UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

Mark one

 

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

 

For the quarterly period ended JanuaryOctober 31, 2018

or

 

oTRANSITION 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. 
 (Exact name of registrant as specified in its charter) 

 

New York 13-2866202
(State or Other Jurisdiction
(IRS. Employer
of Incorporation or Organization) (IRS. Employer
Identification No.)
   
527 Madison Ave, New York, New York 10022
(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.

 

Yesx Noo

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, 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).

 

Yesx Noo

 

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 fileroo Accelerated filerx
Non-accelerated filero(Do not check if smaller reporting company)Smaller reporting companyo
Emerging growth company  oo  

 

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.

YesoNoo

 

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

 

Yeso Nox

 

As of MarchDecember 1, 2018, the Registrant had 47,000,92947,192,429 shares of common stock outstanding.

 

ENZO BIOCHEM, INC.
FORM 10-Q
JanuaryOctober 31, 2018

 

INDEX

 

PART I - FINANCIAL INFORMATION
 
Item 1.Financial Statements3
   
 Consolidated Balance Sheets – JanuaryOctober 31, 2018 (unaudited) and July 31, 2017 (audited)20183
   
 Consolidated Statements of Operations for the three and six months ended JanuaryOctober 31, 2018 and 2017 (unaudited)4
   
 Consolidated Statements of Comprehensive Income (Loss) for the three and six months ended JanuaryOctober 31, 2018 and 2017 (unaudited)5
   
 Consolidated Statement of Stockholders’ Equity for the sixthree months ended JanuaryOctober 31, 2018 and 2017 (unaudited)6
   
 Consolidated Statements of Cash Flows for the sixthree months ended JanuaryOctober 31, 2018 and 2017 (unaudited)7
   
 Notes to the Consolidated Financial Statements8
   
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations19
   
Item 3.Quantitative and Qualitative Disclosures About Market Risk3026
   
Item 4.Controls and Procedures3126
   
Part II – OTHER INFORMATION
 
Item 1.Legal Proceedings3227
   
Item 1A.Risk Factors3227
   
Item 6.Exhibits3227
   
Signatures3227
2

Part 1 Financial Information


Item 1 Financial Statements

 

ENZO BIOCHEM, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)

 

 January 31,
2018
(unaudited)
  July 31,
2017
  October 31,
2018
(unaudited)
  July 31,
2018
 
ASSETS                
Current assets:                
Cash and cash equivalents $64,468  $64,167  $52,777  $60,041 
Accounts receivable, net of allowances  14,977   15,180   12,836   13,147 
Inventories  7,481   7,047   7,588   7,278 
Prepaid expenses and other  2,613   2,690   2,307   2,734 
Total current assets  89,539   89,084   75,508   83,200 
                
Property, plant and equipment, net  7,945   7,901   7,503   7,636 
Goodwill  7,452   7,452   7,452   7,452 
Intangible assets, net  2,449   2,895   1,625   1,886 
Other assets  940   333   2,095   1,486 
Total assets $108,325  $107,665  $94,183  $101,660 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable – trade $9,564  $10,350  $7,155  $9,516 
Accrued liabilities  9,665   6,720   10,848   10,054 
Other current liabilities  642   740   190   616 
Total current liabilities  19,871   17,810   18,193   20,186 
                
Other liabilities  495   983   320   353 
Total liabilities $20,366  $18,793  $18,513  $20,539 
                
Commitments and contingencies                
                
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: 47,077,840 and outstanding: 46,970,929 at January 31, 2018 and shares issued and outstanding: 46,506,176 at July 31, 2017  471   465 
Common Stock, $.01 par value; authorized 75,000,000 shares; shares issued and outstanding: 47,192,429 at October 31, 2018 and 47,182,254 at July 31, 2018  472   472 
Additional paid-in capital  330,425   328,294   331,030   330,770 
Less: Treasury stock at cost 106,911 shares at January 31, 2018 and none at July 31, 2017  (1,014)   
Accumulated deficit  (243,441)  (241,900)  (258,202)  (252,221)
Accumulated other comprehensive income  1,518   2,013   2,370   2,100 
Total stockholders’ equity  87,959   88,872   75,670   81,121 
Total liabilities and stockholders’ equity $108,325  $107,665  $94,183  $101,660 

 

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

3

ENZO BIOCHEM, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(in thousands, except per share data)

 

 Three Months Ended
January 31,
 Six Months Ended
January 31,
  Three Months Ended
October 31,
 
 2018  2017  2018  2017  2018  2017 
Revenues:                
Clinical laboratory services $19,530  $18,837  $39,864  $37,395 
Product revenues  7,122   6,983   14,203   14,409 
Royalty and license fee income  300   440   561   740 
Total revenues  26,952   26,260   54,628   52,544 
Revenues  21,260   26,876 
                        
Operating costs and expenses:                        
Cost of clinical laboratory services  11,730   11,052   23,772   21,948 
Cost of product revenues  3,877   3,520   7,266   6,829 
Cost of revenues  14,239   15,431 
Research and development  812   483   1,559   1,305   728   747 
Selling, general and administrative  11,070   11,218   21,961   22,712   10,970   10,905 
Provision for uncollectible accounts receivable  779   679   1,593   1,348 
Legal fee expense  1,700   370   2,131   742   1,301   431 
Total operating costs and expenses  29,968   27,322   58,282   54,811   27,238   27,514 
                        
Operating loss  (3,016)  (1,062)  (3,654)  (2,340)  (5,978)  (638)
                        
Other income (expense):                        
Interest  185   79   342   125   274   157 
Other  33   24   69   143   47   36 
Foreign exchange gain (loss)  800   (94)  605   (455)
Foreign exchange loss  (324)  (195)
Loss before income taxes  (1,998)  (1,053)  (2,638)  (2,527)  (5,981)  (640)
        
Benefit for income taxes  1,097      1,097          
Net loss $(901) $(1,053) $(1,541) $(2,527) $(5,981) $(640)
                        
Net loss per common share:                        
Basic and diluted $(0.02) $(0.02) $(0.03) $(0.05) $(0.13) $(0.01)
                        
Weighted average common shares outstanding:                        
Basic and diluted  46,941   46,292   46,806   46,282   47,186   46,914 

 

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

4

ENZO BIOCHEM, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(UNAUDITED)
(in thousands)

 

 Three Months Ended
January 31,
 Six Months Ended
January 31,
  Three Months Ended
October 31,
 
 2018  2017  2018  2017  2018  2017 
Net loss $(901) $(1,053) $(1,541) $(2,527) $(5,981) $(640)
Other comprehensive loss:                
Other comprehensive income (loss):        
Foreign currency translation adjustments  (578)  (16)  (495)  238   270   83 
Comprehensive loss $(1,479) $(1,069) $(2,036) $(2,289) $(5,711) $(557)

 

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

5

ENZO BIOCHEM, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
SixThree Months Ended JanuaryOctober 31, 2018 and 2017
(UNAUDITED)
(in thousands, except share data)

 

 Common
Stock
Shares Issued
 Treasury
Stock
Shares
  Common
Stock
Amount
 Additional
Paid-in
Capital
 Treasury Stock
Amount
 Accumulated
Deficit
 Accumulated
Other
Comprehensive
Income
 Total
Stockholders’
Equity
  Common
Stock
Shares Issued
  Common Stock Amount  Additional
Paid-in
Capital
  Accumulated
Deficit
  Accumulated
Other
Comprehensive
Income
  Total
Stockholders’
Equity
 
Balance at July 31, 2017  46,506,176     $465  $328,294  $  $(241,900) $2,013  $88,872 
                                
Net loss for the period ended January 31, 2018                 (1,541)     (1,541)
                                
Cashless option exercise  340,898   106,911      1,014   (1,014)        
                                
Balance at July 31, 2018  47,182,254  $472  $330,770  $(252,221) $2,100  $81,121 
Net loss for the period ended October 31, 2018           (5,981)     (5,981)
Vesting of restricted stock  2,062                         175                
                                
Exercise of stock options  228,704      6   704            710   10,000      25         25 
Share-based compensation charges           413            413         235         235 
                                
Foreign currency translation adjustments                    (495)  (495)              270   270 
                                
Balance at January 31, 2018  47,077,840   106,911  $471  $330,425  $(1,014) $(243,441) $1,518  $87,959 
Balance at October 31, 2018  47,192,429  $472  $331,030  $(258,202) $2,370  $75,670 

  Common
Stock
Shares
Issued
  Treasury
Stock
Shares
  Common
Stock
Amount
  Additional
Paid-in
Capital
  Treasury
Stock
Amount
  Accumulated
Deficit
  Accumulated
Other
Comprehensive
Income
  Total
Stockholders’
Equity
 
Balance at July 31, 2017  46,506,176     $465  $328,294  $  $(241,900) $2,013  $88,872 
Net loss for the period ended October 31, 2017                 (640)     (640)
Purchase of treasury stock     80,751         (815)        (815)
Vesting of restricted stock  1,001                       
Exercise of stock options  487,106      5   1,472            1,477 
Share-based compensation charges           205            205 
Foreign currency translation adjustments                    83   83 
Balance at October 31, 2017  46,994,283   80,751  $470  $329,971  $(815) $(242,540) $2,096  $89,182 

 

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

6

ENZO BIOCHEM, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)

 

 Six Months Ended
January 31,
  Three Months Ended
October 31,
 
 2018  2017  2018  2017 
Cash flows from operating activities:                
Net loss $(1,541) $(2,527) $(5,981) $(640)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:        
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:        
Depreciation and amortization of property, plant and equipment  1,051   1,023   519   521 
Amortization of intangible assets  484   819   247   228 
Provision for uncollectible accounts receivable  1,593   1,348 
Share-based compensation charges  413   392   235   205 
Accrual for share-based 401(k) employer match expense  358   354   196   177 
Foreign exchange (gain) loss  (595)  420 
Foreign exchange loss  302   198 
                
Changes in operating assets and liabilities:                
Accounts receivable  (1,387)  (2,170)  312   713 
Inventories  (430)  (238)  (309)  (198)
Prepaid expenses  27   67 
Prepaid expenses and other assets  449   207 
Accounts payable – trade  (809)  238   (2,361)  (819)
Accrued liabilities, other current liabilities and other liabilities  2,220   (2,558)  187   2,003 
Other assets  (549)   
Total adjustments  2,376   (305)  (223)  3,235 
                
Net cash provided by (used in) operating activities  835   (2,832)
Net cash (used in) provided by operating activities  (6,204)  2,595 
                
Cash flows from investing activities:                
Capital expenditures  (1,066)  (689)  (406)  (461)
Security deposits and other  (10)  2   (609)   
Net cash used in investing activities  (1,076)  (687)  (1,015)  (461)
                
Cash flows from financing activities:                
Proceeds from borrowings under Credit Agreement     40,694 
Repayments under Credit Agreement     (42,251)
Installment loan and capital lease obligation payments  (190)  (323)  (59)  (101)
Proceeds from exercise of stock options  710   71   25   658 
Net cash provided by (used in) financing activities  520   (1,809)
Net cash (used in) provided by financing activities  (34)  557 
                
Effect of exchange rate changes on cash and cash equivalents  22   (22)  (11)  (9)
                
Increase (decrease) in cash and cash equivalents  301   (5,350)
(Decrease) increase in cash and cash equivalents  (7,264)  2,682 
Cash and cash equivalents - beginning of period  64,167   67,777   60,041   64,167 
Cash and cash equivalents - end of period $64,468  $67,427  $52,777  $66,849 

 

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

7

ENZO BIOCHEM, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

As of JanuaryOctober 31, 2018
(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 and Enzo Realty LLC, collectively or with one or more of its subsidiaries referred to as the “Company” or “Companies”. The consolidated balance sheet as of JanuaryOctober 31, 2018, the consolidated statements of operations and comprehensive income (loss) for the three months ended October 31, 2018 and six month2017, the consolidated statements of cash flows for the three months ended JanuaryOctober 31, 2018 and 2017 and the consolidated statement of stockholders’ equity and cash flows for the sixthree months ended JanuaryOctober 31, 2018 and 2017 (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, have been condensed or omitted. The interim statements should be read in conjunction with the consolidated financial statements for the year ended July 31, 20172018 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, 20172018 has been derived from the audited financial statements at that date. The results of operations for the three and six months ended JanuaryOctober 31, 2018 are not necessarily indicative of the results that may be expected for the fiscal year ending July 31, 2018.2019.

 

Effect of New Accounting Pronouncements

 

Recently AdoptedAdoption of New Accounting PronouncementsStandards

 

In March 2016,On August 1, 2018, the Company adopted a new accounting standard issued by the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-09,Improvementson revenue recognition using the full retrospective method. This new accounting standard outlines a single comprehensive model to Employee Share-Based Payment Accounting, which requires all excess tax benefits or deficiencies to be recognized as income tax expense or benefituse in the income statement. In addition, excess tax benefits should be classified alongaccounting for revenue arising from contracts with other income tax cash flows as an operating activity in the statement of cash flows. The adoption of this newcustomers. This standard did not have a material impact on our consolidated financial statements. We adopted this standard as of August 1, 2017.

Pronouncements Issued but Not Yet Adopted

In May 2014, FASB issued ASU No. 2014-09,Revenue from Contracts with Customers: Topic 606. ASU 2014-09supersedes existing revenue recognition requirements and its amendments supersede the currenteliminates most industry-specific revenue recognition guidance including industry-specific guidance.from GAAP. The new standard introduces a five-step model to achieve its core principle of the revenue recognition standard is to require an entity recognizingto recognize as revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entityit expects to be entitled in exchange for thoseto when control of goods or services and on transferare transferred to its customers.

As a result of control, as opposed to transfer of risk and rewards. The standard also expands the required financial statement disclosures regarding revenue recognition. ASU 2014-09 will be effective for our interim periods and the fiscal year beginning August 1, 2018, and we are not early adopting. An entity can apply the revenue standard retrospectively to each prior reporting period presented (full retrospective method) or retrospectively with the cumulative effect of initially applying the standard recognized at the date of initial application in retained earnings. We expect to use the full retrospective method upon adoption. Based on our preliminary assessment, theCompany’s adoption of this ASU may result in partially or substantially allstandard, the majority of the amounts that havewere historically been classified as bad debt expense, primarily related to patient responsibility, could beare now considered an implicit price concession in determining net revenues.revenues from clinical services. Accordingly, we may report the estimate ofCompany reports estimated uncollectible balances associated with patient responsibility as a reduction of the transaction price and therefore as a reduction in net revenues, when historically these amounts were classified and separately reported as bad debt expense within operating costs and expenses. In addition, thea provision for uncollectible accounts receivable. The adoption of this ASU will resultstandard has no impact on revenues reported for life sciences products. The adoption of this new accounting standard resulted in increased disclosure, including qualitative and quantitative disclosuredisclosures about the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts fromwith customers. However,For further details, see Note 3. The impact of the adoption of the standard on consolidated operations and cash flows is presented in the table below:

8

Adoption of the standard impacted the Company’s reported results for the three months ended October 31, 2017 as follows:

 

As Previously Reported

Adjustment for New
Accounting Standard on Revenue Recognition

Reclassification of

Residual

As Restated

Consolidated Statements of Operations:    
Total Revenues$27,676$(800)$26,876
Provision for uncollectible accounts receivable814(800)$(14)
     
Selling, general and administrative expenses10,8911410,905
Net loss(640)$(640)
     
Consolidated Statements of Cash Flows:    
Provision for uncollectible accounts receivable814(814)
Changes in operating assets and liabilities: Accounts receivable (101)814713
     
Balance, July 31, 2018    
Consolidated balance sheet:    
Accounts receivable15,815(2,523)13,292
Less: Allowance for doubtful accounts2,668(2,523)145
Accounts receivable, net of allowance for doubtful accounts13,147 13,147

On August 1, 2018, the Company adopted a new accounting standard issued by FASB which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. Adoption of this ASU is not expectedstandard requires amendments in the update applied prospectively to have a materialan award modified on or after the adoption date. For the foreseeable future, any excess income tax benefits or deficiencies from stock-based compensation, which would be recognized as discrete items within income tax expense rather than additional paid in capital, will be offset by an equivalent adjustment to the deferred tax valuation allowance. Accordingly, adoption of this standard had no impact on our financial position or cash flows.reported operations.

Pronouncements Issued but Not Yet Adopted

 

In February 2016, FASB issued ASU No. 2016-02 –Leases (Topic 842),.as amended. The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for our fiscal year beginning August 1, 2019 including interim periods within that fiscal year. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. As amended in July 2018, an additional and optional transition method to adopt the new leases standard was established. Under this new transition method, an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Consequently, an entity’s reporting for the comparative periods presented in the financial statements in which it adopts the new leases standard will continue to be in accordance with current GAAP (Topic 840, Leases).

We

8

believe the adoption of this standard will materially impact our consolidated financial statements by significantly increasing our non-current assets and non-current liabilities on our consolidated balance sheets in order towhen we record the right of use assets and related lease liabilities for our existing operating leases.

9

We will recognize expense in the consolidated statement of operations similar to current lease accounting, in the cost of sales and selling, general and administrative.

 

In May 2017, theJune 2016, FASB issued ASU 2017-09,No. 2016-13CompensationFinancial InstrumentsStock CompensationCredit Losses (Topic 708) Scope326). 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 Modification Accounting which provides guidance about which changesexpected credit losses will require entities to the terms or conditionsincorporate considerations of a share-based payment award require an entity to apply modification accounting in Topic 718.historical information, current information and reasonable and supportable forecasts. Adoption of the Standardthis standard is required for our annual and interim periods beginning August 1, 2018 with the amendments in the update applied prospectively to an award2020 and must be adopted using a modified on or after the adoption date. Early adoption is permitted.retrospective transition approach. We are currently evaluatingassessing the impact of the adoption of this new standard will have on the consolidatedour results of operations, financial statements.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.

 

Certain prior period amounts have been reclassified to conform to the current period presentation. These reclassifications had no effect on the reported results of operations.

Concentration Risk

 

OneOther than the Medicare program, one provider whose programs are included in the “Third-party payer”payers” and “Health Maintenance Organizations” (“HMO’s”) categories represents approximately 38%41% and 39%40% of the Clinical Labs segment laboratory servicesServices net revenue for the three months ended JanuaryOctober 31, 2018 and 2017 respectively,respectively. Other than the Medicare program, three providers whose programs are included in either “Third-party payers” and/or “Health Maintenance Organizations” (“HMO’s”) categories represent approximately 37% and 39% and 37%47% of Clinical Services net receivables for the sixthree months ended JanuaryOctober 31, 2018 and 2017 respectively.

 

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 six months ended JanuaryOctober 31, 2018 and 2017 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 and unvested restricted stock because to do so would be antidilutive.

 

For the three and six months ended JanuaryOctober 31, 2018 and 2017, the number of potential common shares (“in the money options”) and unvested restricted stock excluded from the calculation of diluted earnings per share was 719,000,135,000 and 825,000, respectively.931,000, respectively, because their effect would be antidilutive. For the three and six months ended JanuaryOctober 31, 2017, approximately 888,000 and 804,000 weighted average stock options were excluded from the calculation of diluted weighted average shares outstanding.

For the three and six months ended January 31, 2018, there were no outstanding “out of the money” options to purchase common shares. For the three and six months ended January 31, 2017, the effect of approximately 494,000 and 247,0001,330,000 of outstanding “out of the money” options to purchase common shares were excluded from the calculation of diluted net income per share because their effect would be anti-dilutive. For the three months ended October 31, 2017, there were no outstanding “out of the money” options to purchase common shares.

Note 3 – Revenue Recognition

Clinical Services Revenue

Net revenues in the Company’s clinical services business accounted for 67% and 73% of the Company’s total net revenues for the three months ended October 31, 2018 and 2017, 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 the 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 (HMO’s)

Reimbursements from third party payers, primarily healthcare insurers, and HMO’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.

10

Collection of the consideration the Company expects to receive is normally a function of providing complete and correct billing information to these third party payers within the various filing deadlines, and typically occurs within 60 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.

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 billings are generally fully reserved for when the related billing reaches 210 days outstanding. Balances are automatically written off when they are sent to collection agencies. Allowances are further adjusted for estimated recoveries of amounts sent to collection agencies based on historical collection experience, which is regularly monitored. Collection of consideration the Company expects to receive typically occurs within 180 days of billing.

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

  Three months ended
October 31, 2018
  Three months ended
October 31, 2017
 
Revenue category            
Third-party payer $7,907   55% $10,860   56%
Patient self-pay  1,974   14   2,859   14 
Medicare  2,751   19   2,985   15 
HMO’s  1,665   12   2,830   15 
Total $14,297   100% $19,534   100%

For the three months ended October 31, 2018 and 2017, all of the Company’s services were provided within the United States.

Products Revenue and royalty income

Products revenues consist of the sale of single-use products used in the identification of genomic information and are recognized at a point in time following the transfer of control of such products to the customer, which generally occurs upon shipment. 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.

11

Royalty income is based on net sales of the Company’s licensed products by a third party. We recognize royalty income in the period the sales occur based on third party evidence received. During the three months ended October 31, 2018 and 2017, royalty income was zero and $261, respectively.

Product revenue by geography is as follows:

  October 31,
2018
  October 31,
2017
 
United States $3,879  $3,736 
Europe  1,342   1,632 
Rest of world  1,742   1,713 
Net product revenues $6,963  $7,081 

 

Note 34 - Supplemental disclosure for statement of cash flows

 

For the sixthree months ended JanuaryOctober 31, 2018 and 2017, income taxes paid by the Company were $15$0 and $996,$15, respectively. 

 

For the sixthree months ended JanuaryOctober 31, 2018 and 2017, interest paid by the Company was $45$12 and $77,$25, respectively.

 

For the sixthree months ended JanuaryOctober 31, 2018 and 2017, the Company financed $0 and $69 respectively, indid not finance any machinery andor transportation equipment under installment loans. 

 

During the six months ended January 31, 2018 and 2017, the Company did not enter into any capital lease agreements.

During the six months ended January 31, 2018 certain officers of the Company exercised 340,898 stock options in non-cash transactions. The officers surrendered 106,911 shares of the Company’s common stock to exercise the stock options. The Company recorded approximately $1,014, the market value of the surrendered shares, as treasury stock.

9

Note 45 – Inventories

 

Inventories consist of the following:

 

 January 31,
2018
  July 31,
2017
  October 31,
2018
  July 31,
2018
 
Raw materials $809  $852  $797  $754 
Work in process  1,951   1,905   2,338   2,174 
Finished products  4,721   4,290   4,453   4,350 
 $7,481  $7,047  $7,588  $7,278 

Note 56 – Goodwill and intangible assets

 

At JanuaryOctober 31, 2018 and July 31, 2017,2018, the Company’s carrying amount of goodwill, related to the Clinical Labs segment,Services is $7,452.

 

The Company’s change in the carrying amount of intangible assets, all in the Life SciencesProducts segment is as follows:

 

  Gross  Accumulated Amortization  Net 
July 31, 2017 $27,436  $(24,541) $2,895 
Amortization expense     (484)  (484)
Foreign currency translation  302   (264)  38 
January 31, 2018 $27,738  $(25,289) $2,449 

  Gross Accumulated Amortization Net 
July 31, 2018 $27,347  $(25,461) $1,886 
Amortization expense     (247)  (247)
Foreign currency translation  (137)  123   (14)
October 31, 2018 $27,210  $(25,585) $1,625 
12

Intangible assets, all finite lived, consist of the following:

 

 January 31, 2018  July 31, 2017  October 31, 2018  July 31, 2018 
 Gross  Accumulated
Amortization
  Net  Gross  Accumulated
Amortization
  Net  Gross  Accumulated
Amortization
  Net  Gross  Accumulated
Amortization
  Net 
Patents $11,027  $(10,964) $63  $11,027  $(10,951) $76  $11,027  $(10,983) $44  $11,027  $(10,980) $47 
Customer relationships  12,046   (9,667)  2,379   11,881   (9,083)  2,798   11,699   (10,118)  1,581   11,836   (9,997)  1,839 
Website and acquired content  1,022   (1,022)     1,011   (1,011)   
Licensed technology and other  498   (491)  7   484   (463)  21 
Trademarks  3,145   (3,145)     3,033   (3,033)   
Total $27,738  $(25,289) $2,449  $27,436  $(24,541) $2,895  $27,210  $(25,585) $1,625  $27,347  $(25,461) $1,886 

 

At JanuaryOctober 31, 2018, information with respect to intangibles assets acquired is as follows:

 

  Useful life assigned Weighted average
remaining useful life
Customer relationships 8 -15 years 32 years
Other intangibles 10 years 24 years

 

At JanuaryOctober 31, 2018, the weighted average remaining useful life of intangible assets is approximately two years.

Note 6 - Loan Payable

In June 2013, the Company entered into a secured Revolving Loan and Security Agreement (the “Credit Agreement”) among the Company and certain of its subsidiaries, with Enzo Therapeutics as a guarantor, and MidCap Financial LLC. (formerly Healthcare Finance Group, LLC). The Credit Agreement, which expired in December 2016, provided for borrowings against eligible US receivables, as defined, of the Clinical Lab and Life Science segments up to $8.0 million at defined eligibility percentages and provided for additional borrowings of $4.0 million for increased eligible assets. Debt issuance costs of $281 were amortized over the life of the Credit Agreement. The Credit Agreement expired and was repaid in full on December 7, 2016.

10

Note 7 – Accrued Liabilities

 

Accrued liabilities consist of the following:

 

  January 31,
2018
  July 31,
2017
 
Payroll, benefits, and commissions $5,217  $4,092 
Professional fees  825   442 
Legal fee expense  1,558   599 
Research and development  143   143 
Other  1,922   1,444 
  $9,665  $6,720 

At January 31, 2018, other accrued liabilities primarily include $400 for a legal settlement.

Note 8 – Other Liabilities

Other liabilities consist of the following:

  January 31,
2018
  July 31,
2017
 
Capital lease obligations, net of short term $488  $551 
Accrued legal settlement     410 
Installment loans, net of short term  7   22 
  $495  $983 

As of January 31, 2018, future minimum payments under the capital leases, net of interest of $89 aggregates $661 including a short term debt portion of $173 included in other current liabilities. Future minimum payments under the installment loans aggregate $67, including a short term portion of $60 included in other current liabilities.

  October 31,
2018
  July 31,
2018
 
Payroll, benefits, and commissions $5,919  $4,870 
Legal fee expense  1,475   2,121 
Professional fees  807   811 
Other  2,647   2,252 
  $10,848  $10,054 

 

Note 98 – Stockholders’ Equity

 

Controlled Equity Offering

 

The Company has a Controlled Equity OfferingSM Sales 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 3.0% 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.

 

On September 1, 2017, the Company filed with the SEC a “shelf” registration and sales agreement prospectus covering the offering, issuance and sale of our Common Stock that may be issued and sold under the existing Sales Agreement in an aggregate amount of up to $19.15 million. A total of $150 million of securities may be sold under this shelf registration, which was declared effective September 15, 2017.

 

During the sixthree months ended JanuaryOctober 31, 2018 and during fiscal 2017, the Company did not sell any shares of Common Stock under the Sales Agreement.

Treasury stock

During the six months ended January 31, 2018, certain officers of the Company exercised 340,898 stock options in non-cash transactions. The officers surrendered 106,911 shares of the Company’s common stock to exercise the stock options. The Company recorded approximately $1,014, the market value of the surrendered shares, as treasury stock.

1113

Share-based compensation

 

The Company has an incentiveOn January 14, 2011, the Company’s stockholders approved the adoption of the 2011 Incentive Plan (the “2011 Plan”) which provides for the issuance of equity awards, including among others, options, restricted stock option and restricted stock award plan (the “2005 Plan”),units for up to 3,000,000 Common Shares. The exercise price of options granted under the 2011 Plan, and a long term incentive share award plan, (the “2011 Plan”), which are more fully described in Note 10consistent with other Plans, is equal to or greater than fair market value of the consolidated financial statements included inCommon Stock on the date of grant. Unless terminated earlier by the Board of Directors, the 2011 Plan will terminate at the earliest of; (a) such time as no shares of Common Stock remain available for issuance under the 2011 Plan or (b) tenth anniversary of the effective date of the 2011 Plan. On January 5, 2018, the Company’s Annual Report on Form 10-K for the fiscal year ended July 31, 2017. The 2011 Incentive Plan, which is the only plan from which awards may now be granted, provides for the award to eligible employees, officers, directors, consultants and other persons of stock options, stock appreciation rights (SARs), restricted stock, restricted stock units, performance awards, and other stock-based awards.

At the 2017 annual meeting, shareholdersstockholders approved the amendment and restatement of the 2011 Plan including anto increase in the number of shares available for issuance by 2,000,000 bringing the total number of common stock authorizedshares available for grantaward under the 2011 Plan from 3 million shares to 5 million shares.5,000,000. Awards outstanding upon expiration of the 2011 Plan shall remain in effect until they have been exercised, terminated, or have expired.

 

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

 

  Three months ended
January 31,
  Six months ended
January 31,
 
  2018  2017  2018  2017 
Stock options $205  $236  $407  $382 
Restricted stock  3   5   6   10 
  $208  $241  $413  $392 
   Three months ended
October 31,
 
    2018   2017 
 Stock options $232  $202 
 Restricted stock  3   3 
   $235  $205 

 

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
January 31,
  Six months ended
January 31,
 
  2018  2017  2018  2017 
Cost of clinical laboratory services $  $1  $  $3 
Selling, general and administrative  208   240   413   389 
  $208  $241  $413  $392 
  Three months ended
October 31,
 
   2018   2017 
Selling, general and administrative  235   205 
  $235  $205 

 

No excess tax benefits were recognized during the sixthree month periods ended JanuaryOctober 31, 2018 and 2017.

Stock Option Plans

The following table summarizes stock option activity during the sixthree month period ended JanuaryOctober 31, 2018:

 

 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, 2017  2,130,995  $4.26       
Outstanding at July 31, 2018  1,882,116  $4.96         
Awarded  112,580  $8.36         $         
Exercised  (569,602) $3.02   $5,594   (10,000) $2.53      $41 
Cancelled or expired  (26,334) $5.82       (2,000) $4.51         
Outstanding at end of period  1,647,639  $4.95  2.8 years $6,785   1,870,116  $4.97   2.6 years  $412 
Exercisable at end of period  1,109,811  $4.18  1.4 years $3,533   1,139,156  $4.29    1.6 years  $142 

 

As of JanuaryOctober 31, 2018, the total future compensation cost related to non-vested options, not yet recognized in the statements of operations, was $1.0$0.9 million and the weighted average period over which the remaining expense of these awards is expected to be recognized is fifteentwelve months.

 

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 options.

14

Restricted Stock Awards

A summary of the activity pursuant to the Company’s unvested restricted stock awards for the sixthree months ended JanuaryOctober 31, 2018 is as follows:

12
 Awards  Weighted
Average
Award Price
  Awards  Weighted
Average
Award Price
 
Outstanding at July 31, 2017  7,436  $4.45 
Outstanding at July 31, 2018  2,613  $1.74 
Awarded            
Vested  (2,062) $(5.92)  (175) $(5.62
Forfeited            
Unvested at end of period  5,374  $3.23   2,438  $1.47 

 

The fair value of a restricted stock award is determined based on the closing stock price on the award date. As of JanuaryOctober 31, 2018, there was approximately $0.1 million of unrecognized compensation cost related to unvested restricted stock-based compensation to be recognized over a weighted average remaining period of approximately twenty twotwenty-seven months.

 

The fair value of the awards that vested during the sixthree months ended JanuaryOctober 31, 2018 and 2017 was $21$1 and $8,$10, respectively.

 

The total number of shares available for grant as equity awards from the 2011 Incentive Plan is approximately 2,263,4001,933,000 shares as of JanuaryOctober 31, 2018.

 

Note 10 – Income taxesPerformance Stock Units

To better align the long-term interest of executives with growing U.S. practices, beginning in fiscal 2018, the Company granted long-term incentive awards in the form of time based stock options and performance-based restricted stock units (“Performance Stock Units” or “PSUs”). The PSUs earned will be determined over a three-year performance period. The primary performance metrics will be revenue and Adjusted EBITDA growth. Payouts based on revenue and adjusted EBITDA goals will be modified based on Total Shareholder Return (“TSR”) performance relative to Enzo’s peer group.

 

On December 22, 2017, legislation commonly known asDuring fiscal year 2018, the Tax Cuts and Jobs ActCompany awarded a total of 2017 (the “Act”) was signed into law making significant changes32,000 PSUs to its executive officers, this award provides for the Internal Revenue Code. Changes include, but are not limited to,grant of shares of our common stock at the end of a corporate tax rate decrease from 35% to 21% effective for tax years beginning after December 31, 2017, the transition of U.S international taxation from a worldwide tax system to a territorial system, and a one-time transition taxthree–year period based on the mandatory deemed repatriationachievement of cumulative foreign earnings asaverage revenue growth and adjusted EBITDA growth over that period. As of December 31, 2017.

The Company calculated its best estimate of the impact of the Act in accordance with its understanding of the Act and guidance available as of the date of this filing and recorded $1.1 million as an income tax benefit in the three months ended JanuaryOctober 31, 2018, the Company did not accrue any compensation expense for these PSU’s as the three-year performance period in which the legislation was enacted, related to a credit for alternative minimum taxes (AMT) paid in prior periods. A provisional amount related to the remeasurement of certain deferred tax assetshas just begun and liabilities based on the rates at which they are expected to reverse in the future was fully offset by an equivalent adjustment to the deferred tax valuation allowance. No provisional amount related to the one-time transition tax on the mandatory deemed repatriation of foreign earnings was deemed necessary.

On December 22, 2017, Staff Accounting Bulletin No. 118 (“SAB 118”) was issued to address the application of US GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effectsachievement of the Act. In accordance with SAB 118,growth goals is currently not probable. At the Company has determined thatgrant date, the $1.1 million income tax benefit, which relates to the AMT credit, is a provisional amount and a reasonable estimate at January 31, 2018.

The Company’s effective tax rate benefit for the three and six months ended January 31, 2018fair value of this award was 54.9% and 41.6%, respectfully and was based on the refundable federal AMT credit. There was no tax provision for the 2017 periods. The Company’s effective tax rate for all periods differed from the expected net operating loss carryforward benefit at the U.S. federal statutory rate primarily due to the inability to recognize such benefit. The carryforward benefit cannot be recognized because of uncertainties relating to future taxable income in terms of both its timing and its sufficiency, which would enable the Company to realize the federal carryforward benefit.$141.

 

Note 119 – Segment reporting

 

The Company has three reportable segments: Products, Clinical Labs, Life Sciences,Services and Therapeutics. The Clinical Labs segment provides diagnostic services to the health care community. The Life SciencesCompany’s Products segment develops, manufactures, and markets products to research and pharmaceutical customers. The TherapeuticClinical 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 three reportable segments.

Legal fee expense incurred to defend the Company’s intellectual property, which may result in settlements recognized in another segment and other general corporate matters isare considered a component of the Other segment. Legal fee expense specific to other segments’ activities hashave been allocated to those segments. When recognized, legal

Legal settlements, net, representsrepresent activities for which royalties would have been received byin the Company’s Life Sciences

13

Products segment hadand expenses related to an investigation within the Company had agreements in place with plaintiffs for the patents or products covered by the settlements.

Clinical Services segment. 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 contained in the Company’s Annual Report on Form 10-K for the year ended July 31, 2017.policies.

15

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

Three months ended October 31, 2018

  Clinical
Services
  Products  Therapeutics  Other  Consolidated 
Revenues  14,297   6,963         21,260 
                     
Operating costs and expenses:                    
Cost of revenues  10,968   3,271         14,239 
Research and development     507  $221      728 
Selling, general and administrative  6,060   2,924     $1,986   10,970 
Legal fee expense  36   7      1,258   1,301 
Total operating costs and expenses  17,064   6,709   221   3,244   27,238 
                     
Operating income (loss)  (2,767)  254   (221)  (3,244)  (5,978)
                     
Other income (expense):                    
Interest  (18)  16      276   274 
Other  40   4      3   47 
Foreign exchange loss     (324)        (324)
Loss before income taxes $(2,745) $(50) $(221) $(2,965) $(5,981)
                     
Depreciation and amortization included above $403  $342  $  $21  $766 
                     
Share-based compensation included in above:                    
Selling, general and administrative  38  $24     $173   235 
Total $38  $24  $  $173  $235 
                     
Capital expenditures $354  $52  $  $  $406 
1416

Three months ended January 31, 2018

  Clinical
Labs
  Life
Sciences
  Therapeutics  Other  Consolidated 
Revenues:                    
Clinical laboratory services $19,530           $19,530 
Product revenues    $7,122         7,122 
Royalty and license fee income     300         300 
   19,530   7,422         26,952 
Operating costs and expenses:                    
Cost of clinical laboratory services  11,730            11,730 
Cost of product revenues     3,877         3,877 
Research and development     591  $221      812 
Selling, general and administrative  6,107   2,899     $2,064   11,070 
Provision for uncollectible accounts receivable  800   (21)        779 
Legal fee expense  8   25      1,667   1,700 
Total operating costs and expenses  18,645   7,371   221   3,731   29,968 
                     
Operating income (loss)  885   51   (221)  (3,731)  (3,016)
                     
Other income (expense):                    
Interest  (23)  11      197   185 
Other  3   1      29   33 
Foreign exchange gain     800         800 
Income (loss) before income taxes $865  $863  $(221) $(3,505) $(1,998)
                     
Depreciation and amortization included above $413  $355  $  $18  $786 
                     
Share-based compensation included in above:                    
Selling, general and administrative  28  $21     $159   208 
Total $28  $21  $  $159  $208 
                     
Capital expenditures $576  $28  $  $  $604 
15

Three months ended JanuaryOctober 31, 2017

 

  Clinical
Labs
  Life
Sciences
  Therapeutics  Other  Consolidated 
Revenues:                    
Clinical laboratory services $18,837           $18,837 
Product revenues    $6,983         6,983 
Royalty and license fee income     440         440 
   18,837   7,423         26,260 
Operating costs and expenses:                    
Cost of clinical laboratory services  11,052            11,052 
Cost of product revenues     3,520         3,520 
Research and development     516  $(33)     483 
Selling, general and administrative  5,897   2,905     $2,416   11,218 
Provision for uncollectible accounts receivable  594   85         679 
Legal fee expense  49   16      305   370 
Total operating costs and expenses  17,592   7,042   (33)  2,721   27,322 
                     
Operating income (loss)  1,245   381   33   (2,721)  (1,062)
                     
Other income (expense):                    
Interest  (28)  12      95   79 
Other  17         7   24 
Foreign exchange loss     (94)        (94)
Income (loss) before income taxes $1,234  $299  $33  $(2,619) $(1,053)
                     
Depreciation and amortization included above $394  $501  $  $20  $915 
                     
Share-based compensation included in above:                    
Cost of clinical laboratory services $1           $1 
Selling, general and administrative  23  $15     $202   240 
Total $24  $15  $  $202  $241 
                     
Capital expenditures $175  $  $  $  $175 
16

Six months ended January 31, 2018

 Clinical
Labs
  Life
Sciences
  Therapeutics  Other  Consolidated  Clinical
Services
  Products  Therapeutics  Other  Consolidated 
Revenues:                    
Clinical laboratory services $39,864           $39,864 
Product revenues    $14,203         14,203 
Royalty and license fee income     561         561 
Revenues  19,534   7,342         26,876 
  39,864   14,764         54,628                     
Operating costs and expenses:                                        
Cost of clinical laboratory services  23,772            23,772 
Cost of product revenues     7,266         7,266   12,042   3,389         15,431 
Research and development     1,114  $445      1,559      523  $224      747 
Selling, general and administrative  12,202   5,513     $4,246   21,961   6,095   2,628     $2,182   10,905 
Provision for uncollectible accounts receivable  1,600   (7)        1,593 
Legal fee expense  21   28      2,082   2,131   13   3      415   431 
Total operating costs and expenses  37,595   13,914   445   6,328   58,282   18,150   6,543   224   2,597   27,514 
                                        
Operating income (loss)  2,269   850   (445)  (6,328)  (3,654)  1,384   799   (224)  (2,597)  (638)
                                        
Other income (expense):                                        
Interest  (48)  23      367   342   (25)  12      170   157 
Other  17   8      44   69   14   7      15   36 
Foreign exchange gain     605         605      (195)        (195)
Income (loss) before income taxes $2,238  $1,486  $(445) $(5,917) $(2,638) $1,373  $623  $(224) $(2,412) $(640)
                                        
Depreciation and amortization included above $817  $681  $  $37  $1,535  $404  $326  $  $19  $749 
                                        
Share-based compensation included in above:                                        
Selling, general and administrative  60  $44     $309   413   32  $23     $150   205 
Total $60  $44  $  $309  $413  $32  $23  $  $150  $205 
                                        
Capital expenditures $994  $72  $  $  $1,066  $418  $43  $  $  $461 
17

Six months ended January 31, 2017

  Clinical
Labs
  Life
Sciences
  Therapeutics  Other  Consolidated 
Revenues:                    
Clinical laboratory services $37,395           $37,395 
Product revenues    $14,409         14,409 
Royalty and license fee income     740         740 
   37,395   15,149         52,544 
Operating costs and expenses:                    
Cost of clinical laboratory services  21,948            21,948 
Cost of product revenues     6,829         6,829 
Research and development     1,143  $162      1,305 
Selling, general and administrative  11,849   5,851     $5,012   22,712 
Provision for uncollectible accounts receivable  1,260   88         1,348 
Legal fee expense  101   28      613   742 
Total operating costs and expenses  35,158   13,939   162   5,625   54,884 
                     
Operating income (loss)  2,237   1,210   (162)  (5,625)  (2,340)
                     
Other income (expense):                    
Interest  (57)  22      160   125 
Other  119         24   143 
Foreign exchange loss     (455)        (455)
Income (loss) before income taxes $2,299  $777  $(162) $(5,441) $(2,527)
                     
Depreciation and amortization included above $795  $1,009  $  $38  $1,842 
                     
Share-based compensation included in above:                    
Cost of clinical laboratory services $3           $3 
Selling, general and administrative  40  $26     $323   389 
Total $43  $26  $  $323  $392 
                     
Capital expenditures $587  $102  $  $  $689 
18

Note 1211 – Contingencies

 

The Company is engaged in litigation in the United States District Court for the Southern District of New York against Roche Diagnostic GmbH and its related company Roche Molecular Systems, Inc. (“Roche”), as declaratory judgment defendant. This case was commenced in May 2004. Roche seeks a declaratory judgment of non-breach of contract and patent invalidity against the Company. Roche has also asserted tort claims against the Company. The Company has asserted breach of contract and patent infringement causes of action against Roche. There has been extensive discovery in the case. In 2011, Roche moved for summary judgment of non-infringement regarding the Company’s patent claims. In 2012, the motion was granted in part and denied in part. In December 2012, Roche moved for summary judgment on the Company’s non-patent claims. Additional discovery was taken and the Company responded to the motions in May 2013. In December 2013, the Court granted in part and denied in part Roche’s summary judgment motion. In October 2014, the Court ordered that damages discovery concerning the Company’s remaining contract and patent claims and Roche’s claims should be completed by the end of January 2015, and expert discovery should be completed following the Court’s not-yet-issued claim construction ruling concerning the Company’s patent infringement claim against Roche. Roche dropped its tort claims during damages discovery. On October 2, 2017, the Court issued its claim construction ruling. On December 21, 2017, the Court issued a revised scheduling order which requires the completion of expert discovery by April 13, 2018 and schedules a conference on May 31, 2018 what will function as a pre-trial conference or a pre-motion conference. The Company and Enzo Life Sciences intend to vigorously press their remaining claims and contest the claims against them.

As of January 31, 2018, there are seven cases that are either pending casesor on appeal, which were originally brought by the Company in the United States District Court for the District of Delaware (“the Court”), alleging patent infringement against various companies. On June 28, 2017, the Court issued an opinion in the Gen-Probe case, granting Gen-Probe’s motion for summary judgment that the asserted claims of the ’180 patent are invalid for nonenablement. The Court entered final judgment of invalidity of the asserted claims of the ‘180 patent on July 19, 2017 in the Gen-Probe and Hologic cases. The Court entered partial final judgment of invalidity of the asserted claims of the ‘180 patent and stayed the remainder of the cases in the Becton Dickinson and Roche cases on July 31, 2017 and August 2, 2017, respectively. The Company filed notices of appeal in each of the Gen-Probe, Hologic, Becton Dickinson, and Roche cases, which were docketed by the United States Court of Appeals for the Federal Circuit (“Federal Circuit”). In the Abbott case, the parties agreed that the Court’s summary judgment ruling in the Gen-Probe case invalidated all of the ’180 patent claims asserted against the Abbott Defendants. On August 15, 2017, the Court granted Abbott’s motion for summary judgment that the asserted claims of the ’405 patent are invalid for nonenablement. On September 1, 2017, the Court entered final judgment of invalidity of the asserted claims of the ‘180 and ‘405 patents for nonenablement in the Abbott case. Enzo subsequently filed a notice of appeal in the Abbott case on September 14, 2017. The Federal Circuit docketed the appeal on September 15, 2017. The Federal Circuit consolidated the appeals from the Abbott, Becton Dickinson, Gen-Probe, Hologic, and Roche litigations (“Consolidated Appeals”). We disagree with the Court’s invalidity decisions regarding the ‘180 and ‘405 patents in the pending cases as set forth in our opening brief in the Consolidated Appeals pending in the Federal Circuit filed on November 28, 2017. In the Consolidated Appeals, we have asked the Federal Circuit to reverse the Court’s grants of final and summary judgment of invalidity of the asserted claims of the ‘180 and ‘405 patents and to remand the cases against Abbott, Becton Dickinson, Gen-Probe, Hologic, and Roche to the Court. Briefing is now complete in the Consolidated Appeals. The responsive briefs from Abbott, Becton Dickinson, Gen-Probe, Hologic, and RocheFederal Circuit has scheduled an oral argument in the Consolidated Appeals are due to be filed on March 9, 2018.for January 7, 2019. In the other two cases involving Hologic, one of the cases is stayed (Hologic II), while the other case (Hologic III) that involves U.S. Patent No. 6,221,581 (“the ‘581 patent”) is proceedingon appeal to the Federal Circuit. The Court issued a claim construction order on October 15, 2018. On October 31, 2018, Enzo and Hologic entered a stipulation that the asserted claims of the ‘581 Patent are not infringed under the Court’s schedulingclaim construction for certain of the claim terms. The Court entered final judgment of non-infringement on November 5, 2018. Enzo filed a notice of appeal on November 28, 2018. The Federal Circuit docketed the appeal and issued a schedule on December 3, 2018. The schedule is as follows: (1) Entry of Appearance is due on 12/17/2018; (2) Certificate of Service is due on 12/17/2018; (3) Docketing Statement is due on 12/17/2018; and (4) Enzo’s opening brief is due on 2/1/2019. Regarding Hologic’s petition requesting institution of an inter partes review proceeding of the ‘581 patent filed with the United States Patent and Trademark Office (“PTO”), the Patent Trial and Appeals Board (“the Board”) denied institution of Hologic’s petition on April 18, 2018. On May 18, 2018, Hologic filed with the Board, a request for rehearing of the order with factdenying institution of inter partes review of the ‘581 patent. The Board denied Hologic’s request for rehearing on November 28, 2018.

The Company and Enzo Life Sciences are engaged in litigation in the United States District Court for the Southern District of New York against Roche Diagnostic GmbH and its related company Roche Molecular Systems, Inc. (“Roche”), as declaratory judgment defendants. This case was commenced in May 2004. Roche seeks a declaratory judgment of non-breach of contract and patent invalidity against the Company and Enzo Life Sciences. Roche has also asserted tort claims against the Company and Enzo Life Sciences. The Company and Enzo Life Sciences have asserted breach of contract and patent infringement causes of action against Roche. There has been extensive discovery. In 2011, Roche moved for summary judgment of non-infringement regarding the Company’s patent claims. In 2012, the motion was granted in part and denied in part. In December 2012, Roche moved for summary judgment on the Company’s non-patent claims. Additional discovery was taken and the Company responded to the motions in May 2013. In December 2013, the Court granted in part and denied in part Roche’s summary judgment motion. In October 2014, the Court ordered that damages discovery concerning the Company’s remaining contract and patent claims and Roche’s claims should be completed by the end of January 2015, and expert discovery deadlines throughshould be completed following the Court’s claim construction ruling concerning the Company’s patent infringement claim against Roche. Roche dropped its tort claims during damages discovery. On October 2, 2017, the Court issued its claim construction ruling. On September 8, 2018, athe Court issued an order (i) directing that motions for summary judgment hearing date in Aprilshould be filed on October 10, 2018 and a proposed pretrial order by February 22, 2019, and a trial date in September 2019.(ii) scheduling an April 8, 2019 trial. On October 10, 2018, the parties filed their motions for summary judgment and also filed motions to preclude. Those motions are now fully briefed. The Court granted Enzo’s motionCompany and Enzo Life Sciences intend to amend its complaint to add two new defendants, Grifols Diagnostic Solutions, Inc.vigorously press their remaining claims and Grifols, S.A, to that case. Grifols, S.A. has moved to dismiss for lack of personal jurisdiction; briefing on that motion is complete butcontest the Court has not set a date for oral argument.claims against them.

 

There can be no assurance that the Company will be successful in 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.

18

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

Note 12 – Subsequent Event

As part of implementing our growth strategy, on November 27, 2018, we closed on the $6 million purchase of a new facility with nearly 36,000 square feet adjacent to our current campus in Farmingdale, NY to be used for manufacturing and distributing our low cost, diagnostic platform products and related services. This facility extends Enzo’s New York campus to nearly 101,000 square feet, complementing our existing sites in Michigan, Switzerland, France and Belgium.

In connection with the purchase, we entered into a fee mortgage security agreement with Citibank, N.A., the mortgagee in the amount of $4.5 million. The mortgage is for a term of 10 years, bears a fixed interest rate of 5.09% per annum, and requires monthly principal and interest payments of $30,106. The mortgage includes financial covenants requiring adherence to certain financial ratios. We have Town of Babylon Industrial Development Agency (IDA) commitments that will provide significant multi-year tax abatements and additional incentives with respect to our entire Farmingdale campus

We assumed an operating lease for the facility from the seller. The current tenant may occupy the facility until December 2019, unless it is given or gives notice to vacate prior to that date.

 

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.

19

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, 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, 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, 20172018 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.

19

Overview

 

Enzo Biochem, Inc. (the “Company” “we”, “our” or “Enzo”) is an integrated diagnostic bioscience company focusing on delivering and applying advanced technology capabilities to produce affordable reliable products and services to allow our customers to meet their clinical needs. We are leading the convergence of clinical laboratories, life sciences, and intellectual property through the development of unique diagnostic platform technologies that provide numerous advantages over previous standards. Utilizing cross-functional teams, we develop, manufacture and sell our proprietary technology solutions and platforms to clinical laboratories, specialty clinics and researchers and physicians globally. Enzo’s structure and business strategy represent the culmination of years of extensive planning and work. The Company now has the unique ability to offer low cost, high performance products and services in molecular diagnostics, which ideally positions itus 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 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 reduces 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.

For example, our AMPIPROBE® technology platform can lead to the development of an entire line of nucleic acid clinical products that can allow laboratories to offer a complete menu of services at a cost that allows them to enjoy an acceptable margin. Our technology solutions provide tools to physicians, clinicians and other health carehealthcare providers to improve detection, treatment and monitoring of a broad spectrum of diseases and conditions.Inconditions. In addition, reduced patient to physician office visits translates into lower healthcare processing costs and greater patient services.

 

In the course of our research and development activities, we have built a substantial portfolio of intellectual property assets, comprised of 336343 issued patents worldwide and over 151157 pending patent applications, along with extensive enabling technologies and platforms.

 

Below are brief descriptions of each of our operating segments (See Note 10 in the Notes to Consolidated Financial Statements):

20

Enzo Clinical LabsServices 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 CLIA-certified and a 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 LabsServices 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 expanding into Connecticut, a free standing “STAT” or rapid response laboratory in New York City and a full service phlebotomy, in-house logistics department, and an information technology department. Given our license in New York State, we are able to offer testing services to clinical laboratories and physicians in the majority of states nationwide.

 

Enzo Life SciencesProducts manufactures, develops and markets products and tools tofor 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 (Seeof our Form 10K for the fiscal year ended July, 31, 2017).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 researchersmarkets 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 more than 101154 patents and patent applications.

2120

Results of Operations

Three months ended JanuaryOctober 31, 2018 compared to JanuaryOctober 31, 2017
(in 000s)

 

Comparative Financial Data for the Three Months Ended JanuaryOctober 31,

 

 2018  2017  Increase
(Decrease)
  %
Change
  2018 2017 Increase
(Decrease)
 %
Change
 
Revenues:                
Clinical laboratory services $19,530  $18,837  $693   4 
Product revenues  7,122   6,983   139   2 
Royalty and license fee income  300   440   (140)  (32)
Total revenues  26,952   26,260   692   3 
                
Revenues $21,260  $26,876  $(5,616)  (21)
                                
Operating costs and expenses:                                
Cost of clinical laboratory services  11,730   11,052   678   6 
Cost of product revenues  3,877   3,520   357   10 
Cost of revenues  14,239   15,431   (1,192)  (8)
Research and development  812   483   329   68   728   747   (19)  (3)
Selling, general and administrative  11,070   11,218   (148)  (1)  10,970   10,905   65   1 
Provision for uncollectible accounts receivable  779   679   100   15 
Legal fee expense  1,700   370   1,330   359   1,301   431   870   ** 
Total operating costs and expenses  29,968   27,322   2,646   10   27,238   27,514   (276)  (1)
                                
Operating loss  (3,016)  (1,062)  (1,954)  (184)  (5,978)  (638)  (5,340)  ** 
                                
Other income (expense):                                
Interest  185   79   106   134   274   157   117   75 
Other  33   24   9   38   47   36   11   31 
Foreign currency gain (loss)  800   (94)  894   ** 
Foreign currency loss  (324)  (195)  (129)  66 
Loss before income taxes $(1,998) $(1,053) $(945)  (90) $(5,981) $(640) $5,341   ** 

 

** not meaningful

 

Consolidated Results:

 

The “2018“2019 period” and the “2017“2018 period” refer to the three months ended JanuaryOctober 31, 2018 and 2017, respectively.

 

Clinical laboratory services revenues for the 20182019 period were $19.5$14.3 million compared to $18.8$19.5 million in the 20172018 period, an increasea decrease of $0.7$5.2 million or 4%. The increase is attributed27% largely due to molecularreduced insurance reimbursement payments and women’s healthmix of testing, which were reimbursed at higher than average rates in the prior year. Total diagnostic testing volume, in women’s health markets,measured by the additionnumber of new accounts, and expansion of the service area versus the 2017 period,accessions, decreased 5% year over year, again due to lower high–value testing, partially offset by weather related delaysan increase in testing experienced during the 2018 period.esoteric testing.

 

Product revenues for the 20182019 period were $7.1was $7.0 million compared to $7.0$7.1 million in the 20172018 period, an increasea decrease of $0.1 million or 2%. The increase resulted from the positive impact of foreign currency translation and organic growth in foreign markets, which was partially offset by due to slightly lower product order volumevolume. There was no royalty income in the United States due to lower research funding and lower pricing due to competition.2019 period because the license agreement has expired. Royalty income in 2018 was $0.3 million.

 

The cost of clinical laboratory services during the 20182019 period was $11.7$11.0 million as compared to $11.0$12.1 million in the 20172018 period, a decrease of $1.1 million or 9% primarily due to test mix. The components of the decrease are $1.2 million for outside reference lab testing costs, internalizing the use of our AMPIPROBE® technology platform, and $0.1 million of testing supplies, partially offset by an increase in compensation related expenses of $0.7 million or 6% due to the volume increase in clinical laboratory services revenue, from molecular testing, primarily for reagent costs and compensation expenses.$0.2 million. Gross profit margin was 40%23% in the 2019 period and 38% in the 2018 period, impacted by the mix of tests and 41% in the 2017 period.decreased payer reimbursement rates.

 

The cost of product revenues was $3.9$3.3 million in the 2019 period and $3.4 million in the 2018 period, and $3.5 million in the 2017 period, an increasea decrease of $0.4$0.1 million or 10% primarily3% due to the sale of lower margin items and an increase in headcount.product sales. The gross profit margin on products was 45.6%53% in the 2019 period and 52% in the 2018 period and 49.6% in the 2017 period and was also impacted by price discounting.due to mix of products sold.

22

Research and development expenses were $0.8$0.7 million versusin the 2019 and 2018 periods. The expense for Life Sciences Products was $0.5 million in both periods and the 2018 period, an increase of $0.3 million or 68%. The expense for the Life Sciences segment increased $0.1 million due to compensation expenses. The expense for theEnzo Therapeutics segment in the 2018 period increasedwas $0.2 million due to the impact of an adjustment recorded in the 2017 period decreasing an obligation for clinical trial activity.both periods.

 

Selling, general and administrative expenses were approximately $11.1$11.0 million during the 2019 period versus $10.9 million during the 2018 period, versus $11.2 million during the 2017 period, a decreasean increase of $0.1 million or 1%. Clinical Services expense was unchanged, as the cost of increased headcount to market our new molecular diagnostic products for use by other reference labs was offset by lower sales commissions. The Clinical Lab segmentProducts expense increased $0.2$0.3 million primarily compriseddue to increased headcount focused on sales, marketing and business development of billing expenses. The Life Sciences segment expense was comparable in both periods.our diagnostic platform technologies. The Other segment expense decreased $0.3$0.2 million, comprised ofdue to a decrease in compensation related expenses.

The provision for uncollectible accounts receivable, primarily related to the Clinical Labs segment, was approximately $0.8 million in the 2018 period and $0.7 million in the 2017 period, an increase of approximately $0.1 million. As a percentage of Clinical laboratory services, the provision for uncollectible accounts receivable relating to the Clinical Labs segment was 4.1% in the 2018 period and 3.2% in the 2017 period.

21

Legal fee expense was $1.7$1.3 million during the 20182019 period compared to $0.4 million in the 20172018 period, an increase of $1.3$0.9 million or 359% due to the timing of legal activity and related costs associated with on-going litigation and contract dispute where the Company is the plaintiff.

 

Segment Results:

Clinical Labs

Revenue from laboratory services for the 2018 period were $19.5 million compared to $18.8 million in the 2017 period. The increase of $0.7 million or 4% is attributed to increased molecular and women’s health testing volume and the addition of new accounts and expansion of the service area, partially offset by weather related delays in testing experienced during the 2018 period. Cost of services during the 2018 period was $11.7 million as compared to $11.0 million in the 2017 period, an increase of $0.7 million or 6% due to higher testing volume, primarily for reagent costs and compensation expenses. Gross profit margin was 40% in the 2018 period and 41% in the 2017 period. As a percentage of revenues, the provision for uncollectable accounts, primarily for self-pay patient accounts, was 4.1% for the 2018 period and 3.2% for the 2017 period. Income before taxes was $0.9 million for 2018 period as compared to $1.2 million in the 2017 period, a decrease of $0.3 million.

Life Sciences

Product revenues for the 2018 period were $7.1 million compared to $7.0 million in the 2017 period, an increase of $0.1 million or 2%. The increase resulted from the positive impact of foreign currency translation, which was partially offset by lower product order volume in the United States due to lower research funding and lower pricing due to competition. The segment’s gross profit was $3.5 million in the 2018 period and $3.9 million in the 2017 period. The gross profit margin on products was 45.6% in the 2018 period and 49.6% in the 2017 period and was negatively impacted by the sale of lower margin products, increase in headcount, and price discounting. Selling general and administrative expenses were comparable in both periods. Research and development increased $0.1 million compared to the 2017 period. Due to significant appreciation of foreign currencies versus the US dollar at the end of the 2018 period compared to the end of the 2017 period, in particular the British pound, Euro and Swiss franc, the foreign currency gain was $0.8 million compared to a loss of $0.1 million in the 2017 period, a favorable change of $0.9 million. Income before taxes was $0.9 million for the 2018 period as compared to $0.3 million for the 2017 period, an increase of $0.6 million.

Therapeutics

The Therapeutics segment’s operating loss before income taxes was approximately $0.2 million in the 2018 period. The segment was breakeven during the 2017 period due to the impact of an adjustment decreasing an obligation for clinical trial activity.

Other

The Other segment’s operating loss before taxes for the 2018 period was approximately $3.5 million compared to $2.6 million for the 2017 period, an increase of $0.9 million. The 2018 period legal expense associated with on-going litigation and contract dispute increased $1.3 million. Compensation related expenses decreased $0.3 million. Interest income increased $0.1 million due toin the impact of a higher2019 period from rising interest raterates earned on cash and cash equivalents during the 2018 period and because interest expense was incurred only in the 2017 period on a loan payable which was then outstanding. The loan was repaid during the 2017 period.

23

Results of Operations

Six months ended January 31, 2018 compared to January 31, 2017
(in 000s)

Comparative Financial Data for the Six Months Ended January 31,

  2018  2017  Increase
(Decrease)
  %
Change
 
Revenues:                
Clinical laboratory services $39,864  $37,395  $2,469   7 
Product revenues  14,203   14,409   (206)  (1)
Royalty and license fee income  561   740   (179)  (24)
Total revenues  54,628   52,544   2,084   4 
                 
Operating costs and expenses:                
Cost of clinical laboratory services  23,772   21,948   1,824   8 
Cost of product revenues  7,266   6,829   437   6 
Research and development  1,559   1,305   254   19 
Selling, general and administrative  21,961   22,712   (751)  (3)
Provision for uncollectible accounts receivable  1,593   1,348   245   18 
Legal fee expense  2,131   742   1,389   187 
Total operating costs and expenses  58,282   54,884   3,398   6 
                 
Operating loss  (3,654)  (2,340)  (1,314)  (56)
                 
Other income (expense):                
Interest  342   125   217   174 
Other  69   143   (74)  (52)
Foreign currency gain (loss)  605   (455)  1,060   ** 
Loss before income taxes $(2,638) $(2,527) $(111)  (4)

** not meaningful

Consolidated Results:

The “2018 period” and the “2017 period” refer to the six months ended January 31, 2018 and 2017, respectively.

Clinical laboratory services revenues for the 2018 period were $39.9 million compared to $37.4 million in the 2017 period, an increase of $2.5 million or 7%. The increase is attributed to molecular and women’s health testing volume in women’s health markets, the addition of new accounts, and expansion of the service area versus the 2017 period, partially offset by weather related delays in testing experienced during the 2018 period.

Product revenues for the 2018 period were $14.2 million compared to $14.4 million in the 2017 period, a decrease of $0.2 million or 1%. The decrease resulted from lower product order volume due to lower research funding and lower pricing due to competition in the United States, which was partially offset by organic growth in foreign markets and the positive impact of foreign currency translation.

The cost of clinical laboratory services during the 2018 period was $23.8 million as compared to $21.9 million in the 2017 period, an increase of $1.8 million or 8% due to the volume increase in clinical laboratory services revenue from molecular testing, primarily for reagent costs, compensation expenses, and outside reference testing. Gross profit margin was 40% in the 2018 period and 41% in the 2017 period

The cost of product revenues was $7.3 million in the 2018 period and $6.8 million in the 2017 period, an increase of $0.4 million or 6% due to the sale of lower margin items and an increase in headcount. The gross profit margin on products was 48.8% in the 2018 period and 52.6% in the 2017 period, and was also negatively impacted by lower pricing due to competition.

24

Research and development expenses were $1.6 million versus $1.3 million in the 2018 period, an increase of $0.3 million or 19%. The expense for the Therapeutics segment was $0.5 million in the 2018 period and $0.2 million in the 2017 period. The lower expense in the 2017 period was due to the impact of an adjustment decreasing an obligation for clinical trial activity. The expense for the Life Sciences segment was comparable in both periods.

Selling, general and administrative expenses were approximately $22.0 million during the 2018 period versus $22.7 million during the 2017 period, a decrease of $0.7 million or 3%. The Clinical Lab segment expense increased $0.3 million comprised of a $0.3 million increase in billing expenses and a $0.1 million increase in information technology and bank fee expenses, partially offset by a decrease of $0.1 million in salary expenses, primarily for commissions. The Life Sciences segment expense decreased $0.3 million due to a decrease in intangibles amortization. The Other segment expense decreased $0.7 million, comprised of a decrease in compensation related expenses of $0.6 million and a decrease of $0.1 million in professional fees and office expenses.

The provision for uncollectible accounts receivable, primarily related to the Clinical Labs segment, was approximately $1.6 million in the 2018 period and $1.3 million in the 2017 period, an increase of approximately $0.3 million. As a percentage of Clinical laboratory services, the provision for uncollectible accounts receivable relating to the Clinical Labs segment was 4.0% in the 2018 period and 3.4% in the 2017 period.

Legal fee expense was $2.1 million during the 2018 period compared to $0.7 million in the 2017 period, an increase of $1.4 million or 187% due to the timing of legal activity and related costs associated with on-going litigation and contract dispute where the Company is the plaintiff.

Segment Results:

Clinical Labs

Revenue from laboratory services for the 2018 period were $39.9 million compared to $37.4 million in the 2017 period. The increase of $2.5 million or 7% is attributed to increased molecular and women’s health testing volume and the addition of new accounts and expansion of the service area, partially offset by weather related delays in testing during the 2018 period. Cost of services during the 2018 period was $23.8 million as compared to $21.9 million in the 2017 period, an increase of $1.8 million or 8% due to higher testing volume, primarily for reagent costs, compensation expenses, and outside reference testing. Gross profit margin was 40% in the 2018 period and 41% in the 2017 period. As a percentage of revenues, the provision for uncollectable accounts, primarily for self-pay patient accounts, was 4.0% for the 2018 period and 3.4% for the 2017 period. Income before taxes was $2.2 million for 2018 period as compared to $2.3 million in the 2017 period, a decrease of $0.1 million.

Life Sciences

Product revenues for the 2018 period were $14.2 million compared to $14.4 million in the 2017 period, a decrease of $0.2 million or 1%. The decrease resulted from lower product order volume in the United States due to lower research funding and lower pricing due to competition, which was partially offset by organic growth in foreign markets and the positive impact of foreign currency translation. The segment’s gross profit was $7.5 million in the 2018 period and $8.3 million in the 2017 period, impacted by lower revenues, the sale of lower margin items and an increase in headcount. The gross profit margin on products was 48.8% in the 2018 period and 52.6% in the 2017 period and was negatively impacted by the sale of lower margin products and price discounting. In the 2018 period, selling general and administrative expenses decreased $0.3 million compared to the 2017 period. Due to significant appreciation of foreign currencies versus the US dollar at the end of the 2018 period compared to the end of the 2017 period, in particular the British pound. Euro and Swiss franc, the foreign currency gain was $0.6 million compared to a loss of $0.5 million in the 2017 period, a favorable change of $1.1 million. Income before taxes was $1.5 million for the 2018 period as compared to $0.8 million for the 2017 period, an increase of $0.7 million.

Therapeutics

The Therapeutics segment’s operating loss before income taxes was approximately $0.4 million in the 2018 period and $0.2 million in the 2017 period. The lower expense during the 2017 period was due to the impact of an adjustment decreasing an obligation for clinical trial activity.

Other

The Other segment’s operating loss before taxes for the 2018 period was approximately $5.9 million compared to $5.4 million for the 2017 period, an increase of $0.5 million. During the 2018 period, legal fee expense associated with on-going litigation and contract dispute increased $1.5 million. The 2018 period selling general and

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administrative expense declined $0.7 million compared to the 2017 period due to decreases in compensation related expenses, and a $0.1 decrease in professional fees and office expense. Interest income increased $0.2 million in the 2018 period due to the impact of a higher interest rate earned on cash and cash equivalents and because interest expense was incurred only in the 2017 period on the loan payable then outstanding. The loan was repaid during the second quarter of 2017 period..equivalents.

 

Liquidity and Capital Resources

 

At JanuaryOctober 31,, 2018, the Company had cash and cash equivalents of $64.5$52.8 million of which $0.5$0.4 million was in foreign accounts, as compared to cash and cash equivalents of $64.2$60.0 million, of which $0.5$0.4 million was in foreign accounts at July 31, 2017.2018. It is the Company’s current intent to permanently reinvest these 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 $69.7$57.3 million at JanuaryOctober 31,, 2018 compared to $71.3$63.0 million at July 31, 2017.2018. The decrease in working capital of $1.6$5.7 million was primarily due to the period loss and net changes in operating assets and liabilities.

 

Net cash used in operating activities during the 2019 period was approximately $6.2 million as compared to cash provided by operating activities as of January 31,$2.6 million during the 2018 was approximately $0.8 million as compared to cash used in operating activities of $2.8 million in fiscal 2017, an increaseperiod, a decrease of approximately $3.6$8.8 million. The increasedecrease is mainly due to net changesloss of $5.3 million and net change in assets and liabilities of $3.7 million and decrease in net loss of $1.0 million offset by $1.1 million in non-cash adjustments.$3.6 million.

 

Net cash used in investing activities in fiscal 20182019 and 20172018 was approximately $1.1$1.0 million and $0.7$0.5 million, respective, which consists primarily of capital expenditures.respectively. The increase in the 2019 period is mainly due to security deposits.

 

Net cash used in financing activities in fiscal 2019 was less than $0.1 million as compared to cash provided by financing activities in fiscal 2018 was approximately $0.5 million as compared to cash used in financing activities of $1.8$0.6 million in fiscal 2017.2018. The change of $2.3$0.6 million is mainly due to borrowingsa decrease in proceeds from the credit agreement of $1.6 million in the 2017 period and the exercise of stock options $0.7 million in the 2018 period.options.

 

The Company believes that its current cash and cash equivalents level, and utilization of the Controlled Equity Offering program if necessary, as disclosed in Form 10-K Note 10 to the financial statements are sufficient for its foreseeable liquidity and capital resource needs over at least the next twelve (12) months, although there can be no assurance that future events will not alter such view. Although there can be no assurances, in the event additional capital is required, the Company believes it has the ability to raise additional funds through equity offerings or other sources. Our liquidity plans are subject to a number of risks and uncertainties, including those described in the Item 1A. “Risk Factors” section of our Form 10-K for the year ended July 31, 2017,2018, 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.

 

Contractual Obligations

 

Subsequent to the end of the period covered by this report, the Company completed the $6 million purchase of a 36,000 square foot commercial facility and as part of the purchase entered into a mortgage of $4.5 million with a 10 year term and bearing a fixed interest rate of 5.09%. We assumed an operating lease for the facility from the seller that runs to December 2019. See Note 12. There have been no other material changes to our Contractual Obligations as reported in our Form 10-K for the fiscal year ended July 31, 2017.2018.

 

Management is not aware of any material claims, disputes or settled matters concerning third party reimbursement that would have a material effect on our financial statements, except as disclosed in Note 1110 to the Consolidated Financial Statements.

 

Off-Balance Sheet Arrangements

 

The Company does not have any “off-balance sheet arrangements” as such term is defined in Item 303(a)(4) of Regulation S-K.

 

Critical Accounting Policies

 

The Company’s discussion and analysis of its financial condition and results of operations are based upon Enzo Biochem, Inc.’s consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United 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.

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On an on-going basis, we evaluate our estimates, including those related to contractual expense, allowance for uncollectible accounts, inventory, intangible assets 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

26

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.

 

Product revenues

Revenues from product sales are recognized when the products are shipped and title transfers, the sales price is fixed or determinable and collectability is reasonably assured.

Royalties

Royalty revenues are recorded in the period earned. Royalties received in advance of being earned are recorded as deferred revenues.

Revenues – Clinical laboratory servicesServices

Revenues from Clinical Labs are recognized upon completion of the testing process for a specific patient and reported to the ordering physician. These revenues and the associated accounts receivable are based on gross amounts billed or billable for services rendered, net of a contractual adjustment, which is the difference between amounts billed to payers and the expected approved reimbursable settlements from such payers.

The following table represents the clinical laboratory segment’s net revenues and percentages by revenue category:

  Three months ended
January 31, 2018
  Three months ended
January 31, 2017
 
Revenue category                
Third-party payer $11,102   57% $10,773   57%
Patient self-pay  2,383   12   2,772   15 
Medicare  3,230   17   2,796   15 
HMO’s  2,815   14   2,496   13 
Total $19,530   100% $18,837   100%

  Six months ended
January 31, 2018
  Six months ended
January 31, 2017
 
Revenue category                
Third-party payer $22,762   57% $20,966   56%
Patient self-pay  5,242   13   5,875   16 
Medicare  6,215   16   5,631   15 
HMO’s  5,645   14   4,923   13 
Total $39,864   100% $37,395   100%

The Company provides services to certain patients covered by various third-party payers, including the Federal Medicare program. Laws and regulations governing Medicare are complex and subject to interpretation for which action for noncompliance includes fines, penalties and exclusion from the Medicare programs.

Other than the Medicare program, one provider whose programs are included in the “Third-party payers” and “Health Maintenance Organizations” (“HMO’s”) categories represents approximately 38% and 39% of the Clinical Labs segment net revenue for the three months ended January 31, 2018 and 2017 respectively, and 39% and 37% for the six months ended January 31, 2018 and 2017, respectively.

 

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 party payers, including Medicare, HMO’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.

27

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 laboratory 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 JanuaryOctober 31, 2018 and 2017, the contractual adjustment percentages, determined using current and historical reimbursement statistics, were 84.1%87.5% and 82.8%85.0%, respectively, of gross billings. During the six months ended January 31, 2018 and 2017, the contractual adjustment percentages, determined using current and historical reimbursements statistics, were 84.5% and 83.4%, respectively. 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 molecular 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 laboratory services revenues of approximately $2.6$1.1 million and $2.3$1.4 million for the sixthree months ended JanuaryOctober 31, 2018 and 2017, respectively, and a change in the net accounts receivable of approximately $0.6$0.5 million as of JanuaryOctober 31, 2018.

 

Our clinical laboratoryservices 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.
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.23

Accounts Receivable and Allowance for Doubtful Accounts

 

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 segment. Theservices and by products. Net receivables for Clinical Labs segment’s net receivablesServices are detailed by billing category and as a percent to its total net receivables. At JanuaryOctober 31, 2018, and July 31, 2017,2018, approximately 73%74% and 75%, respectively, of the Company’s net accounts receivable relates to its Clinical Labsservices business, which operates in the New York, New Jersey and Connecticut medical communities.

 

The Life Sciences segment’s accounts receivable balance for Products includes $1.3$1.1 million or 32% and $1.1 million or 29% of foreign receivables as of JanuaryOctober 31, 2018 and July 31, 2017, and includes royalty receivables of $0.4 and $0.4 million, as of January 31, 2018 and July 31, 2017, respectively, from its licensee Qiagen.2018.

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Net accounts receivable

 

Billing category As of
January 31, 2018
  As of
July 31, 2017
 
Clinical Labs                
Third party payers $7,218   66% $7,256   64%
Medicare  1,730   16   1,385   12 
HMO’s  1,181   11   1,169   10 
Patient self-pay  788   7   1,591   14 
Total Clinical Labs  10,917   100%  11,401   100%
Total Life Sciences  4,060       3,779     
Total accounts receivable $14,977      $15,180     

Changes in the Company’s allowance for doubtful accounts are as follows:

  Six months ended
January 31, 2018
  Fiscal year ended
July 31, 2017
 
Beginning balance $3,576  $3,517 
Provision for doubtful accounts  1,593   2,775 
Write-offs, net  (1,383)  (2,716)
Ending balance $3,786  $3,576 

For the Clinical Labs segment, the allowance for doubtful accounts represents amounts that the Company does not expect to collect after the Company has exhausted its collection procedures. The Company estimates its allowance for doubtful accounts in the period the related services are billed and reduces the allowance in future accounting periods based on write-offs during those periods. The Company bases the estimate for the allowance on the evaluation of historical experience of accounts going to collections and the net amounts not received. Accounts going to collection include the balances, after receipt of the approved settlements from third party payers, for the insufficient diagnosis information received from the ordering physician which result in denials of payment and our estimate of the uncollected portion of receivables from self-payers, including deductibles and copayments, which are subject to credit risk and patients’ ability to pay. The Company fully reserves through its contractual allowances amounts that have not been written off because the payer’s filing date deadline has not occurred or the collection process has not been exhausted. The Company adjusts the historical collection analysis for recoveries, if any, on an on-going basis.

Billing category As of
October 31, 2018
  As of
July 31, 2018
 
Clinical Services                
Third party payers $4,792   51% $4,692   48%
Patient self-pay  2,268   23   2,010   20 
Medicare  1,682   18   1,740   18 
HMO’s  731   8   1,329   14 
Total Clinical Services  9,473   100%  9,771   100%
Total Products  3,363       3,376     
Total accounts receivable $12,836      $13,147     

 

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 assess the impact, if any, on the allowance estimates, which involves judgment.

 

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 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.

 

Billing for laboratoryclinical services is complicated because of many factors, especially: 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. The allowance for doubtful accounts as a percentage of total accounts receivable at January 31, 2018 and July 31, 2017 was 20.2% and 19.1%, respectively.

 

The following table indicates the Clinical LabsServices aged gross receivables by payer group which is prior to adjustment to gross receivables for: 1) contractual adjustment, 2) fully reserved balances not yet written off, and 3) other revenue adjustments.

 

As of January 31, 2018 Total  %  Third
Party
Payers
  %  Self-Pay  %  Medicare  %  HMO’s  % 
As of October 31, 2018 Total % Third Party Payers % Medicare % Self-Pay % HMO’s % 
1-30 days $27,330   46  $18,242   44  $1,125   19  $4,414   56  $3,549   92  24,365   53  $15,486   55  $4,136   50  $1,695   27  $3,048   93 
31-60 days  6,536   11   4,515   11   873   14   974   12   174   5   5,764   13   3,473   12   891   11   1,278   20   122   4 
61-90 days  4,973   9   3,326   8   806   13   806   10   35   1   4,173   9   2,779   10   653   8   707   11   34   1 
91-120 days  4,580   8   3,128   8   734)  12   710   9   8      2,716   6   1,605   6   485   6   604   9   22   1 
121-150 days  3,563   6   2,453   6   577   10   521   7   12      2,341   5   1,303   5   504   6   529   8   5    
Greater than 150 days  12,053   20   9,545   23   1,955)  32   464   6   89   2   6,654   14   3,435   12   1,550   19   1,617   25   52   1 
Totals $59,035   100% $41,209   100% $6,070   100% $7,889   100% $3,867   100% $46,013   100% $  28,081   100% $8,219   100% $6,430   100% $  3,283   100%
2924

As of July 31, 2017 Total  %  Third
Party
Payers
  %  Self-Pay  %  Medicare  %  HMO’s  % 
As of July 31, 2018 Total % Third Party Payers % Medicare % Self-Pay % HMO’s % 
1-30 days $25,357   42  $16,683   40  $1,082   16  $4,022   60  $3,570   82  $22,788   47  14,886   48  $4,102   46  $864   15  $2,936   90 
31-60 days  8,732   15   5,723   14   1,183   17   1,294   19   532   12   6,821   14   4,540   15   1,069   12   995   17   217   7 
61-90 days  5,703   10   4,208   10   927   14   529   9   39   1   4,526   9   2,877   9   784   9   843   15   22   1 
91-120 days  3,749   6   2,732   6   701   10   288   4   28   1   3,460   7   2,307   8   463   5   666   11   24   1 
121-150 days  3,689   6   2,772   7   672   10   228   3   17      2,705   6   1,602   5   490   6   601   10   12    
Greater than 150 days  12,455   21   9,652   23   2,270   33   379   5   154   4   8,357   17   4,481   15   1,976   22   1,862   32   38   1 
Totals $59,685   100% $41,770   100% $6,835   100% $6,740   100% $4,340   100% 48,657   100% $  30,693   100% $8,884   100% $5,831   100% $  3,249   100%

 

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 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

 

The Company values inventory at the lower of cost (first-in, first-out) or net realizable value, which approximates market. 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.

 

Goodwill and Intangible Assets

 

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

25

The Company tests goodwill and long-lived assets annually as of the first day of the fourth quarter, or more frequently if indicators of potential impairment exist. In assessing goodwill and long-lived assets for impairment, the Company has the option to 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 a quantitative test in assessing goodwill and long-lived assets 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 and intangibles allocated to the reporting unit.

 

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 foreign locations (See Item 1A. Risk Factors section of the Form 10-K for the fiscal year ended July 31, 2017)2018) that

30

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 JanuaryOctober 31, 2018, our assets and liabilities would decrease by $0.5$0.4 million and $0.1 million, respectively, and our net sales and net earnings (loss) would decrease by $0.9$0.8 million and $0.1$0.3 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 $1.4 million on an annual basis.

 

Interest Rate Risk

 

As of JanuaryOctober 31, 2018, we have fixed interest rate financing on transportation and equipment leases.

 

Item 4. Controls and Procedures

 

(a) Evaluation of Disclosure Controls and ProceduresProcedure

 

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 not effective as of the end of the period covered by this report.report as management identified deficiencies in internal control over financial reporting that were determined to be material weaknesses. 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 waswere no changechanges in the Company’sour internal controlscontrol over financial reporting that occurred during the fiscal quarter covered by this reportended October 31, 2018 that hashave materially affected, or isare reasonably likely to materially affect, our internal control over financial reporting.

Plan to Remediate Material Weaknesses

As of October 31, 2018, we are in the process of remediating the material weaknesses over financial reporting identified and reported in our Form 10-K for the fiscal year ended July 31, 2018 related to (1) insufficient controls to fully and timely take into account changes in the business environment and experience with ultimate collection from third-party payers in the determination of contractual adjustment amounts and collectability of accounts receivable and (2) inadequate information technology controls intended to control change management, program access and monitoring; however, the material weaknesses cannot be considered remediated until the procedures designed to address the deficient controls have been tested for effectiveness.  

3126

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 for the fiscal year ended July 31, 20172018 filed with the Securities and Exchange Commission, other than as noted in Note 1110 to the Consolidated Financial Statements as of JanuaryOctober 31, 2018.

 

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, 2017.2018.

 

Item 6.Exhibits

 

Exhibit No. Exhibit
31.1 Certification of Elazar Rabbani, Ph.D. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   
31.2 Certification of Barry Weiner pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   
32.1 Certification of Elazar Rabbani, Ph.D. pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
32.2 Certification of Barry Weiner pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
101. INS* XBRL Instance Document
   
101. SCH* XBRL Taxonomy Extension Schema Document
   
101. CAL* XBRL Taxonomy Extension Calculation Linkbase Document
   
101.DEF* XBRL Taxonomy Extension Definitions Linkbase Document
   
101.LAB* XBRL Taxonomy Extension Label Linkbase Document
   
101.PRE* XBRL Taxonomy Extension Presentation Linkbase Document

 

*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.

 

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: March 12,December 10, 2018by:/s/ Barry Weiner
  President, Chief Financial Officer, Principal Accounting Officer, Treasurer and Director
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