and terms of similar meaning in connection with any discussion of future operations or financial performance.

In particular, these include statements relating to future actions, including the Asset Purchase Agreement with respect to the sale of substantially all assets and assignment of certain liabilities of the Clinical Labs division and the timing of its closing, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, interest rates, foreign currency rates, intellectual property matters, the outcome of contingencies, such as legal proceedings, impacts of the COVID-19 pandemic and measures we have taken in response, and financial results. We cannot guarantee that any forward-looking statement will be realized, although we believe we have been prudent in our plans and assumptions. Achievement of future results is subject to risks, uncertainties and inaccurate assumptions. Should known or unknown risks or uncertainties materialize, or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. As a result, investors are cautioned not to place undue reliance on any of our forward-looking statements. Investors should bear this in mind as they consider forward-looking statements. We do not assume any obligation to update or revise any forward-looking statement that we make, even if new information becomes available or other events occur in the future. We are also affected by other factors that may be identified from time to time in our filings with the Securities and Exchange Commission, some of which are set forth in Item 1A - Risk Factors in our Form 10-K filing for the July 31, 20212022 fiscal year. You are advised to consult any further disclosures we make on related subjects in our Forms 10-Q, 8-K and 10-K reports to the Securities and Exchange Commission. Although we have attempted to provide a list of important factors which may affect our business, investors are cautioned that other factors may prove to be important in the future and could affect our operating results.

You should understand that it is not possible to predict or identify all such factors or to assess the impact of each factor or combination of factors on our business. Consequently, you should not consider any such list to be a complete set of all potential risks or uncertainties.

Impact of COVID-19 pandemic

We made substantial investments to expand and maintain the amount of COVID-19 has severely impactedtesting available in the economycommunities we serve since the start of the United Statespandemic in March 2020. We applied our technical expertise in molecular diagnostics to develop next generation COVID-19 diagnostic and other countries aroundantibody testing options which were approved under the world. FDA Emergency Use Authorization (EUA). During the fiscal year ended July 31, 2022, the Company generated substantial COVID-19 related services revenues, representing 44% of all services revenues. This testing had a significantly positive impact on the profitability and cash flow of our Clinical services segment for most of fiscal 2022. Revenues from COVID-19 testing during the three and six months ended January 31, 2022 represented 56% and 52%, respectively of all services revenues. The rate of transmission of COVID-19 and the severity of its variants have dramatically declined in the US. Revenues from COVID-19 testing during the three and six months ended January 31, 2023 represented approximately 4% and 6%, respectively of all services revenues.


In March 2022, the U.S. Health Resources and Services Administration (“HRSA”) informed providers that, after March 22, 2022, it would stop accepting claims for testing and treatment for uninsured individuals under the HRSA COVID-19 Uninsured Program and that claims submitted prior to that date would be subject to eligibility and availability of funds. Although we believe that our estimates for contractual allowances and patient price concessions are appropriate, actual results could differ from those estimates. If the HRSA receives additional funding, it might again accept claims under the Uninsured Program.

Federal, state and local governmental policies and initiatives designed to reduce the transmission of COVID-19 and its variants have resulted in, among other things, a significant reduction in physician office visits, the cancellation of elective medical procedures, customers of our products closing or severely curtailing their operations (voluntarily or in response to government orders), and the adoptioncontinuation of work-from-home or shelter-in-place policies. The COVID-19 impact on the Company’s operations is consistent with the overall industry and publicly issued statements fromour competitors, partners, and vendors.

Enzo was granted FDA Emergency Use Authorizations (EUAs) and EUA extensions for our molecular diagnostic and serological testing for COVID-19 and related antibody testing options, for our sample collection kit, an innovative virus-inactivating specimen collection media that lessens transmission risks for healthcare providers and clinical laboratory personnel, for our use of pooled samples, and for our rapid extraction method. Other innovations include the development of more relevant positive controls for the tests, and improved sensitivity. During the fiscal year ended July 31, 2021, While we experienced growing demand for COVID-19 testing and we made significant investments to expand our capacity throughout the period in order to satisfy the demand, which substantially increased our testing volumes.


While the Company anticipatesanticipate that COVID-19 will continue to impact itsour business ininto the second half of fiscal 2022 and potentially beyond, the Company expects thatfuture, increases in vaccination rates and booster shots, the development of new therapeutics and greater availability of rapid COVID-19 tests should resulthas resulted in a continued, significant decline in demand for our COVID-19 Testing, in the Company’s region.testing. As a result, volume, revenues, profitability, and cash flow from COVID-19 Testing demandtesting during the current periods were all substantially and materially lower than the prior year period levels. COVID-19 testing is no longer a material part of our Services business.

We expect volume and revenues from COVID-19 testing will remain less significant in fiscal year 2022 is not anticipatedthe periods ahead as the percentage of Americans who are vaccinated increases, the severity of its variants declines, and the general increase in the use of “at home” testing. However, the emergence and spread of potentially more serious variants may cause our COVID-19 testing volume to match 2021 levels. Global supply chain issues dueincrease again. With respect to our non-COVID-19 operations, even after the COVID-19 pandemic impact has greatly moderated, we may continue to experience similar adverse effects to our businesses, consolidated results of operations, financial position and cash flows resulting from a recessionary economic environment, including inflation and actions by the Federal Reserve to increase interest rates.

The Company assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the pandemic continueCompany and the unknown future impacts of COVID-19 and the recessionary economic environment, including inflation and actions by the Federal Reserve to hamper bothincrease interest rates as of January 31, 2023 and through the manufacturingdate of products withinthis Quarterly Report. The accounting matters assessed included, but were not limited to, the life scienceCompany’s patient self-pay revenue concessions and credit losses in the Clinical Services segment, accounts receivable, inventories and the carrying value of goodwill and other long-lived assets. The Company’s future assessment of the magnitude and duration of COVID-19, as well as testing capabilitiesother economic factors, could result in additional material adverse impacts to the clinical laboratory.Company’s consolidated financial statements in future reporting periods.

Overview

Enzo Biochem, Inc. (the “Company”, “we”, “our”, or “Enzo”) is an integrated diagnostics, clinical lab, and life sciences company focused on delivering and applying advanced technology capabilities to produce affordable reliable products and services that enable our customers to meet their clinical needs. Through a connection with the market, we provide advanced biotechnology solutions to the global community as affordable and flexible quality products and services. We develop, manufacture and sell our proprietary technology solutions and platforms to clinical laboratories, specialty clinics, researchers and physicians globally. Enzo’s structure and business strategy represent the culmination of years of extensive planning and work.  The Company has the unique ability to offer low cost, high performance products and services for diagnostic testing, which ideally positions us to capitalize on the reimbursement pressures facing diagnostic labs. Our pioneering work in genomic analysis coupled with our extensive patent estate and enabling platforms have positioned the Company to continue to play an important role in the rapidly growing molecular medicine marketplaces.


Enzo develops low cost diagnostic platform products and related services. Our platform development includes automation-compatible reagent systems and associated products for sample collection and processing through analysis. We develop affordable products and services to improve healthcare, one of the greatest challenges today. Enzo combines over 40 years of expertise in technology development with assay development capabilities and diagnostic testing services to create high performance, cost-effective, and open assay solutions. The ability to combine these assets in one company is unique. With our strong intellectual property portfolio integrated with assay development know-how, production, distribution, validation and services capabilities, we have enabled sustainable products and services for a market that is facing increasing pressure in costs and reimbursement.

Enzo technology solutions and platforms and unique operational structure are designed to reduce overall healthcare costs for both government and private insurers. Our proprietary technology platforms reducesreduce our customers’ need for multiple, specialized instruments, and offer a variety of high throughput capabilities together with a demonstrated high level of accuracy and reproducibility. Our genetic test panels are focused on large and growing markets primarily in the areas of personalized medicine, women’s health, infectious diseases and genetic disorders.

In the course of our research and development activities, we have built a substantial portfolio of intellectual property assets, comprised of approximately 472 issued patents worldwide and over 64 pending patent applications, along with extensive enabling technologies and platforms.

Below are brief descriptions of each of our two operating segments (See Note 11 in the Notes to Consolidated Financial Statements):

Enzo Clinical Services is a clinical reference laboratory providing a wide range of clinical services to physicians, medical centers, other clinical labs and pharmaceutical companies. The Company believes having a Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified and College of American Pathologists (“CAP”) accredited medical laboratory located in New York provides us the opportunity to more rapidly introduce cutting edge products and services to the clinical marketplace. Enzo Clinical Labs offers an extensive menu of molecular and other clinical laboratory tests and procedures used in patient care by physicians to establish or support a diagnosis, monitor treatment or medication, and search for an otherwise undiagnosed condition. Our laboratory is equipped with state-of-the-art communication and connectivity solutions enabling the rapid transmission, analysis and interpretation of generated data. We operate a full service clinical laboratory in Farmingdale, New York, a network of over 30 patient service centers throughout New York, New Jersey and Connecticut, two free standing “STAT” or rapid response laboratories in New York City and Connecticut, an in-house logistics department, and an information technology department. Under our license in New York State, we are able to offer testing services to clinical laboratories and physicians nationwide.


The Clinical Laboratory Services reporting unit is impacted by various risk factors, including among others, loss of a substantial portion of revenues from COVID-19 testing, reduced reimbursements from third party payers for testing performed and from recent health care legislation. Despite the growth we have experienced in previous years, there can be no assurance future growth can be achieved. The introduction of new molecular and esoteric tests is expected to increase our revenue per test and could offset impacts from the above factors. The Company anticipates improved profitability with increased service volume.

On March 16, 2023, the Company entered into an Asset Purchase Agreement with respect to the sale of assets and assignment of certain liabilities of the Clinical Labs division. See Note 13 Subsequent Events.

Enzo Products manufactures, develops and markets products and tools for clinical research, drug development and bioscience research customers worldwide. Underpinned by broad technological capabilities, Enzo Life Sciences has developed proprietary products used in the identification of genomic information by laboratories around the world. Information regarding our technologies can be found in the “Core Technologies” section of our most recently filed Form 10-K. We are internationally recognized and acknowledged as a leader in the development, manufacturing validation and commercialization of numerous products serving not only the clinical research market, but also the life sciences markets in the fields of cellular analysis and drug discovery, among others. Our operations are supported by global operations allowing for the efficient marketing and delivery of our products around the world.


Enzo Therapeutics is a biopharmaceutical venture that has developed multiple novel approaches in the areas of gastrointestinal, infectious, ophthalmic and metabolic diseases, many of which are derived from the pioneering work of Enzo Life Sciences. Enzo Therapeutics has focused its efforts on developing treatment regimens for diseases and conditions for which current treatment options are ineffective, costly, and/or cause unwanted side effects. This focus has generated a clinical and preclinical pipeline, as well as numerous patents and patent applications.  

Results of Operations

Three months ended April 30, 2022January 31, 2023 compared to April 30, 2021January 31, 2022
(in 000s)

Comparative Financial Data for the Three Months Ended April 30,January 31,

  2022  2021  Favorable (Unfavorable)  

%

Change

 
             
Revenues $26,222  $32,797  $(6,575)  (20)
                 
Operating costs and expenses:                
Cost of revenues  16,049   16,751   702   4 
Research and development  1,133   836   (297)  (36)
Selling, general and administrative  11,442   12,082   640   5 
Legal and related expenses, net  734   1,061   327   31 
Total operating costs and expenses  29,358   30,730   1,372   4 
                 
Operating (loss) income  (3,136)  2,067   (5,203)  ** 
                 
Other income (expense):                
Interest, net  54   60   (6)  (10)
Other  (716)  (88)  (628)  ** 
Foreign currency loss  (1,056)  (33)  (1,023)  ** 
Total other (expense)  (1,718)  (61)  (1,657)  ** 
                 
Net (loss) income $(4,854) $2,006  $(6,860)  ** 
                 
Net (loss) income per common share:                
Basic $(0.10) $0.04         
Diluted $(0.10) $0.04         
Weighted average common shares outstanding:                
Basic  48,713   48,391         
Diluted  48,713   48,788         
  2023  2022  Favorable
(Unfavorable)
  % Change 
             
Revenues $16,338  $34,046  $(17,708)  (52)
                 
Operating costs and expenses:                
Cost of revenues  15,079   17,838   2,759   15 
Research and development  1,431   820   (611)  (75)
Selling, general and administrative  11,812   14,466   2,654   18 
Legal and related expenses  995   2,845   1,850   65 
Total operating costs and expenses  29,317   35,969   6,652   18 
                 
Operating loss  (12,979)  (1,923)  (11,056)  ** 
                 
Other income (expense):                
Interest  62   68   (6)  (9)
Other  125   (350)  475   ** 
Foreign exchange gain (loss)  1,472   (450)  1,922   ** 
Loss before income taxes $(11,320) $(2,655) $(8,665)  ** 

**not meaningful


Consolidated Results:

Consolidated Results:

The “2022“2023 period” and the “2021“2022 period” refer to the three months ended April 30,January 31, 2023 of fiscal year 2023 and January 31, 2022 and April 30, 2021,of the fiscal year 2022, respectively.

Impacts of COVID-19

In July 2020, Enzo was grantedWe made substantial investments to expand and maintain the amount of COVID-19 testing available in the communities we serve since the start of the pandemic in March 2020. We applied our technical expertise in molecular diagnostics to develop next generation COVID-19 diagnostic and antibody testing options which were approved under the FDA Emergency Use Authorization (EUA). During the fiscal year ended July 31, 2022, the Company generated substantial COVID-19 related services revenues, representing 44% of all services revenues. This testing had a significantly positive impact on the profitability and cash flow of our Clinical services segment for its molecular diagnostic and serological testing for COVID-19 and related antibody testing options. In January 2021, Enzo received an expansionmost of its Emergency Use Authorization (EUA)fiscal 2022. Revenues from the U.S. Food and Drug Administration (FDA) authorizing the use of pooled samples containing up to five individual swab specimens with the Company’s AMPIPROBE® SARS-Cov-2 Test System utilizing tests on three different platforms including Enzo’s proprietary GENFLEX® automated high-throughput platform. In July 2021, Enzo received an expansion of its FDA Emergency Use Authorization (EUA) for the Company’s rapid extraction method on its proprietary test system.

Due to the COVID-19 pandemic, we have experienced significant volatility, including periods of material decline compared to prior year periods in testing volume in our base business and periods of significant demand for COVID-19 testing services, with demand generally fluctuating in line with changes induring the prevalence of the virusthree and its related variants. Compared to historical levels, our revenue per requisition has been positively impacted by COVID-19 molecular testing. While the Company anticipates that COVID-19 will continue to impact its business for the rest of fiscal 2022 and potentially beyond, the Company expects that increases in vaccination rates and booster shots, the development of new therapeutics and greater availability of rapid COVID-19 tests will likely result in a continued, significant decline in demand for COVID-19 testing for the foreseeable future. We experienced a sequential quarter decrease in Clinical laboratory services revenues of $5.0 million in the 2022 period when compared to the second quartersix months ended January 31, 2022 based on decreasedrepresented 56% and 52%, respectively of all services revenues. The rate of transmission of COVID-19 testing. As a result,and the severity of its variants have dramatically declined in the US. Revenues from COVID-19 testing revenues forduring the fiscal year ending Julythree and six months ended January 31, 2022 have not2023 represented approximately 4% and likely will not match fiscal 2021 levels.6%, respectively of all services revenues.

In March 2022, the U.S. Health Resources and Services Administration (“HRSA”) informed providers that, after March 22, 2022, it would stop accepting claims for testing and treatment for uninsured individuals under the HRSA COVID-19 Uninsured Program and that claims submitted prior to that date would be subject to eligibility and availability of funds. Although we believe that our estimates for contractual allowances and patient price concessions are appropriate, actual results could differ from those estimates. If the HRSA receives additional funding, it might again accept claims under the Uninsured Program.


Federal, state and local governmental policies and initiatives designed to reduce the transmission of COVID-19 resulted in, among other things, a significant reduction in physician office visits, the cancellation of elective medical procedures, and the continuation of work-from-home policies. The COVID-19 impact on the Company’s operations is consistent with the overall industry and our competitors, partners, and vendors. While we anticipate that COVID-19 will continue to impact our business into the future, increases in vaccination rates and booster shots, the development of new therapeutics and greater availability of rapid COVID-19 tests has resulted in a continued, significant decline in demand for our COVID-19 testing. As a result, volume, revenues, profitability, and cash flow from COVID-19 testing during the current periods were all substantially and materially lower than the prior year period levels. COVID-19 testing is no longer a material part of our Services business.

We expect volume and revenues from COVID-19 testing will remain less significant in the periods ahead as the percentage of Americans who are vaccinated increases, the severity of its variants declines, and the general increase in the use of “at home” testing. However, the emergence and spread of potentially more serious variants may cause our COVID-19 testing volume to increase again. With respect to our non-COVID-19 operations, even after the COVID-19 pandemic impact has greatly moderated, we may continue to experience similar adverse effects to our businesses, consolidated results of operations, financial position and cash flows resulting from a recessionary economic environment, including inflation and actions by the Federal Reserve to increase interest rates.

The Company assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 and the recessionary economic environment, including inflation and actions by the Federal Reserve to increase interest rates as of January 31, 2023 and through the date of this Quarterly Report. The accounting matters assessed included, but were not limited to, the Company’s patient self-pay revenue concessions and credit losses in the Clinical Services segment, accounts receivable, inventories and the carrying value of goodwill and other long-lived assets. The Company’s future assessment of the magnitude and duration of COVID-19, as well as other economic factors, could result in additional material adverse impacts to the Company’s consolidated financial statements in future reporting periods.

Clinical services revenues for the 20222023 period were $18.6$8.8 million compared to $25.0$23.7 million in the 20212022 period, a decrease of $6.4$14.9 million or 26%63%. Revenues from COVID-19 testing decreased approximately $12.9 million and represented 43%4% and 59%56% of Clinical revenues in the 20222023 and 20212022 periods, respectively due to lower volume as well as pricing pressures. DiagnosticCOVID-19 accessions declined 96% in the 2023 period versus the 2022 period. Accessions from all other testing volume measured byincreased 7% versus the total number of accessions for all our2022 period but revenues from this testing services decreasedwas down approximately 23%$2.0 million period over period resulting in the 2022 period’s revenue decrease.due to payer and test mix and liquidation rate adjustments. Due to a Medicaid audit, we recorded a $1.0 million charge as a reduction of revenue.

Estimated collection amounts are subject to the complexities and ambiguities of third-partythird party payer billing, reimbursement regulations and claims processing, as well as issues unique to Medicare and Medicaid programs, and require us to consider the potential for adjustments when estimating variable consideration in the recognition of revenue in the period that the related services are rendered. Furthermore, the current recessionary environment, including inflation and actions by the Federal Reserve to increase interest rates, have, in part, resulted in longer lag periods between the time when we perform and report on our clinical services and when we are ultimately paid. Changes in our estimates of collections could have a material adverse impact on our consolidated financial statements.

In 2014, Congress passed the U.S. Protecting Access to Medicare Act of 2014 (PAMA), which included substantial changes to the way in which clinical laboratory services are paid under Medicare. Beginning in 2018, Medicare payments for clinical laboratory services are paid based upon the volume-weighted median of private payer rates as reported by certain clinical laboratories across the US, replacing the previous system which was based upon fee schedules derived from historical charges for clinical laboratory tests. We estimate that the effect of PAMA directly negatively impacted reimbursements from Medicare and Medicaid in each ofboth the 2023 and 2022 periods by $0.3 million.

Product revenues were $7.5 million in the 2023 period and $10.4 million in the 2022 period, a decrease of $2.9 million or 28%. The 2022 period includes a $2.8 million bulk sale of a GMP reagent to a large industrial customer in the US. Excluding the bulk sale, in the 2023 period, small decreases in revenues from European and 2021 periodsAsia Pacific markets were almost offset by approximately $0.3 million.a small increase in revenues in the US market.


 

Product revenues were $7.6 million in the 2022 period and $7.8 million in the 2021 period, a decrease of $0.2 million or 2%. We experienced a decrease in sales in both the European and Asia Pacific markets, nearly offset by an increase in the US market.

The cost of Clinical Services was $11.2$10.5 million in the 2023 period and $12.6 million in the 2022 period, and $12.7 million in the 2021 period, a decrease of $1.5$2.1 million or 12% due17%. Due to the decline in revenues.revenues in the 2023 period versus 2022, our reagent costs decreased by $1.0 million and salaries by $1.1 million. During the 2022 period, reagent andwe significantly reduced our outside reference testing expenses declined $2.1 million, which was partially offsetcosts for COVID-19 by an increase in labor expensesutilizing our internal manufacturing capabilities, thereby reducing some of $0.6 million.our reliance on testing and reagents sourced from third parties. The gross profit (loss) margin on Clinical Services revenues in the 20222023 period was approximately 40%(19%) versus 49%47% in the 20212022 period, due to the magnitude of the decline in high margin COVID-19 testing, which has higher margins than non-specialty testing.the Medicaid audit charge, and market changes resulting in liquidation rate adjustments.

The cost of Product revenues was $4.9$4.6 million in the 2023 period and $5.3 million in the 2022 period, and $4.0 million in the 2021 period, an increasea decrease of $0.9approximately $0.6 million or 21%.12%, driven by lower revenues. The gross profit margin on Products was 36%39% in the 2023 period and 49% in the 2022 period and 48% inperiod. During the 2021 period. The 2022 period grosswe made a large bulk sale of a GMP reagent which had a significantly positive impact on the period’s profit was negatively impacted by increased manufacturing headcount, increases in the cost of materials consumed, and the product mix sold.margin.

Research and development expenses were $1.1$1.4 million in the 20222023 period and $0.8 million in the 20212022 period, an increase of $0.3$0.6 million or 36%. Research activities include lab developed tests (LDTs) for sexually transmitted infection (STI) panels75%, due to headcount increases and the detection of COVID-19.materials consumed.

Selling, general and administrative expenses were $11.4$11.8 million during the 2023 period versus $14.5 million during the 2022 period, versus $12.1 million during the 2021 period, a decrease of $0.6$2.6 million or 5%18%. The Clinical Services expense decreased $0.3 million due to lower commission compensation earned on lower services revenues. The Other segment expense decreased $0.3$2.3 million net primarily dueduring the 2023 period compared to a reversal of accumulated performance stock unit compensation expense of $0.12022. In the 2022 period we recorded $2.6 million for severance and other discrete employment matters related to athe termination of our former chief executive officer. During the 2023 period, increases in salaries, bonuses and a decreasebenefits of $0.5 million were partially offset by decreases in consultingshare based compensation, professional fees and other professional fees.insurance totaling $0.2 million. The Life Sciences Products expense decreased $0.5 million during the 2023 period, of which $0.4 million was unchanged period over period.due to a decrease in marketing expenses and a $0.1 million decrease in administrative costs. The Clinical Services expense increased $0.1 million due to increased marketing, information technology and insurance costs partially offset by a decrease in outside services for administrative functions.

Legal and related expenses were $0.7$1.0 million during the 20222023 period compared to $1.0$2.8 million in the 20212022 period, a decrease of $0.3$1.8 million or 31%65%. LegalDuring the 2022 period, we incurred higher legal activities were slightly lower asassociated with strategic initiatives which include the Company is working to reduce its legal initiativessale of assets, and other corporate expenses.matters related to two former executives’ arbitration, which are ongoing. The 2023 period expense is net of a reimbursement of $0.8 million under the Company’s directors and officers insurance policy.

Interest income, net was approximatelyless than $0.1 million in both the 2023 and 2022 and 2021 periods andperiods. The 2023 period’s income was higher due to higher interest earned on cash in a money market fund. In the 2022 period, we also earned some interest on marketable securities in bond funds, and is net offunds. In both periods we had interest expense primarily incurred on a mortgage.

Other income (expense) in the 2023 and 2022 period was $(0.7)$0.1 million compared to $(0.1)and ($0.4) million in the 2021 period, an unfavorablerespectively, a favorable variance of approximately $0.6$0.5 million. During the 2022 period, the primary component of the expense was realizedunrealized losses on marketable securities in bond funds. As of the end of the 2022 period, we had sold all our holdings in these bond funds.funds held at that time as trading securities.

The foreign currency revaluation lossexchange gain (loss) recognized by the Life Sciences Products segment during the 20222023 period was $1.1$1.4 million compared to nil($0.5) million in the 2021 period. The 2022 period, a favorable variance of $1.9 million. The 2023 period revaluation lossgain was due to depreciationthe significant appreciation of the Euro, British pound and Swiss franc versus the U.S. dollar ranging from 4.4% to 6.4% as of the end of the 2023 period compared to its start. The slight revaluation loss in the 20212022 period was due to the depreciation of the Euro, British pound and Swiss franc versus the U.S. dollar ranging from 0.5% to 2.1% as of the end of that period compared to its start.


 

Results of Operations

NineSix months ended April 30, 2022January 31, 2023 compared to April 30, 2021January 31, 2022
(in 000s)

Comparative Financial Data for the NineSix Months Ended April 30,January 31,

  2022  2021  Favorable (Unfavorable)  

%

Change

 
             
Revenues $86,787  $92,918  $(6,131)  (7)
                 
Operating costs and expenses:                
Cost of revenues  49,160   49,154   (6)  ** 
Research and development  2,697   2,388   (309)  (13)
Selling, general and administrative  36,960   33,109   (3,851)  (12)
Legal and related expenses, net  4,861   3,993   (868)  (22)
Total operating costs and expenses  93,678   88,644   (5,034)  (6)
                 
Operating (loss) income  (6,891)  4,274   (11,165)  ** 
                 
Other income (expense):��               
Interest, net  161   (40)  201   ** 
Other  (1,211)  (55)  (1,156)  ** 
Foreign currency (loss) gain  (1,887)  428   (2,315)  ** 
Total other income (expense)  (2,937)  333   (3,270)  ** 
                 
Net (loss) income $(9,828) $4,607  $(14,435)  ** 
                 
Net (loss) income per common share:                
Basic $(0.20) $0.10         
Diluted $(0.20) $0.10         
Weighted average common shares outstanding:                
Basic  48,552   48,097         
Diluted  48,552   48,201         
  2023  2022  Favorable (Unfavorable)  % Change 
             
Revenues $34,614  $60,565  $(25,951)  (43)
                 
Operating costs and expenses:                
Cost of revenues  29,750   33,111   3,361   10 
Research and development  2,427   1,564   (863)  (55)
Selling, general and administrative  23,263   25,518   2,255   9 
Legal and related expenses  2,066   4,127   2,061   50 
Total operating costs and expenses  57,506   64,320   6,814   11 
                 
Operating loss  (22,892)  (3,755)  (19,137)  ** 
                 
Other income (expense):                
Interest  132   107   25   23 
Other  130   (495)  625   ** 
Foreign exchange gain (loss)  675   (831)  1,506   ** 
Loss before income taxes $(21,955) $(4,974) $(16,981)  ** 

**not meaningful

Consolidated Results:

The “2022“2023 period” and the “2021“2022 period” refer to the ninesix months ended April 30,January 31, 2023 and January 31, 2022, and April 30, 2021, respectively, which represent the threefirst two quarters of the Company’s fiscal year ending July 31.

Clinical services revenues for the 20222023 period were $62.0$20.0 million compared to $70.2$43.4 million in the 20212022 period, a decrease of $8.2$23.4 million or 12%54%. Revenues from COVID-19 testing decreased approximately $21.3 million and represented 49%6% and 52% of Clinical revenues in the 20222023 and 20212022 periods, respectively due to lower volume as well as pricing pressures. DiagnosticCOVID-19 accessions declined 95% in the 2023 period versus the 2022 period. Accessions from all other testing volume measured by the total number of accessions for all ourincreased approximately 3% period but revenues from this testing services decreasedwas down approximately 13%$2.1 million period over period which resulted in the 2022 period’s revenue decrease.due to payer and test mix and liquidation rate adjustments. Due to a Medicaid audit, we recorded a $1.0 million charge as a reduction of revenue.

Estimated collection amounts are subject to the complexities and ambiguities of third-partythird party payer billing, reimbursement regulations and claims processing, as well as issues unique to Medicare and Medicaid programs, and require us to consider the potential for adjustments when estimating variable consideration in the recognition of revenue in the period that the related services are rendered. Furthermore, the current recessionary environment, including inflation and actions by the Federal Reserve to increase interest rates, have, in part, resulted in longer lag periods between the time when we perform and report on our clinical services and when we are ultimately paid. While we believe this to be a timing issue, any changes in our estimates of collections could have a material adverse impact on our consolidated financial statements.

In 2014, Congress passed the U.S. Protecting Access to Medicare Act of 2014 (PAMA), which included substantial changes to the way in which clinical laboratory services are paid under Medicare. Beginning in 2018, Medicare payments for clinical laboratory services are paid based upon the volume-weighted median of private payer rates as reported by certain clinical laboratories across the US, replacing the previous system which was based upon fee schedules derived from historical charges for clinical laboratory tests. We estimate that the effect of PAMA directly negatively impacted reimbursements from Medicare and Medicaid in the 20222023 and 20212022 periods by $0.9$0.5 and $0.6 million, and $1.1 million, respectively.


 

Product revenues were $24.7$14.6 million in the 2023 period and $17.2 million in the 2022 period, and $22.7 million in the 2021 period, an increasea decrease of $2.0approximately $2.5 million or 9%15%. During theThe 2022 period we completedincludes a $2.8 million bulk sale of a GMP reagent to a large industrial customer in the USUS. Excluding the bulk sale, in the amount of $2.8 million. It is not known at this time if2023 period, there will be repeat sales to this customer. Excluding this bulk sale,was an approximate $0.4 million increase in salesrevenues in the US market, was not enough topartially offset larger declinesby a small decrease in bothrevenues in the European and Asia Pacific markets. During the first quarter of the 2022 period, we completed the winding down and closure of our manufacturing and distribution center in Ann Arbor, MI and moved the operations to our Farmingdale, NY campus. As a result of the winding down, we experienced some disruption in the manufacture and distribution of our products, and experienced delays in product availability and fulfillment, which particularly impacted our customers in Europe. These disruptions were resolved during by latter part of the 2022 period.market.

The cost of Clinical Services was $35.0$20.5 million in the 2023 period and $23.8 million in the 2022 period, and $37.4 million in the 2021 period, a decrease of $2.4$3.2 million or 7%, in line with14%. Due to the decline in revenues.Services revenues in the 2023 period versus 2022, our reagent costs decreased by $1.8 million and salaries by $1.4 million. The gross profit (loss) margin on Clinical Services revenues in the 2023 period was approximately (3%) versus 45% in the 2022 period, due to the magnitude of the decline in high margin COVID-19 testing, the Medicaid charge, and market changes resulting in liquidation rate adjustments. During the 2022 period, we significantly reduced our outside reference testing costs for COVID-19 by approximately $3.2 million by utilizing our internal manufacturing capabilities, thereby reducing some of our reliance on testing and reagents sourced from third parties, as compared towhich improved the 2021 period, and from lower COVID-19 accessions in the 2022 period. Due to lower accessions for testing other than COVID-19, reagent costs declined $1.4 million in the 2022 period. These cost reductions were partially offset by higher personnel costs related to COVID-19 testing, totaling $2.0 million and other costs of $0.2 million. The grossperiod’s profit margin on Clinical Services revenues in the 2022 and 2021 periods was approximately 44% and 47% respectively. The lower margin in the 2022 period was due to the decline in COVID-19 testing, which has higher margins than non-specialty testing.margin.

The cost of Product revenues was $14.2$9.2 million in the 2023 period and $9.3 million in the 2022 period, and $11.7 million in the 2021 period, an increasea decrease of $2.5$0.1 million or 21%1%. The gross profit margin on Products was 43%approximately 37% in the 20222023 period and 48%46% in the 20212022 period. During the 2022 period we completed the winding down and closuremade a large bulk sale of our manufacturing and distribution center in Ann Arbor, MI and moved the operations to our Farmingdale, NY campus. As a result of the operational transition, there wasGMP reagent which had a temporary increase and overlap in manufacturing headcount and overhead costs during the beginning of the period, which negatively affected the 2022significantly positive impact on that period’s profit margin. The 2023 period gross profit margin.was also impacted by an increase in production headcount compared to the 2022 period.

Research and development expenses were $2.7$2.4 million in the 2023 period and $1.6 million in the 2022 period, and $2.4 million in the 2021 period, an increase of $0.3$0.8 million or 13%. Research activities include lab developed tests (LDTs) for sexually transmitted infection (STI) panels55%, due to headcount increases and the detection of COVID-19.materials consumed.

Selling, general and administrative expenses were $37.0$23.3 million during the 2023 period versus $25.5 million during the 2022 period, versus $33.1a decrease of $2.2 million or 9%. The Other segment expense decreased $1.8 million during the 20212023 period. In the 2022 period we recorded $2.6 million for severance and other discrete employment matters related to the termination of our former chief executive officer. During the 2023 period, salaries, bonuses and benefits also decreased $0.1 million. These decreases were partially offset by an increase of $3.9$0.9 million or 12%.for professional fees relating to advisory services including the evaluation of strategic alternatives for the Company. The Life Sciences Products expense increasedin the 2023 period decreased $1.1 million during thecompared to 2022, period, of which $0.4$0.6 million was due to a decrease in marketing and selling expenses and a $0.1 million decrease in administrative costs. Additionally, the 2022 period includes $0.4 million for employee severance expensesand winding down costs associated with the completionclosure of the winding down and closure of ourAnn Arbor MI manufacturing and distribution center in Ann Arbor, MI and the cost of moving its operations to our Farmingdale, NY campus at the beginning of the period. The segment also experienced increases in marketing expenses such as website ads, promotions and campaigns, trade shows, an increase in sales and marketing headcount, and an increase in facility expenses such as maintenance and utilities. The Other segment expense increased $2.8 million during the 2022 period and includes compensation expense (on a net basis) of $1.3 million for a former executive’s severance. The expense also increased in the 2022 period by $0.8 million for bonus accruals and share based compensation and $0.7 million for salaries, benefits and facility costs.center. The Clinical Services expense was unchanged period over period asincreased $0.7 million due to increased salaries, marketing and facility costs totaling $1.6 million, partially offset by lower commissions earned in the 2022 period were offset by increases in other compensation and facility costs.outside administrative support services totaling $0.9 million.

Legal and related expenses were $4.9$2.1 million on a net basis during the 2023 period compared to $4.1 million in the 2022 period, compared to $4.0 million in the 2021 period, an increasea decrease of $0.9$2.0 million or 22%49%. During the 2022 period, we incurred higher legal expense for activities associated with strategic initiatives which include the sale of assets, and other corporate matters related to two former executives’ arbitration, which were partially offset by the recognitionare ongoing. The 2023 period expense is net of a creditreimbursement of $1.0$0.8 million associated with a fee settlementunder the Company’s directors and release agreement with a former legal services provider.officers insurance policy.

Interest income, net was $0.2$0.1 million in both the 2023 and 2022 period versusperiods. The 2023 period’s interest (expense), net of less than $(0.1) millionincome was earned on cash in the 2021 period, a favorable variance of $0.2 million. Duringmoney market fund. In the 2022 period, we earned interest on marketable securities in bond funds, net offunds. In both periods we had interest expense primarily on a mortgage. During the 2021 period, we were not invested in interest earning marketable securities until the latter part of that period, earned insignificant interest on cash and cash equivalents, and incurred interest expense on the mortgage.


Other expenseincome (expense) in the 2023 period was $0.1 million versus ($0.5) million in the 2022 period, was $1.2 million and less than $0.1 million in the 2021 period, an unfavorablea favorable variance of $1.2approximately $0.6 million. During the 2022 period, the primary component of the expense was realizedunrealized losses net on marketable securities in bond funds of $1.3 million. As of the end of the 2022 period, we had sold all our holdings in these bond funds. During the 2022 and 2021 periods, we earned interest from these investments approximating $0.3 million and $0.1 million respectively, which amounts are included in interest income, net.held at that time as trading securities.

The foreign currency revaluationexchange gain (loss) gain recognized by the Life Sciences Products segment during the 20222023 period was $(1.9)$0.7 million compared to a gain of $0.4($0.8) million in the 20212022 period, an unfavorablea favorable variance of $2.3$1.5 million. The 20222023 period revaluation lossgain was due to the substantial depreciationsignificant appreciation of the Euro, British pound and Swiss franc versus the U.S. dollar as of the end of the 2023 period compared to its start, ranging from 7.0% to 11.2%.start. The revaluation gainloss in the 20212022 period was due to appreciationthe depreciation of the Euro, British pound and Swiss franc versus the U.S. dollar as of the end of that period compared to its start, ranging from 0% to 5.8%.start.


Liquidity and Capital Resources

During the six months ended January 31, 2023, the Company incurred a net loss of $21,955 and used cash in operating activities of $14,891. The Company believes that based on its fiscal 2023 forecast, its current cash and cash equivalents level is not sufficient for its foreseeable liquidity and capital resource needs over at least the next twelve (12) months, which conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date that the unaudited interim financial statements are issued.

In response to these conditions, the Company is evaluating various financing strategies to obtain sufficient additional liquidity to meet its operating, and capital requirements for the next twelve months following the date of issuance of the unaudited interim consolidated financial statements. Specifically, on March 10, 2023, the Company signed a commitment letter providing for up to $8,000 of a revolving line of credit subject to closing, and as previously disclosed has been exploring various strategic alternatives including the sale of segment operating assets. However, there can be no assurance that either of these capital raising strategies will be successful, and the Company may need to raise additional capital during the current fiscal year. On March 16, 2023, the Company entered into an Asset Purchase Agreement with respect to substantially all assets and assignment of certain liabilities of the Clinical Labs division. See Note 13 Subsequent Events. Although there can be no assurances, in the event additional capital is required, the Company believes it has the ability to raise additional funds, either through additional debt secured by real property owned, private debt, selling preferred stock, reactivating and utilizing the Controlled Equity Offering Program, or through other sources. That Program’s Form S-3 expired in October 2020 but may be refiled at any time at the discretion of the Company, as disclosed in Note 10 in the Notes to the Consolidated Financial Statements. Our liquidity plans are subject to a number of risks and uncertainties, some of which are outside our control. Macroeconomic conditions could limit our ability to successfully execute our business plans and therefore adversely affect our liquidity plans. The unaudited interim financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.

At April 30, 2022,January 31, 2023, the Company had cash and cash equivalents totaling $31.1$5.1 million of which $0.6$0.5 million was in foreign accounts, as compared to cash and cash equivalents and marketable securities of $43.5$21.6 million, of which $0.9$0.6 million was in foreign accounts at July 31, 2021.2022. It is the Company’s current intent to permanently reinvest these foreign funds outside of the United States, and its current plans do not demonstrate a need to repatriate them to fund its United States operations.

The Company had working capital of $37.6$4.29 million at April 30, 2022,January 31, 2023, compared to $44.5$29.8 million at July 31, 2021,2022, a decrease of $6.9$25.6 million. The decrease in working capital was due to the use of cash and cash equivalents to fund operations, capital expenditures, and capital expenditures.the reclassification of mortgage debt from long term to current.

Net cash used in operating activities during the 20222023 period was approximately $7.5$14.9 million, compared to net cash provided by operating activities of $0.3$6.7 million during the 20212022 period, an unfavorable variance of $7.8approximately $8.3 million. The net cash used in the 20222023 period was due to the net loss of $9.8$22.0 million, which was partially offset by a net increase of $3.6 million in operating assets,liabilities, primarily accounts receivable and inventories, and a net decrease of $1.0 millionpayable, an increase in operating liabilities, primarily accrued liabilities and accounts payable. These uses were partially offset by non-cash expense adjustments of $6.9 million. The net cash provided by operating activities in the 2021 period of $0.3 million was due to the net income of $4.6$2.1 million, and net non-cash expenses of approximately $2.8 million which were partially offset by a net increase of $7.1 milliondecrease in operating assets including, but not limitedof $1.4 million, primarily prepaid assets and accounts receivable. In order to conserve cash and maintain overall liquidity, the Company has been working with some vendors and professional services providers to delay payments, which has resulted in a large increase in its accounts receivable and inventories.

Net cash provided by investing activities during the 2022 period was approximately $25.6 millionpayable-trade balance at January 31, 2023 as compared to July 31, 2022.

Net cash used in investing activities of $32.9during the 2023 period was approximately $1.5 million as compared to $2.3 million in the 2021 period. During the 2022 period we sold all of the marketable securities we had purchased in the 2021 period. Capital expenditures in the 2022 and 2021 periods were $3.1 million and $2.9 million, respectively andprimarily represent capital expenditures to support and grow our existing operations, including investments in laboratory equipment, information technology, and the buildout of our Farmingdale campus.

Cash used in financing activities in both the 20222023 and 20212022 periods approximated $0.2$0.1 million for payments related to a mortgage and finance leases.


As of April 30, 2022January 31, 2023 we had a mortgage principal balance of $4.0$3.9 million entered into for the purchase of a building facility at our Farmingdale campus, which bears a fixed interest rate of 5.09% per annum. It requires monthly mortgage payments of $30.totaling $0.4 million annually. Our obligations under the mortgage agreement are secured by the facility, assets of the Company, and by a $1,000$1.0 million cash collateral deposit with the mortgagee as additional security, which is included in other assets as of April 30, 2022. January 31, 2023.

Effective October 19, 2020, the Company and the mortgagee agreed to a covenant restructure whereby the mortgagee waived the Company’s financial ratio covenant for the fiscal period ended July 31, 2020 and modified the mortgage to replace a financial ratio covenant with a liquidity covenant. The liquidity covenant required that we own and maintain at all times, and throughout the remaining term of the loan, at least $25 million of liquid assets, defined as time deposits, money market accounts and commercial paper, and obligations issued by the U.S. government or any of its agencies. The cash collateral agreement was also modified to require compliance with the liquidity covenant for two consecutive fiscal years before the collateral is released back to us. As of July 31, 2021, the Company was in compliance with the financial and liquidity covenants in effect at that time related to this mortgage.


Effective September 29, 2021, the Company and the mortgagee agreed to further covenant restructuring whereby (a) the liquidity covenant was reduced to 150% of the loan principal (or approximately $6$5.8 million at April 30,October 31, 2022) from $25 million previously, and (b) the collateral requirement would be increased from $0.75 million to $1.0 million. The Company increased the collateral deposit to $1.0 million in November 2021 and was in compliance with the liquidity covenant as of April 30,October 31, 2022 and July 31, 2022. As of January 31, 2023, the Company was not in compliance with the liquidity covenant, but was in compliance with the other financial covenants related to this mortgage. Effective March 20, 2023, the Company and the mortgagee agreed to a waiver of the liquidity covenant default as of January 31, 2023. While the Company believes it will be able to either achieve compliance or obtain further waivers going forward, as there can be no assurances, all of the mortgage debt has been classified as current in the consolidated balance sheet as of January 31, 2023.

Revolving Line of Credit commitment

On March 10, 2023, the Company entered into a commitment for a one-year credit facility with an asset based lender specializing in direct lending to middle-market companies in the healthcare sector. The facility is an $8 million revolving line of credit based on the Company’s eligible accounts receivable. The annual interest rate is equal to the 90 day term SOFR rate plus 5.5%. The line of credit would terminate one year from closing and unused line fees and early prepayment penalties apply. The Company and the lender are using their best efforts to close on the line of credit as soon as possible. The expected closing time period is the end of March 2023.

Other conditions to closing are

satisfactory completion of the Company’s collateral field exam confirming, among other things, a borrowing base reasonably consistent with the results of lender’s underwriting,

the execution of loan and security agreements with terms, representations, covenants, defaults, clauses, conditions, and closing requirements satisfactory to lender,

Deposit account control agreements and lockbox agreements with depository banks in form and substance acceptable to the lender,

A signed Asset Purchase Agreement (APA) for the sale of the Company’s Clinical Services segment in an amount and on terms and conditions satisfactory to lender,

Borrowers shall provide all collateral and financial reports as lender may reasonably request, and

Borrowers shall have satisfactory insurance coverage with lender loss payee and additional insured endorsements in favor of lender on all collateral.


Off-Balance Sheet Arrangements

Asset Purchase Agreement

 

Contractual Obligations

There have been no material changesOn March 16, 2023, the Company filed a Form 8-K, indicating that along with Enzo Clinical Labs, Inc. (the “Subsidiary” and, together with the Company, the “Seller”) entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Laboratory Corporation of America Holdings, a Delaware corporation (the “Buyer”). Pursuant to our Contractual Obligations as reported in our Form 10-Kthe Purchase Agreement, the Seller has agreed to sell substantially all of the operating assets and assign certain liabilities of its clinical labs business (the “Business”) to the Buyer which are necessary for the fiscal year ended July 31, 2021. Management is not aware of any material claims, disputes or settled matters concerning third party reimbursement that would have a material effectBuyer to operate the Business in exchange for approximately $146,000,000 in cash (subject to certain adjustments), on our financial statements, except as disclosed in Note 12and subject to the Consolidated Financial Statements.

Off-Balance Sheet Arrangementsterms and conditions set forth therein (such transaction, the “Transaction”).

 

The Purchase Agreement contains customary representations, warranties, covenants and termination rights for a transaction of this nature, including, among other things, customary covenants: (i) relating to the conduct of the Business between the signing of the Purchase Agreement and the closing of the Transaction and (ii) regarding the efforts of the parties to cause the Transaction to be consummated, including obtaining certain consents and approvals. The consummation of the Transaction is subject to the satisfaction or waiver of customary closing conditions, including the expiration or termination of any required waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. In addition, closing under the Purchase Agreement is contingent on the Company does notobtaining approval of the Transaction by shareholders of the Company holding a majority of the shares of its and directors of the Company have any “off-balance sheet arrangements” as such term is definedagreed with Buyer to vote the shares they beneficially own, totaling up to approximately 11% of the shares outstanding, in Item 303(a)(4)favor of Regulation S-K.the Transaction.

 

Critical Accounting PoliciesThe Purchase Agreement also includes customary termination provisions for both the Company and Buyer and provides that, in connection with the termination of the Purchase Agreement under specified circumstances, including termination by the Company to accept and enter into a definitive agreement with respect to an unsolicited Superior Proposal, the Company will be required to pay Buyer a termination fee of $5,000,000, or reimbursement of Buyer’s expenses of up to $5,000,000.

 

Subject to the terms and conditions stated in the Purchase Agreement, after shareholder approval of the Transaction, Buyer will be obligated to pay a fee to the Company for each day after the date of such approval until the closing of the Transaction. At the closing of the Transaction, such fee will be wholly or partially credited against the purchase price.

There can be no assurances that the Purchase Agreement will close and if it does close, the exact proceeds to be received by the Company. 

General and estimates

The Company’s discussion and analysis of its financial condition and results of operations are based upon Enzo Biochem, Inc.’s interim consolidated financial statements, certain information and footnote disclosure, normally included in annual financial statementswhich have been prepared in accordance with accounting principles generally accepted in the United States, have been condensed or omitted, as permitted under rules promulgated by the Security and Exchange Commission.States. The preparation of these financial statements requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. These estimates and judgments also affect related disclosure of contingent assets and liabilities.


On an on-going basis, we evaluate our estimates, including those related to contractual expense, allowance for uncollectible accounts, inventory, operating lease liabilities,intangible assets, goodwill and income taxes. The Company bases its estimates on experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Revenues – Clinical Services

Contractual Adjustment

The Company’s estimate of contractual adjustment is based on significant assumptions and judgments, such as its interpretation of payer reimbursement policies, and bears the risk of change. The estimation process is based on the experience of amounts approved as reimbursable and ultimately settled by payers, versus the corresponding gross amount billed to the respective payers. The contractual adjustment is an estimate that reduces gross revenue, based on gross billing rates, to amounts expected to be approved and reimbursed.

Gross billings are based on a standard fee schedule we set for all third-partythird party payers, including Medicare, HMOsHMO’s and managed care. The Company adjusts the contractual adjustment estimate quarterly, based on its evaluation of current and historical settlement experience with payers, industry reimbursement trends, and other relevant factors. The other relevant factors that affect our contractual adjustment include the monthly and quarterly review of: 1) current gross billings and receivables and reimbursement by payer, 2) current changes in third party arrangements and 3) the growth of in-network provider arrangements and managed care plans specific to our Company.


Our clinical business is primarily dependent upon reimbursement from third-party payers, such as Medicare (which principally serves patients 65 and older) and insurers. We are subject to variances in reimbursement rates among different third-party payers, as well as constant changes of reimbursement rates. Changes that decrease reimbursement rates or coverage would negatively impact our revenues. The number of individuals covered under managed care contracts or other similar arrangements has grown over the past several years and may continue to grow in the future. In addition, Medicare and other government healthcare programs continue to shift to managed care. These trends will continue to reduce our revenues from these programs.

During the three months ended April 30,January 31, 2023 and 2022, and 2021, the contractual adjustment percentages, determined using current and historical reimbursement statistics, was 83.3%90.6% and 81.2%80.5% respectively, of gross billings. During the ninesix months ended April 30,January 31, 2023 and 2022, and 2021, the contractual adjustment percentages, determined using current and historical reimbursement statistics, was 82.5%89.1% and 82.2%82.1% respectively, of gross billings. In general, the Company believes a decline in reimbursement rates or a shift to managed care or similar arrangements may be offset by the positive impact of an increase in the number of tests we perform. However, there can be no assurance that we can increase the number of tests we perform or that if we do increase the number of tests we perform, that we can maintain that higher number of tests performed, or that an increase in the number of tests we perform would result in increased revenue.

The Company estimates (by using a sensitivity analysis) that each 1% point change in the contractual adjustment percentage could result in a change in clinical services revenues of approximately $3.5$1.8 million and $3.9$2.4 million for the ninesix months periods ended April 30,January 31, 2023 and 2022 and 2021 respectively, and a change in the net accounts receivable of approximately $0.4 million as of April 30, 2022.January 31, 2023.

Our clinical services financial billing system records gross billings using a standard fee schedule for all payers and does not record contractual adjustment by payer at the time of billing. Therefore, we are unable to quantify the effect contractual adjustments recorded during the current period have on revenue recorded in a previous period. However, we can reasonably estimate our monthly contractual adjustment to revenue on a timely basis based on our quarterly review process, which includes:

an analysis of industry reimbursement trends;

 
an evaluation of third-party reimbursement rates changes and changes in reimbursement arrangements with third-party payers;

 
a rolling monthly analysis of current and historical claim settlement and reimbursement experience statistics with payers; and

 
an analysis of current gross billings and receivables by payer.


Accounts Receivable

Accounts receivable are reported at realizable value, net of allowances for doubtful accounts, which is estimated and recorded in the period of the related revenue.

The following is a table of the Company’s net accounts receivable by services and by products. Netsegment. The Clinical Laboratory Services segment’s net receivables for Clinical Services are detailed by billing category and as a percent to its total net receivables. At April 30, 2022As of January 31, 2023 and July 31, 2021,2022, approximately 66%57% and 59%, respectively of the Company’s net accounts receivable relates to its Clinical Laboratory Services business, which operates in the New York, New Jersey and Connecticut medical communities.

The Life Sciences products segment’s accounts receivable balance for Life Science products includes foreign receivables of $0.9approximately $1.3 million or 22%29% and $1.4$1.1 million or 33%24% of its total segment receivables as of April 30, 2022January 31, 2023 and July 31, 2021,2022, respectively.


Net accounts receivable (in thousands)

Billing category As of
April 30,
2022
  As of
July 31,
2021
 
Clinical Services            
Third party payers $3,271   42% $2,195   36%
Patient self-pay  2,887   37   2,007   33 
Medicare  781   10   1,122   19 
HMOs  836   11   692   12 
Total Clinical Services  7,775   100%  6,016   100%
Total Life Sciences  3,986       4,182     
Total accounts receivable - net $11,761      $10,198     
  January 31, 2023  July 31, 2022 
Net accounts receivable by segment Amount  %  Amount  % 
Clinical Labs (by billing category)            
Third party payers $2,512   41  $2,647   40 
Patient self-pay  2,407   39   2,779   41 
Medicare  885   14   768   11 
HMO’s  395   6   560   8 
Total Clinical Labs  6,199   100%  6,754   100%
Total Life Sciences  4,667       4,762     
Total accounts receivable – net $10,866      $11,516     

The Company’s ability to collect outstanding receivables from third party payers is critical to its operating performance and cash flows. The primary collection risk lies with uninsured patients or patients for whom primary insurance has paid but a patient portion remains outstanding. The Company also assesses the current state of its billing functions in order to identify any known collection or reimbursement issues in order to assessissues. The Company assesses the impact, if any, on the allowance estimates, which involves Company’s management judgment. TheIt is important to note that the collection of these receivables is not guaranteed from Third Party Payers.

The Company believes that the collectability of its receivables is directly linked to the quality of its billing processes, most notably, those related to obtaining the accurate patient information in order to effectively bill effectively for the services provided. Should circumstances change (e.g. shift in payer mix, decline in economic conditions or deterioration in aging of receivables), our estimates of net realizable value of receivables could be reduced by a material amount. As of April 30, 2022,January 31, 2023, approximately 20%16% of Clinical Labs receivables are from one provider whose programspayer other than Medicare and as of July 31, 2022, approximately 23%, of Clinical Labs receivables are included in the “Third-party payers” and “Health Maintenance Organizations” (“HMOs”) categories.from two payers other than Medicare.

Billing for clinicallaboratory services is complicated because of manydue to several factors, especially:including, but not limited to, the differences between our standard gross fee schedule for all payers and the reimbursement rates of the various payers we deal with, disparity of coverage and information requirements among the various payers, and disputes with payers as to which party is responsible for reimbursement.

Income Taxes

The Company accounts for income taxes under the liability method of accounting for income taxes. Under the liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The liability method requires that any tax benefits recognized for net operating loss carry forwards and other items be reduced by a valuation allowance where it is not more likely than not the benefits will be realized in the foreseeable future. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under the liability method, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. It is the Company’s policy to provide for uncertain tax positions, if any, and the related interest and penalties based upon management’s assessment of whether a tax benefit is more likely than not to be sustained upon examination by tax authorities. To the extent the Company prevails in matters for which a liability for an unrecognized tax benefit is established or is required to pay amounts in excess of the liability, the Company’s effective tax rate in a given financial statement period may be affected.


Inventory

Inventory

The Company values inventory at the lower of cost (first-in, first-out) or net realizable value, which approximates market.value. Work-in-process and finished goods inventories consist of material, labor, and manufacturing overhead. Write downs of inventories to net realizable value are based on a review of inventory quantities on hand and estimated sales forecasts based on sales history and anticipated future demand. Unanticipated changes in demand could have a significant impact on the value of our inventory and require additional write downs of inventory which would impact our results of operations.


Leases - right of use assetsGoodwill and operating lease liabilitiesLong-Lived Assets

The Company determines if an arrangement is or contains a lease at contract inception. The Company leases buildings, office space, patient service centers, and equipment primarily through operating leases, and equipment through a limited number of finance leases. Generally, a right-of-use asset, representing the right to use the underlying asset during the lease term, and a lease liability, representing the payment obligation arising from the lease, are recognized on the balance sheet at lease commencement based on the present value of the payment obligation. For operating leases, expense is recognized on a straight-line basis over the lease term. For finance leases, interest expense on the lease liability is recognized using the effective interest method and amortization of the right-of-use asset is recognized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet; the Company recognizes lease expense for these leases on a straight-line basis over the lease term. The Company primarily uses its incremental borrowing rate in determining the present value of lease payments as the Company’s leases generally do not provide an implicit rate. The Company has lease agreements with (i) right-of-use asset payments and (ii) non-lease components (i.e. payments related to maintenance fees, utilities, etc.,) which have generally been combined and accounted for as a single lease component.

On at least an annual basis, we perform a review of our business to determine if events or changes in circumstances have occurred that indicate that it is more likely than not that the carrying amount of an asset group, including long lived assets such as right of use assets, is not recoverable. If such events or changes in circumstances were deemed to have occurred, we would perform an impairment test of such long lived assets and record any noted impairment loss.

Goodwill, Intangible and long-lived assets

Goodwill represents the excess of the cost of an acquisition over the fair value of the net assets acquired. Intangible assets (exclusive of patents), arose primarily from acquisitions, and primarily consist of customer relationships, trademarks, licenses, and website and database content. These finite-lived intangible assets are amortized according to their estimated useful lives, which range from 4 to 15 years.

The Company tests goodwill annually as of the first day of the fourth quarter, or more frequently if indicators of potential impairment exist. In assessing goodwill for impairment, the Company has the option to first perform a qualitative assessment to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the Company determines that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, the Company is not required to perform any additional tests in assessing goodwill for impairment. However, if the Company concludes otherwise or elects not to perform the qualitative assessment, then it identifies the reporting units and compares the fair value of each of these reporting units to their respective carrying amount. If the carrying amount of the reporting unit is less than its fair value, no impairment exists. If the carrying amount of the reporting unit is higher than its fair value, the impairment charge is the amount by which the carrying amount exceeds its fair value, not to exceed the total amount of goodwill allocated to the reporting unit.

The Company reviews the recoverability of the carrying value of long-lived assets (including finite lived intangible assets) of an asset or asset group for impairment annually as of the end of the fiscal year, or more frequently if indicators of potential impairment exist.

Should indicators of impairment exist, the carrying values of the assets are evaluated in relation to the operating performance and future undiscounted cash flows of an asset or asset group. The net book value of the long-lived asset is adjusted to fair value if its expected future undiscounted cash flow is less than its book value. The Company has determined that there is no impairment of goodwill or long-lived assets at January 31, 2023.


Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are exposed to market risk from changes in foreign currency exchange rates resulting from acquisitions with respect to the operations of our foreign subsidiaries and which impact our results of operations and financial position. Seelocations (See Item 1A. Risk Factors section of the Form 10-K for the fiscal year ended July 31, 2021.2022) that could impact our results of operations and financial position. We do not currently engage in any hedging or market risk management tools.

 

Foreign Currency Exchange Rate Risk

The financial reporting of our non-U.S. subsidiaries is denominated in currencies other than the U.S. dollar. Since the functional currency of our non-U.S. subsidiaries is the local currency, foreign currency translation adjustments are accumulated as a component of accumulated other comprehensive income in stockholders’ equity. Assuming a hypothetical increase of 10% in the value of the U.S. dollar versus foreign currencies at April 30, 2022,January 31, 2023, our assets and liabilities would decrease by $0.3$0.4 million and $0.1 million, respectively, and our net revenues and net income (loss) would decrease by $0.9$0.8 million and $0.4$0.1 million, respectively, on an annual basis.

We also maintain intercompany balances and loans with subsidiaries in different local currencies. These amounts are at risk of foreign exchange losses if exchange rates fluctuate. Assuming a hypothetical increase of 10% in the value of the U.S. dollar versus foreign currencies, our pre-tax earnings (loss) would be unfavorably impacted by approximately $1.9$2.1 million on an annual basis.


Interest Rate Risk

As of April 30, 2022,January 31, 2023, we have fixed interest rate financing on a building mortgage and equipment finance leases.

Item 4. Controls and Procedures

(a) Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this report, the Company’s management conducted an evaluation (as required under Rules 13a-15(b) and 15d-15(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) of the Company’s “disclosure controls and procedures” (as such term is defined under the Exchange Act), under the supervision and with the participation of the principal executive officer and the principal financial officer. Based on this evaluation, the principal executive officer and the principal financial officer concluded that the Company’s disclosure controls and procedures are effective as of the end of the period covered by this report. Notwithstanding the foregoing, a control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that it will detect or uncover failures within the Company to disclose material information otherwise required to be set forth in the Company’s periodic reports.

(b) Changes in Internal Controls over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the quarter ended April 30, 2022January 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


 

PART II - OTHER INFORMATION

Item 1. Legal Proceedings

There have been no other material developments with respect to previously reported legal proceedings discussed in the annual report on Form 10-K, as amended for the fiscal year ended July 31, 20212022 filed with the Securities and Exchange Commission, other than as noted in Note 12 to the Consolidated Financial Statements as of April 30, 2022.January 31, 2023.

Item 1A. Risk Factors

There have been no material changes from the risk factors disclosed in Part 1, Item 1A of the Company’s Annual Report on Form 10-K for the fiscal year ended July 31, 2021.2022, except as follows:

Liquidity and Going Concern

During the six months ended January 31, 2023, the Company incurred a net loss of $21,955 and used cash in operating activities of $14,891. The Company believes that based on its fiscal 2023 forecast, its current cash and cash equivalents level is not sufficient for its foreseeable liquidity and capital resource needs over at least the next twelve (12) months, which conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year after the date that the unaudited interim financial statements are issued.

In response to these conditions, the Company is evaluating various financing strategies to obtain sufficient additional liquidity to meet its operating and capital requirements for the next twelve months following the date of issuance of these unaudited interim consolidated financial statements. Specifically, on March 10, 2023, the Company signed a commitment letter providing for up to $8,000 of a revolving line of credit subject to closing, and as previously disclosed is exploring various strategic alternatives including the sale of segment operating assets. On March 16, 2023, the Company entered into an Asset Purchase Agreement with respect to the sale to Labcorp of substantially all the operating assets and assignment of certain liabilities which are necessary for Labcorp to operate the business of the Clinical Labs division. See Note 13 Subsequent Events. However, there can be no assurance that either of these capital raising strategies will be successful, and the Company may need to raise additional capital during the current fiscal year. The Company also believes it has the ability to raise additional funds, either through additional debt secured by real property owned, private debt, selling preferred stock, reactivating its Sales Agreement with Cantor, or through other sources, but there can be no assurances that the Company will be able to raise capital pursuant to the foregoing on favorable terms or at all. The Registration Statement on Form S-3 filed in connection with the Sales Agreement expired in October 2020 but a new Registration Statement could be filed at any time at the discretion of the Company, as disclosed in Note 10 in the Notes to the Consolidated Financial Statements. Our liquidity plans are subject to a number of risks and uncertainties, some of which are outside our control. Macroeconomic conditions could limit our ability to successfully execute our business plans and therefore adversely affect our liquidity plans. The unaudited interim financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.

 

There can be no guarantee that the Asset Sale will be completed and, if not completed, we may have to file for bankruptcy and liquidation.

The consummation of the Asset Sale is subject to the satisfaction or waiver of various conditions, including the approval of the Asset Sale by our stockholders. We cannot guarantee that the closing conditions set forth in the Asset Purchase Agreement will be satisfied. If we are unable to satisfy the closing conditions in Buyer's favor or if other mutual closing conditions are not satisfied, Buyer will not be obligated to complete the Asset Sale. If the Asset Sale is not completed, our board of directors, in discharging its fiduciary obligations to our stockholders, will evaluate other strategic alternatives that may be available, which alternatives may not be as favorable to our stockholders as the Asset Sale and may include a bankruptcy and liquidation of the Company.

The Company has incurred and will continue to incur substantial expenses, including transaction-related costs, pending the Asset Sale.

Claims, liabilities and expenses from operations, such as operating costs, salaries, directors’ and officers’ insurance, payroll and local taxes, legal, accounting and consulting fees and office expenses will continue to be incurred by us during the pendency of the Asset Sale. Further, Enzo has incurred, and expects to continue to incur, a number of non-recurring transaction-related costs in initiating and completing the Asset Sale. Non-recurring transaction costs include, but are not limited to, fees paid to Enzo’s financial, legal and accounting advisors, filing fees and printing costs. These fees and costs have been, and will continue to be, substantial. We cannot estimate what the aggregate of these expenses will be and these costs may be higher than expected.  There can be no assurance of the exact amount of net cash proceeds Enzo will receive from the Asset Sale or the exact timing at which it will receive such proceeds. Therefore, it is uncertain the extent to which our financial condition and operations will benefit from or improve as a result of or after the Asset Sale.


The Purchase Agreement also includes customary termination provisions for both the Company and Buyer and provides that, in connection with the termination of the Purchase Agreement under specified circumstances, including termination by the Company to accept and enter into a definitive agreement with respect to an unsolicited Superior Proposal, the Company will be required to pay Buyer a termination fee of $5,000,000, or reimbursement of Buyer’s expenses of up to $5,000,000.

Subject to the terms and conditions stated in the Purchase Agreement, after shareholder approval of the Transaction, Buyer will be obligated to pay a fee to the Company for each day after the date of such approval until the closing of the Transaction.  At the closing of the Transaction, such fee will be wholly or partially credited against the purchase price.

There can be no assurance that the Purchase Agreement will close and that if it does close, the exact proceeds to be received by the Company.

Item 6. Exhibits

Exhibit
No.
Exhibit
10.1Amended and Restated Employment Agreement with Kara Cannon (a)
10.2Amended and Restated Employment Agreement with Hamid Erfanian (b)
31.1Certification of Hamid Erfanian pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2Certification of David BenchPatricia Eckert pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1Certification of Hamid Erfanian pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2Certification of David BenchPatricia Eckert pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101. INS*Inline XBRL Instance Document.
101. SCH*Inline XBRL Taxonomy Extension Schema Document.
101. CAL*Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

*XBRL (Extensible Business Reporting Language) information is being furnished and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934.

(a)Filed as Exhibit 10.1 of Form 8-K filed November 4, 2022.
(b)Filed as Exhibit 10.2 of Form 8-K filed November 4, 2022.

 


 

 

SIGNATURES

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 thereunto duly authorized.

ENZO BIOCHEM, INC.
(Registrant)
Date: June 9, 2022March 20, 2023by:/s/ David BenchPatricia Eckert

Interim Chief Financial Officer and

Principal Accounting Officer

3844

 

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