5 unchanged sentences
Property and equipment, net of accumulated depreciation of $ 12,462,783 and $ 12,153,626 , respectively
−Removed: Intangible assets, net of
−Removed: accumulated amortization of $-0-, respectively
+Added: Intangible assets, net of accumulated amortization of $- 0 -, respectively
Operating lease - right-of-use asset
3 unchanged sentences
Total other assets
−Removed: LIABILITIES AND SHAREHOLDERS’
+Added: LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
5 unchanged sentences
Lease obligation - operating lease, current portion
−Removed: Senior secured promissory note - related party, current portion
Total current liabilities
8 unchanged sentences
Total liabilities
−Removed: The accompanying notes are an integral
−Removed: part of these unaudited condensed consolidated financial statements.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: CONDENSED CONSOLIDATED BALANCE SHEETS
−Removed: Shareholders’
+Added: Shareholders’ equity:
Series J convertible preferred stock;
1 unchanged sentence
50 shares authorized;
−Removed: 0 issued and outstanding as of December 31, 2020 and 24.0344 issued and outstanding as of March 31, 2020
+Added: 0 issued and outstanding as of June 30, 2021 and March 31, 2021
Common Stock;
1 unchanged sentence
1,445,000,000 shares authorized;
−Removed: 1,009,276,752 shares issued and 1,009,176,752 shares outstanding as of December 31, 2020;
−Removed: 840,504,367 shares issued and
−Removed: 840,404,367 shares outstanding as of March 31, 2020
+Added: 1,011,381,988 shares issued and 1,011,281,988 shares outstanding as of June 30, 2021;
+Added: 1,009,276,752 shares issued and 1,009,176,752 shares outstanding as of March 31, 2021
Additional paid-in capital
Treasury stock;
−Removed: 100,000 shares as of December 31, 2020 and March 31, 2020;
+Added: 100,000 shares as of June 30, 2021 and March 31, 2021;
Accumulated deficit
1 unchanged sentence
( 148,957,989 )
−Removed: Total shareholders’
−Removed: Total liabilities and shareholders’
−Removed: The accompanying notes are an integral
−Removed: part of these unaudited condensed consolidated financial statements.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: Total shareholders’ equity
+Added: Total liabilities and shareholders’ equity
+Added: accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: For the Three Months Ended
−Removed: For the Nine Months Ended
+Added: CONSOLIDATED STATEMENTS OF OPERATIONS
+Added: For the Three Months Ended June 30,
Manufacturing fees
1 unchanged sentence
Total revenue
−Removed: Cost of revenue
+Added: Cost of manufacturing
Operating expenses:
4 unchanged sentences
Total operating expenses
−Removed: Income (loss) from operations
+Added: Income from operations
Other income (expense):
3 unchanged sentences
Interest income
−Removed: Proceeds from sale of ANDAs
Other income (expense), net
−Removed: Income (loss) from operations before income taxes
−Removed: Income tax benefit (expense)
−Removed: Net income (loss) attributable to common shareholders
−Removed: $ (1,860,680 )
−Removed: $ (3,176,719 )
−Removed: Basic net income (loss) per share attributable to common shareholders
−Removed: Diluted net income (loss) per share attributable to common shareholders
+Added: Income from operations before income taxes
+Added: Net benefit for sale of state net operating losses and credits
+Added: Net income attributable to common shareholders
+Added: Basic net income per share attributable to common shareholders
+Added: Diluted net income per share attributable to common shareholders
Basic weighted average Common Stock outstanding
2 unchanged sentences
1,009,199,886
−Removed: The accompanying notes are an integral
−Removed: part of these unaudited condensed consolidated financial statements.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: 1,001,130,122
+Added: The accompanying notes are an integral part
+Added: of these unaudited condensed consolidated financial statements.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: SHAREHOLDERS’
−Removed: Series J Preferred Stock
+Added: CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
+Added: J Preferred Stock
+Added: Additional Paid-In
Treasury Stock
−Removed: Shareholders’
+Added: Total Shareholders’
Balance as of March 31, 2021
1 unchanged sentence
$ 164,407,480
−Removed: Non-cash compensation through the issuance of employee stock options
−Removed: Shares issued in payment of salaries
−Removed: Balance at June 30, 2020
$ ( 306,841 )
−Removed: Conversion of Preferred Stock to Common Stock
$ ( 148,957,989 )
−Removed: Initial commitment shares issued pursuant to the 2020 Lincoln Park purchase agreement
−Removed: Common Stock sold pursuant to the 2020 Lincoln Park purchase agreement
−Removed: Common Stock issued as additional commitment shares pursuant to the 2020 Lincoln Park purchase agreement
−Removed: Costs associated with raising capital
Non-cash compensation through the issuance of employee stock options
−Removed: Shares issued in payment of Director fees
Shares issued in payment of salaries
−Removed: Shares issued in payment of consulting expenses
−Removed: Balance at September 30, 2020
−Removed: 1,009,276,752
+Added: Balance at June 30, 2021
1,011,381,988
−Removed: Non-cash compensation through the issuance of employee stock options
−Removed: Balance at December 31, 2020
$ 164,565,685
1 unchanged sentence
$ ( 146,568,871 )
−Removed: The accompanying notes are an integral
−Removed: part of these unaudited condensed consolidated financial statements.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: SHAREHOLDERS’
−Removed: Series J Preferred Stock
+Added: Additional Paid-In
Treasury Stock
−Removed: Shareholders’
+Added: Total Shareholders’
Balance as of March 31, 2020
2 unchanged sentences
$ ( 154,046,410 )
−Removed: Common Stock sold pursuant to the Lincoln Park purchase agreement
−Removed: Common Stock issued as additional commitment shares pursuant to the LPC purchase agreement
−Removed: Costs associated with raising capital
Non-cash compensation through the issuance of employee stock options
+Added: Shares issued in payment of salaries
Balance at June 30, 2020
$ 150,319,552
−Removed: Common Stock sold pursuant to the Lincoln Park purchase agreement
−Removed: Common Stock issued as additional commitment shares pursuant to the LPC purchase agreement
−Removed: Costs associated with raising capital
−Removed: Non-cash compensation through the issuance of employee stock options
−Removed: Balance at September 30, 2019
$ ( 306,841 )
−Removed: Common Stock sold pursuant to the Lincoln Park purchase agreement
−Removed: Common Stock issued as additional commitment shares pursuant to the LPC purchase agreement
−Removed: Costs associated with raising capital
−Removed: Non-cash compensation through the issuance of employee stock options
−Removed: Reclassification of mezzanine equity to permanent equity
−Removed: Balance at December 31, 2019
$ ( 152,969,061 )
−Removed: $ (154,982,778 )
−Removed: The accompanying notes are an integral
−Removed: part of these unaudited condensed consolidated financial statements.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF
−Removed: For the Nine Months Ended December 31,
+Added: CONSOLIDATED STATEMENTS OF CASH FLOWS
+Added: For the Three Months Ended
CASH FLOWS FROM OPERATING ACTIVITIES:
−Removed: Net income (loss)
−Removed: $ (3,176,719 )
−Removed: Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
+Added: Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization
7 unchanged sentences
Accounts receivable
+Added: ( 1,690,615 )
+Added: ( 1,423,931 )
Prepaid expenses and other current assets
2 unchanged sentences
Lease obligations - operating leases
−Removed: Net cash provided by (used in) operating activities
+Added: Net cash provided by operating activities
CASH FLOWS FROM INVESTING ACTIVITIES:
1 unchanged sentence
Proceeds from disposal of property and equipment
−Removed: Net cash used in investing activities
+Added: Net cash (used in) provided by investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
−Removed: Proceeds from the issuance of Common Stock
Proceeds from loans payable
−Removed: Payment of bond principal
Other loan payments
7 unchanged sentences
Stock issued in payment of Directors fees, salaries and consulting expenses
−Removed: Commitment shares issued to Lincoln Park Capital
−Removed: Conversion of preferred stock to Common Stock
Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets
−Removed: The accompanying notes are an integral
−Removed: part of these unaudited condensed consolidated financial statements.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
−Removed: Elite Pharmaceuticals,
−Removed: (the “Company”
−Removed: or “Elite”) was incorporated on October 1, 1997 under the laws of the State of Delaware,
−Removed: and its wholly-owned subsidiary Elite Laboratories, Inc.
−Removed: (“Elite Labs”) was incorporated on August 23, 1990 under the
−Removed: laws of the State of Delaware.
−Removed: On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of Nevada.
+Added: Pharmaceuticals, Inc.
+Added: (the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the State
+Added: of Delaware, and its wholly-owned subsidiary Elite Laboratories, Inc.
+Added: (“Elite Labs”) was incorporated on August 23, 1990
+Added: under the laws of the State of Delaware.
+Added: On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of
Elite Labs engages primarily in researching, developing, licensing and manufacture of generic, oral dose pharmaceuticals.
−Removed: is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when the products
+Added: Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when the products
are approved.
These products include drugs that cover therapeutic areas for allergy, bariatric, attention deficit and infection.
−Removed: Research and development activities are performed with an objective of developing products that will secure marketing approvals
−Removed: from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting such products.
−Removed: Principles of Consolidation
−Removed: The accompanying unaudited
−Removed: condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the
−Removed: United States (“GAAP”).
−Removed: The unaudited condensed consolidated financial statements include the accounts of the Company
−Removed: and its wholly-owned subsidiary, Elite Laboratories, Inc.
+Added: and development activities are performed with an objective of developing products that will secure marketing approvals from the United
+Added: States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting such products.
+Added: of Consolidation
+Added: accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting
+Added: principles in the United States (“GAAP”).
+Added: The unaudited condensed consolidated financial statements include the accounts
+Added: of the Company and its wholly-owned subsidiary, Elite Labs.
All significant intercompany accounts and transactions have been eliminated
in consolidation.
−Removed: The unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring
−Removed: items, which are, in the opinion of management, necessary for a fair presentation of such statements.
−Removed: The results of operations
−Removed: for the three and nine months ended December 31, 2020 are not necessarily indicative of the results that may be expected for the
−Removed: Segment Information
−Removed: Financial Accounting
−Removed: Standards Board (“FASB”) Accounting Standards Codification 280 (“ASC 280”), Segment Reporting , establishes
−Removed: standards for reporting information about operating segments.
−Removed: Operating segments are defined as components of an enterprise about
−Removed: which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making
+Added: The unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring items,
+Added: which are, in the opinion of management, necessary for a fair presentation of such statements.
+Added: The results of operations for the three
+Added: months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the entire year.
+Added: Accounting Standards Board (“FASB”) Accounting Standards Codification 280 (“ASC 280”), Segment Reporting ,
+Added: establishes standards for reporting information about operating segments.
+Added: Operating segments are defined as components of an enterprise
+Added: 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.
−Removed: The Company’s
−Removed: chief operating decision maker is the Chief Executive Officer, who reviews the financial performance and the results of operations
−Removed: of the segments prepared in accordance with GAAP when making decisions about allocating resources and assessing performance of
−Removed: The Company has determined
−Removed: that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug Applications (“ANDA”)
−Removed: and products whose marketing approvals were secured via a New Drug Application (“NDA”).
−Removed: ANDA products are referred
−Removed: to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals.
−Removed: There are currently
−Removed: no intersegment revenues.
−Removed: Asset information by operating segment is not presented below since the chief operating decision maker
−Removed: does not review this information by segment.
+Added: Company’s chief operating decision maker is the Chief Executive Officer, who reviews the financial performance and the results
+Added: of operations of the segments prepared in accordance with GAAP when making decisions about allocating resources and assessing performance
+Added: of the Company.
+Added: Company has determined that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug Applications
+Added: (“ANDA”) and products whose marketing approvals were secured via a New Drug Application (“NDA”).
+Added: ANDA products
+Added: are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals.
+Added: are currently no intersegment revenues.
+Added: Asset information by operating segment is not presented below since the chief operating decision
+Added: maker does not review this information by segment.
The reporting segments follow the same accounting policies used in the preparation
−Removed: of the Company’s condensed unaudited consolidated financial statements.
+Added: of the Company’s condensed unaudited consolidated financial statements.
Please see Note 15 for further details.
−Removed: Revenue Recognition
−Removed: The Company generates
−Removed: revenue primarily from manufacturing and licensing fees.
−Removed: Manufacturing fees include the development of pain management products,
−Removed: manufacturing of a line of generic pharmaceutical products with approved ANDA, through the manufacture of formulations and the
−Removed: development of new products.
−Removed: Licensing fees include the commercialization of products either by license and the collection of royalties,
−Removed: or the expansion of licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures,
−Removed: and other collaborations.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: Under ASC 606, Revenue
−Removed: from Contacts with Customers (“ASC 606”), the Company recognizes revenue when the customer obtains control of promised
−Removed: goods or services, in an amount that reflects the consideration which is expected to be received in exchange for those goods or
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Company generates revenue primarily from manufacturing and licensing fees.
+Added: Manufacturing fees include the development of pain management
+Added: products, manufacturing of a line of generic pharmaceutical products with approved ANDA, through the manufacture of formulations and
+Added: the development of new products.
+Added: Licensing fees include the commercialization of products either by license and the collection of royalties,
+Added: or the expansion of licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other
+Added: collaborations.
+Added: ASC 606, Revenue from Contacts with Customers (“ASC 606”), the Company recognizes revenue when the customer obtains
+Added: control of promised goods or services, in an amount that reflects the consideration which is expected to be received in exchange for
+Added: those goods or services.
The Company recognizes revenues following the five-step model prescribed under ASC 606:
−Removed: (i) identify contract(s) with
+Added: (i) identify contract(s)
+Added: with a customer;
(ii) identify the performance obligation(s) in the contract;
2 unchanged sentences
transaction price to the performance obligation(s) in the contract;
−Removed: and (v) recognize revenues when (or as) the Company satisfies
−Removed: a performance obligation.
−Removed: The Company only applies the five-step model to contracts when it is probable that the entity will collect
−Removed: the consideration it is entitled to in exchange for the goods or services it transfers to the customer.
−Removed: At contract inception,
−Removed: once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each
−Removed: contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.
−Removed: The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation
−Removed: when (or as) the performance obligation is satisfied.
−Removed: Sales, value add, and other taxes collected on behalf of third parties are
−Removed: excluded from revenue.
−Removed: Nature of goods and services
−Removed: The following is a
−Removed: description of the Company’s goods and services from which the Company generates revenue, as well as the nature, timing of
−Removed: satisfaction of performance obligations, and significant payment terms for each, as applicable:
−Removed: a) Manufacturing Fees
−Removed: The Company is equipped
−Removed: to manufacture controlled-release products on a contract basis for third parties, if, and when, the products are approved.
−Removed: products include products using controlled-release drug technology.
−Removed: The Company also develops and markets (either on its own or
−Removed: by license to other companies) generic and proprietary controlled-release pharmaceutical products.
−Removed: The Company recognizes
−Removed: revenue when the customer obtains control of the Company’s product based on the contractual shipping terms of the contract.
−Removed: The Company is primarily responsible for fulfilling the promise to provide the product, is responsible to ensure that the product
−Removed: is produced in accordance with the related supply agreement and bears risk of loss while the inventory is in-transit to the commercial
−Removed: Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products
−Removed: to a customer.
−Removed: b) License Fees
−Removed: The Company enters
−Removed: into licensing and development agreements, which may include multiple revenue generating activities, including milestones payments,
−Removed: licensing fees, product sales and services.
−Removed: The Company analyzes each element of its licensing and development agreements in accordance
−Removed: with ASC 606 to determine appropriate revenue recognition.
+Added: and (v) recognize revenues when (or as) the Company satisfies a performance
+Added: The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration
+Added: it is entitled to in exchange for the goods or services it transfers to the customer.
+Added: At contract inception, once the contract is determined
+Added: to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that
+Added: are performance obligations and assesses whether each promised good or service is distinct.
+Added: The Company then recognizes as revenue the
+Added: amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is
+Added: Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
+Added: of goods and services
+Added: following is a description of the Company’s goods and services from which the Company generates revenue, as well as the nature,
+Added: timing of satisfaction of performance obligations, and significant payment terms for each, as applicable:
+Added: Manufacturing Fees
+Added: Company is equipped to manufacture controlled-release products on a contract basis for third parties, if, and when, the products are
+Added: These products include products using controlled-release drug technology.
+Added: The Company also develops and markets (either on
+Added: its own or by license to other companies) generic and proprietary controlled-release pharmaceutical products.
+Added: Company recognizes revenue when the customer obtains control of the Company’s product based on the contractual shipping terms of
+Added: the contract.
+Added: The Company is primarily responsible for fulfilling the promise to provide the product, is responsible to ensure that the
+Added: product is produced in accordance with the related supply agreement and bears risk of loss while the inventory is in-transit to the commercial
+Added: Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products to a
+Added: Company enters into licensing and development agreements, which may include multiple revenue generating activities, including milestones
+Added: payments, licensing fees, product sales and services.
+Added: The Company analyzes each element of its licensing and development agreements in
+Added: accordance with ASC 606 to determine appropriate revenue recognition.
The terms of the license agreement may include payment to the Company
−Removed: of licensing fees, non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties
−Removed: on product sales.
−Removed: If the contract contains
−Removed: a single performance obligation, the entire transaction price is allocated to the single performance obligation.
−Removed: Contracts that
−Removed: contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone
−Removed: selling prices of the promised products or services underlying each performance obligation.
−Removed: The Company determines standalone selling
−Removed: prices based on the price at which the performance obligation is sold separately.
+Added: of licensing fees, non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on
+Added: product sales.
+Added: the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation.
+Added: Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative
+Added: standalone selling prices of the promised products or services underlying each performance obligation.
+Added: The Company determines standalone
+Added: selling prices based on the price at which the performance obligation is sold separately.
If the standalone selling price is not observable
−Removed: through past transactions, the Company estimates the standalone selling price taking into account available information such as
−Removed: market conditions and internally approved pricing guidelines related to the performance obligations.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: through past transactions, the Company estimates the standalone selling price taking into account available information such as market
+Added: conditions and internally approved pricing guidelines related to the performance obligations.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: The Company recognizes
−Removed: revenue from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual
−Removed: property to the customer.
−Removed: For those milestone payments which are contingent on the occurrence of particular future events (for
−Removed: example, payments due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion
−Removed: in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Company recognizes revenue from non-refundable upfront payments at a point in time, typically upon fulfilling the delivery of the associated
+Added: intellectual property to the customer.
+Added: For those milestone payments which are contingent on the occurrence of particular future events
+Added: (for example, payments due upon a product receiving FDA approval), the Company determined that these need to be considered for inclusion
+Added: 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.
−Removed: Given the inherent uncertainty of the occurrence of future events, the Company will recognize revenue from the milestone when there
−Removed: is not a high probability of a reversal of revenue, which typically occurs near or upon achievement of the event.
−Removed: Significant management
−Removed: judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects
−Removed: to complete its performance obligations under the arrangement.
−Removed: If the Company cannot reasonably estimate when its performance obligations
−Removed: either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such
+Added: Given the inherent
+Added: uncertainty of the occurrence of future events, the Company will recognize revenue from the milestone when there is not a high probability
+Added: of a reversal of revenue, which typically occurs near or upon achievement of the event.
+Added: management judgment is required to determine the level of effort required under an arrangement and the period over which the Company
+Added: expects to complete its performance obligations under the arrangement.
+Added: If the Company cannot reasonably estimate when its performance
+Added: obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make
+Added: such estimates.
Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method.
−Removed: When determining the
−Removed: transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly
−Removed: after performance, resulting in a significant financing component.
−Removed: Applying the practical expedient in ASC 606-10-32-18, the Company
−Removed: does not assess whether a significant financing component exists if the period between when the Company performs its obligations
+Added: determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before
+Added: or significantly after performance, resulting in a significant financing component.
+Added: Applying the practical expedient in ASC 606-10-32-18,
+Added: 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.
−Removed: None of the Company’s contracts contained a significant
−Removed: financing component as of December 31, 2020.
−Removed: In accordance with
−Removed: ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
−Removed: The Company entered
−Removed: into a sales and distribution licensing agreement with Epic Pharma LLC, (“Epic”) dated June 4, 2015 (the “2015
−Removed: Epic License Agreement”), which has been determined to satisfy the criteria for consideration as a collaborative agreement,
+Added: None of the Company’s contracts contained a significant financing
+Added: component as of June 30, 2021.
+Added: accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
+Added: Company entered into a sales and distribution licensing agreement with Epic Pharma LLC, (“Epic”) dated June 4, 2015 (the
+Added: “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.
−Removed: The Company entered
−Removed: into a Master Development and License Agreement with SunGen Pharma LLC dated August 24, 2016 (the “SunGen Agreement”),
+Added: 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.
−Removed: On April 3, 2020, Elite and SunGen mutually agreed to discontinue any further joint product development activities.
−Removed: Disaggregation of revenue
−Removed: In the following table,
−Removed: revenue is disaggregated by type of revenue generated by the Company.
−Removed: The table also includes a reconciliation of the disaggregated
−Removed: revenue with the reportable segments:
+Added: April 3, 2020, Elite and SunGen mutually agreed to discontinue any further joint product development activities.
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Disaggregation
+Added: the following table, revenue is disaggregated by type of revenue generated by the Company.
+Added: The table also includes a reconciliation of
+Added: the disaggregated revenue with the reportable segments:
+Added: SCHEDULE OF DISAGGREGATION OF REVENUE
For the Three Months Ended
−Removed: For the Nine Months Ended
Licensing fees
4 unchanged sentences
Total revenue
−Removed: Selected information
−Removed: on reportable segments and reconciliation of operating income by segment to income (loss) from operations before income taxes are
−Removed: disclosed within Note 15.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: The Company considers
−Removed: all highly liquid investments with an original maturity of three months or less to be cash equivalents.
−Removed: Cash and cash equivalents
−Removed: consist of cash on deposit with banks and money market instruments.
−Removed: The Company places its cash and cash equivalents with high-quality,
+Added: Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents.
+Added: Cash and cash
+Added: equivalents consist of cash on deposit with banks and money market instruments.
+Added: The Company places its cash and cash equivalents with
+Added: high-quality, U.S.
financial institutions and, to date has not experienced losses on any of its balances.
−Removed: Restricted Cash
−Removed: As of December 31,
−Removed: 2020, and March 31, 2020, the Company had $405,005 and $404,802, of restricted cash, respectively, related to debt service
−Removed: reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 5).
−Removed: Accounts Receivable
−Removed: Accounts receivable
−Removed: are comprised of balances due from customers, net of estimated allowances for uncollectible accounts.
+Added: of June 30, 2021, and March 31, 2021, the Company had $ 405,013 and $ 405,013 , of restricted cash, respectively, related to debt service
+Added: reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 5).
+Added: 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.
−Removed: Inventory is recorded
−Removed: at the lower of cost or market on specific identification by lot number basis.
−Removed: Long-Lived Assets
−Removed: The Company periodically
−Removed: evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events or changes
−Removed: in circumstances indicate that its carrying amounts may not be recoverable.
−Removed: Property and equipment
−Removed: are stated at cost.
+Added: is recorded at the lower of cost or market on specific identification by lot number basis.
+Added: Company periodically evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events
+Added: or changes in circumstances indicate that its carrying amounts may not be recoverable.
+Added: and equipment are stated at cost.
Depreciation is provided on the straight-line method based on the estimated useful lives of the respective
1 unchanged sentence
Major repairs or improvements are capitalized.
−Removed: Minor replacements and maintenance
−Removed: and repairs which do not improve or extend asset lives are expensed currently.
−Removed: Upon retirement or
−Removed: other disposition of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting gain
−Removed: or loss, if any, is recognized in income.
−Removed: Intangible Assets
−Removed: The Company capitalizes
−Removed: certain costs to acquire intangible assets;
−Removed: if such assets are determined to have a finite useful life they are amortized on a
−Removed: straight-line basis over the estimated useful life.
−Removed: Costs to acquire indefinite lived intangible assets, such as costs related
−Removed: to ANDAs are capitalized accordingly.
−Removed: The Company tests its
−Removed: intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that indicate
−Removed: impairment may have occurred.
−Removed: A significant amount of judgment is involved in determining if an indicator of impairment has occurred.
+Added: Minor replacements and maintenance and repairs
+Added: which do not improve or extend asset lives are expensed currently.
+Added: retirement or other disposition of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting
+Added: gain or loss, if any, is recognized in income.
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Company capitalizes certain costs to acquire intangible assets;
+Added: if such assets are determined to have a finite useful life they are amortized
+Added: on a straight-line basis over the estimated useful life.
+Added: Costs to acquire indefinite lived intangible assets, such as costs related to
+Added: ANDAs are capitalized accordingly.
+Added: Company tests its intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that
+Added: indicate impairment may have occurred.
+Added: A significant amount of judgment is involved in determining if an indicator of impairment has
Such indicators may include, among others and without limitation:
−Removed: a significant decline in the Company’s expected future
−Removed: a sustained, significant decline in the Company’s stock price and market capitalization;
−Removed: a significant adverse
−Removed: change in legal factors or in the business climate of the Company’s segments;
+Added: a significant decline in the Company’s expected future
+Added: a sustained, significant decline in the Company’s stock price and market capitalization;
+Added: a significant adverse change
+Added: in legal factors or in the business climate of the Company’s segments;
unanticipated competition;
−Removed: and slower growth
−Removed: As of December 31,
−Removed: 2020, the Company did not identify any indicators of impairment.
−Removed: Please also see Note
−Removed: 4 for further details on intangible assets.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: Research and Development
−Removed: Research and development
−Removed: expenditures are charged to expense as incurred.
+Added: and slower growth rates.
+Added: of June 30, 2021, the Company did not identify any indicators of impairment.
+Added: also see Note 4 for further details on intangible assets.
+Added: and Development
+Added: and development expenditures are charged to expense as incurred.
Contingencies
−Removed: Occasionally, the Company
−Removed: may be involved in claims and legal proceedings arising from the ordinary course of its business.
+Added: Occasionally,
+Added: the Company may be involved in claims and legal proceedings arising from the ordinary course of its business.
The Company records a provision
−Removed: for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably
−Removed: If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s
−Removed: condensed consolidated financial statements.
−Removed: Contingencies are inherently unpredictable, and the assessments of the value can involve
−Removed: a series of complex judgments about future events and can rely heavily on estimates and assumptions.
−Removed: Income taxes are accounted
−Removed: for under the asset and liability method.
−Removed: Deferred tax assets and liabilities are recognized for the estimated future tax consequences
−Removed: attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective
−Removed: Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary
−Removed: differences are expected to be recovered or settled.
−Removed: Where applicable, the Company records a valuation allowance to reduce any
−Removed: deferred tax assets that it determines will not be realizable in the future.
−Removed: The Company recognizes
−Removed: 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
−Removed: is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position.
−Removed: These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate
−Removed: The Company operates
−Removed: in multiple tax jurisdictions within the United States of America.
−Removed: The Company remains subject to examination in all tax jurisdiction
−Removed: until the applicable statutes of limitation expire.
−Removed: As of December 31, 2020, a summary of the tax years that remain subject
+Added: for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably estimated.
+Added: If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed
+Added: consolidated financial statements.
+Added: Contingencies are inherently unpredictable, and the assessments of the value can involve a series
+Added: of complex judgments about future events and can rely heavily on estimates and assumptions.
+Added: taxes are accounted for under the asset and liability method.
+Added: Deferred tax assets and liabilities are recognized for the estimated future
+Added: tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and
+Added: their respective tax bases.
+Added: Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which
+Added: those temporary differences are expected to be recovered or settled.
+Added: Where applicable, the Company records a valuation allowance to reduce
+Added: any deferred tax assets that it determines will not be realizable in the future.
+Added: 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
+Added: tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position.
+Added: These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution.
+Added: Company operates in multiple tax jurisdictions within the United States of America.
+Added: The Company remains subject to examination in all
+Added: tax jurisdiction until the applicable statutes of limitation expire.
+Added: As of June 30, 2021, a summary of the tax years that remain subject
to examination in our major tax jurisdictions are:
−Removed: United States –
−Removed: Federal, 2016 and forward, and State, 2012 and forward.
−Removed: The Company did not record unrecognized tax positions for the three and nine months ended December 31, 2020 and 2019.
−Removed: Warrants and Preferred Shares
−Removed: The accounting treatment
−Removed: of warrants and preferred share series issued is determined pursuant to the guidance provided by ASC 470, Debt , ASC 480,
−Removed: Distinguishing Liabilities from Equity , and ASC 815, Derivatives and Hedging , as applicable.
−Removed: Each feature of a freestanding
−Removed: financial instrument including, without limitation, any rights relating to subsequent dilutive issuances, dividend issuances, equity
−Removed: sales, rights offerings, forced conversions, optional redemptions, automatic monthly conversions, dividends and exercise is assessed
−Removed: with determinations made regarding the proper classification in the Company’s financial statements.
−Removed: Stock-Based Compensation
−Removed: The Company accounts
−Removed: for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation .
−Removed: Under the fair value recognition
−Removed: provisions, stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized
+Added: United States – Federal, 2016 and forward, and State, 2013 and forward.
+Added: Company did not record unrecognized tax positions for the three months ended June 30, 2021 and 2020.
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: and Preferred Shares
+Added: accounting treatment of warrants and preferred share series issued is determined pursuant to the guidance provided by ASC 470, Debt ,
+Added: ASC 480, Distinguishing Liabilities from Equity , and ASC 815, Derivatives and Hedging , as applicable.
+Added: Each feature of a
+Added: freestanding financial instrument including, without limitation, any rights relating to subsequent dilutive issuances, dividend issuances,
+Added: equity sales, rights offerings, forced conversions, optional redemptions, automatic monthly conversions, dividends and exercise is assessed
+Added: with determinations made regarding the proper classification in the Company’s financial statements.
+Added: Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation .
+Added: Under the fair value
+Added: 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
−Removed: payments to nonemployees that are fully vested and non-forfeitable as at the grant date is measured and recognized at that date,
−Removed: unless there is a contractual term for services in which case such compensation would be amortized over the contractual term.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: payments to nonemployees that are fully vested and non-forfeitable as at the grant date is measured and recognized at that date, unless
+Added: there is a contractual term for services in which case such compensation would be amortized over the contractual term.
+Added: accordance with the Company’s Director compensation policy and certain employment contracts, director’s fees and a portion
+Added: of employee’s salaries are to be paid via the issuance of shares of the Company’s Common Stock (“Common Stock”),
+Added: 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
+Added: Company’s Common Stock.
+Added: Per Share Attributable to Common Shareholders’
+Added: Company follows ASC 260, Earnings Per Share , which requires presentation of basic and diluted earnings per share (“EPS”)
+Added: on the face of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator and
+Added: denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation.
+Added: In the accompanying financial
+Added: statements, basic earnings per share is computed by dividing net income by the weighted average number of shares of Common Stock outstanding
+Added: during the period.
+Added: The computation of diluted net income per share does not include the conversion of securities that would have an antidilutive
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: In accordance with
−Removed: the Company’s Director compensation policy and certain employment contracts, director’s fees and a portion of employee’s
−Removed: salaries are to be paid via the issuance of shares of the Company’s Common Stock (“Common Stock”), in lieu of
−Removed: cash, with the valuation of such share being calculated on a quarterly basis and equal to the simple average closing price of the
−Removed: Company’s Common Stock for each trading day of the quarter then ended.
−Removed: Earnings (Loss) Per Share Attributable
−Removed: to Common Shareholders’
−Removed: The Company follows
−Removed: ASC 260, Earnings Per Share , which requires presentation of basic and diluted earnings (loss) per share (“EPS”)
−Removed: on the face of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator
−Removed: and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation.
−Removed: In the accompanying
−Removed: financial statements, basic earnings (loss) per share is computed by dividing net income (loss) by the weighted average number
−Removed: of shares of Common Stock outstanding during the period.
−Removed: The computation of diluted net income (loss) per share does not include
−Removed: the conversion of securities that would have an antidilutive effect.
−Removed: The following is the
−Removed: computation of earnings (loss) per share applicable to common shareholders for the periods indicated:
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: following is the computation of earnings per share applicable to common shareholders for the periods indicated:
+Added: SCHEDULE OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
For the Three Months Ended
−Removed: For the Nine Months Ended
−Removed: Net income (loss) - basic
−Removed: $ (1,860,680 )
−Removed: $ (3,176,719 )
+Added: Net income - basic
Effect of dilutive instrument on net income
−Removed: Net income (loss) - diluted
−Removed: $ (1,860,680 )
−Removed: $ (3,176,719 )
+Added: Net income - diluted
Weighted average shares of Common Stock outstanding - basic
3 unchanged sentences
1,009,199,886
−Removed: Net income (loss) per share
−Removed: Fair Value of Financial Instruments
−Removed: ASC 820, Fair Value
−Removed: Measurements and Disclosures (“ASC 820”) provides a framework for measuring fair value in accordance with generally
−Removed: accepted accounting principles.
−Removed: ASC 820 defines fair
−Removed: value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market
−Removed: participants at the measurement date.
−Removed: ASC 820 establishes a fair value hierarchy that distinguishes between (1) market participant
−Removed: assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own
−Removed: assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: The fair value hierarchy
−Removed: consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets
−Removed: or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).
−Removed: The three levels of the fair value hierarchy
−Removed: under ASC 820 are described as follows:
−Removed: ● Level 1 –
−Removed: Unadjusted quoted prices in active markets for identical assets or liabilities
−Removed: that are accessible at the measurement date.
−Removed: ● Level 2 –
−Removed: Inputs other than quoted prices included within Level 1 that are observable for
−Removed: the asset or liability, either directly or indirectly.
−Removed: Level 2 inputs include quoted prices for similar assets or liabilities in
−Removed: active markets;
−Removed: quoted prices for identical or similar assets or liabilities in markets that are not active;
−Removed: inputs other than
−Removed: quoted prices that are observable for the asset or liability;
−Removed: and inputs that are derived principally from or corroborated by observable
−Removed: market data by correlation or other means.
−Removed: ● Level 3 –
+Added: 1,001,130,122
+Added: Net income per share
+Added: Value of Financial Instruments
+Added: 820, Fair Value Measurements and Disclosures (“ASC 820”) provides a framework for measuring fair value in accordance
+Added: with generally accepted accounting principles.
+Added: 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
+Added: between market participants at the measurement date.
+Added: ASC 820 establishes a fair value hierarchy that distinguishes between (1) market
+Added: participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s
+Added: own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable
+Added: fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for
+Added: identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).
+Added: The three levels of the fair value
+Added: hierarchy under ASC 820 are described as follows:
+Added: 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible at the measurement date.
+Added: 2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly
+Added: or indirectly.
+Added: Level 2 inputs include quoted prices for similar assets or liabilities in active markets;
+Added: quoted prices for identical
+Added: or similar assets or liabilities in markets that are not active;
+Added: inputs other than quoted prices that are observable for the asset
+Added: or liability;
+Added: and inputs that are derived principally from or corroborated by observable market data by correlation or other means.
3 – Inputs that are unobservable for the asset or liability.
−Removed: Measured on a Recurring
−Removed: The following table
−Removed: presents information about our liabilities measured at fair value on a recurring basis, aggregated by the level in the fair value
−Removed: hierarchy within which those measurements fell:
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Measured on a Recurring Basis
+Added: The following table presents information
+Added: about our liabilities measured at fair value on a recurring basis, aggregated by the level in the fair value hierarchy within which those
+Added: measurements fell:
+Added: SCHEDULE OF LIABILITIES MEASURED AT FAIR VALUE ON A RECURRING BASIS
Fair Value Measurement Using
−Removed: December 31, 2020
+Added: June 30, 2021
Derivative financial instruments - warrants
3 unchanged sentences
inputs used in determining fair value.
−Removed: The carrying amounts
−Removed: of the Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other current
−Removed: assets, accounts payable and accrued expenses, approximate their fair values because of the short maturity of these instruments.
−Removed: Based upon current borrowing rates with similar maturities the carrying value of long-term debt approximates fair value.
−Removed: Non-Financial Assets
−Removed: that are Measured at Fair Value on a Non-Recurring Basis
−Removed: Non-financial assets
−Removed: such as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized.
−Removed: Company did not record an impairment charge related to these assets in the periods presented.
+Added: The carrying amounts of the Company’s
+Added: financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued
+Added: expenses, approximate their fair values because of the short maturity of these instruments.
+Added: Based upon current borrowing rates with similar
+Added: maturities the carrying value of long-term debt approximates fair value.
+Added: Non-Financial Assets that are
+Added: Measured at Fair Value on a Non-Recurring Basis
+Added: Non-financial assets such as intangible
+Added: assets, and property and equipment are measured at fair value only when an impairment loss is recognized.
+Added: The Company did not record an
+Added: impairment charge related to these assets in the periods presented.
Treasury Stock
−Removed: The Company records
−Removed: treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: Recently Issued Accounting
−Removed: Pronouncements
−Removed: In June 2016, the FASB
−Removed: issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326):
+Added: The Company records treasury stock
+Added: at the cost to acquire it and includes treasury stock as a component of shareholders’ equity.
+Added: Recently Issued Accounting Pronouncements
+Added: In June 2016, the FASB issued
+Added: ASU 2016-13, Financial Instruments - Credit Losses (Topic 326):
Measurement of Credit Losses on Financial Instruments .
−Removed: This update requires immediate recognition of management’s estimates of current expected credit losses (“CECL”).
−Removed: Under the prior model, losses were recognized only as they were incurred.
−Removed: The new model is applicable to all financial instruments
−Removed: that are not accounted for at fair value through net income.
−Removed: The standard is effective for fiscal years beginning after December
−Removed: 15, 2022 for public entities qualifying as smaller reporting companies.
+Added: requires immediate recognition of management’s estimates of current expected credit losses (“CECL”).
+Added: Under the prior
+Added: model, losses were recognized only as they were incurred.
+Added: The new model is applicable to all financial instruments that are not accounted
+Added: for at fair value through net income.
+Added: The standard is effective for fiscal years beginning after December 15, 2022 for public entities
+Added: qualifying as smaller reporting companies.
Early adoption is permitted.
−Removed: The Company is currently assessing
−Removed: the impact of this update on the consolidated financial statements and does not expect a material impact on the consolidated financial
−Removed: Management has evaluated
−Removed: other recently issued accounting pronouncements and does not believe that any of these pronouncements will have a significant impact
−Removed: on our consolidated financial statements and related disclosures.
−Removed: Inventory consisted
−Removed: of the following:
+Added: The Company is currently assessing the impact of this update on
+Added: the consolidated financial statements and does not expect a material impact on the consolidated financial statements.
+Added: Management has evaluated other
+Added: recently issued accounting pronouncements and does not believe that any of these pronouncements will have a significant impact on our
+Added: consolidated financial statements and related disclosures.
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Inventory consisted of the following:
+Added: SCHEDULE OF INVENTORY
+Added: June 30, 2021
+Added: March 31, 2021
Finished goods
1 unchanged sentence
Raw materials
+Added: Inventory, net
PROPERTY AND EQUIPMENT, NET
−Removed: Property and equipment
−Removed: consisted of the following:
+Added: Property and equipment consisted
+Added: of the following:
+Added: SCHEDULE OF PROPERTY AND EQUIPMENT
+Added: June 30, 2021
+Added: March 31, 2021
Land, building and improvements
2 unchanged sentences
Furniture and fixtures
+Added: Property and equipment, gross
Accumulated depreciation
−Removed: (11,834,185 )
−Removed: (10,957,334 )
−Removed: Depreciation expense
−Removed: was $505,987 and $326,908 for the three months ended, and $980,227 and $982,456 for the nine months ended December 31, 2020 and
−Removed: 2019, respectively.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: INTANGIBLE ASSETS
−Removed: The following table summarizes the Company’s
+Added: Property and equipment, net
+Added: Depreciation expense was $ 309,157
+Added: and $ 324,071 for the three months ended June 30, 2021 and 2020, respectively.
INTANGIBLE ASSETS
−Removed: December 31, 2020
+Added: The following table summarizes
+Added: the Company’s intangible assets:
+Added: SCHEDULE OF INTANGIBLE ASSETS
+Added: June 30, 2021
Patent application costs
3 unchanged sentences
ANDA acquisition costs
−Removed: application costs were incurred in relation to the Company’s abuse deterrent opioid
−Removed: Amortization of the patent costs will begin upon the issuance of marketing
−Removed: authorization by the FDA.
−Removed: Amortization will then be calculated on a straight-line basis
−Removed: through the expiry of the related patent(s).
−Removed: During August 2005,
−Removed: the Company refinanced a bond issue occurring in 1999 through the issuance of Series A and B Notes tax-exempt bonds (the “NJEDA
−Removed: and/or “Bonds”).
−Removed: During July 2014, the Company retired all outstanding Series B Notes, at par, along with
−Removed: all accrued interest due and owed.
−Removed: In relation to the
−Removed: Series A Notes, the Company is required to maintain a debt service reserve.
−Removed: The debt service reserve is classified as restricted
−Removed: cash on the accompanying unaudited condensed consolidated balance sheets.
−Removed: The NJEDA Bonds require the Company to make an annual
−Removed: principal payment on September 1st based on the amount specified in the loan documents and semi-annual interest payments on March
−Removed: 1st and September 1st, equal to interest due on the outstanding principal.
−Removed: The annual interest rate on the Series A Note is 6.5%.
−Removed: The NJEDA Bonds are collateralized by a first lien on the Company’s facility and equipment acquired with the proceeds of
−Removed: the original and refinanced bonds.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: Patent application costs were incurred in relation to the Company’s abuse deterrent opioid technology.
+Added: Amortization of the patent costs will begin upon the issuance of marketing authorization by the FDA.
+Added: Amortization will then be calculated on a straight-line basis through the expiry of the related patent(s).
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: The following tables
−Removed: summarize the Company’s bonds payable liability:
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: During August 2005, the Company
+Added: refinanced a bond issue occurring in 1999 through the issuance of Series A and B Notes tax-exempt bonds (the “NJEDA Bonds”
+Added: and/or “Bonds”).
+Added: During July 2014, the Company retired all outstanding Series B Notes, at par, along with all accrued interest
+Added: due and owed.
+Added: In relation to the Series A Notes,
+Added: the Company is required to maintain a debt service reserve.
+Added: The debt service reserve is classified as restricted cash on the accompanying
+Added: unaudited condensed consolidated balance sheets.
+Added: The NJEDA Bonds require the Company to make an annual principal payment on September
+Added: 1st based on the amount specified in the loan documents and semi-annual interest payments on March 1st and September 1st, equal to interest
+Added: due on the outstanding principal.
+Added: The annual interest rate on the Series A Note is 6.5 %.
+Added: The NJEDA Bonds are collateralized by a first
+Added: lien on the Company’s facility and equipment acquired with the proceeds of the original and refinanced bonds.
+Added: The following tables summarize
+Added: the Company’s bonds payable liability:
+Added: OF BONDS PAYABLE LIABILITY
+Added: June 30, 2021
+Added: March 31, 2021
Gross bonds payable
13 unchanged sentences
Long term portion of bonds payable, net of bond offering costs
−Removed: Amortization expense
−Removed: was $3,544 and $3,545 for the three months ended, and $10,634 and $10,630 for the nine months ended December 31, 2020 and 2019,
−Removed: respectively.
+Added: Amortization expense was $ 3,545
+Added: and $ 3,545 for the three months ended June 30, 2021 and 2020, respectively.
+Added: As of June 30, 2021 and March 31, 2021, interest payable was
+Added: $ 31,850 and $ 7,963 , respectively.
LOANS PAYABLE
−Removed: Loans payable consisted
−Removed: of the following:
−Removed: Equipment and insurance financing loans payable, between 3.5% and 12.73% interest and maturing between January 2021 and October 2025
−Removed: Loan received pursuant to the Payroll Protection Program Term Note
+Added: Loans payable consisted of the
+Added: OF LOANS PAYABLE
+Added: June 30, 2021
+Added: March 31, 2021
+Added: Equipment and insurance financing loans payable, between 3.5 % and 12.73 % interest and maturing between June 2021 and October 2025
Current portion of loans payable
Long-term portion of loans payable
−Removed: The interest expense
−Removed: associated with the loans payable was $19,422 and $18,291 for the three months ended, and $58,062 and $63,170 for the nine months
−Removed: ended December 31, 2020 and 2019, respectively.
−Removed: 2020 Paycheck Protection
−Removed: Program Term Note
−Removed: In April 2020, the
−Removed: Company entered into a Paycheck Protection Program Term Note (the “PPP Note”) with TD Bank, NA in the amount of $1,013,480.
−Removed: The PPP Note was issued to the Company pursuant to the Coronavirus, Aid, Relief, and Economic Security Act’s (the “CARES
−Removed: Act”) (P.L.
−Removed: 116-136) Paycheck Protection Program (the “Program”).
−Removed: Under the Program, all or a portion of the
−Removed: PPP Note may be forgiven in accordance with the Program requirements.
−Removed: In January 2021, the Company’s application for forgiveness
−Removed: of amounts due under the PPP Note was approved, in full, in accordance with the CARES Act and the Program.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: The interest expense associated
+Added: with the loans payable was $ 6,109 and $ 17,880 for the three months ended June 30, 2021 and 2020, respectively.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: RELATED PARTY SECURED PROMISSORY
−Removed: NOTE WITH MIKAH PHARMA, LLC
−Removed: For consideration of
−Removed: the assets acquired on May 15, 2017, the Company issued a Secured Promissory Note (the “Note”) to Mikah Pharma, LLC
−Removed: (“Mikah”) for the principal sum of $1,200,000.
−Removed: Mikah was founded in 2009 by Nasrat Hakim (“Hakim”), a related
−Removed: party and, the Company’s President, Chief Executive Officer and Chairman of the Board.
−Removed: The Note matures on December 31, 2020 at
−Removed: which time the Company shall pay the outstanding principal balance of the Note.
−Removed: Interest shall be computed on the unpaid principal
−Removed: amount at the per annum rate of ten percent (10%);
−Removed: provided, upon the occurrence of an Event of Default as defined within the Note,
−Removed: the principal balance shall bear interest from the date of such occurrence until the date of actual payment at the per annum rate
−Removed: of fifteen percent (15%).
−Removed: All interest payable hereunder shall be computed on the basis of actual days elapsed and a year of 360
−Removed: Installment payments of interest on the outstanding principal shall be paid as follows:
−Removed: quarterly commencing August 1, 2017
−Removed: and on November 1, February 1, May 1, and August 1 of each year thereafter.
−Removed: No principal or interest payments have been made on
−Removed: the Note since its issuance.
−Removed: All unpaid principal and accrued but unpaid interest shall be due and payable in full on the Maturity
−Removed: The interest expense associated with the Note was $30,000 for the three months ended and $90,000 for the nine months ended
−Removed: December 31, 2020 and 2019, respectively.
−Removed: Accrued interest due and owing on this note was $435,000 and $345,000 as of December 31,
−Removed: 2020 and March 31, 2020, respectively.
−Removed: The Note matured on
−Removed: December 31, 2020 without repayment.
−Removed: Subsequent to December 31, 2020, amounts due pursuant to the note, consisting of unpaid principal
−Removed: of $1,200,000 plus unpaid accrued interest through December 31, 2020 of $435,000 remain as a general, non-interest bearing liability
−Removed: of the Company.
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: RELATED PARTY SECURED PROMISSORY NOTE WITH
+Added: MIKAH PHARMA, LLC
+Added: For consideration of the assets
+Added: acquired on May 15, 2017, the Company issued a Secured Promissory Note (the “Mikah Note”) to Mikah Pharma, LLC (“Mikah”)
+Added: for the principal sum of $ 1,200,000 .
+Added: Mikah was founded in 2009 by Nasrat Hakim (“Hakim”), a related party and the Company’s
+Added: President, Chief Executive Officer and Chairman of the Board.
+Added: The Mikah Note matured on December 31, 2020 and was retired at par in March
+Added: The principal amount of $ 1,200,000 was repaid by the Company at maturity.
+Added: Interest expense associated with
+Added: the Note was $ 30,000 for the three months ended June 30, 2020.
+Added: A total of $ 435,000 in accrued interest expense, representing interest
+Added: expense accrued during the life of the Mikah Note, was due and owing as of the maturity date of the Mikah Note.
+Added: Of the $ 435,000
+Added: accrued interest due at maturity, $ 343,379 of accrued interest was satisfied by offset against amounts due from Mikah pursuant to the
+Added: development agreement between the Company and Mikah, dated December 3, 2018 (see Note 16).
+Added: The balance of $ 91,621 of accrued interest
+Added: expense owing in relation to the Mikah Note was recorded as a non-interest bearing, general liability of the Company.
DEFERRED REVENUE
−Removed: Deferred revenues in
−Removed: the aggregate amount of $68,891 as of December 31, 2020, were comprised of a current component of $13,333 and a long-term
−Removed: component of $55,558.
−Removed: Deferred revenues in the aggregate amount of $238,891 as of March 31, 2020, were comprised of a current
−Removed: component of $180,000 and a long-term component of $58,891.
−Removed: These line items represent the unamortized amounts of a $200,000 advance
−Removed: payment received for a TAGI Pharma (“TAGI”) licensing agreement with a fifteen-year term beginning in September 2010
−Removed: and ending in August 2025 and the $5,000,000 advance payment Epic Collaborative Agreement with a five-year term beginning in June
−Removed: 2015 and ending in May 2020.
−Removed: These advance payments were recorded as deferred revenue when received and are earned, on a straight-line
−Removed: basis over the life of the licenses.
−Removed: The current component is equal to the amount of revenue to be earned during the 12-month period
−Removed: immediately subsequent to the balance sheet date and the long-term component is equal to the amount of revenue to be earned thereafter.
+Added: Deferred revenues in the aggregate
+Added: amount of $ 55,558 as of June 30, 2021, were comprised of a current component of $ 13,333 and a long-term component of $ 42,225 .
+Added: revenues in the aggregate amount of $ 58,891 as of March 31, 2021, were comprised of a current component of $ 13,333 and a long-term component
+Added: of $ 45,558 .
+Added: These line items represent the unamortized amounts of a $ 200,000 advance payment received for a TAGI Pharma (“TAGI”)
+Added: licensing agreement with a fifteen -year term beginning in September 2010 and ending in August 2025 and the $ 5,000,000 advance payment
+Added: Epic Collaborative Agreement with a five -year term beginning in June 2015 and ending in May 2020 .
+Added: These advance payments were recorded
+Added: as deferred revenue when received and are earned, on a straight-line basis over the life of the licenses.
+Added: The current component is equal
+Added: 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
+Added: is equal to the amount of revenue to be earned thereafter.
COMMITMENTS AND CONTINGENCIES
−Removed: Occasionally, the Company
−Removed: may be involved in claims and legal proceedings arising from the ordinary course of its business.
−Removed: The Company records a provision
−Removed: for a liability when it believes that is both probable that a liability has been incurred, and the amount can be reasonably estimated.
−Removed: If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed
−Removed: consolidated financial statements.
−Removed: Contingencies are inherently unpredictable, and the assessments of the value can involve a series
−Removed: of complex judgments about future events and can rely heavily on estimates and assumptions.
−Removed: Operating Leases –
−Removed: 135 Ludlow Ave.
−Removed: The Company entered
−Removed: into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the “135
−Removed: lease”).
+Added: Occasionally, the Company may
+Added: be involved in claims and legal proceedings arising from the ordinary course of its business.
+Added: The Company records a provision for a liability
+Added: when it believes that is both probable that a liability has been incurred, and the amount can be reasonably estimated.
+Added: If these estimates
+Added: and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed consolidated financial
+Added: Contingencies are inherently unpredictable, and the assessments of the value can involve a series of complex judgments about
+Added: future events and can rely heavily on estimates and assumptions.
+Added: Operating Leases
+Added: The Company entered into an operating
+Added: lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the “135 Ludlow Ave.
The 135 Ludlow Ave.
lease is for approximately 15,000 square feet of floor space and began on July 1, 2010.
−Removed: During July 2014, the Company modified the 135 Ludlow Ave.
−Removed: lease in which the Company was permitted to occupy the entire
−Removed: 35,000 square feet of floor space in the building (“135 Ludlow Ave.
−Removed: modified lease”).
+Added: During July 2014, the Company
+Added: modified the 135 Ludlow Ave.
+Added: lease in which the Company was permitted to occupy the entire 35,000 square feet of floor space in the building
+Added: (“135 Ludlow Ave.
+Added: modified lease”).
The 135 Ludlow Ave.
−Removed: modified lease includes an initial term, which expired on December 31, 2016 with two tenant renewal options of five years each,
−Removed: at the sole discretion of the Company.
−Removed: On June 22, 2016, the Company exercised the first of these renewal options, with such option
−Removed: including a term that begins on January 1, 2017 and expires on December 31, 2021.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: modified lease
+Added: includes an initial term, which expired on December 31, 2016 with two tenant renewal options of five years each, at the sole discretion
+Added: of the Company.
+Added: On June 22, 2016, the Company exercised the first of these renewal options, with such option including a term that begins
+Added: on January 1, 2017 and expires on December 31, 2021 .
+Added: On June 30, 2021, the Company exercised the second of the renewal options, with such
+Added: option including a term that begins on January 1, 2022 and expires on December 31, 2026.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The 135 Ludlow Ave.
−Removed: modified lease property required significant leasehold improvements and qualifications, as a prerequisite, for its intended future
−Removed: Manufacturing, packaging, warehousing, and regulatory activities are currently conducted at this location.
−Removed: Additional renovations
−Removed: and construction to further expand the Company’s manufacturing resources are in progress.
−Removed: The Company assesses
−Removed: whether an arrangement is a lease or contains a lease at inception.
−Removed: For arrangements considered leases or that contain a lease
−Removed: that is accounted for separately, the Company determines the classification and initial measurement of the right-of-use asset and
−Removed: lease liability at the lease commencement date, which is the date that the underlying asset becomes available for use.
−Removed: has elected to account for non-lease components associated with its leases and lease components as a single lease component.
−Removed: The Company recognizes
−Removed: a right-of-use asset, which represents the Company’s right to use the underlying asset for the lease term, and a lease liability,
−Removed: which represents the present value of the Company’s obligation to make payments arising over the lease term.
−Removed: value of the lease payments is calculated using either the implicit interest rate in the lease or an incremental borrowing rate.
−Removed: Lease assets and liabilities
−Removed: are classified as follows on the condensed consolidated balance sheet:
+Added: modified lease
+Added: property required significant leasehold improvements and qualifications, as a prerequisite, for its intended future use.
+Added: Manufacturing,
+Added: packaging, warehousing and regulatory activities are currently conducted at this location.
+Added: Additional renovations and construction to
+Added: further expand the Company’s manufacturing resources are in progress.
+Added: In October 2020, the Company entered
+Added: into an operating lease for office space in Pompano Beach, Florida (the “Pompano Office Lease”).
+Added: The Pompano Office Lease
+Added: is for approximately 1,275 square feet of office space, with Elite taking occupancy on November 1, 2020.
+Added: The Pompano Office includes a
+Added: 3 month abatement from November 2020 through February 2021 and has a term of three years, ending on October 31, 2023.
+Added: The Company assesses whether an
+Added: arrangement is a lease or contains a lease at inception.
+Added: For arrangements considered leases or that contain a lease that is accounted
+Added: for separately, the Company determines the classification and initial measurement of the right-of-use asset and lease liability at the
+Added: lease commencement date, which is the date that the underlying asset becomes available for use.
+Added: The Company has elected to account for
+Added: non-lease components associated with its leases and lease components as a single lease component.
+Added: The Company recognizes a right-of-use
+Added: asset, which represents the Company’s right to use the underlying asset for the lease term, and a lease liability, which represents
+Added: the present value of the Company’s obligation to make payments arising over the lease term.
+Added: The present value of the lease payments
+Added: is calculated using either the implicit interest rate in the lease or an incremental borrowing rate.
+Added: Lease assets and liabilities are
+Added: classified as follows on the condensed consolidated balance sheet:
+Added: SCHEDULE OF LEASE ASSETS AND LIABILITIES
Classification
−Removed: Operating lease –
−Removed: right-of-use asset
+Added: As of June 30, 2021
+Added: Operating lease – right-of-use asset
Total leased assets
−Removed: Lease obligation –
−Removed: operating lease
−Removed: Lease obligation –
−Removed: operating lease, net of current portion
+Added: Lease obligation – operating lease
+Added: Lease obligation – operating lease, net of current portion
Total lease liabilities
−Removed: Rent expense is recorded
−Removed: on the straight-line basis.
+Added: Rent expense is recorded on the
+Added: straight-line basis.
Rent expense under the 135 Ludlow Ave.
−Removed: modified lease for the three months ended December 31, 2020
−Removed: and 2019 was $55,986 and $18,296, respectively, and $167,958 and $128,072 for the nine months ended December 31, 2020 and 2019,
+Added: modified lease for the three months ended June 30, 2021 and 2020 was $ 57,105
+Added: and $ 55,986 , respectively.
+Added: Rent expense under the Pompano Office Lease for the three months ended June 30, 2021 and 2020 was $ 5,772 and
$ 0 , respectively.
−Removed: Rent expense is recorded in general and administrative expense in the unaudited condensed consolidated statements
−Removed: of operations.
+Added: Rent expense is recorded in general and administrative expense in the unaudited condensed consolidated statements of
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The table below shows
the future minimum rental payments, exclusive of taxes, insurance and other costs, under the 135 Ludlow Ave.
−Removed: modified lease:
+Added: modified lease and the Pompano
+Added: Office Lease:
+Added: OF THE FUTURE MINIMUM RENTAL PAYMENTS
Years ending March 31,
1 unchanged sentence
Present value of lease payments
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: The weighted-average
−Removed: remaining lease term and the weighted-average discount rate of our lease was as follows:
+Added: The weighted-average remaining
+Added: lease term and the weighted-average discount rate of our lease was as follows:
+Added: OF WEIGHTED-AVERAGE REMAINING LEASE TERM AND THE WEIGHTED-AVERAGE DISCOUNT RATE
Lease Term and Discount Rate
+Added: June 30, 2021
Remaining lease term (years)
2 unchanged sentences
Operating leases
−Removed: The Company has an
−Removed: obligation for the restoration of its leased facility and the removal or dismantlement of certain property and equipment as a result
−Removed: of its business operation in accordance with ASC 410, Asset Retirement and Environmental Obligations –
−Removed: Asset Retirement
−Removed: The Company records the fair value of the asset retirement obligation in the period in which it is incurred.
−Removed: Company increases, annually, the liability related to this obligation.
−Removed: The liability is accreted to its present value each period
−Removed: and the capitalized cost is depreciated over the useful life of the related asset.
−Removed: Upon settlement of the liability, the Company
−Removed: records either a gain or loss.
−Removed: As of December 31, 2020, and March 31, 2020, the Company had a liability of $37,069 and
−Removed: $35,442, respectively, recorded as a component of other long-term liabilities.
+Added: The Company has an obligation
+Added: for the restoration of its leased facility and the removal or dismantlement of certain property and equipment as a result of its business
+Added: operation in accordance with ASC 410, Asset Retirement and Environmental Obligations – Asset Retirement Obligations .
+Added: Company records the fair value of the asset retirement obligation in the period in which it is incurred.
+Added: The Company increases, annually,
+Added: the liability related to this obligation.
+Added: The liability is accreted to its present value each period and the capitalized cost is depreciated
+Added: over the useful life of the related asset.
+Added: Upon settlement of the liability, the Company records either a gain or loss.
+Added: As of June 30,
+Added: 2021, and March 31, 2021, the Company had a liability of $ 38,195 and $ 37,628 , respectively, recorded as a component of other long-term
PREFERRED STOCK
Series J convertible preferred stock
−Removed: On April 28, 2017,
−Removed: the Company created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the Certificate
−Removed: of Designations (“Series J COD”).
−Removed: A total of 50 shares of Series J Preferred were authorized, zero shares are issued
−Removed: and outstanding, with a stated value of $1,000,000 per share and a par value of $0.01 as of December 31, 2020.
−Removed: On April 27, 2017,
−Removed: a total of 24.0344 shares of Series J Preferred were issued pursuant to an exchange agreement (the “Exchange Agreement”)
−Removed: with Hakim, a related party and the Company’s President, Chief Executive Officer and Chairman of the Board of Directors.
−Removed: The Exchange Agreement provided for Hakim to exchange 158,017,321 shares of Common Stock for 24.0344 shares of Series J Preferred
−Removed: and warrants to purchase 79,008,661 shares of Common Stock at $0.1521 per share.
−Removed: The aggregate stated value of the Series J Preferred
−Removed: issued was equal to the aggregate value of the shares of Common Stock exchanged, with such value of each share of Common Stock
−Removed: exchanged being equal to the closing price of the Common Stock on April 27, 2017.
−Removed: In connection with the Exchange Agreement, the
−Removed: Company also issued warrants to purchase 79,008,661 shares of Common Stock at $0.1521 per share, and such warrants are classified
−Removed: as liabilities on the accompanying unaudited condensed consolidated balance sheet as of December 31, 2020 (See Note 11).
−Removed: An amendment to the
−Removed: Company’s Articles of Incorporation to increase the number of shares of Common Stock the Company is authorized to issue from
−Removed: 995,000,000 shares to 1,445,000,000 shares was approved at the Company’s Annual Meeting of Shareholders held on December
−Removed: Prior to the approval of the increase in the number of authorized shares, there were insufficient authorized shares if
−Removed: the Series J Preferred Stock were converted.
+Added: On April 28, 2017, the Company
+Added: created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the Certificate of Designations
+Added: (“Series J COD”).
+Added: A total of 50 shares of Series J Preferred were authorized, zero shares are issued and outstanding, with
+Added: a stated value of $ 1,000,000 per share and a par value of $ 0.01 as of June 30, 2021.
+Added: On April 27, 2017, a total of
+Added: 24.0344 shares of Series J Preferred were issued pursuant to an exchange agreement (the “Exchange Agreement”) with Hakim,
+Added: a related party and the Company’s President, Chief Executive Officer and Chairman of the Board of Directors.
+Added: The Exchange Agreement
+Added: provided for Hakim to exchange 158,017,321 shares of Common Stock for 24.0344 shares of Series J Preferred and warrants to purchase 79,008,661
+Added: shares of Common Stock at $ 0.1521 per share.
+Added: The aggregate stated value of the Series J Preferred issued was equal to the aggregate value
+Added: of the shares of Common Stock exchanged, with such value of each share of Common Stock exchanged being equal to the closing price of the
+Added: Common Stock on April 27, 2017.
+Added: In connection with the Exchange Agreement, the Company also issued warrants to purchase 79,008,661 shares
+Added: of Common Stock at $ 0.1521 per share, and such warrants are classified as liabilities on the accompanying unaudited condensed consolidated
+Added: balance sheet as of June 30, 2021 (See Note 11).
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: An amendment to the Company’s
+Added: Articles of Incorporation to increase the number of shares of Common Stock the Company is authorized to issue from 995,000,000 shares
+Added: to 1,445,000,000 shares was approved at the Company’s Annual Meeting of Shareholders held on December 4, 2019.
+Added: Prior to the approval
+Added: of the increase in the number of authorized shares, there were insufficient authorized shares if the Series J Preferred Stock were converted.
As a result, the shares were classified in mezzanine equity.
−Removed: After the approval of
−Removed: the increase in the number of authorized shares, there are now sufficient authorized shares in the event of a full conversion of
−Removed: Series J Preferred Stock.
−Removed: With the approval of the increase in the number of authorized shares, there is no longer the presumption
−Removed: that a cash settlement will be required.
−Removed: Therefore, the Series J Preferred was reclassified from mezzanine equity to permanent
−Removed: equity at its carrying amount of $13,903,960 on the consolidated balance sheet as of March 31, 2020.
−Removed: On June 23, 2020, the
−Removed: Company held a Special Meeting of Shareholders, with such including a proposal for shareholders to again vote on the above referenced
−Removed: amendment to the Company’s Articles of Incorporation.
+Added: After the approval of the increase in the number of authorized shares, there
+Added: are now sufficient authorized shares in the event of a full conversion of Series J Preferred Stock.
+Added: With the approval of the increase
+Added: in the number of authorized shares, there is no longer the presumption that a cash settlement will be required.
+Added: Therefore, the Series
+Added: J Preferred was reclassified from mezzanine equity to permanent equity at its carrying amount of $ 13,903,960 on the consolidated balance
+Added: sheet as of March 31, 2020.
+Added: On June 23, 2020, the Company
+Added: held a Special Meeting of Shareholders, with such including a proposal for shareholders to again vote on the above referenced amendment
+Added: to the Company’s Articles of Incorporation.
This proposal was also passed by shareholder vote.
−Removed: On August 24, 2020,
−Removed: Hakim converted the 24.0344 shares of Series J Preferred into 158,017,321 shares of Common Stock at a conversion price of $0.1521
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
+Added: On August 24, 2020, Hakim converted
+Added: the 24.0344 shares of Series J Preferred into 158,017,321 shares of Common Stock at a conversion price of $ 0.1521 per share.
DERIVATIVE FINANCIAL INSTRUMENTS –
−Removed: The Company evaluates
−Removed: and accounts for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments and Hedging
−Removed: The Company issued
−Removed: warrants, with a term of ten years, to affiliates in connection with an exchange agreement dated April 28, 2017, as further described
−Removed: in this note below.
−Removed: A summary of warrant
−Removed: activity is as follows:
−Removed: December 31, 2020
+Added: The Company evaluates and accounts
+Added: for its freestanding instruments in accordance with ASC 815, Accounting for Derivative Instruments and Hedging Activities .
+Added: The Company issued warrants, with
+Added: a term of ten years, to affiliates in connection with an exchange agreement dated April 28, 2017, as further described in this note below.
+Added: A summary of warrant activity
+Added: is as follows:
+Added: SCHEDULE OF WARRANT ACTIVITY
+Added: June 30, 2021
March 31, 2021
3 unchanged sentences
Weighted Average Exercise Price
−Removed: Balance at beginning of period –
−Removed: April 1, 2020 and 2019,
+Added: Balance at beginning of period
Warrants granted pursuant to the issuance of Series J convertible preferred shares
1 unchanged sentence
Balance at end of period
−Removed: On April 28, 2017,
−Removed: the Company entered into an Exchange Agreement with Hakim, the Chairman of the Board, President, and Chief Executive Officer of
−Removed: the Company, pursuant to which the Company issued to Hakim 24.0344 shares of its Series J Preferred and warrants to purchase an
−Removed: aggregate of 79,008,661 shares of its Common Stock (the “Series J Warrants”
−Removed: and, along with the Series J Preferred
−Removed: issued to Hakim, the “Securities”) in exchange for 158,017,321 shares of Common Stock owned by Hakim.
−Removed: The fair value
−Removed: of the Series J Warrants was determined to be $6,474,674 upon issuance at April 28, 2017.
−Removed: The Series J Warrants
−Removed: are exercisable for a period of 10 years from the date of issuance, commencing April 28, 2020.
−Removed: The initial exercise price is $0.1521
−Removed: per share and the Series J Warrants can be exercised for cash or on a cashless basis.
−Removed: The exercise price is subject to adjustment
−Removed: for any issuances or deemed issuances of Common Stock or Common Stock equivalents at an effective price below the then exercise
−Removed: Such exercise price adjustment feature prohibits the Company from being able to conclude the warrants are indexed to its
−Removed: own stock and thus such warrants are classified as liabilities and measured initially and subsequently at fair value.
−Removed: J Warrants also provide for other standard adjustments upon the happening of certain customary events.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: On April 28, 2017, the Company
+Added: entered into an Exchange Agreement with Hakim, the Chairman of the Board, President, and Chief Executive Officer of the Company, pursuant
+Added: 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
+Added: of its Common Stock (the “Series J Warrants” and, along with the Series J Preferred issued to Hakim, the “Securities”)
+Added: in exchange for 158,017,321 shares of Common Stock owned by Hakim.
+Added: The fair value of the Series J Warrants was determined to be $ 6,474,674
+Added: upon issuance at April 28, 2017.
+Added: The Series J Warrants are exercisable
+Added: for a period of 10 years from the date of issuance, commencing April 28, 2020.
+Added: The initial exercise price is $ 0.1521 per share and the
+Added: Series J Warrants can be exercised for cash or on a cashless basis.
+Added: The exercise price is subject to adjustment for any issuances or deemed
+Added: issuances of Common Stock or Common Stock equivalents at an effective price below the then exercise price.
+Added: Such exercise price adjustment
+Added: feature prohibits the Company from being able to conclude the warrants are indexed to its own stock and thus such warrants are classified
+Added: as liabilities and measured initially and subsequently at fair value.
+Added: The Series J Warrants also provide for other standard adjustments
+Added: upon the happening of certain customary events.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: The fair value of the
−Removed: Series J Warrants was calculated using a Black-Scholes model instead of a Monte Carlo Simulation because the probability with the
−Removed: shareholder approval provisions was no longer a factor.
−Removed: The following assumptions were used in the Black-Scholes model to calculate
−Removed: the fair value of the Series J Warrants:
−Removed: Fair value of the Company’s Common Stock
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: The fair value of the Series J
+Added: Warrants was calculated using a Black-Scholes model instead of a Monte Carlo Simulation because the probability with the shareholder approval
+Added: provisions was no longer a factor.
+Added: The following assumptions were used in the Black-Scholes model to calculate the fair value of the Series
+Added: OF THE FAIR VALUE OF THE WARRANTS ISSUED
+Added: June 30, 2021
+Added: March 31, 2021
+Added: Fair value of the Company’s Common Stock
Initial exercise price
1 unchanged sentence
Risk free rate
−Removed: The changes in warrants
−Removed: (Level 3 financial instruments) measured at fair value on a recurring basis for the nine months ended December 31, 2020 were as
+Added: The changes in warrants (Level
+Added: 3 financial instruments) measured at fair value on a recurring basis for the three months ended June 30, 2021 were as follows:
+Added: OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
Balance at March 31, 2021
Change in fair value of derivative financial instruments - warrants
−Removed: Balance at December 31, 2020
−Removed: SHAREHOLDERS’
−Removed: Lincoln Park Capital –
+Added: Balance at June 30, 2021
+Added: SHAREHOLDERS’ EQUITY
+Added: Lincoln Park Capital – May 1, 2017 Purchase
+Added: On May 1, 2017, the Company entered
+Added: into a purchase agreement (the “2017 LPC Purchase Agreement”), together with a registration rights agreement (the “2017
+Added: LPC Registration Rights Agreement”), with Lincoln Park.
+Added: Under the terms and subject to
+Added: the conditions of the 2017 LPC Purchase Agreement, the Company had the right to sell to and Lincoln Park was obligated to purchase up
+Added: to $ 40 million in shares of Common Stock, subject to certain limitations, from time to time, over the 36-month period that commenced on
+Added: June 5, 2017.
+Added: The 2017 LPC Agreement expired
+Added: on July 1, 2020.
+Added: During the three months ended
+Added: June 30, 2020, there were no shares sold to Lincoln Park pursuant to the 2017 LPC Agreement.
+Added: In addition, there were no shares issued
+Added: to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Agreement.
+Added: Lincoln Park Capital Transaction - July 8, 2020
Purchase Agreement
−Removed: On May 1, 2017, the
−Removed: Company entered into a purchase agreement (the “2017 LPC Purchase Agreement”), together with a registration rights
−Removed: agreement (the “2017 LPC Registration Rights Agreement”), with Lincoln Park.
−Removed: Under the terms and
−Removed: subject to the conditions of the 2017 LPC Purchase Agreement, the Company had the right to sell to and Lincoln Park was obligated
−Removed: to purchase up to $40 million in shares of Common Stock, subject to certain limitations, from time to time, over the 36-month period
−Removed: that commenced on June 5, 2017.
−Removed: The 2017 LPC Agreement expired on July 1,
−Removed: During the nine months
−Removed: ended December 31, 2020, there were no shares sold to Lincoln Park pursuant to the 2017 LPC Agreement.
−Removed: In addition, there were
−Removed: no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Agreement.
−Removed: During the nine months ended
−Removed: December 31, 2019, a total of 8,895,233 shares were sold to Lincoln Park pursuant to the 2017 LPC Agreement for net proceeds totaling
−Removed: In addition, 111,778 shares were issued to Lincoln Park as additional commitment shares, pursuant to the 2017 LPC Agreement.
−Removed: Lincoln Park Capital Transaction
−Removed: - July 8, 2020 Purchase Agreement
−Removed: On July 8, 2020, the
−Removed: Company entered into a purchase agreement (the “2020 LPC Purchase Agreement”), and a registration rights agreement
−Removed: (the “2020 LPC Registration Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant
−Removed: 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,
−Removed: from time to time over the term of the 2020 LPC Purchase Agreement, at the Company’s direction.
−Removed: During the nine months ended December 31, 2020 the Company issued
−Removed: an aggregate of 5,975,857 shares of Common Stock in the amount of $469,105 to Lincoln Park as initial commitment shares.
−Removed: sold 640,543 shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the nine months ended December 31, 2020
−Removed: for net proceeds totaling $42,223.
−Removed: In addition, 10,094 shares were issued to Lincoln Park as additional commitment shares, pursuant
−Removed: to the 2020 LPC Agreement.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: On July 8, 2020, the Company entered
+Added: into a purchase agreement (the “2020 LPC Purchase Agreement”), and a registration rights agreement (the “2020 LPC Registration
+Added: Rights Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park has committed
+Added: 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
+Added: 2020 LPC Purchase Agreement, at the Company’s direction.
+Added: During the three months ended
+Added: June 30, 2021, there were no shares sold to Lincoln Park pursuant to the 2020 LPC Purchase Agreement.
+Added: In addition, there were no shares
+Added: issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Purchase Agreement.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
STOCK-BASED COMPENSATION
−Removed: Part of the compensation
−Removed: paid by the Company to its Directors and employees consists of the issuance of Common Stock or via the granting of options to purchase
−Removed: Common Stock.
+Added: Part of the compensation paid
+Added: 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-based Director Compensation
−Removed: The Company’s
−Removed: Director compensation policy, instituted in October 2009 and further revised in January 2016, includes provisions that a portion
−Removed: 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
−Removed: valuation of such shares being calculated on a quarterly basis and equal to the simple average of the closing price of the Company’s
−Removed: Common Stock for each trading day of the quarter then ended.
−Removed: During the nine months
−Removed: ended December 31, 2020, the Company issued 1,550,343 shares of Common Stock to its Directors in payment of director’s fees totaling
−Removed: an aggregate of $135,000 and with such aggregate director’s fees being earned and accrued over the twenty-seven month period beginning
−Removed: on January 1, 2018 and ending on March 31, 2020.
−Removed: In addition, the Company made cash payments totaling an aggregate of $67,500 in
−Removed: payment of director’s fees earned over the same twenty-seven month period.
−Removed: During the nine months ended December 31,
−Removed: 2020, the Company accrued director’s fees totaling $67,500, which will be paid via cash payments totaling $22,500 and the
+Added: The Company’s Director
+Added: compensation policy, instituted in October 2009 and further revised in January 2016, includes provisions that a portion of director’s
+Added: 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
+Added: being calculated on a quarterly basis and equal to the average closing price of the Company’s Common Stock.
+Added: During the three months ended
+Added: June 30, 2021, the Company issued 886,710 shares of Common Stock to its Directors in payment of director’s fees totaling an aggregate
+Added: of $ 60,000 and with such aggregate director’s fees being earned and accrued over the twelve month period beginning on April 1, 2020
+Added: and ending on March 31, 2021.
+Added: In addition, the Company made cash payments totaling an aggregate of $ 30,000 in payment of director’s
+Added: fees earned over the same twelve month period.
+Added: During the three months ended
+Added: June 30, 2021, the Company accrued director’s fees totaling $ 22,500 , which will be paid via cash payments totaling $ 7,500 and the
issuance of 268,963 shares of Common Stock.
−Removed: As of December 31,
−Removed: 2020, the Company owed its Directors a total of $22,500 in cash payments and 638,393 shares of Common Stock in payment of director
−Removed: fees totaling $67,500 due and owing.
−Removed: The Company anticipates that these shares of Common Stock will be issued prior to the end
−Removed: of the current fiscal year.
+Added: As of June 30, 2021, the Company
+Added: owed its Directors a total of $ 7,500 in cash payments and 268,963 shares of Common Stock in payment of director fees totaling $ 22,500
+Added: due and owing.
+Added: 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
−Removed: Employment contracts
−Removed: with the Company’s President and Chief Executive Officer, Chief Financial Officer and certain other employees and engagement
−Removed: contracts with certain consultants include provisions for a portion of each employee’s salaries or consultant’s fees
−Removed: 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
−Removed: calculated on a quarterly basis and equal to the simple average of the closing price of the Company’s Common Stock for the
−Removed: quarter then ended.
−Removed: During the nine months
−Removed: ended December 31, 2020, the Company issued 646,336 shares of Common Stock in payment of salaries totaling $56,250 pursuant to
−Removed: the employment contract of the Company’s Executive Vice President of Operations and with such salaries being earned and accrued
−Removed: over the thirty-month period beginning on January 1, 2018 and ending on June 30, 2020.
−Removed: During the nine months
−Removed: ended December 31, 2020, the Company accrued salaries totaling $597,500 owed to the Company’s President and Chief Executive
−Removed: Officer, Chief Financial Officer and certain other employees which will be paid via the issuance of 8,492,964 shares of Common
−Removed: As of December 31,
−Removed: 2020, the Company owed its President and Chief Executive Officer, Chief Financial Officer and certain other employees’
−Removed: totaling $2,858,750 which will be paid via the issuance of 32,753,296 shares of Common Stock.
−Removed: During the nine months
−Removed: ended December 31, 2020, the Company issued 1,931,891 shares of Common Stock in payment of consulting fees totaling $161,033, pursuant
−Removed: to engagement contracts with a certain consultant, and with such consulting expenses being earned and accrued over the twenty seven
−Removed: month period beginning on January 1, 2018 and ending March 31, 2020.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: Employment contracts with the
+Added: Company’s President and Chief Executive Officer and certain other employees and engagement contracts with
+Added: certain consultants include provisions for a portion of each employee’s salaries or consultant’s fees to be paid via the issuance
+Added: of shares of the Company’s Common Stock, in lieu of cash, with the valuation of such shares being calculated on a quarterly basis
+Added: and equal to the average closing price of the Company’s Common Stock.
+Added: During the three months ended
+Added: June 30, 2021, the Company issued 1,218,526 shares of Common Stock in payment of salaries totaling $ 97,500 pursuant to the employment
+Added: contract of the Company’s former Chief Financial Officer, with such salaries being earned and accrued over the thirty-month
+Added: period beginning on October 1, 2018 and ending on March 31, 2021.
+Added: During the three months ended
+Added: June 30, 2021, the Company accrued salaries totaling $ 193,750 owed to the Company’s President and Chief Executive Officer and certain
+Added: other employees which will be paid via the issuance of 3,506,847 shares of Common Stock.
+Added: As of June 30, 2021, the Company
+Added: owed its President and Chief Executive Officer and certain other employees’ salaries totaling $ 3,156,250 , which will be
+Added: paid via the issuance of 38,373,435 shares of Common Stock.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: Under its 2014 Stock
−Removed: Option Plan and prior options plans, the Company may grant stock options to officers, selected employees, as well as members of
−Removed: the Board of Directors and advisory board members.
−Removed: All options have generally been granted at a price equal to or greater than
−Removed: the fair market value of the Company’s Common Stock at the date of the grant.
−Removed: Generally, options are granted with a vesting
−Removed: period of up to three years and expire ten years from the date of grant.
−Removed: A summary of the activity of Company’s 2014 Stock
−Removed: Option Plan for the nine months ended December 31, 2020 is as follows:
−Removed: Exercise Price
−Removed: Weighted Average
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Under its 2014 Stock Option Plan
+Added: and prior options plans, the Company may grant stock options to officers, selected employees, as well as members of the Board of Directors
+Added: and advisory board members.
+Added: All options have generally been granted at a price equal to or greater than the fair market value of the Company’s
+Added: Common Stock at the date of the grant.
+Added: Generally, options are granted with a vesting period of up to three years and expire ten years
+Added: from the date of grant.
+Added: A summary of the activity of Company’s 2014 Stock Option Plan for the three months ended June 30, 2021 is
+Added: OF STOCK OPTION PLAN
Remaining Contractual
−Removed: Aggregate Intrinsic
−Removed: Outstanding at April 1, 2020
−Removed: Forfeited and expired
−Removed: Outstanding at December 31, 2020
−Removed: Exercisable at December 31, 2020
−Removed: The aggregate intrinsic
−Removed: value for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted
−Removed: price of the Company’s Common Stock as of December 31, 2020 and March 31, 2020 of $0.09 and $0.07, respectively.
+Added: Term (in years)
+Added: Outstanding at March 31, 2021
+Added: Outstanding at June 30, 2021
+Added: Exercisable at June 30, 2021
+Added: The aggregate intrinsic value
+Added: for outstanding options is calculated as the difference between the exercise price of the underlying awards and the quoted price of the
+Added: Company’s Common Stock as of June 30, 2021 and March 31, 2021 of $ 0.08 and $ 0.07 , respectively.
CONCENTRATIONS AND CREDIT RISK
−Removed: Two customers accounted
−Removed: for approximately 93% of the Company’s revenues for the nine months ended December 31, 2020.
−Removed: These two customers accounted
−Removed: for approximately 79% and 14% of revenues each, respectively.
−Removed: The same two customers accounted for 82% and 12% of revenues each,
−Removed: respectively, for the three months ended December 31, 2020.
−Removed: Three customers accounted
−Removed: for approximately 94% of the Company’s revenues for the nine months ended December 31, 2019.
−Removed: These three customers accounted
−Removed: for approximately 57%, 24%, and 13% of revenues each, respectively.
−Removed: The same three customers accounted for approximately 69%, 12%
−Removed: and 13% of revenues each for three months ended December 31, 2019.
+Added: Two customers accounted for approximately
+Added: 92 % of the Company’s revenues for the three months ended June 30, 2021.
+Added: These two customers accounted for approximately 83 % and
+Added: 9 % of revenues each, respectively.
+Added: Two customers accounted for approximately
+Added: 92 % of the Company’s revenues for the three months ended June 30, 2020.
+Added: These two customers accounted for approximately 73 % and
+Added: 19 % of revenues each, respectively.
Accounts Receivable
−Removed: Two customers accounted
−Removed: for approximately 94% of the Company’s accounts receivable as of December 31, 2020.
−Removed: These two customers accounted for
−Removed: approximately 88% and 6% of accounts receivable each, respectively.
−Removed: Four customers accounted
−Removed: for substantially all the Company’s accounts receivable as of March 31, 2020.
−Removed: These four customers accounted for approximately
+Added: Two customers accounted for approximately
+Added: 93 % of the Company’s accounts receivable as of June 30, 2021.
+Added: These two customers accounted for approximately 84 % and 9 % of accounts
+Added: receivable each, respectively.
+Added: Three customers accounted for
+Added: substantially all the Company’s accounts receivable as of March 31, 2021.
+Added: These three customers accounted for approximately 73 %,
15 % and 11 % of accounts receivable each, respectively.
−Removed: Four suppliers accounted
−Removed: for more than 81% of the Company’s purchases of raw materials for the nine months ended December 31, 2020.
−Removed: These four suppliers
−Removed: accounted for approximately 59%, 12%, 5% and 5% of purchases each, respectively.
−Removed: Eight suppliers accounted
−Removed: for more than 85% of the Company’s purchases of raw materials for the nine months ended December 31, 2019.
−Removed: Included in these
−Removed: seven suppliers were three suppliers accounting for approximately 34%, 25%, and 11% of purchases each, respectively.
−Removed: ELITE PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
+Added: Four suppliers accounted for more
+Added: than 64 % of the Company’s purchases of raw materials for the three months ended June 30, 2021.
+Added: These four suppliers accounted for
+Added: approximately 38 %, 14 %, 7 % and 5 % of purchases each, respectively.
+Added: Three suppliers accounted for
+Added: more than 81 % of the Company’s purchases of raw materials for the three months ended June 30, 2020.
+Added: These three suppliers accounted
+Added: for approximately 63 %, 14 %, and 4 % of purchases each, respectively.
SEGMENT RESULTS
−Removed: FASB ASC 280-10-50
−Removed: requires use of the “management approach”
−Removed: model for segment reporting.
−Removed: The management approach is based on the way
−Removed: a company’s management organized segments within the company for making operating decisions and assessing performance.
−Removed: segments are based on products and services, geography, legal structure, management structure, or any other manner in which management
−Removed: disaggregates a company.
−Removed: The Company has determined
−Removed: that its reportable segments are ANDAs for generic products and NDAs for branded products.
−Removed: The Company identified its reporting
−Removed: segments based on the marketing authorization relating to each and the financial information used by its chief operating decision
−Removed: maker to make decisions regarding the allocation of resources to and the financial performance of the reporting segments.
−Removed: Asset information by
−Removed: operating segment is not presented below since the chief operating decision maker does not review this information by segment.
−Removed: The reporting segments follow the same accounting policies used in the preparation of the Company’s unaudited condensed consolidated
−Removed: financial statements.
−Removed: Disaggregated revenue by reportable segments is included within Note 1.
−Removed: The following represents
−Removed: selected information for the Company’s reportable segments:
−Removed: For the Three Months Ended
−Removed: For the Nine Months Ended
+Added: FASB ASC 280-10-50 requires use
+Added: of the “management approach” model for segment reporting.
+Added: The management approach is based on the way a company’s management
+Added: organized segments within the company for making operating decisions and assessing performance.
+Added: Reportable segments are based on products
+Added: and services, geography, legal structure, management structure, or any other manner in which management disaggregates a company.
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: The Company has determined that
+Added: its reportable segments are ANDAs for generic products and NDAs for branded products.
+Added: The Company identified its reporting segments based
+Added: on the marketing authorization relating to each and the financial information used by its chief operating decision maker to make decisions
+Added: regarding the allocation of resources to and the financial performance of the reporting segments.
+Added: Asset information by operating
+Added: segment is not presented below since the chief operating decision maker does not review this information by segment.
+Added: The reporting segments
+Added: follow the same accounting policies used in the preparation of the Company’s unaudited condensed consolidated financial statements.
+Added: The following represents selected
+Added: information for the Company’s reportable segments:
+Added: OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS
+Added: For the three Months Ended June 30,
Operating Income by Segment
−Removed: The table below reconciles
−Removed: the Company’s operating income by segment to income (loss) from operations before income taxes as reported in the Company’s
+Added: The table below reconciles the
+Added: Company’s operating income by segment to income from operations before provision for income taxes as reported in the Company’s
unaudited condensed consolidated statements of operations.
−Removed: For the Three Months Ended
−Removed: For the Nine Months Ended
+Added: OF OPERATING LOSS BY SEGMENT TO (LOSS) INCOME FROM OPERATIONS
+Added: For the Three Months Ended June 30,
Operating income by segment
5 unchanged sentences
Change in fair value of derivative instruments
−Removed: Income (loss) from operations before income taxes
−Removed: $ (1,860,680 )
−Removed: $ (3,174,719 )
−Removed: RELATED PARTY AGREEMENTS WITH MIKAH PHARMA, LLC
−Removed: On December 3, 2018,
−Removed: the Company executed a development agreement with Mikah pursuant to which Mikah and the Company will collaborate to develop and
−Removed: commercialize generic products including formulation development, analytical method development, bioequivalence studies and manufacture
−Removed: of development batches of generic products.
−Removed: As of the date of this report, the Company has incurred costs which are $229,451 in
−Removed: excess of advanced payments received to date from Mikah.
−Removed: This balance due from Mikah is included in the financial statement line
−Removed: of prepaid expenses and other current assets on the accompanying consolidated balance sheet.
−Removed: ELITE PHARMACEUTICALS, INC.
+Added: Income from operations before income taxes
+Added: RELATED PARTY AGREEMENTS WITH MIKAH PHARMA,
+Added: On December 3, 2018, the Company
+Added: executed a development agreement with Mikah, pursuant to which Mikah and the Company will collaborate to develop and commercialize
+Added: generic products including formulation development, analytical method development, bioequivalence studies and manufacture of development
+Added: batches of generic products.
+Added: As of March 31, 2021, the Company has incurred costs which are $ 238,451 in excess of advanced payments received
+Added: to date from Mikah.
+Added: This balance due from Mikah was offset, in full, against accrued interest due and owing to Mikah pursuant to the
+Added: Mikah Note (see Note 7).
+Added: In May 2020, SunGen Pharma LLC
+Added: (“SunGen”), pursuant to an asset purchase agreement, assigned its rights and obligations under the SunGen Agreement
+Added: for Amphetamine IR and Amphetamine ER to Mikah Pharmaceuticals.
+Added: The ANDAs for Amphetamine IR and Amphetamine ER are now registered under
+Added: Elite’s name.
+Added: Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and
+Added: obligations for these products from SunGen.
+Added: Mikah Pharmaceuticals was founded in 2009 by Nasrat Hakim, a related party and the Company’s
+Added: President, Chief Executive Officer and Chairman of the Board.
+Added: In June 2021, the Company entered
+Added: into a development and license agreement with Mikah Pharma LLC, pursuant to which Mikah Pharma LLC will engage in the research,
+Added: development, sales and licensing of generic pharmaceutical products.
+Added: In addition, Mikah Pharma LLC will collaborate to develop
+Added: and commercialize generic products including formulation development, analytical method development, manufacturing, sales and marketing
+Added: of generic products.
+Added: Initially two generic products were identified for the parties to develop.
+Added: PHARMACEUTICALS, INC.
AND SUBSIDIARY
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL
−Removed: Sale of New Jersey Net Operating
−Removed: Loss and R&D Tax Credits
−Removed: In April 2020, Elite
−Removed: Laboratories Inc., a wholly owned subsidiary of Elite Pharmaceuticals Inc., received final approval from the New Jersey Economic
−Removed: Development Authority for the sale of net tax benefits of $607,635 relating to New Jersey net operating losses and net tax benefits
−Removed: of $338,772, relating to R&D tax credits.
−Removed: The Company sold the net tax benefits approved for sale for total proceeds of $946,407,
−Removed: which is captured within the Income tax benefit (expense) line item on the Company’s Condensed Consolidated Statement of
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Sale of New Jersey Net Operating Loss
+Added: In April 2020, Elite Labs
+Added: received final approval from the New Jersey Economic Development Authority for the sale of net tax benefits of $ 607,635 relating
+Added: to New Jersey net operating losses and net tax benefits of $ 338,772 , relating to R&D tax credits.
+Added: The Company sold the net tax benefits
+Added: approved for sale for total proceeds of $ 946,407 , during the three months ended June 30, 2020.
+Added: Sale of New Jersey Net Operating Loss and Research
+Added: and Development Tax Credit
+Added: In April 2021, Elite Labs
+Added: received final approval from the New Jersey Economic Development Authority for the sale of net tax benefits of $ 796,860 relating
+Added: to New Jersey net operating losses and net tax benefits of $ 58,490 , relating to research and development tax credits.
+Added: The Company sold
+Added: the net tax benefits approved for sale at a transfer price equal to ninety three and one half cents for every benefit dollar and incurred
+Added: transaction fees of $ 12,861 , resulting in net proceeds to the Company of $ 855,350 , during the three months ended June 30, 2021.
COVID-19 UPDATE
−Removed: In December 2019, the
−Removed: Novel Corona Virus, COVID-19 was reported to have emerged in Wuhan, China.
−Removed: In March 2020, the World Health Organization (“WHO”)
−Removed: declared the COVID-19 outbreak a global pandemic.
−Removed: Governments at the national, state and local level in the United States, and
−Removed: globally, have implemented aggressive actions to reduce the spread of the virus, with such actions including, without limitation,
−Removed: lockdown and shelter in place orders, limitations on non-essential gatherings of people, suspension of all non-essential travel,
−Removed: and ordering certain businesses and governmental agencies to cease non-essential operations at physical locations.
−Removed: Under current
−Removed: and applicable laws and regulations, the Company’s business is deemed essential and it has continued to operate in all aspects
−Removed: of its pharmaceutical manufacturing, distribution, product development, regulatory compliance, and other activities.
−Removed: The Company’s
−Removed: management has developed and implemented a range of measures to address the risks, uncertainties, and operational challenges associated
−Removed: with operating in a COVID-19 environment.
−Removed: The Company is closely monitoring the rapidly evolving and changing situation and are
−Removed: implementing plans intended to limit the impact of COVID-19 on our business so that the Company can continue to manufacture those
−Removed: medicines used by end user patients.
−Removed: Actions the Company has taken to date are, without limitation, further described below.
−Removed: The Company has taken
−Removed: and will continue to take, proactive measures to provide for the well-being of its workforce while continuing to safely produce
−Removed: pharmaceutical products.
−Removed: The Company has implemented alternative working practices, which include, without limitation, modified
−Removed: schedules, shift rotation and work at home abilities for appropriate employees to best ensure adequate social distancing.
−Removed: the Company increased its already thorough cleaning protocols throughout its facilities and has prohibited visits from non-essential
−Removed: Certain of these measures have resulted in increased costs.
+Added: In December 2019, the Novel Corona
+Added: Virus, COVID-19 was reported to have emerged in Wuhan, China.
+Added: In March 2020, the World Health Organization (“WHO”) declared
+Added: the COVID-19 outbreak a global pandemic.
+Added: Governments at the national, state and local level in the United States, and globally, have implemented
+Added: aggressive actions to reduce the spread of the virus, with such actions including, without limitation, lockdown and shelter in place orders,
+Added: limitations on non-essential gatherings of people, suspension of all non-essential travel, and ordering certain businesses and governmental
+Added: agencies to cease non-essential operations at physical locations.
+Added: Under current and applicable laws and regulations, the Company’s
+Added: business is deemed essential and it has continued to operate in all aspects of its pharmaceutical manufacturing, distribution, product
+Added: development, regulatory compliance and other activities.
+Added: The Company’s management has developed and implemented a range of measures
+Added: to address the risks, uncertainties, and operational challenges associated with operating in a COVID-19 environment.
+Added: The Company is closely
+Added: monitoring the rapidly evolving and changing situation and are implementing plans intended to limit the impact of COVID-19 on our business
+Added: so that the Company can continue to manufacture those medicines used by end user patients.
+Added: Actions the Company has taken to date are,
+Added: without limitation, further described below.
+Added: The Company has taken and will
+Added: continue to take, proactive measures to provide for the well-being of its workforce while continuing to safely produce pharmaceutical
+Added: The Company has implemented alternative working practices, which include, without limitation, modified schedules, shift rotation
+Added: and work at home abilities for appropriate employees to best ensure adequate social distancing.
+Added: In addition, the Company increased its
+Added: already thorough cleaning protocols throughout its facilities and has prohibited visits from non-essential visitors.
+Added: Certain of these
+Added: measures have resulted in increased costs.
Manufacturing and Supply Chain
−Removed: During the three and
−Removed: nine months ended December 31, 2020, and as of the date of this Quarterly Report on Form 10-Q, the Company has not experienced
−Removed: material, detrimental issues related to COVID-19 in its manufacturing, supply chain, quality assurance and regulatory compliance
−Removed: activities, and has been able to operate without interruption.
−Removed: The Company has taken, and plans to continue to take, commercially
−Removed: practical measures to keep its facilities open.
−Removed: The Company’s supply chains remain intact and operational, and the Company
−Removed: is in regular communications with its suppliers and third-party partners.
−Removed: A prolonging of the current situation relating to COVID-19
−Removed: may result in an increased risk of interruption in the Company supply chain in the future, with no assurances given as the materiality
−Removed: of such future interruption on the Company’s business, financial condition, results of operations and cash flows.
+Added: During the three months ended
+Added: June 30, 2021, and as of the date of this Quarterly Report on Form 10-Q, the Company has not experienced material, detrimental issues
+Added: related to COVID-19 in its manufacturing, supply chain, quality assurance and regulatory compliance activities, and has been able to operate
+Added: without interruption.
+Added: The Company has taken, and plans to continue to take, commercially practical measures to keep its facilities open.
+Added: The Company’s supply chains remain intact and operational, and the Company is in regular communications with its suppliers and third-party
+Added: A prolonging of the current situation relating to COVID-19 may result in an increased risk of interruption in the Company supply
+Added: chain in the future, with no assurances given as the materiality of such future interruption on the Company’s business, financial
+Added: condition, results of operations and cash flows.
SUBSEQUENT EVENTS
−Removed: Forgiveness of Payroll Protection
−Removed: On January 12, 2021,
−Removed: the Company received notification that the United States Small Business Administration (“SBA”), had approved, in full,
−Removed: the Company’s application for forgiveness of amounts received pursuant to the CARES Act and the Program.
−Removed: MANAGEMENT’S DISCUSSION
−Removed: AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: The following discussion
−Removed: of our financial condition and results of operations for the three and nine months ended December 31, 2020 and 2019 should be read
−Removed: in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements that are included
−Removed: elsewhere in this report.
−Removed: Our discussion includes forward-looking statements based upon current expectations that involve risks
−Removed: and uncertainties, such as our plans, objectives, expectations, and intentions.
−Removed: Actual results and the timing of events could differ
−Removed: materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth
−Removed: under Item 1A.
−Removed: Risk Factors appearing in our Annual Report on Form 10-K for the year ended March 31, 2020.
−Removed: We use words such
−Removed: as “anticipate,”
−Removed: “estimate,”
−Removed: “plan,”
−Removed: “project,”
−Removed: “continuing,”
−Removed: “ongoing,”
−Removed: “expect,”
−Removed: “believe,”
−Removed: “intend,”
−Removed: “may,”
−Removed: “will,”
−Removed: “should,”
−Removed: “could,”
−Removed: and similar expressions to identify forward-looking statements.
−Removed: Unless expressly
−Removed: indicated or the context requires otherwise, the terms “Elite”, the “Company”, “we”, “us”,
−Removed: and “our”
−Removed: refer to Elite Pharmaceuticals, Inc., and subsidiary.
−Removed: Elite Pharmaceuticals,
−Removed: Inc., a Nevada corporation (the “Company”, “Elite”, “Elite Pharmaceuticals”, the “registrant”,
−Removed: “we”, “us”
−Removed: or “our”) was incorporated on October 1, 1997 under the laws of the State of Delaware,
−Removed: and its wholly-owned subsidiary, Elite Laboratories, Inc.
−Removed: (“Elite Labs”), was incorporated on August 23, 1990 under
−Removed: the laws of the State of Delaware.
−Removed: On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of
−Removed: We are a specialty
−Removed: pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, using proprietary
−Removed: know-how and technology for the manufacture of generic pharmaceuticals.
−Removed: Our strategy includes developing generic versions of controlled-release
−Removed: drug products with high barriers to entry.
−Removed: We occupy manufacturing,
−Removed: warehouse, laboratory and office space at 165 Ludlow Avenue and 135 Ludlow Avenue in Northvale, NJ (the “Northvale Facility”).
−Removed: The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States Drug Enforcement
−Removed: Agency (“DEA”) registered facility for research, development, and manufacturing.
−Removed: We focus our efforts
−Removed: on the following areas:
−Removed: (i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New Drug Applications
−Removed: (“ANDAs”);
−Removed: (ii) development of additional generic pharmaceutical products;
−Removed: (iii) development of the other products
−Removed: in our pipeline including products co-developed with partners;
−Removed: (iv) commercial exploitation of our products either by sales under
−Removed: our own label, license and the collection of royalties, or through the manufacture of our formulations;
−Removed: and (v) development of
−Removed: new products for sale under our own label, and the expansion of our licensing agreements with other pharmaceutical companies, including
−Removed: co-development projects, joint ventures and other collaborations.
−Removed: Our focus is on the
−Removed: development of various types of drug products, including branded drug products which require New Drug Applications (“NDAs”)
−Removed: under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Drug Price
−Removed: Competition Act”) as well as generic drug products which require ANDAs.
−Removed: We believe that our
−Removed: business strategy enables us to reduce its risk by having a diverse product portfolio that includes both branded and generic products
−Removed: in various therapeutic categories and to build collaborations and establish licensing agreements with companies with greater resources
−Removed: thereby allowing us to share costs of development and improve cash-flow.
−Removed: Commercial Products
−Removed: We own, license, contract
−Removed: manufacture or have contractual rights to receive royalties from the following products currently approved for commercial sale:
−Removed: Phentermine HCl 37.5mg tablets
−Removed: (“Phentermine 37.5mg”)
−Removed: Adipex-P®
−Removed: Phendimetrazine Tartrate 35mg tablets
−Removed: (“Phendimetrazine 35mg”)
−Removed: November 2012
−Removed: Phentermine HCl 15mg and 30mg capsules
−Removed: (“Phentermine 15mg”
−Removed: and “Phentermine 30mg”)
−Removed: Adipex-P®
−Removed: Naltrexone HCl 50mg tablets
−Removed: (“Naltrexone 50mg”)
−Removed: Addiction Treatment
−Removed: September 2013
−Removed: Isradipine 2.5mg and 5mg capsules
−Removed: (“Isradipine 2.5mg”
−Removed: and “Isradipine 5mg”)
−Removed: Cardiovascular
−Removed: Oxycodone HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets (“OXY IR 5mg”, “Oxy IR 10mg”, “Oxy IR 15mg”, “OXY IR 20mg”
−Removed: and “Oxy IR 30mg”)
−Removed: Roxycodone®
−Removed: Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine 100mg”)
−Removed: Surmontil®
−Removed: Antidepressant
−Removed: 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”
−Removed: and “Amphetamine IR 30mg”)
−Removed: Adderall®
−Removed: Central Nervous System (“CNS”) Stimulant
−Removed: Dantrolene Sodium Capsules 25mg, 50mg and 100mg (“Dantrolene 25mg”, “Dantrolene 50mg”, “Dantrolene 100mg”)
−Removed: Dantrium®
−Removed: Muscle Relaxant
−Removed: 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”)
−Removed: Adderall XR®
−Removed: Central Nervous System (“CNS”) Stimulant
−Removed: Products Not Yet Commercialized
−Removed: SequestOx™
−Removed: SequestOx™
−Removed: our abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
−Removed: In January 2016, the
−Removed: Company submitted an NDA for SequestOx ™
−Removed: and on July 15, 2016, the US Food and Drug Administration (“FDA”)
−Removed: issued a Complete Response Letter, (“CRL”), regarding the NDA.
−Removed: The CRL stated that the review cycle for the SequestOx™
−Removed: NDA is complete and the application was not ready for approval in its present form.
−Removed: The Company developed
−Removed: pilot data to address a key FDA concern in the CRL, but the Company has now paused development of this product and, in light of
−Removed: the current market and litigation around opioid products, the Company is evaluating the feasibility of continuing development.
−Removed: Generic version
−Removed: of an antibiotic product
−Removed: On January 3, 2019,
−Removed: the Company filed an ANDA with the FDA for a generic version of an antibiotic product.
−Removed: The product is jointly owned by Elite and
−Removed: SunGen Pharma LLC.
−Removed: Upon approval by the FDA of this ANDA, Elite will manufacture and package the product on a cost-plus basis.
−Removed: The ANDA is currently under review by the FDA.
−Removed: Loxapine (“Loxapine
−Removed: Capsules”)
−Removed: The FDA approved a
−Removed: transfer for manufacturing of Loxapine Capsules at the Northvale Facility.
−Removed: The approved ANDAs for Loxapine Capsules were acquired
−Removed: from Mikah Pharma.
−Removed: The Company anticipates commercial launch of this product during the first quarter of the fiscal year ending
−Removed: March 31, 2022.
−Removed: Acetaminophen
−Removed: and Codeine Phosphate
−Removed: The Company received
−Removed: approval from the FDA of an ANDA for a generic version of Tylenol®
−Removed: with Codeine (acetaminophen and codeine phosphate).
−Removed: Acetaminophen
−Removed: with codeine is a combination medication indicated for the management of mild to moderate pain, where treatment with an opioid
−Removed: is appropriate and for which alternative treatments are inadequate.
−Removed: The Company is not pursuing licensing deals for any opioids
−Removed: at this time and, in light of the current market and litigation around opioid products, the Company has no plans to commercialize
−Removed: this product at this time.
−Removed: Critical Accounting Policies and Estimates
−Removed: The preparation of
−Removed: the unaudited condensed consolidated financial statements and related disclosures in conformity with GAAP, and our discussion and
−Removed: analysis of its financial condition and operating results require our management to make judgments, assumptions and estimates that
−Removed: affect the amounts reported in its unaudited condensed consolidated financial statements and accompanying notes.
−Removed: Management bases
−Removed: its estimates on historical experience and on various other assumptions it believes to be reasonable under the circumstances, the
−Removed: results of which form the basis for making judgments about the carrying values of assets and liabilities.
−Removed: Actual results may differ
−Removed: from these estimates and such differences may be material.
−Removed: There were no significant
−Removed: changes during the nine months ended December 31, 2020 to the items that we disclosed as our Critical Accounting Policies and Estimates
−Removed: described in Item 7 of the Company’s financial statements as contained in the Company’s Annual Report on Form 10-K
−Removed: for the fiscal year ended March 31, 2020.
−Removed: Results of Operations
−Removed: The following set forth
−Removed: our results of operations for the periods presented.
−Removed: The period-to-period comparison of financial results is not necessarily indicative
−Removed: of future results.
−Removed: ended December 31, 2020 compared to December 31, 2019
−Removed: Revenue, Cost of
−Removed: revenue and Gross profit:
−Removed: For the Three Months Ended
−Removed: Manufacturing fees
−Removed: Licensing fees
−Removed: Total revenue
−Removed: Cost of revenue
−Removed: Gross profit - percentage
−Removed: Total revenues for
−Removed: three months ended December 31, 2020 increased by $1.0 million or 20%, to $6.0 million, as compared to $5.0 million for the corresponding
−Removed: period in 2019, primarily due to revenues earned from Amphetamine ER Capsules, which were launched during the current fiscal year,
−Removed: offset by decreases in license fee revenues resulting from the full amortization of SequestOx™
−Removed: milestone revenues occurring
−Removed: in June 2020 and accordingly providing no contribution to revenues during the three months ended December 31, 2020, while contributing
−Removed: to revenues in the comparable period of the prior year.
−Removed: Manufacturing fees
−Removed: increased by $1.1 million, or 29%, primarily due to revenues earned from Amphetamine ER Capsules, which were launched during the
−Removed: current fiscal year, and increased sales of Amphetamine IR Tablets, Dantrolene capsules and Trimipramine capsules during the three
−Removed: months ended December 31, 2020 as compared to the comparable period of the prior year.
−Removed: Licensing fees decreased
−Removed: by $0.1 million, or 8%.
−Removed: This decrease is primarily due to the full amortization of SequestOx™
−Removed: milestone license fees occurring
−Removed: in June 2020.
−Removed: Costs of revenue consists
−Removed: of manufacturing and assembly costs.
−Removed: Our costs of revenue increased by $0.4 million or 22%, to $2.6 million as compared to $2.2
−Removed: million for the corresponding period in the prior fiscal year.
−Removed: This increase was due in large part to the increased manufacturing
−Removed: activities and related manufacturing revenues during the three months ended December 31, 2020, as compared to the comparable period
−Removed: of the prior fiscal year, and also due to there being a strong positive correlation of costs of revenue to manufacturing revenues.
−Removed: Our gross profit margin
−Removed: was 56% during the three months ended December 31, 2020 as compared to 57% during the comparable period of the prior fiscal year.
−Removed: Operating expenses:
−Removed: For the Three Months Ended
−Removed: Operating expenses:
−Removed: Research and development
−Removed: General and administrative
−Removed: Non-cash compensation
−Removed: Depreciation and amortization
−Removed: Total operating expenses
−Removed: Operating expenses
−Removed: consist of research and development costs, general and administrative, non-cash compensation and depreciation and amortization
−Removed: Operating expenses for the three months ended December 31, 2020 increased by $0.2 million or 9% to $2.4 million, as compared
−Removed: to $2.2 million for the corresponding period in 2019.
−Removed: Research and development
−Removed: costs for the three months ended December 31, 2020 were $1.2 million, an increase of $0.2 million, or 26%, from $1.0 million of
−Removed: such costs for the comparable period of the prior year.
−Removed: The increase was a result of the timing and nature of product development
−Removed: activities during the three months ended December 31, 2020 as compared to the comparable period of the prior year.
−Removed: General and administrative
−Removed: expenses for the three months ended December 31,2020 were $0.8 million, a decrease of $0.1 million or 6% from $0.9 million of such
−Removed: costs for the comparable period of the prior year.
−Removed: The decrease was due in large part to increased utilization rates of our manufacturing
−Removed: facility as compared with the comparable period of the prior year, and ongoing cost reduction and cost control initiatives.
−Removed: Non-cash compensation
−Removed: expense for the three months ended December 31, 2020 and 2019 was less than $0.1 million.
−Removed: Depreciation and amortization
−Removed: expenses for the three months ended December 31,2020 were $0.3 million and remained relatively unchanged from $0.3 million of such
−Removed: costs for the comparable period of the prior year.
−Removed: As a result of the
−Removed: foregoing, our income from operations for the three months ended December 31,2020 was $1.0 million, compared to $0.7 million for
−Removed: the comparable period of the prior year.
−Removed: Other income (expense):
−Removed: For the Three Months Ended
−Removed: Other income (expense):
−Removed: Interest expense and amortization of debt issuance costs
−Removed: Gain on sale of assets
−Removed: Proceeds from sale of ANDA’s
−Removed: Change in fair value of derivative instruments
−Removed: Interest income
−Removed: Other income (expense), net
−Removed: $ (2,551,875 )
−Removed: Other income, net for
−Removed: the three months ended December 31, 2020 was $1.1 million, an increase in other income, net of $3.6 million from other expense,
−Removed: net of $2.6 million for the comparable period of the prior year.
−Removed: The increase in other income (expense), net was due to income
−Removed: relating to changes in the fair value of our outstanding derivative warrants during the three months ended December 31, 2020.
−Removed: note that the change in the fair value of derivative instruments is determined in large part by the change in the closing price
−Removed: 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,
−Removed: with a strong inverse relationship between the fair value of our derivatives instruments and decreases in the closing price of
−Removed: the Company’s Common Stock.
−Removed: As a result of the
−Removed: foregoing, our net income for the three months ended December 31, 2020 was $2.0 million, compared to a net loss of $1.9 million
−Removed: for the comparable period of the prior year.
−Removed: Nine months ended December 31, 2020
−Removed: compared to December 31, 2019
−Removed: Revenue, Cost of
−Removed: revenue and Gross profit:
−Removed: For the Nine Months Ended
−Removed: Manufacturing fees
−Removed: Licensing fees
−Removed: Total revenue
−Removed: Cost of revenue
−Removed: Gross profit - percentage
−Removed: Total revenues for
−Removed: the nine-month period ended December 31, 2020 increased by $7.9 million or 61%, to $21.0 million, as compared to $13.1 million,
−Removed: for the corresponding period of the prior year primarily due to revenues earned from Amphetamine ER Capsules, which were launched
−Removed: during the current fiscal year, and increased sales of Amphetamine IR Tablets during the nine-month period ended December 31, 2020
−Removed: as compared to the comparable period of the prior fiscal year.
−Removed: Manufacturing fees
−Removed: increased by $6.8 million, or 63%, primarily due to revenues earned from Amphetamine ER Capsules, which were launched during the
−Removed: current fiscal year, and increased sales of Amphetamine IR Tablets during the nine month period ended December 31, 2020 as compared
−Removed: to the comparable period of the prior fiscal year.
−Removed: Licensing fees increased
−Removed: by $1.1 million, or 51%.
−Removed: This increase is primarily due to licensing fees earned from Amphetamine ER Capsules which were launched
−Removed: during the current fiscal year, and increased licensing fees earned from the sale of Amphetamine IR Tablets, Naltrexone and Phentermine
−Removed: during the nine months ended December 31, 2020 as compared to the comparable period of the prior fiscal year, offset by the full
−Removed: amortization of license fee revenues recognized from SequestOx™
−Removed: milestones occurring during June 2020.
−Removed: The nine months ended
−Removed: December 31, 2020 included less than three months of such license fee revenues as compared to the comparable period of the prior
−Removed: year which included a full nine months of such license fee revenues.
−Removed: Costs of revenue
−Removed: consists of manufacturing and assembly costs.
−Removed: Our costs of revenue increased by $3.5 million or 46%, to $11.0 million as compared
−Removed: to $7.5 million for the corresponding period in the prior fiscal year.
−Removed: This increase was due in large part to the increased manufacturing
−Removed: activities and related manufacturing revenues during the nine months ended December 31, 2020, as compared to the comparable period
−Removed: of the prior fiscal year, and also due to there being a strong positive correlation of costs of revenue to manufacturing revenues.
−Removed: gross profit margin was 48% during the nine months ended December 31, 2020 as compared to 42% during the comparable period of the
−Removed: prior fiscal year.
−Removed: Operating expenses:
−Removed: For the Nine Months Ended
−Removed: Operating expenses:
−Removed: Research and development
−Removed: General and administrative
−Removed: Non-cash compensation
−Removed: Depreciation and amortization
−Removed: Total operating expenses
−Removed: Operating expenses
−Removed: consist of research and development costs, general and administrative, non-cash compensation and depreciation and amortization
−Removed: Operating expenses for the nine months ended December 31, 2020 increased by $0.4 million, or 6%, to $6.8 million as compared
−Removed: to $6.4 million for the corresponding period in the prior fiscal year.
−Removed: Research and development
−Removed: costs for the nine months ended December 31, 2020 were $3.3 million, an increase of $0.3 million, or 10%, from approximately $3.0
−Removed: million of such costs for the comparable period of the prior year.
−Removed: The increase was a result of the timing and nature of product
−Removed: development activities during the nine-month period ended December 31, 2020 as compared to the comparable period of the prior fiscal
−Removed: General and administrative
−Removed: expenses for the nine months ended December 31, 2020 were $2.5 million, an increase of $0.1 million, or 6% from $2.4 million of
−Removed: such costs for the comparable period of the prior year with such increase being attributed in large part to increased costs and
−Removed: headcounts relating to regulatory compliance and laboratory activities, offset by increased facility utilization rates and ongoing
−Removed: cost reduction initiatives.
−Removed: Non-cash compensation
−Removed: expense for the nine months ended December 31, 2020 and 2019 was less than $0.1 million.
−Removed: Depreciation and amortization
−Removed: expenses for the nine months ended December 31, 2020 were $1.0 million, which was virtually unchanged from $1.0 million in such
−Removed: costs for the comparable period of the prior fiscal year.
−Removed: As a result of the
−Removed: foregoing, our income from operations for the nine months ended December 31, 2020 was $3.2 million, compared to a loss from
−Removed: operations of $0.9 million for the comparable period of the prior fiscal year.
−Removed: Other income (expense):
−Removed: For the Nine Months Ended
−Removed: Other income (expense):
−Removed: Interest expense and amortization of debt issuance costs
−Removed: Gain on sale of assets
−Removed: Proceeds from sale of ANDA’s
−Removed: Change in fair value of derivative instruments
−Removed: Interest income
−Removed: Other income, net
−Removed: $ (2,263,677 )
−Removed: Other income,
−Removed: net for the nine months ended December 31, 2020 was $1.5 million, an increase of $3.8 million from the other expense, net of $2.3
−Removed: million for the comparable period of the prior fiscal year.
−Removed: The increase in other income (expense) was due to income relating to
−Removed: changes in the fair value of our outstanding derivative warrants during the nine months ended December 31, 2020.
−Removed: Please note that
−Removed: 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
−Removed: 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
−Removed: relationship between the fair value of our derivatives instruments and decreases in the closing price of the Company’s Common
−Removed: Please see Note 10 to the Unaudited Condensed Consolidated Financial Statements above.
−Removed: As a result of the
−Removed: foregoing, our net income before the net benefit from sale of net operating loss credits for the nine months ended December 31,
−Removed: 2020 was $4.6 million, compared to net loss $3.2 million for the comparable period of the prior fiscal year.
−Removed: The Company received
−Removed: a net benefit from sale of net operating loss credits of $0.9 million during the nine months ended December 31, 2020, resulting
−Removed: in net income attributable to common shareholders of $5.5 million, compared to a net loss of $3.2 million for the comparable period
−Removed: of the prior fiscal year.
−Removed: Liquidity and Capital Resources
−Removed: Capital Resources
−Removed: Current assets
−Removed: Current liabilities
−Removed: $ (1,397,198 )
−Removed: Working capital
−Removed: Our working capital
−Removed: (total current assets less total current liabilities) increased by $5.7 million from $1.6 million as of March 31, 2020 to
−Removed: $7.3 million as of December 31, 2020, with such increase being primarily related to the net income of $5.6 million and a net
−Removed: positive cash flow of $4.3 million achieved during the nine months ended December 31, 2020.
−Removed: Summary of Cash
−Removed: For the Nine Months Ended
−Removed: Net cash provided by (used in) operating activities
−Removed: Net cash used in investing activities
−Removed: Net cash provided by financing activities
−Removed: Net cash provided by
−Removed: operating activities for the nine months ended December 31, 2020 was $3.9 million, which included net income of $5.6 million and
−Removed: increases in non-cash expenses totaling $0.1 million, offset by net increases in assets and decreases in liabilities totaling $1.8
−Removed: Net cash used in investing
−Removed: activities for the nine months ended December 31, 2020 was comprised of purchases of purchases of property and equipment of $0.15
−Removed: million offset by proceeds from the sale of property and equipment of $0.07 million.
−Removed: Net cash provided by
−Removed: financing activities was $0.4 million for the nine months ended December 31, 2020 which consisted primarily of proceeds from the
−Removed: payroll protection program loan offset by loan payments.
−Removed: Capital –
−Removed: July 8, 2020 Purchase Agreement
−Removed: On July 8, 2020, the
−Removed: Company entered into a purchase agreement (the “2020 LPC Purchase Agreement”), and a registration rights agreement,
−Removed: with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park has committed to purchase up to
−Removed: $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
−Removed: Purchase Agreement, at the Company’s direction.
−Removed: During the nine months
−Removed: ended December 31, 2020 the Company issued an aggregate of 5,975,857 shares of Common Stock in the amount of $469,105 to Lincoln
−Removed: Park as initial commitment shares.
−Removed: The Company sold 640,543 shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement
−Removed: during the nine months ended December 31, 2020 for net proceeds totaling $42,223.
−Removed: In addition, 10,094 shares were issued to Lincoln
−Removed: Park as additional commitment shares, pursuant to the 2020 LPC Agreement.
−Removed: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
−Removed: As a smaller reporting
−Removed: company, we are not required to provide the information required by this Item.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.