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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

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

 

FOR THE QUARTERLY PERIOD ENDED DECEMBER 31, 2022

 

OR

 

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

 

FOR THE TRANSITION PERIOD FROM _______________ TO _______________

 

COMMISSION FILE NUMBER: 001-15697

 

ELITE PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)

 

nevada   22-3542636

(State or other jurisdiction of

incorporation or organization)

  

(I.R.S. Employer

Identification No.)

 

165 LUDLOW AVENUE

NORTHVALE, new jersey

   07647
(Address of principal executive offices)   (Zip Code)

 

(201) 750-2646
(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which registered
Common Stock, par value $0.001 per share   ELTP   OTCQB

 

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 was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
    Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

Indicate the number of shares outstanding of each of the issuer’s classes of Common Stock, as of the latest practicable date: 1,014,015,081 shares of Common Stock were issued, and 1,013,915,081 shares of Common Stock were outstanding as of February 14, 2023.

 

 

 

   
 

 

    PAGE
PART I FINANCIAL INFORMATION F-1
     
ITEM 1. Financial Statements F-1
  Condensed Consolidated Balance Sheets as of December 31, 2022 (Unaudited) and March 31, 2022 F-1
  Condensed Consolidated Statements of Operations for the Three and Nine Months Ended December 31, 2022 and 2021 (Unaudited) F-2
  Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three and Nine Months Ended December 31, 2022 and 2021 (Unaudited) F-3
  Condensed Consolidated Statements of Cash Flows for the Nine Months Ended December 31, 2022 and 2021 (Unaudited) F-5
  Notes to the Unaudited Condensed Consolidated Financial Statements F-6
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 1
ITEM 3. Quantitative and Qualitative Disclosure About Market Risk 7
ITEM 4. Controls and Procedures 7
     
PART II OTHER INFORMATION 9
     
ITEM 1. Legal Proceedings 9
ITEM 1A. Risk Factors 9
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 9
ITEM 3. Defaults Upon Senior Securities 9
ITEM 4. Mine Safety Disclosures 9
ITEM 5. Other Information 9
ITEM 6. Exhibits 10
     
SIGNATURES 11

 

 ii  
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

 

PART I - FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

   December 31, 2022   March 31, 2022 
   (Unaudited)     
ASSETS          
Current assets:          
Cash  $17,909,077   $8,535,357 
Accounts receivable   5,545,843    3,057,913 
Inventory   8,601,858    6,741,170 
Prepaid expenses and other current assets   1,108,062    526,949 
Total current assets   33,164,840    18,861,389 
           
Property and equipment, net of accumulated depreciation of $14,271,930 and $13,348,565, respectively   10,230,034    5,952,992 
           
Intangible assets, net of accumulated amortization of $-0-, respectively   6,634,035    6,634,035 
           
Operating lease - right-of-use asset   18,502    1,031,884 
           
Deferred income tax asset   2,171,821    2,171,821 
           
Other assets:          
Restricted cash - debt service for NJEDA bonds   405,164    405,039 
Security deposits   91,738    91,738 
Total other assets   496,902    496,777 
Total assets  $52,716,134   $35,148,898 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $1,472,198   $1,430,985 
Accrued expenses   4,676,244    4,693,142 
Deferred revenue, current portion   13,333    13,333 
Bonds payable, current portion, net of bond issuance costs   110,822    100,822 
Loans payable, current portion   360,616    253,006 
Lease obligation - operating lease, current portion   21,149    202,953 
Total current liabilities   6,654,362    6,694,241 
           
Long-term liabilities:          
Deferred revenue, net of current portion   22,223    32,226 
Bonds payable, net of current portion and bond issuance costs   1,025,479    1,139,848 
Loans payable, net of current portion and loan costs   14,463,789    249,046 
Lease obligation - operating lease, net of current portion   —    835,893 
Derivative financial instruments - warrants   375,767    936,837 
Other long-term liabilities   —    38,780 
Total long-term liabilities   15,887,258    3,232,630 
Total liabilities   22,541,620    9,926,871 
Shareholders’ equity:          
Series J convertible preferred stock; par value of $0.01; 50 shares authorized; 0 issued and outstanding as of December 31, 2022 and March 31, 2022   —    — 
Common stock; par value $0.001; 1,445,000,000 shares authorized; 1,014,015,081 and 1,011,381,988 shares issued as of December 31, 2022 and March 31, 2022, respectively; 1,013,915,081 and 1,011,281,988 shares outstanding as of December 31, 2022 and March 31, 2022, respectively   1,014,019    1,011,385 
Additional paid-in capital   164,735,980    164,577,227 
Treasury stock; 100,000 shares as of December 31, 2022 and March 31, 2022; at cost   (306,841)   (306,841)
Accumulated deficit   (135,268,644)   (140,059,744)
Total shareholders’ equity   30,174,514    25,222,027 
Total liabilities and shareholders’ equity  $52,716,134   $35,148,898 

 

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

 

F-1
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

                             
   For the Three Months Ended December 31,   For the Nine Months Ended December 31, 
   2022   2021   2022   2021 
Revenue:                    
Manufacturing fees  $7,798,159   $7,667,674   $21,312,663   $20,639,421 
Licensing fees   1,451,907    1,307,140    4,200,888    3,950,623 
Total revenue   9,250,066    8,974,814    25,513,551    24,590,044 
Cost of manufacturing   4,330,841    4,957,150    12,360,935    13,209,430 
Gross profit   4,919,225    4,017,664    13,152,616    11,380,614 
                     
Operating expenses:                    
Research and development   1,443,361    956,628    3,775,107    3,312,540 
General and administrative   1,186,049    929,547    4,356,752    2,930,126 
Non-cash compensation through issuance of stock options   13,030    3,630    24,325    10,617 
Depreciation and amortization   317,685    296,559    933,531    908,297 
Total operating expenses   2,960,125    2,186,364    9,089,715    7,161,580 
                     
Income from operations   1,959,100    1,831,300    4,062,901    4,219,034 
                     
Other income (expense):                    
Change in fair value of derivative instruments   372,894    489,500    561,070    1,523,394 
Interest expense and amortization of debt issuance costs   (322,681)   (37,400)   (782,221)   (126,376)
Gain on sale of ANDA   1,000,000    —    1,000,000    — 
Interest income   15    13    187    77 
Other income, net   1,050,228    452,113    779,036    1,397,095 
                     
Income before income taxes   3,009,328    2,283,413    4,841,937    5,616,129 
                     
Income tax expense   (39,250)   —    (50,837)   (4,000)
                     
Net benefit for sale of state net operating losses and credits   —    —    —    857,379 
                     
Net income attributable to common shareholders  $2,970,078   $2,283,413   $4,791,100   $6,469,508 
                     
Basic net income per share attributable to common shareholders  $0.00   $0.00   $0.00   $0.01 
                     
Diluted net income per share attributable to common shareholders  $0.00   $0.00   $0.01   $0.00 
                     
Basic weighted average Common Stock outstanding   1,013,915,081    1,011,281,988    1,012,480,115    1,010,416,823 
                     
Diluted weighted average Common Stock outstanding   1,013,915,081    1,011,281,988    1,012,480,115    1,010,416,823 

 

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

 

F-2
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

(UNAUDITED)

 

   Shares   Amount   Shares   Amount  

Capital

   Shares   Amount   Deficit  Equity 
   Series J Preferred Stock   Common Stock  

Additional

Paid-In

   Treasury Stock   Accumulated  

Total

Shareholders’

 
   Shares   Amount   Shares   Amount  

Capital

   Shares   Amount   Deficit  Equity 
Balance as of March 31, 2022   —   $     —    1,011,381,988   $1,011,385   $164,577,227    100,000   $(306,841)  $(140,059,744)  $25,222,027 
                                              
Net income   —    —    —    —    —    —    —    305,883    305,883 
                                              
Non-cash compensation through the issuance of employee stock options   —    —    —    —    5,322    —    —    —    5,322 
                                              
Shares issued in payment of salaries   —    —    —    —    —    —    —    —    — 
                                              
Balance at June 30, 2022   —   $—    1,011,381,988   $1,011,385   $164,582,549    100,000   $(306,841)  $(139,753,861)  $25,533,232 
                                              
Net income   —    —    —    —    —    —    —    1,515,139    1,515,139 
                                              
Non-cash compensation through the issuance of employee stock options   —    —    —    —    5,974    —    —    —    5,974 
                                              
Share issued in payment of director salaries   —    —    1,378,608    1,379    58,621    —    —    —    60,000 
                                              
Shares issued in payment of consultants   —    —    1,254,485    1,255    75,807    —    —    —    77,062 
                                              
Balance at September 30, 2022   —   $—    1,014,015,081   $1,014,019   $164,722,951    100,000   $(306,841)  $(138,238,722)  $27,191,407 
                                              
Net income   —    —    —    —    —    —    —    2,970,078    2,970,078 
                                              
Non-cash compensation through the issuance of employee stock options   —    —    —   $—   $13,029    —   $—   $—    13,029 
                                              
Balance at December 31, 2022   —   $—    1,014,015,081   $1,014,019   $164,735,980    100,000   $(306,841)  $(135,268,644)  $30,174,514 

 

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

 

F-3
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY

(UNAUDITED)

 

   Series J Preferred Stock   Common Stock  

Additional

Paid-In

   Treasury Stock   Accumulated  

Total

Shareholders’

 
   Shares   Amount   Shares   Amount   Capital   Shares   Amount   Deficit  Equity 
Balance as of March 31, 2021   —         —    1,009,276,752   $1,009,279   $164,407,480    100,000   $(306,841)  $(148,957,989)  $16,151,929 
                                              
Net income   —    —    —    —    —    —    —    2,389,118    2,389,118 
                                              
Non-cash compensation through the issuance of employee stock options   —    —    —    —    2,811    —    —    —    2,811 
                                              
Shares issued in payment of salaries   —    —    2,105,236    2,106    155,394    —    —    —    157,500 
                                              
Balance at June 30, 2021   —   $—    1,011,381,988   $1,011,385   $164,565,685    100,000   $(306,841)  $(146,568,871)  $18,701,358 
                                              
Net income   —    —    —    —    —    —    —    1,796,977    1,796,977 
                                              
Non-cash compensation through the issuance of employee stock options   —    —    —    —    4,176    —    —    —    4,176 
                                              
Balance at September 30, 2021   —   $—    1,011,381,988   $1,011,385   $164,569,861    100,000   $(306,841)  $(144,771,894)  $20,502,511 
                                              
Net income   —    —    —    —    —    —    —    2,283,413    2,283,413 
                                              
Non-cash compensation through the issuance of employee stock options   —    —    —    —    3,630    —    —    —    3,630 
                                              
Balance at December 31, 2021   —   $—    1,011,381,988   $1,011,385   $164,573,491    100,000   $(306,841)  $(142,488,481)  $22,789,554 

 

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

 

F-4
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

   2022   2021 
  

For the Nine Months Ended

December 31,

 
   2022   2021 
CASH FLOWS FROM OPERATING ACTIVITIES:          
Net income  $4,791,100   $6,469,508 
Adjustments to reconcile net income to net cash provided by operating activities:          
Depreciation and amortization   933,531    908,297 
Amortization of operating leases - right-of-use assets   61,621    175,306 
Change in fair value of derivative financial instruments - warrants   (561,070)   (1,523,394)
Non-cash compensation accrued   430,778    641,664 
Non-cash compensation through the issuance of employee stock options   24,325    10,617 
Non-cash rent expense and lease accretion   602    559 
Change in operating assets and liabilities:          
Accounts receivable   (2,487,930)   834,963 
Inventory   (1,860,688)   (1,681,168)
Prepaid expenses and other current assets   (581,113)   (367,154)
Accounts payable, accrued expenses and other current liabilities   (309,950)   (373,820)
Deferred revenue   (10,003)   (9,999)
Lease obligations - operating leases   (61,182)   (182,401)
Net cash provided by operating activities   370,021    4,902,978 
           
CASH FLOWS FROM INVESTING ACTIVITIES:          
Purchase of property and equipment   (5,200,407)   (234,387)
Net cash used in investing activities   (5,200,407)   (234,387)
           
CASH FLOWS FROM FINANCING ACTIVITIES:          
Payment of bond principal   (115,000)   (110,000)
Proceeds from loans payable   14,550,001    — 
Other loan payments   (230,770)   (462,889)
Net cash provided by (used in) financing activities   14,204,231    (572,889)
           
Net change in cash and restricted cash   9,373,845    4,095,702 
           
Cash and restricted cash, beginning of period   8,940,396    3,597,781 
           
Cash and restricted cash, end of period  $18,314,241   $7,693,483 
           
Supplemental disclosure of cash and non-cash transactions:          
Cash paid for interest  $782,221   $126,376 

Cash paid for income taxes

  $

127,522

   $— 
Financing of equipment purchases and insurance renewal  $—   $244,124 
Stock issued in payment of Directors fees, salaries and consulting expenses  $137,063   $157,500 
Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets  $—   $1,042,800 

 

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

 

F-5
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Overview

 

Elite Pharmaceuticals, Inc. (the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the State of Delaware, and its wholly-owned subsidiary Elite Laboratories, Inc. (“Elite Labs”) was incorporated on August 23, 1990 under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of Nevada. Elite Labs engages primarily in researching, developing, licensing and manufacture of generic, oral dose pharmaceuticals. The Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when the product candidates are approved. These products include drugs that cover therapeutic areas for allergy, bariatric, attention deficit and infection. Research and development activities are performed with an objective of developing product candidates that will secure marketing approvals from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting such products.

 

Principles of Consolidation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Elite Labs. All significant intercompany accounts and transactions have been eliminated in consolidation. The unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring items, which are, in the opinion of management, necessary for a fair presentation of such statements. The results of operations for the nine months ended December 31, 2022 are not necessarily indicative of the results that may be expected for the entire year.

 

Segment Information

 

Financial Accounting Standards Board (“FASB”) Accounting Standards Codification 280 (“ASC 280”), Segment Reporting, establishes standards for reporting information about operating segments. Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.

 

The Company’s chief operating decision maker is the Chief Executive Officer, who reviews the financial performance and the results of operations of the segments prepared in accordance with GAAP when making decisions about allocating resources and assessing performance of the Company.

 

The Company has determined that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug Applications (“ANDA”) and products whose marketing approvals were secured via a New Drug Application (“NDA”). ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals.

 

There are currently no intersegment revenues. Asset information by operating segment is not presented below since the chief operating decision maker does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation of the Company’s condensed unaudited consolidated financial statements. Please see Note 15 for further details.

 

Revenue Recognition

 

The Company generates revenue primarily from manufacturing and licensing fees. Manufacturing fees include the development of pain management products, manufacturing of a line of generic pharmaceutical products with approved ANDA, through the manufacture of formulations and the development of new products. Licensing fees include the commercialization of products either by license and the collection of royalties, or the expansion of licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.

 

F-6
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Under ASC 606, Revenue from Contacts with Customers (“ASC 606”), the Company recognizes revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration which is expected to be received in exchange for those goods or services. The Company recognizes revenues following the five-step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenues when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.

 

Nature of goods and services

 

The following is a description of the Company’s goods and services from which the Company generates revenue, as well as the nature, timing of satisfaction of performance obligations, and significant payment terms for each, as applicable:

 

a) Manufacturing Fees

 

The Company is equipped to manufacture controlled-release products on a contract basis for third parties, if, and when, the products are approved. These products include products using controlled-release drug technology. The Company also develops and markets (either on its own or by license to other companies) generic and proprietary controlled-release pharmaceutical products.

 

The Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms of the contract. The Company is primarily responsible for fulfilling the promise to provide the product, is responsible to ensure that the product is produced in accordance with the related supply agreement and bears risk of loss while the inventory is in-transit to the commercial partner. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a customer.

 

b) License Fees

 

The Company enters into licensing and development agreements, which may include multiple revenue generating activities, including milestones payments, licensing fees, product sales and services. The Company analyzes each element of its licensing and development agreements in accordance with ASC 606 to determine appropriate revenue recognition. The terms of the license agreement may include payment to the Company of licensing fees, non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales.

 

If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations.

 

The Company recognizes revenue from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. For those milestone payments which are contingent on the occurrence of particular future events (for example, payments due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, the Company assesses each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty of the occurrence of future events, the Company will recognize revenue from the milestone when there is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event.

 

F-7
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method.

 

When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in ASC 606-10-32-18, the Company does not assess whether a significant financing component exists if the period between when the Company performs its obligations under the contract and when the customer pays is one year or less. None of the Company’s contracts contained a significant financing component as of December 31, 2022.

 

In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.

 

The Company entered into a sales and distribution licensing agreement with Epic Pharma LLC, (“Epic”) dated June 4, 2015 (the “2015 Epic License Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly. The 2015 Epic License Agreement expired on June 4, 2020 without renewal.

 

The Company entered into a Master Development and License Agreement with SunGen Pharma LLC dated August 24, 2016 (the “SunGen Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly. On April 3, 2020, Elite and SunGen mutually agreed to discontinue any further joint product development activities.

 

Disaggregation of revenue

 

In the following table, revenue is disaggregated by type of revenue generated by the Company. The table also includes a reconciliation of the disaggregated revenue with the reportable segments:

 SCHEDULE OF DISAGGREGATION OF REVENUE

   For the Three Months Ended December 31,   For the Nine Months Ended December 31, 
   2022   2021   2022   2021 
NDA:                    
Licensing fees  $—   $—   $—   $— 
Total NDA revenue   —    —    —    — 
ANDA:                    
Manufacturing fees  $7,798,159   $7,667,674   $21,312,663   $20,639,421 
Licensing fees   1,451,907    1,307,140    4,200,888    3,950,623 
Total ANDA revenue   9,250,066    8,974,814    25,513,551    24,590,044 
Total revenue  $9,250,066   $8,974,814   $25,513,551   $24,590,044 

 

Cash

 

The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks and money market instruments. The Company places its cash and cash equivalents with high-quality, U.S. financial institutions and, to date has not experienced losses on any of its balances.

 

F-8
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Restricted Cash

 

As of December 31, 2022, and March 31, 2022, the Company had $405,164 and $405,039, of restricted cash, respectively, related to debt service reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 6).

 

Accounts Receivable

 

Accounts receivable are comprised of balances due from customers, net of estimated allowances for uncollectible accounts. In determining collectability, historical trends are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances.

 

Inventory

 

Inventory is recorded at the lower of cost or net realizable value on specific identification by lot number basis.

 

Long-Lived Assets

 

The Company periodically evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events or changes in circumstances indicate that its carrying amounts may not be recoverable.

 

Property and equipment are stated at cost. Depreciation is provided on the straight-line method based on the estimated useful lives of the respective assets which range from three to forty years. Major repairs or improvements are capitalized. Minor replacements and maintenance and repairs which do not improve or extend asset lives are expensed currently.

 

Upon retirement or other disposition of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting gain or loss, if any, is recognized in income.

 

Intangible Assets

 

The Company capitalizes certain costs to acquire intangible assets; if such assets are determined to have a finite useful life they are amortized on a straight-line basis over the estimated useful life. Costs to acquire indefinite lived intangible assets, such as costs related to ANDAs are capitalized accordingly.

 

The Company tests its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that indicate impairment may have occurred. A significant amount of judgment is involved in determining if an indicator of impairment has occurred. Such indicators may include, among others and without limitation: a significant decline in the Company’s expected future cash flows; a sustained, significant decline in the Company’s stock price and market capitalization; a significant adverse change in legal factors or in the business climate of the Company’s segments; unanticipated competition; and slower growth rates.

 

As of December 31, 2022, the Company did not identify any indicators of impairment.

 

Please also see Note 4 for further details on intangible assets.

 

Research and Development

 

Research and development expenditures are charged to expense as incurred.

 

Contingencies

 

Occasionally, the Company may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated. If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed consolidated financial statements. Contingencies are inherently unpredictable, and the assessments of the value can involve a series of complex judgments about future events and can rely heavily on estimates and assumptions.

 

F-9
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Income Taxes

 

Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce any deferred tax assets that it determines will not be realizable in the future.

 

The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution.

 

The Company operates in multiple tax jurisdictions within the United States of America. The Company remains subject to examination in all tax jurisdiction until the applicable statutes of limitation expire. As of December 31, 2022, a summary of the tax years that remain subject to examination in our major tax jurisdictions are: United States – Federal, 2016 and forward. The Company did not record unrecognized tax positions for the nine months ended December 31, 2022.

 

Warrants and Preferred Shares

 

The accounting treatment of warrants and preferred share series issued is determined pursuant to the guidance provided by ASC 470, Debt, ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging, as applicable. Each feature of a freestanding financial instrument including, without limitation, any rights relating to subsequent dilutive issuances, dividend issuances, equity sales, rights offerings, forced conversions, optional redemptions, automatic monthly conversions, dividends and exercise is assessed with determinations made regarding the proper classification in the Company’s financial statements.

 

Stock-Based Compensation

 

The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation. Under the fair value recognition provisions, stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as an expense on a straight-line basis over the requisite service period, based on the terms of the awards. The cost of the stock-based payments to nonemployees that are fully vested and non-forfeitable as at the grant date is measured and recognized at that date, unless there is a contractual term for services in which case such compensation would be amortized over the contractual term.

 

In accordance with the Company’s Director compensation policy and certain employment contracts, director’s fees and a portion of employee’s salaries are to be paid via the issuance of shares of the Company’s Common Stock (“Common Stock”), in lieu of cash, with the valuation of such share being calculated on a quarterly basis and equal to the average closing price of the Company’s Common Stock.

 

Sale of ANDA

 

During the nine months ended December 31, 2022, the Company entered into an agreement with Pyros Pharmaceuticals, Inc. (“Pyros”) pursuant to which the Company sold to Pyros its rights in and to the Company’s approved abbreviated new drug applications (ANDAs) for its generic Sabril drug. The Company sold its rights to Pyros for $1,000,000, which was recorded as gain on sale of ANDA during the nine months ended December 31, 2022. There is no further action required by the Company regarding the rights which would affect future periods.

 

In conjunction with the sale of its Product to Pyros, the Company executed a Manufacturing and Supply agreement (the “Pyros Agreement”) with Pyros. Under the terms of the Pyros Agreement, the Company will receive an agreed-upon price per drug for the manufacturing and packaging of Sabril over a term of three years. Revenue per the Pyros Agreement will be recognized as control of the manufactured and supplied drugs is transferred to Pyros (at the time of delivery).

 

Earnings Per Share Attributable to Common Shareholders’

 

The Company follows ASC 260, Earnings Per Share, which requires presentation of basic and diluted earnings per share (“EPS”) on the face of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. In the accompanying financial statements, basic earnings per share is computed by dividing net income by the weighted average number of shares of Common Stock outstanding during the period. The computation of diluted net income per share does not include the conversion of securities that would have an antidilutive effect.

 

F-10
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

The following is the computation of earnings per share applicable to common shareholders for the periods indicated:

 

 SCHEDULE OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS

   2022   2021   2022   2021 
   For the Three Months Ended December 31,   For the Nine Months Ended December 31, 
   2022   2021   2022   2021 
Numerator                    
Net income - basic  $2,970,078   $2,283,413   $4,791,100   $6,469,508 
Effect of dilutive instrument on net income   372,894    (489,500)   561,070    (1,523,394)
Net income - diluted  $3,342,972   $1,793,913   $5,352,170   $4,946,114 
                     
Denominator                    
Weighted average shares of Common Stock outstanding - basic   1,013,915,081    1,011,281,988    1,012,480,115    1,010,416,823 
                     
Dilutive effect of stock options and convertible securities   —    —    —    — 
                     
Weighted average shares of Common Stock outstanding - diluted   1,013,915,081    1,011,281,988    1,012,480,115    1,010,416,823 
                     
Net income per share                    
Basic  $0.00   $0.00   $0.00   $0.01 
Diluted  $0.00   $0.00   $0.01   $0.00 

 

Fair Value of Financial Instruments

 

ASC 820, Fair Value Measurements and Disclosures (“ASC 820”) provides a framework for measuring fair value in accordance with generally accepted accounting principles.

 

ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC 820 establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs).

 

The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy under ASC 820 are described as follows:

 

  ● Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible at the measurement date.
  ● Level 2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset or liability; and inputs that are derived principally from or corroborated by observable market data by correlation or other means.
  ● Level 3 – Inputs that are unobservable for the asset or liability.

 

F-11
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Measured on a Recurring Basis

 

The following table presents information about our liabilities measured at fair value on a recurring basis, aggregated by the level in the fair value hierarchy within which those measurements fell:

 SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE ON A RECURRING BASIS

       Fair Value Measurement Using 
   Amount at Fair Value   Level 1   Level 2   Level 3 
Balance as of March 31, 2022  $936,837   $—   $—   $936,837 
Change in fair value of derivative instruments   (561,070)   —    —    (561,070)
Balance as of December 31, 2022  $375,767   $—   $—   $375,767 

 

See Note 11 for specific inputs used in determining fair value.

 

The carrying amounts of the Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses, approximate their fair values because of the short maturity of these instruments. Based upon current borrowing rates with similar maturities the carrying value of long-term debt approximates fair value.

 

Non-Financial Assets that are Measured at Fair Value on a Non-Recurring Basis

 

Non-financial assets such as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized. The Company did not record an impairment charge related to these assets in the periods presented.

 

Treasury Stock

 

The Company records treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’ equity.

 

Recently Issued Accounting Pronouncements

 

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. This update requires immediate recognition of management’s estimates of current expected credit losses (“CECL”). Under the prior model, losses were recognized only as they were incurred. The new model is applicable to all financial instruments that are not accounted for at fair value through net income. The standard is effective for fiscal years beginning after December 15, 2022 for public entities qualifying as smaller reporting companies. Early adoption is permitted. The Company is currently assessing the impact of this update on the consolidated financial statements and does not expect a material impact on the consolidated financial statements.

 

Management has evaluated other recently issued accounting pronouncements and does not believe that any of these pronouncements will have a significant impact on our consolidated financial statements and related disclosures.

 

NOTE 2. INVENTORY

 

Inventory consisted of the following:

 SCHEDULE OF INVENTORY

   December 31, 2022   March 31, 2022 
Finished goods  $327,827   $159,808 
Work-in-progress   99,283    1,203,204 
Raw materials   8,174,748    5,378,158 
Inventory, net  $8,601,858   $6,741,170 

 

F-12
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

NOTE 3. PROPERTY AND EQUIPMENT, NET

 

Property and equipment consisted of the following:

  

   December 31, 2022   March 31, 2022 
Land, building and improvements  $10,556,523   $5,456,524 
Laboratory, manufacturing, warehouse and transportation equipment   13,118,139    13,017,731 
Office equipment and software   373,601    373,601 
Furniture and fixtures   453,701    453,701 
Property and equipment, gross   24,501,964    19,301,557 
Less: Accumulated depreciation   (14,271,930)   (13,348,565)
Property and equipment, net  $10,230,034   $5,952,992 

 

Depreciation expense was $314,610 and $293,014 for the three months ended December 31, 2022 and 2021, respectively, and $923,365 and $897,662 for the nine months ended December 31, 2022 and 2021, respectively.

 

NOTE 4. INTANGIBLE ASSETS

 

The following table summarizes the Company’s intangible assets:


   December 31, 2022 
   Estimated   Gross                 
   Useful   Carrying           Accumulated   Net Book 
   Life   Amount   Additions   Reductions   Amortization   Value 
Patent application costs   *   $465,684   $     —   $     —   $      —   $465,684 
ANDA acquisition costs   Indefinite     6,168,351    —    —    —    6,168,351 
        $6,634,035   $—   $—   $—   $6,634,035 

 

   March 31, 2022 
   Estimated   Gross                 
   Useful   Carrying           Accumulated   Net Book 
   Life   Amount   Additions   Reductions   Amortization   Value 
Patent application costs  *   $465,684   $     —   $     —   $     —   $465,684 
ANDA acquisition costs   Indefinite     6,168,351    —    —    —    6,168,351 
        $6,634,035   $—   $—   $—   $6,634,035 

 

*Patent application costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs will begin upon the issuance of marketing authorization by the FDA. Amortization will then be calculated on a straight-line basis through the expiry of the related patent(s).

 

F-13
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

NOTE 5. ACCRUED EXPENSES

 

As of December 31, 2022 and March 31, 2022, the Company’s accrued expenses consisted of the following:

 

   December 31, 2022   March 31, 2022 
Salaries and fees payable in common stock   4,000,000    3,625,000 
Income tax   54,550    414,989 
Consultant contract fees   153,333    153,333 
Audit fees   144,000    140,000 
Director dues   67,500    90,000 
EWB loan interest   104,386    — 
Employee bonuses   37,500    143,000 
Other accrued expenses   114,975    126,820 
Total accrued expenses  $4,676,244   $4,693,142 

 

NOTE 6. NJEDA BONDS

 

In August 2005, the Company issued NJEDA tax exempt Bonds with Series A Notes outstanding. The Company is required to maintain a debt service reserve. The debt service reserve is classified as restricted cash on the accompanying unaudited condensed consolidated balance sheets. The NJEDA Bonds require the Company to make an annual principal payment on September 1st based on the amount specified in the loan documents and semi-annual interest payments on March 1st and September 1st, equal to interest due on the outstanding principal. The annual interest rate on the Series A Note is 6.5%. The NJEDA Bonds are collateralized by a first lien on the Company’s facility and equipment acquired with the proceeds of the original and refinanced bonds.

 

The following tables summarize the Company’s bonds payable liability:

  

   December 31, 2022   March 31, 2022 
Gross bonds payable          
NJEDA Bonds - Series A Notes  $1,245,000   $1,360,000 
Less: Current portion of bonds payable (prior to deduction of bond offering costs)   (125,000)   (115,000)
Long-term portion of bonds payable (prior to deduction of bond offering costs)  $1,120,000   $1,245,000 
           
Bond offering costs  $354,454   $354,454 
Less: Accumulated amortization   (245,753)   (235,124)
Bond offering costs, net  $108,701   $119,330 
           
Current portion of bonds payable - net of bond offering costs          
Current portions of bonds payable  $125,000   $115,000 
Less: Bonds offering costs to be amortized in the next 12 months   (14,178)   (14,178)
Current portion of bonds payable, net of bond offering costs  $110,822   $100,822 
           
Long term portion of bonds payable - net of bond offering costs          
Long term portion of bonds payable   1,120,000   $1,245,000 
Less: Bond offering costs to be amortized subsequent to the next 12 months   (94,521)   (105,152)
Long term portion of bonds payable, net of bond offering costs  $1,025,479   $1,139,848 

 

Amortization expense was $3,544 and $3,545 for the three months ended December 31, 2022 and 2021, and $10,629 and $10,635 for the nine months ended December 31, 2022 and 2021, respectively. As of December 31, 2022 and March 31, 2022, interest payable was $6,744 and $7,367, respectively.

 

F-14
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Maturities of bonds for the next five years are as follows:

   

Years ending March 31,  Amount 
2023  $— 
2024   125,000 
2025   130,000 
2026   140,000 
2027   150,000 
Thereafter   700,000 
Total  $1,245,000 

 

NOTE 7. LOANS PAYABLE

 

On April 2, 2022, the Company and Elite Labs entered into a Loan and Security Agreement (the “EWB Loan Agreement”) with East West Bank (“EWB”). Pursuant to the EWB Loan Agreement, the Company and Elite Labs received one term loan for a principal amount of $12,000,000 (the “EWB Term Loan”) and a revolving line of credit up to $2,000,000 (the “EWB Revolver,” together with the “EWB Term Loan,” the EWB Loans”), each of which shall be used for working capital. The EWB Term Loan bears interest at a rate of 9.23% (1.73% plus the prime rate (“Prime”)) and is repayable over five years, maturing on May 1, 2027. The EWB Revolver bears interest at a rate of (8.37% (0.87% plus Prime)) and matures on May 1, 2027. The total transaction costs associated with the EWB Loans incurred as of December 31, 2022, were $40,120, which are being amortized on a monthly basis over five years, beginning in April 2022. The EWB Loans are secured by a security interest in the personal property of the Company and Elite Labs. The EWB Loan Agreement contains customary representations, warranties and covenants. These covenants include, but are not limited to, maintaining maximum leverage ratios of 3.50 to 1.00, minimum liquidity of $5,000,000, minimum cash of $1,000,000, a fixed charge coverage ratio of 1.25 to 1.00 and restrictions on mergers or sales of assets and debt borrowings. As of December 31, 2022, the Company is in compliance with each financial covenant and the Company has not used any of the Revolving line of credit.

 

On July 1, 2022, the EWB provided a mortgage loan (“EWB Mortgage Loan”) in the amount of $2.55 million for the purchase of the property at 135-137 Ludlow Avenue, which was formerly a lease held by the Company. The EWB Mortgage Loan matures in 10 years and bears interest at a rate of 4.75% fixed for 5 years then adjustable at WSJP plus 0.5% with floor rate of 4.5%. The total transaction costs associated with the EWB Mortgage Loan incurred as of December 31, 2022, were $34,952, which are being amortized on a monthly basis over ten years, beginning in July 2022. The EWB Mortgage Loan contains customary representations, warranties and covenants. These covenants include maintaining a minimum debt coverage ratio of 1.50 to 1.00 tested annually and a minimum trailing 12-month debt coverage ratio of 1.50 to 1.00. As of December 31, 2022, the Company was in compliance with each financial covenant.

 

Loans payable consisted of the following:

  

   December 31, 2022   March 31, 2022 
Equipment and insurance financing and mortgage loans payable, between 4.75% and 12.02% interest and maturing between March 2023 and June 2032  $14,824,405   $502,052 
Less: Current portion of loans payable   (360,616)   (253,006)
Long-term portion of loans payable  $14,463,789   $249,046 

 

The interest expense associated with the loans payable was $317,844 and $14,692 for the three months ended December 31, 2022 and 2021, respectively, and $579,109 and $50,290 for the nine months ended December 31, 2022 and 2021, respectively.

 

F-15
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Loan principal payments for the next five years are as follows:

  

Years ending March 31,  Amount 
2023 (excluding the nine months ended December 31, 2022)  $149,322 
2024   327,317 
2025   294,157 
2026   227,306 
2027   198,040 
2028 and thereafter   13,628,263 
Total remaining principal balance  $14,824,405 

 

NOTE 8. DEFERRED REVENUE

 

Deferred revenues in the aggregate amount of $35,556 as of December 31, 2022, were comprised of a current component of $13,333 and a long-term component of $22,223. Deferred revenues in the aggregate amount of $45,559 as of March 31, 2022, were comprised of a current component of $13,333 and a long-term component of $32,226. These line items represent the unamortized amounts of a $200,000 advance payment received for a TAGI Pharma (“TAGI”) licensing agreement with a fifteen-year term beginning in September 2010 and ending in August 2025. These advance payments were recorded as deferred revenue when received and are earned, on a straight-line basis over the life of the licenses. The current component is equal to the amount of revenue to be earned during the 12-month period immediately subsequent to the balance sheet date and the long-term component is equal to the amount of revenue to be earned thereafter.

 

NOTE 9. COMMITMENTS AND CONTINGENCIES

 

Operating Leases

 

The Company entered into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the “Ludlow Ave. lease”) which began in 2010. On June 30, 2021, the Company exercised a renewal option, with such option including a term that begins on January 1, 2022 and expires on December 31, 2026. The Ludlow Ave. lease was terminated on July 1, 2022, when the Company purchased the underlying property.

 

In October 2020, the Company entered into an operating lease for office space in Pompano Beach, Florida (the “Pompano Office Lease”). The Pompano Office Lease is for approximately 1,275 square feet of office space, with Elite taking occupancy on November 1, 2020. The Pompano Office has a term of three years, ending on October 31, 2023.

 

The Company assesses whether an arrangement is a lease or contains a lease at inception. For arrangements considered leases or that contain a lease that is accounted for separately, the Company determines the classification and initial measurement of the right-of-use asset and lease liability at the lease commencement date, which is the date that the underlying asset becomes available for use. The Company has elected to account for non-lease components associated with its leases and lease components as a single lease component.

 

The Company recognizes a right-of-use asset, which represents the Company’s right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments arising over the lease term. The present value of the lease payments is calculated using either the implicit interest rate in the lease or an incremental borrowing rate.

 

F-16
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Rent expense is recorded on the straight-line basis. Rent expense under the leases for the three months ended December 31, 2022 and 2021 was $6,330 and $63,249, respectively, and $77,238 and $189,003 for the nine months ended December 31, 2022 and 2021, respectively. Rent expense is recorded in general and administrative expense in the unaudited condensed consolidated statements of operations.

 

The table below shows the future minimum rental payments, exclusive of taxes, insurance and other costs, under the Ludlow Ave. modified lease and the Pompano Office Lease:

  

Years ending March 31,  Amount 
2023 (excluding the nine months ended December 31, 2022)  $6,330 
2024   14,840 
2025   — 
2026   — 
Thereafter   — 
Total future minimum lease payments   21,170 
Less: interest   (21)
Present value of lease payments  $21,149 

 

The Company has an obligation for the restoration of its leased facility and the removal or dismantlement of certain property and equipment as a result of its business operation in accordance with ASC 410, Asset Retirement and Environmental Obligations – Asset Retirement Obligations. The Company records the fair value of the asset retirement obligation in the period in which it is incurred. The Company increases, annually, the liability related to this obligation. The liability is accreted to its present value each period and the capitalized cost is depreciated over the useful life of the related asset. Upon settlement of the liability, the Company records either a gain or loss. As of December 31, 2022, and March 31, 2022, the Company had a liability of $0 and $38,780, respectively, recorded as other long-term liabilities.

 

NOTE 10. DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS

 

The Company evaluates and accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments and Hedging Activities.

 

The Company issued warrants, with a term of ten years, to affiliates in connection with an exchange agreement dated April 28, 2017, as further described in this note below. The warrant share balance is 79,008,661 as of December 31, 2022, and March 31, 2022 with a weighted average exercise price of $0.1521 as of December 31, 2022, and March 31, 2022.

 

On April 28, 2017, the Company entered into an Exchange Agreement with Nasrat Hakim (“Hakim”), the Chairman of the Board, President, and Chief Executive Officer of the Company, pursuant to which the Company issued to Hakim 24.0344 shares of its Series J Preferred and warrants to purchase an aggregate of 79,008,661 shares of its Common Stock (the “Series J Warrants” and, along with the Series J Preferred issued to Hakim, the “Securities”) in exchange for 158,017,321 shares of Common Stock owned by Hakim. The fair value of the Series J Warrants was determined to be $6,474,674 upon issuance at April 28, 2017.

 

The Series J Warrants are exercisable for a period of 10 years from the date of issuance, commencing April 28, 2020. The initial exercise price is $0.1521 per share and the Series J Warrants can be exercised for cash or on a cashless basis. The exercise price is subject to adjustment for any issuances or deemed issuances of Common Stock or Common Stock equivalents at an effective price below the then exercise price. Such exercise price adjustment feature prohibits the Company from being able to conclude the warrants are indexed to its own stock and thus such warrants are classified as liabilities and measured initially and subsequently at fair value. The Series J Warrants also provide for other standard adjustments upon the occurrence of certain customary events.

 

F-17
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

The fair value of the Series J Warrants was calculated using a Black-Scholes model. The following assumptions were used in the Black-Scholes model to calculate the fair value of the Series J Warrants:

   

   December 31, 2022   March 31, 2022 
Fair value of the Company’s Common Stock  $0.0295   $0.0350 
Volatility   63.63%   76.55%
Initial exercise price  $0.1521   $0.1521 
Warrant term (in years)   4.3    5.1 
Risk free rate   3.96%   2.40%

 

The changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the nine months ended December 31, 2022 were as follows:

  

Balance at March 31, 2022  $936,837 
Change in fair value of derivative financial instruments - warrants   (561,070)
Balance at December 31, 2022  $375,767 

 

NOTE 11. SHAREHOLDERS’ EQUITY

 

Lincoln Park Capital Transaction - July 8, 2020 Purchase Agreement

 

On July 8, 2020, the Company entered into a purchase agreement (the “2020 LPC Purchase Agreement”), and a registration rights agreement (the “2020 LPC Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park has committed to purchase up to $25.0 million of the Company’s Common Stock, $0.001 par value per share, from time to time over the term of the 2020 LPC Purchase Agreement, at the Company’s direction.

 

The Company did not issue any shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the nine months ended December 31, 2022. In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Agreement.

 

As of December 31, 2022, the Company has issued an aggregate of 5,975,857 shares of Common Stock for net proceeds of $469,105 to Lincoln Park as initial commitment shares.

 

NOTE 12. STOCK-BASED COMPENSATION

 

Part of the compensation paid by the Company to its Directors and employees consists of the issuance of Common Stock or via the granting of options to purchase Common Stock.

 

Stock-based Director Compensation

 

The Company’s Director compensation policy, instituted in October 2009 and further revised in January 2016, includes provisions that a portion of director’s fees are to be paid via the issuance of shares of the Company’s Common Stock, in lieu of cash, with the valuation of such shares being calculated on quarterly basis and equal to the average closing price of the Company’s Common Stock.

 

As of December 31, 2022, the Company accrued director’s fees totaling $67,500, which will be paid via cash payments totaling $22,500 and the issuance of 1,193,253 shares of Common Stock. The Company anticipates that these shares of Common Stock will be issued prior to the end of the current fiscal year.

 

Stock-based Employee/Consultant Compensation

 

Employment contracts with the Company’s President and Chief Executive Officer and certain other employees and engagement contracts with certain consultants include provisions for a portion of each employee’s salaries or consultant’s fees to be paid via the issuance of shares of the Company’s Common Stock, in lieu of cash, with the valuation of such shares being calculated on a quarterly basis and equal to the average closing price of the Company’s Common Stock.

 

During the nine months ended December 31, 2022, the Company accrued salaries totaling $375,000 owed to the Company’s President and Chief Executive Officer which will be paid via the issuance of 10,000,176 shares of Common Stock.

 

As of December 31, 2022, the Company owed its President and Chief Executive Officer and certain other employees’ salaries totaling $4,000,000 which will be paid via the issuance of 60,190,955 shares of Common Stock.

 

F-18
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Options

 

Under its 2014 Stock Option Plan and prior options plans, the Company may grant stock options to officers, selected employees, as well as members of the Board of Directors and advisory board members. All options have generally been granted at a price equal to or greater than the fair market value of the Company’s Common Stock at the date of the grant. Generally, options are granted with a vesting period of up to three years and expire ten years from the date of grant. A summary of the activity of Company’s 2014 Stock Option Plan for the nine months ended December 31, 2022 is as follows:

  

   Shares Underlying Options   Weighted Average Exercise Price   Weighted Average Remaining Contractual Term (in years)  

Aggregate Intrinsic

Value

 
Outstanding at March 31, 2022   5,650,000   $0.14    2.8   $— 
Granted   4,100,000   $0.04    4.5   $— 
Outstanding at December 31, 2022   9,750,000   $0.17    2.3   $— 
Exercisable at December 31, 2022   4,530,001   $0.16    1.8   $— 

 

Options granted during the nine months ended December 31, 2022 were valued using the Black Scholes model with the following assumptions:

 

   December 31, 2022 
Term   3.0 - 10.0 
Stock Price  $0.03 
Exercise Price  $0.04 
Dividend Yield  $— 
Expected Volatility   63.6%
Risk Free Rate   4.0%

 

The aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company’s Common Stock as of December 31, 2022 and March 31, 2022 of $0.03 and $0.03, respectively.

 

As of December 31, 2022, there was $95,888 in unrecognized stock based compensation expense that will be recognized over 2.3 years.

 

NOTE 13. CONCENTRATIONS AND CREDIT RISK

 

Revenues

 

Two customers accounted for approximately 96% of the Company’s revenues for the nine months ended December 31, 2022. These two customers accounted for approximately 85% and 11% of revenues each, respectively. The same two customers accounted for 85% and 12% of revenues each, respectively, for the three months ended December 31, 2022.

 

Two customers accounted for approximately 96% of the Company’s revenues for the nine months ended December 31, 2021. These two customers accounted for approximately 85% and 11% of revenues each, respectively. The same two customers accounted for 84% and 9% of revenues each, respectively, for the three months ended December 31, 2021.

 

Accounts Receivable

 

One customer accounted for approximately 89% of the Company’s accounts receivable as of December 31, 2022.

 

F-19
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Two customers accounted for approximately 91% the Company’s accounts receivable as of March 31, 2022. These two customers accounted for approximately 78% and 13% of accounts receivable each, respectively.

 

Purchasing

 

One supplier accounted for approximately 62% of the Company’s purchases of raw materials for the nine months ended December 31, 2022.

 

One supplier accounted for approximately 55% of the Company’s purchases of raw materials for the nine months ended December 31, 2021.

 

NOTE 14. SEGMENT RESULTS

 

FASB ASC 280-10-50 requires use of the “management approach” model for segment reporting. The management approach is based on the way a company’s management organized segments within the company for making operating decisions and assessing performance. Reportable segments are based on products and services, geography, legal structure, management structure, or any other manner in which management disaggregates a company.

 

The Company has determined that its reportable segments are ANDAs for generic products and NDAs for branded products. The Company identified its reporting segments based on the marketing authorization relating to each and the financial information used by its chief operating decision maker to make decisions regarding the allocation of resources to and the financial performance of the reporting segments.

 

Asset information by operating segment is not presented below since the chief operating decision maker does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation of the Company’s unaudited condensed consolidated financial statements.

 

The following represents selected information for the Company’s reportable segments:

  

   2022   2021   2022   2021 
   For the Three Months Ended December 31,  

For the Nine Months Ended

December 31,

 
   2022   2021   2022   2021 
Operating Income by Segment                    
ANDA  $3,828,493   $3,061,035   $7,947,118   $8,068,073 
NDA   —   $—    —   $— 
Operating income by Segment  $3,828,493   $3,061,035   $7,947,118   $8,068,073 

 

The table below reconciles the Company’s operating income by segment to income before income taxes as reported in the Company’s unaudited condensed consolidated statements of operations.

 

   2022   2021   2022   2021 
   For the Three Months Ended December 31,   For the Nine Months Ended December 31, 
   2022   2021   2022   2021 
Operating income by segment  $3,828,493   $3,061,035   $7,947,118   $8,068,073 
Corporate unallocated costs   (378,867)   (716,881)   (1,465,792)   (2,288,461)
Interest income   15    13    187    77 
Interest expense and amortization of debt issuance costs   (322,681)   (37,400)   (782,221)   (126,376)
Depreciation and amortization expense   (317,685)   (296,559)   (933,531)   (908,297)
Significant non-cash items   (172,841)   (216,295)   (484,894)   (652,281)
Change in fair value of derivative instruments   372,894    489,500    561,070    1,523,394 
Income before income taxes  $3,009,328   $2,283,413   $4,841,937   $5,616,129 

 

F-20
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

NOTE 15. RELATED PARTY AGREEMENTS WITH MIKAH PHARMA, LLC

 

On December 3, 2018, the Company executed a development agreement with Mikah Pharma LLC (“Mikah”), pursuant to which Mikah and the Company will collaborate to develop and commercialize generic products including formulation development, analytical method development, bioequivalence studies and manufacture of development batches of generic products. Mikah was founded in 2009 by Hakim, a related party and the Company’s President, Chief Executive Officer and Chairman of the Board. As of March 31, 2021, the Company has incurred costs which are $238,451 in excess of advanced payments received to date from Mikah. This balance due from Mikah was offset, in full, against accrued interest due and owing to Mikah pursuant to the Secured Promissory Note, dated May 15, 2017, issued by the Company to Mikah..

 

In May 2020, SunGen Pharma LLC (“SunGen”), pursuant to an asset purchase agreement, assigned its rights and obligations under the SunGen Agreement for Amphetamine IR and Amphetamine ER to Mikah Pharmaceuticals. The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s name. Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations for these products from SunGen. Mikah Pharmaceuticals was founded in 2009 by Nasrat Hakim, a related party and the Company’s President, Chief Executive Officer and Chairman of the Board.

 

In June 2021, the Company entered into a development and license agreement with Mikah Pharma LLC, pursuant to which Mikah Pharma LLC will engage in the research, development, sales and licensing of generic pharmaceutical products. In addition, Mikah Pharma LLC will collaborate to develop and commercialize generic products including formulation development, analytical method development, manufacturing, sales and marketing of generic products. Initially two generic products were identified for the parties to develop.

 

NOTE 16. INCOME TAXES

 

The Company’s effective tax rate was 11.5% and income tax expense for the nine months ended December 31, 2022 was $50,837. The Company’s effective tax rate was 10.75% and income tax expense was $4,000 for the nine months ended December 31, 2021. The Company has evaluated its deferred tax assets, specifically its net operating loss carryovers, for realizability and has provided a valuation allowance on the majority of its deferred tax assets. The valuation allowance is the reason that the effective tax rate and income tax expense are different than the statutory rate of 21%.

 

NOTE 17. COVID-19 UPDATE

 

In December 2019, the Novel Corona Virus, COVID-19 was reported to have emerged in Wuhan, China. In March 2020, the World Health Organization (“WHO”) declared the COVID-19 outbreak a global pandemic. Governments at the national, state and local level in the United States, and globally, have implemented aggressive actions to reduce the spread of the virus, with such actions including, without limitation, lockdown and shelter in place orders, limitations on non-essential gatherings of people, suspension of all non-essential travel, and ordering certain businesses and governmental agencies to cease non-essential operations at physical locations. Under current and applicable laws and regulations, the Company’s business is deemed essential and it has continued to operate in all aspects of its pharmaceutical manufacturing, distribution, product development, regulatory compliance and other activities. The Company’s management has developed and implemented a range of measures to address the risks, uncertainties, and operational challenges associated with operating in a COVID-19 environment. The Company is closely monitoring the rapidly evolving and changing situation and are implementing plans intended to limit the impact of COVID-19 on our business so that the Company can continue to manufacture those medicines used by end user patients. Actions the Company has taken to date are, without limitation, further described below.

 

F-21
 

 

ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Workforce

 

The Company has taken and will continue to take, proactive measures to provide for the well-being of its workforce while continuing to safely produce pharmaceutical products. The Company has implemented alternative working practices, which include, without limitation, modified schedules, shift rotation and work at home abilities for appropriate employees to best ensure adequate social distancing. In addition, the Company increased its already thorough cleaning protocols throughout its facilities and has prohibited visits from non-essential visitors. Certain of these measures have resulted in increased costs.

 

Manufacturing and Supply Chain

 

During the nine months ended December 31, 2022, and as of the date of this Quarterly Report on Form 10-Q, the Company has not experienced material, detrimental issues related to COVID-19 in its manufacturing, supply chain, quality assurance and regulatory compliance activities, and has been able to operate without interruption. The Company has taken, and plans to continue to take, commercially practical measures to keep its facilities open. The Company’s supply chains remain intact and operational, and the Company is in regular communications with its suppliers and third-party partners. A prolonging of the current situation relating to COVID-19 may result in an increased risk of interruption in the Company supply chain in the future, with no assurances given as the materiality of such future interruption on the Company’s business, financial condition, results of operations and cash flows.

 

NOTE 18. SUBSEQUENT EVENTS

 

[update through filing]

 

F-22
 

 

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 for the nine months ended December 31, 2022 and 2021 should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements that are included elsewhere in this report. Our discussion includes forward-looking statements based upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth under Item 1A. Risk Factors appearing in our Annual Report on Form 10-K for the year ended March 31, 2022. We use words such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions to identify forward-looking statements.

 

Unless expressly indicated or the context requires otherwise, the terms “Elite”, the “Company”, “we”, “us”, and “our” refer to Elite Pharmaceuticals, Inc. and subsidiary.

 

Background

 

Elite Pharmaceuticals, Inc., a Nevada corporation (the “Company”, “Elite”, “Elite Pharmaceuticals”, the “registrant”, “we”, “us” or “our”) was incorporated on October 1, 1997 under the laws of the State of Delaware, and its wholly-owned subsidiary, Elite Laboratories, Inc. (“Elite Labs”), was incorporated on August 23, 1990 under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of Nevada.

 

We are a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, using proprietary know-how and technology for the manufacture of generic pharmaceuticals. Our strategy includes developing generic versions of controlled-release drug products with high barriers to entry.

 

We occupy manufacturing, warehouse, laboratory and office space at 165 Ludlow Avenue and 135 Ludlow Avenue in Northvale, NJ (the “Northvale Facility”) . The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States Drug Enforcement Agency (“DEA”) registered facility for research, development and manufacturing. We are also party to an operating lease for office space at Pompano Beach, Florida (the “Pompano Office Lease”).

 

Strategy

 

We focus our efforts on the following areas: (i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New Drug Applications (“ANDAs”); (ii) development of additional generic pharmaceutical products; (iii) development of the other products in our pipeline including the products with our partners; (iv) commercial exploitation of our products either by license and the collection of royalties, or through the manufacture of our formulations; and (v) development of new products and the expansion of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.

 

Our focus is on the development of various types of drug products, including generic drug products which require ANDAs as well as branded drug products which require New Drug Applications (“NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Drug Price Competition Act”).

 

We believe that our business strategy enables us to reduce its risk by having a diverse product portfolio that includes generic products in various therapeutic categories and to build collaborations and establish licensing agreements with companies with greater resources thereby allowing us to share costs of development and improve cash-flow.

 

1
 

 

Recent Developments

 

Pyros Agreement

 

During the nine months ended December 31, 2022, the Company entered into an agreement with Pyros Pharmaceuticals, Inc. (“Pyros”) pursuant to which the Company sold to Pyros its rights in and to the Company’s approved abbreviated new drug applications (ANDAs) for its generic Sabril drug. The Company sold its rights to Pyros for $1,000,000, which was recorded as gain on sale of ANDA during the nine months ended December 31, 2022. There is no further action required by the Company regarding the rights which would affect future periods.

 

In conjunction with the sale of its Product to Pyros, the Company executed a Manufacturing and Supply agreement (the “Pyros Agreement”) with Pyros. Under the terms of the Pyros Agreement, the Company will receive an agreed-upon price per drug for the manufacturing and packaging of Sabril over a term of three years. Revenue per the Pyros Agreement will be recognized as control of the manufactured and supplied drugs is transferred to Pyros (at the time of delivery).

 

Notice of Termination of License, Supply and Distribution Agreement

 

On September 14, 2022, the Company has provided written notice pursuant to Section 8.2 of the License, Supply and Distribution Agreement between the Company and Elite Laboratories, Inc. and Epic Pharma, Inc. dated November 21, 2020 (“the Epic Agreement”) that the Company and Elite Laboratories, Inc. are now providing notice of termination of the Epic Agreement, with such termination to be effective March 31, 2023.

 

Commercial Products

 

We own, license, contract manufacture or have contractual rights to receive royalties from the following products currently approved for commercial sale:

 

Product   Branded Product Equivalent   Therapeutic Category  

Launch

Date

Phentermine HCl 37.5mg tablets (“Phentermine 37.5mg”)     Adipex-P®   Bariatric     April 2011
Phendimetrazine Tartrate 35mg tablets (“Phendimetrazine 35mg”)     Bontril®   Bariatric     November 2012
Phentermine HCl 15mg and 30mg capsules (“Phentermine 15mg” and “Phentermine 30mg”)     Adipex-P®   Bariatric     April 2013

Naltrexone HCl 50mg tablets

(“Naltrexone 50mg”)

  Revia®   Addiction Treatment     September 2013
Isradipine 2.5mg and 5mg capsules (“Isradipine 2.5mg” and “Isradipine 5mg”)     n/a   Cardiovascular   January 2015
Oxycodone HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets (“OXY IR 5mg”, “Oxy IR 10mg”, “Oxy IR 15mg”, “OXY IR 20mg” and “Oxy IR 30mg”)     Roxycodone®   Pain     March 2016
Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine 100mg”)     Surmontil®   Antidepressant   May 2017
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets (“Amphetamine IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine IR 12.5mg”, “Amphetamine IR 15mg”, “Amphetamine IR 20mg” and “Amphetamine IR 30mg”)     Adderall®   Central Nervous System (“CNS”) Stimulant     April 2019
Dantrolene Sodium Capsules 25mg, 50mg and 100mg (“Dantrolene 25mg”, “Dantrolene 50mg”, “Dantrolene 100mg”)     Dantrium®   Muscle Relaxant     June 2019
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules (“Amphetamine ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine ER 20mg”, “Amphetamine ER 25mg”, and “Amphetamine ER 30mg”)   Adderall XR®   Central Nervous System (“CNS”) Stimulant   March 2020
Loxapine Succinate 5mg, 10mg, 25mg and 50gm capsules (“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”, and Loxapine 50mg”)   Loxapine®   Antipsychotic   May 2021

 

2
 

 

Approved Products Not Yet Commercialized

 

Acetaminophen and Codeine Phosphate

 

The Company received approval on September 10, 2019 from the FDA of an ANDA for a generic version of Tylenol® with Codeine (acetaminophen and codeine phosphate). Acetaminophen with codeine is a combination medication indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. The Company is not pursuing licensing deals for any opioids at this time and, in light of the current market and litigation around opioid products, the Company has no plans to commercialize this product at this time.

 

The Company received approval on June 27, 2022 from the FDA of an ANDA for a generic version of Sabril® (Vigabatrin USP) 500 mg powder for solution packet. Vigabatrin is an antiepileptic drug indicated for refractory complex partial seizures and used as an adjunctive therapy in patients who have inadequately responded to several alternative treatments. We are evaluating potential commercial opportunities.

 

The Company received approval on April 4, 2022 from the FDA of an ANDA for a generic version of Doxycycline (doxycycline hyclate) 100mg tablets. Doxycycline hyclate is an antibiotic that is used to treat a wide variety of bacterial infections. This product was co-developed and co-owned by Elite and Praxgen Pharmaceuticals LLC, formerly SunGen Pharma LLC. We are evaluating potential commercial opportunities.

 

Critical Accounting Policies and Estimates

 

The preparation of the unaudited condensed consolidated financial statements and related disclosures in conformity with GAAP, and our discussion and analysis of the Company’s financial condition and operating results require our management to make judgments, assumptions and estimates that affect the amounts reported in the Company’s unaudited condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on various other assumptions it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates and such differences may be material.

 

There were no significant changes during the nine months ended December 31, 2022 to the items that we disclosed as our significant accounting policies and estimates described in “Note 1, Summary of Significant Accounting Policies” to the Company’s financial statements as contained in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2022.

 

Results of Operations

 

The following set forth our results of operations for the periods presented. The period-to-period comparison of financial results is not necessarily indicative of future results.

 

Three months ended December 31, 2022 compared to December 31, 2021

 

Revenue, Cost of revenue and Gross profit:

 

   For the Three Months Ended December 31,   Change 
   2022   2021   Dollars   Percentage 
Manufacturing fees  $7,798,159   $7,667,674   $130,485    2%
Licensing fees   1,451,907    1,307,140    144,767    11%
Total revenue   9,250,066    8,974,814    275,252    3%
Cost of manufacturing   4,330,841    4,957,150    (626,309)   (13)%
Gross profit  $4,919,225   $4,017,664   $901,561    22%
                     
Gross profit - percentage   53%   45%          

 

Total revenues for the three-month period ended December 31, 2022 increased by $0.28 million or 3%, to $9.25 million, as compared to $8.97 million, for the corresponding period of the prior year, primarily due to the increased sales of Amphetamine IR Tablets and Amphetamine ER Capsules during the three month period ended December 31, 2022 as compared to the comparable period of the prior fiscal year.

 

Manufacturing fees increased by $0.13 million, or 2%, primarily due to increased sales of Amphetamine IR Tablets and Amphetamine ER Capsules during the three month period ended December 31, 2022 as compared to the comparable period of the prior fiscal year.

 

Licensing fees increased by $0.14 million, or 11%. This increase is primarily due to licensing fees earned from the sale of Amphetamine ER Capsules and Amphetamine IR Tablets during the three months ended December 31, 2022 as compared to the comparable period of the prior fiscal year.

 

Costs of revenue consists of manufacturing and assembly costs. Our costs of revenue decreased by $0.63 million or 13%, to $4.33 million as compared to $4.96 million for the corresponding period in the prior fiscal year. This decrease was due in large part to an improved margin on products sold during the three months ended December 31, 2022, as compared to the comparable period of the prior fiscal year.

 

3
 

 

Our gross profit margin was 53% during the three months ended December 31, 2022 as compared to 45% during the comparable period of the prior fiscal year.

 

Operating expenses:

 

   For the Three Months Ended December 31,   Change 
   2022   2021   Dollars   Percentage 
Operating expenses:                    
Research and development  $1,443,361   $956,628   $486,733    51%
General and administrative   1,186,049    929,547    256,502    28%
Non-cash compensation   13,030    3,630    9,400    259%
Depreciation and amortization   317,685    296,559    21,126    7%
Total operating expenses  $2,960,125   $2,186,364   $773,761    35%

 

Operating expenses consist of research and development costs, general and administrative costs, non-cash compensation and depreciation and amortization expenses. Operating expenses from the three months ended December 31, 2022 increased by $0.8 million, or 35%, to $3.0 million as compared to $2.2 million for the corresponding period in the prior fiscal year.

 

Research and development costs during the three months ended December 31, 2022 were $1.4 million, an increase of $0.5 million, or 51%, from approximately $1.0 million of such costs for the comparable period of the prior year. The increase was a result of the timing and nature of product development activities during the three month period ended December 31, 2022 as compared to the comparable period of the prior fiscal year.

 

General and administrative expenses during the three months ended December 31, 2022 were $1.2 million, an increase of $0.3 million, or 28% from $0.9 million of such costs for the comparable period of the prior year due to increased spending in payroll and professional expense.

 

Non-cash compensation expense during the three months ended December 31, 2022 and December 31, 2021 was less than $0.1 million.

 

Depreciation and amortization expenses during the three months ended December 31, 2022 were $0.3 million, which was virtually unchanged from $0.3 million in such costs for the comparable period of the prior fiscal year.

 

As a result of the foregoing, our income from operations during the three months ended December 31, 2022 was $2.0 million, compared to income from operations of $1.8 million for the comparable period of the prior fiscal year.

 

Other income (expense):

 

   For the Three Months Ended December 31,   Change 
   2022   2021   Dollars   Percentage 
Other income (expense):                    
Change in fair value of derivative instruments  $372,894   $489,500   $(116,606)   (24)%
Interest expense and amortization of debt issuance costs   (322,681)   (37,400)   (285,281)   763%
Gain on sale of ANDA   1,000,000    —    1,000,000    100%
Interest income   15    13    2    15%
Other (expense) income, net  $1,050,228   $452,113   $598,115    132%

 

4
 

 

Other income (expense) for the three months ended December 31, 2022 was $1.1 million, an increase of $0.6 million from the other income (expense) of $0.5 million for the comparable period of the prior fiscal year. The increase was due to the gain on sale of ANDA, offset by an increase in interest expense and amortization of debt issuance costs during the three months ended December 31, 2022. Please note that the change in the fair value of derivative instruments is determined in large part by the change in the closing price of the Company’s Common Stock as of the end of the period, as compared to the closing price at the beginning of the period, with a strong inverse relationship between the fair value of our derivatives instruments and decreases in the closing price of the Company’s Common Stock. Please see Note 11 to the Unaudited Condensed Consolidated Financial Statements above.

 

The increase in interest expense was primarily attributable to the increased interest payments related to the loan and mortgage the Company obtained from East West Bank.

 

As a result of the foregoing, our net income before the net benefit from sale of net operating loss credits for the three months ended December 31, 2022 was $3.0 million, compared to net income $2.3 million for the comparable period of the prior fiscal year.

 

Nine months ended December 31, 2022 compared to December 31, 2021

 

Revenue, Cost of revenue and Gross profit:

 

   For the Nine Months Ended December 31,   Change 
   2022   2021   Dollars   Percentage 
Manufacturing fees  $21,312,663   $20,639,421   $673,242    3%
Licensing fees   4,200,888    3,950,623    250,265    6%
Total revenue   25,513,551    24,590,044    923,507    4%
Cost of manufacturing   12,360,935    13,209,430    (848,495)   (6)%
Gross profit  $13,152,616   $11,380,614   $1,772,002    16%
                     
Gross profit - percentage   52%   46%          

 

Total revenues for the nine months period ended December 31, 2022 increased by $0.9 million or 4%, to $25.5 million, as compared to $24.6 million, for the corresponding period of the prior year, primarily due to the increased sales of Amphetamine IR Tablets and Amphetamine ER Capsules during the nine months ended December 31, 2022 as compared to the comparable period of the prior fiscal year.

 

Manufacturing fees increased by $0.7 million, or 3%, primarily due to increased sales of Amphetamine IR Tablets and Amphetamine ER Capsules during the nine months ended December 31, 2022 as compared to the comparable period of the prior fiscal year.

 

Licensing fees increased by $0.3 million, or 6%. This increase is primarily due to licensing fees earned from the sale of Amphetamine ER Capsules and Amphetamine IR Tablets during the nine months ended December 31, 2022 as compared to the comparable period of the prior fiscal year.

 

Costs of revenue consists of manufacturing and assembly costs. Our costs of revenue decreased by $0.8 million or 6%, to $12.4 million as compared to $13.2 million for the corresponding period in the prior fiscal year. This decrease was due to an improved margin on products sold during the nine months ended December 31, 2022, as compared to the comparable period of the prior fiscal year.

 

Our gross profit margin was 52% during the nine months ended December 31, 2022 as compared to 46% during the comparable period of the prior fiscal year.

 

5
 

 

Operating expenses:

 

   For the Nine Months Ended December 31,   Change 
   2022   2021   Dollars   Percentage 
Operating expenses:                    
Research and development  $3,775,107   $3,312,540   $462,567    14%
General and administrative   4,356,752    2,930,126    1,426,626    49%
Non-cash compensation   24,325    10,617    13,708    129%
Depreciation and amortization   933,531    908,297    25,234    3%
Total operating expenses  $9,089,715   $7,161,580   $1,928,135    27%

 

Operating expenses consist of research and development costs, general and administrative costs, non-cash compensation and depreciation and amortization expenses. Operating expenses for the nine months ended December 31, 2022 increased by $1.9 million, or 27%, to $9.1 million as compared to $7.2 million for the corresponding period in the prior fiscal year.

 

Research and development costs during the nine months ended December 31, 2022 were $3.8 million, an increase of $0.5 million, or 14%, from approximately $3.3 million of such costs for the comparable period of the prior year. The increase was a result of the timing and nature of product development activities during the nine months ended December 31, 2022 as compared to the comparable period of the prior fiscal year.

 

General and administrative expenses for the nine months ended December 31, 2022 were $4.4 million, an increase of $1.4 million, or 49% from $2.9 million of such costs for the comparable period of the prior year due to increased spending in payroll and professional expense.

 

Non-cash compensation expense for the nine months ended December 31, 2022 and December 31, 2021 was less than $0.1 million.

 

Depreciation and amortization expenses from the nine months ended December 31, 2022 were $0.9 million, which was virtually unchanged from $0.9 million in such costs for the comparable period of the prior fiscal year.

 

As a result of the foregoing, our income from operations during the nine months ended December 31, 2022 was $4.1 million, compared to income from operations of $4.2 million for the comparable period of the prior fiscal year.

 

Other income (expense):

 

   For the Nine Months Ended December 31,   Change 
   2022   2021   Dollars   Percentage 
Other income (expense):                    
Change in fair value of derivative instruments  $561,070   $1,523,394   $(962,324)   (63)%
Interest expense and amortization of debt issuance costs   (782,221)   (126,376)   (655,845)   519%
Gain on sale of ANDA   1,000,000    —    1,000,000    100%
Interest income   187    77    110    143%
Other (expense) income, net  $779,036   $1,397,095   $(618,059)   (44)%

 

Other income (expense) for the nine months ended December 31, 2022 was $0.8 million, a decrease of $0.6 million from $1.4 million for the comparable period of the prior fiscal year. The decrease was due to decreased income relating to changes in the fair value of our outstanding derivative warrants and increased interest expense and amortization of debt issuance costs, offset by the gain on sale of ANDA during the nine months ended December 31, 2022. Please note that the change in the fair value of derivative instruments is determined in large part by the change in the closing price of the Company’s Common Stock as of the end of the period, as compared to the closing price at the beginning of the period, with a strong inverse relationship between the fair value of our derivatives instruments and decreases in the closing price of the Company’s Common Stock. Please see Note 11 to the Unaudited Condensed Consolidated Financial Statements above.

 

As a result of the foregoing, our net income before the net benefit from sale of net operating loss credits for the nine months ended December 31, 2022 was $4.8 million, compared to net income $5.6 million for the comparable period of the prior fiscal year.

 

Liquidity and Capital Resources

 

Capital Resources

 

   December 31, 2022   March 31, 2022   Change 
Current assets  $33,164,840   $18,861,389   $14,303,451 
Current liabilities  $6,654,362   $6,694,241   $(39,879)
Working capital  $26,510,478   $12,167,148   $14,343,330 

 

Our working capital (total current assets less total current liabilities) increased by $14.3 million from $12.2 million as of March 31, 2022 to $26.5 million as of December 31, 2022, with such increase being primarily related to the cash proceeds of $14.6 million from the new loan during the nine months ended December 31, 2022.

 

6
 

 

Summary of Cash Flows:

 

   For the Nine Months Ended December 31, 
   2022   2021 
Net cash provided by operating activities  $370,021   $4,902,978 
Net cash used in investing activities  $(5,200,407)  $(234,387)
Net cash provided by (used in) financing activities  $14,204,231   $(572,889)

 

Net cash provided by operating activities for the nine months ended December 31, 2022 was $0.4 million, which included net income of $4.8 million and increases in non-cash expenses totaling $0.9 million, offset by net changes in assets and liabilities totaling $5.3 million.

 

Net cash used in investing activities for the nine months ended December 31, 2022 was comprised of purchases of property and equipment of approximately $5.2 million.

 

Net cash provided by financing activities was $14.2 million for the nine months ended December 31, 2022 which proceeds from loan issuances totaling $14.6 million, offset by loan payments totaling $0.2 million.

 

Lincoln Park Capital – July 8, 2020 Purchase Agreement

 

On July 8, 2020, the Company entered into a purchase agreement (the “2020 LPC Purchase Agreement”), and a registration rights agreement, with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park has committed to purchase up to $25.0 million of the Company’s Common Stock, $0.001 par value per share, from time to time over the term of the 2020 LPC Purchase Agreement, at the Company’s direction.

 

During the nine months ended December 31, 2022 and December 31, 2021, respectively, there were no shares sold to Lincoln Park pursuant to the 2020 LPC Purchase Agreement. In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Purchase Agreement.

 

The Company did not issue any shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the nine months ended December 31, 2021. In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Agreement.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

As a smaller reporting company, we are not required to provide the information required by this Item.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. As required by Rules 13a-15(b) and 15d-15(b) of the Exchange Act, our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2022 at the reasonable assurance level.

 

7
 

 

Management’s Report on Internal Control Over Financial Reporting

 

Internal control over financial reporting refers to the process designed by, or under the supervision of, our Chief Executive Officer and Chief Financial Officer, and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles, and includes those policies and procedures that:(1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.

 

Internal control over financial reporting may not prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are achieved. Further, the design of a control system must be balanced against resource constraints, and therefore the benefits of controls must be considered relative to their costs. Given the inherent limitations in all systems of controls, no evaluation of controls can provide absolute assurance all control issues and instances of fraud, if any, within a company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions or the degree of compliance with policies or procedures may deteriorate. Accordingly, given the inherent limitations in a cost-effective system of internal control, financial statement misstatements due to error or fraud may occur and may not be detected. Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance of achieving their objectives. We conduct periodic evaluations of our systems of controls to enhance, where necessary, our control policies and procedures.

 

Management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting. Management has used the framework set forth in the report entitled “Internal Control—Integrated Framework (2013)” published by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of our internal control over financial reporting. Based on its evaluation, management has concluded that our internal control over financial reporting was effective as of December 31, 2022 at the reasonable assurance level.

 

Changes in Internal Controls Over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and Rule 15d-15(f) under the Exchange Act) during the period covered by this Quarterly Report.

 

8
 

 

PART II - OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

Pending Litigation

 

We may be subject from time to time to various claims and legal actions arising during the ordinary course of our business. We believe that there are currently no claims or legal actions that would reasonably be expected to have a material adverse effect on our results of operations, financial condition or cash flows.

 

ITEM 1A. RISK FACTORS

 

There have been no material changes in the risk factors described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2022.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

None.

 

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ITEM 6. EXHIBITS

 

Exhibit No.   Description
       
10.1   Employment Agreement, dated September 5, 2022, between Elite Pharmaceuticals, Inc. and Kirko Kirkov, incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on September 7, 2022.
     
31.1   Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a) and Rule 15d-14(a)*
     
31.2   Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a) and Rule 15d-14(a)*
     
32.1   Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
     
32.2   Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
     
101.INS   Inline XBRL Instance Document
101.SCH   Inline XBRL Taxonomy Schema Document
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* Filed herewith.
** Furnished herewith.

 

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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.

 

  ELITE PHARMACEUTICALS, INC.
     
February 14, 2023 By: /s/ Nasrat Hakim
   

Nasrat Hakim

    Chief Executive Officer, President and
    Chairman of the Board of Directors
    (Principal Executive Officer)
     
February 14, 2023 By: /s/ Robert Chen
   

Robert Chen

    Chief Financial Officer
    (Principal Accounting and Financial Officer)

 

11

 

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