FINANCIAL STATEMENTS
−Removed: expenses and other current assets
+Added: September 30, 2022
+Added: March 31, 2022
Current assets:
−Removed: and equipment, net of accumulated depreciation of $ 13,641,313 and $ 13,348,565 , respectively
−Removed: assets, net of accumulated amortization of $- 0 -, respectively
−Removed: lease - right-of-use asset
−Removed: income tax asset
−Removed: cash - debt service for NJEDA bonds
−Removed: AND SHAREHOLDERS’ EQUITY
−Removed: revenue, current portion
−Removed: payable, current portion, net of bond issuance costs
−Removed: payable, current portion
−Removed: obligation - operating lease, current portion
+Added: Accounts receivable
+Added: Prepaid expenses and other current assets
+Added: Total current assets
+Added: Property and equipment, net of accumulated depreciation of $ 13,957,320 and $ 13,348,565 , respectively
+Added: Intangible assets, net of accumulated amortization of $- 0 -, respectively
+Added: Operating lease - right-of-use asset
+Added: Deferred income tax asset
+Added: Other assets:
+Added: Restricted cash - debt service for NJEDA bonds
+Added: Security deposits
+Added: Total other assets
+Added: LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
−Removed: revenue, net of current portion
−Removed: payable, net of current portion and bond issuance costs
−Removed: payable, net of current portion and loan costs
−Removed: obligation - operating lease, net of current portion
−Removed: financial instruments - warrants
−Removed: long-term liabilities
+Added: Accounts payable
+Added: Accrued expenses
+Added: Deferred revenue, current portion
+Added: Bonds payable, current portion, net of bond issuance costs
+Added: Loans payable, current portion
+Added: Lease obligation - operating lease, current portion
+Added: Total current liabilities
Long-term liabilities:
−Removed: Shareholders’
−Removed: Series J convertible
−Removed: preferred stock;
+Added: Deferred revenue, net of current portion
+Added: Bonds payable, net of current portion and bond issuance costs
+Added: Loans payable, net of current portion and loan costs
+Added: Lease obligation - operating lease, net of current portion
+Added: Derivative financial instruments – warrants
+Added: Other long-term liabilities
+Added: Total long-term liabilities
+Added: Total liabilities
+Added: Shareholders’ equity:
+Added: Series J convertible preferred stock;
par value of $ 0.01 ;
50 shares authorized;
−Removed: 0 issued and outstanding as of June 30, 2022 and March 31, 2022
+Added: 0 issued and outstanding as of September 30, 2022 and March 31, 2022
+Added: Common stock;
par value $ 0.001 ;
1,445,000,000 shares authorized;
−Removed: 1,011,381,988 shares issued as of June 30, 2022 and March 31, 2022;
−Removed: 1,011,281,988
−Removed: shares outstanding as of June 30, 2022 and March 31, 2022.
−Removed: paid-in capital
+Added: 1,014,015,081 shares issued as of September 30, 2022 and March 31, 2022;
+Added: 1,013,915,081 shares outstanding as of September 30, 2022 and March 31, 2022.
+Added: Additional paid-in capital
Treasury stock;
−Removed: shares as of June 30, 2022 and March 31, 2022;
+Added: 100,000 shares as of September 30, 2022 and March 31, 2022;
+Added: Accumulated deficit
( 138,238,722 )
( 140,059,744 )
−Removed: shareholders’ equity
−Removed: liabilities and shareholders’ equity
+Added: Total shareholders’ equity
+Added: Total liabilities and shareholders’ equity
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2 unchanged sentences
CONSOLIDATED STATEMENTS OF OPERATIONS
−Removed: the Three Months Ended June 30,
−Removed: Manufacturing
−Removed: of manufacturing
−Removed: and development
−Removed: and administrative
−Removed: compensation through issuance of stock options
−Removed: and amortization
+Added: For the Three Months Ended
+Added: September 30,
+Added: For the Six Months Ended
+Added: September 30,
+Added: Manufacturing fees
+Added: Licensing fees
+Added: Total revenue
+Added: Cost of manufacturing
Operating expenses:
−Removed: from operations
−Removed: income (expense):
−Removed: in fair value of derivative instruments
−Removed: expense and amortization of debt issuance costs
−Removed: (expense) income, net
−Removed: from operations before income taxes
−Removed: benefit for sale of state net operating losses and credits
−Removed: income attributable to common shareholders
−Removed: net income per share attributable to common shareholders
−Removed: net income per share attributable to common shareholders
−Removed: weighted average Common Stock outstanding
+Added: Research and development
+Added: General and administrative
+Added: Non-cash compensation through issuance of stock options
+Added: Depreciation and amortization
+Added: Total operating expenses
+Added: Income from operations
+Added: Other income (expense):
+Added: Change in fair value of derivative instruments
+Added: Interest expense and amortization of debt issuance costs
+Added: Interest income
+Added: Other (expense) income, net
+Added: Income from operations before income taxes
+Added: Income tax expense
+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
+Added: Basic weighted average Common Stock outstanding
1,012,228,256
1,011,281,988
−Removed: weighted average Common Stock outstanding
1,011,762,632
1,010,059,593
+Added: Diluted weighted average Common Stock outstanding
+Added: 1,012,228,256
+Added: 1,011,281,988
+Added: 1,011,762,632
+Added: 1,010,059,593
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2 unchanged sentences
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
−Removed: J Preferred Stock
+Added: Series J Preferred Stock
+Added: Additional Paid-In
+Added: Treasury Stock
Shareholders’
−Removed: as of March 31, 2022
+Added: Balance as of March 31, 2022
1,011,381,988
2 unchanged sentences
$ ( 140,059,744 )
−Removed: compensation through the issuance of employee stock options
−Removed: at June 30, 2022
+Added: Non-cash compensation through the issuance of employee stock options
+Added: Balance at June 30, 2022
1,011,381,988
2 unchanged sentences
$ ( 139,753,861 )
−Removed: J Preferred Stock
−Removed: Shareholders’
−Removed: as of March 31, 2021
+Added: Non-cash compensation through the issuance of employee stock options
+Added: Share issued in payment of director salaries
+Added: Shares issued in payment of consultants
+Added: Balance at September 30, 2022
1,014,015,081
2 unchanged sentences
$ ( 138,238,722 )
−Removed: compensation through the issuance of employee stock options
−Removed: issued in payment of salaries
−Removed: at June 30, 2021
+Added: Series J Preferred Stock
+Added: Additional Paid-In
+Added: Treasury Stock
+Added: Total Shareholders’
+Added: Balance as of March 31, 2021
1,009,276,752
2 unchanged sentences
$ ( 148,957,989 )
−Removed: accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
+Added: Non-cash compensation through the issuance of employee stock options
+Added: Shares issued in payment of salaries
+Added: Balance at June 30, 2021
+Added: 1,011,381,988
+Added: $ 164,565,685
+Added: $ ( 306,841 )
+Added: $ ( 146,568,871 )
+Added: Non-cash compensation through the issuance of employee stock options
+Added: Balance at September 30, 2021
+Added: 1,011,381,988
+Added: $ 164,569,861
+Added: $ ( 306,841 )
+Added: $ ( 144,771,894 )
+Added: The accompanying notes are an integral part
+Added: of these unaudited condensed consolidated financial statements.
PHARMACEUTICALS, INC.
1 unchanged sentence
CONSOLIDATED STATEMENTS OF CASH FLOWS
−Removed: the Three Months Ended June 30,
−Removed: FLOWS FROM OPERATING ACTIVITIES:
−Removed: to reconcile net income to net cash provided by operating activities:
−Removed: and amortization
−Removed: of operating leases - right-of-use assets
−Removed: in fair value of derivative financial instruments - warrants
−Removed: compensation accrued
−Removed: compensation through the issuance of employee stock options
−Removed: rent expense and lease accretion
−Removed: in operating assets and liabilities:
+Added: For the Six Months Ended September 30,
+Added: CASH FLOWS FROM OPERATING ACTIVITIES:
+Added: Adjustments to reconcile net income to net cash provided by operating activities:
+Added: Depreciation and amortization
+Added: Amortization of operating leases - right-of-use assets
+Added: Change in fair value of derivative financial instruments - warrants
( 1,033,894 )
−Removed: expenses and other current assets
−Removed: payable, accrued expenses and other current liabilities
−Removed: obligations - operating leases
−Removed: cash (used in) provided by operating activities
−Removed: FLOWS FROM INVESTING ACTIVITIES:
−Removed: of property and equipment
−Removed: cash used in investing activities
−Removed: FLOWS FROM FINANCING ACTIVITIES:
−Removed: from loans payable
−Removed: loan payments
−Removed: cash provided by (used in) financing activities
−Removed: change in cash and restricted cash
−Removed: and restricted cash, beginning of period
−Removed: and restricted cash, end of period
−Removed: disclosure of cash and non-cash transactions:
−Removed: paid for interest
−Removed: of equipment purchases and insurance renewal
−Removed: issued in payment of Directors fees, salaries and consulting expenses
−Removed: non-cash amounts of lease liabilities arising from obtaining right of use assets
−Removed: accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
+Added: Non-cash compensation accrued
+Added: Non-cash compensation through the issuance of employee stock options
+Added: Non-cash rent expense and lease accretion
+Added: Change in operating assets and liabilities:
+Added: Accounts receivable
+Added: ( 1,171,625 )
+Added: ( 1,175,982 )
+Added: ( 1,532,756 )
+Added: Prepaid expenses and other current assets
+Added: Accounts payable, accrued expenses and other current liabilities
+Added: Deferred revenue
+Added: Lease obligations - operating leases
+Added: Net cash provided by operating activities
+Added: CASH FLOWS FROM INVESTING ACTIVITIES:
+Added: Purchase of property and equipment
+Added: ( 5,199,696 )
+Added: Net cash used in investing activities
+Added: ( 5,199,696 )
+Added: CASH FLOWS FROM FINANCING ACTIVITIES:
+Added: Payment of bond principal
+Added: Proceeds from loans payable
+Added: Other loan payments
+Added: Net cash provided by (used in) financing activities
+Added: Net change in cash and restricted cash
+Added: Cash and restricted cash, beginning of period
+Added: Cash and restricted cash, end of period
+Added: Supplemental disclosure of cash and non-cash transactions:
+Added: Cash paid for interest
+Added: Financing of equipment purchases and insurance renewal
+Added: Stock issued in payment of Directors fees, salaries and consulting expenses
+Added: Supplemental non-cash amounts of lease liabilities arising from obtaining right of use assets
+Added: The accompanying notes are an integral part
+Added: of these unaudited condensed consolidated financial statements.
PHARMACEUTICALS, INC.
3 unchanged sentences
Pharmaceuticals, Inc.
−Removed: (the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the
−Removed: State of Delaware, and its wholly-owned subsidiary Elite Laboratories, 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.
(“Elite Labs”) was incorporated on August 23, 1990
under the laws of the State of Delaware.
−Removed: On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the
−Removed: State of Nevada.
−Removed: Elite Labs engages primarily in researching, developing, licensing and manufacture of generic, oral dose
−Removed: pharmaceuticals.
−Removed: The Company is equipped to manufacture controlled-release products on a contract basis for third parties and
−Removed: itself, if and when the product candidates are approved.
−Removed: These products include drugs that cover therapeutic areas for allergy,
−Removed: bariatric, attention deficit and infection.
−Removed: Research and development activities are performed with an objective of developing
−Removed: product candidates that will secure marketing approvals from the United States Food and Drug Administration (“FDA”), and
−Removed: thereafter, commercially exploiting such products.
+Added: On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of
+Added: Elite Labs engages primarily in researching, developing, licensing and manufacture of generic, oral dose pharmaceuticals.
+Added: Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when the product
+Added: candidates are approved.
+Added: These products include drugs that cover therapeutic areas for allergy, bariatric, attention deficit and infection.
+Added: Research and development activities are performed with an objective of developing product candidates that will secure marketing approvals
+Added: from the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting such products.
of Consolidation
7 unchanged sentences
which are, in the opinion of management, necessary for a fair presentation of such statements.
−Removed: The results of operations for the three
−Removed: months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the entire year.
+Added: The results of operations for the six
+Added: months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the entire year.
Accounting Standards Board (“FASB”) Accounting Standards Codification 280 (“ASC 280”), Segment Reporting ,
97 unchanged sentences
None of the Company’s contracts contained a significant financing
−Removed: component as of June 30, 2022.
+Added: component as of September 30, 2022.
accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the customer’s products occurs.
11 unchanged sentences
OF DISAGGREGATION OF REVENUE
−Removed: the Three Months Ended June 30,
−Removed: Manufacturing
−Removed: Manufacturing
+Added: For the Three Months Ended September 30,
+Added: For the Six Months Ended September 30,
+Added: Licensing fees
+Added: Total NDA revenue
+Added: Manufacturing fees
+Added: Licensing fees
+Added: Total ANDA revenue
+Added: Total revenue
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents.
4 unchanged sentences
financial institutions and, to date has not experienced losses on any of its balances.
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: of June 30, 2022, and March 31, 2022, the Company had $ 405,163 and $ 405,039 , of restricted cash, respectively, related to debt service
+Added: of September 30, 2022, and March 31, 2022, the Company had $ 405,164 and $ 405,039 , of restricted cash, respectively, related to debt service
reserve in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 6).
28 unchanged sentences
and slower growth rates.
−Removed: of June 30, 2022, the Company did not identify any indicators of impairment.
+Added: of September 30, 2022, the Company did not identify any indicators of impairment.
also see Note 4 for further details on intangible assets.
−Removed: and Development
−Removed: and development expenditures are charged to expense as incurred.
PHARMACEUTICALS, INC.
1 unchanged sentence
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: and Development
+Added: and development expenditures are charged to expense as incurred.
Contingencies
21 unchanged sentences
tax jurisdiction until the applicable statutes of limitation expire.
−Removed: As of June 30, 2022, a summary of the tax years that remain subject
−Removed: to examination in our major tax jurisdictions are:
+Added: As of September 30, 2022, a summary of the tax years that remain
+Added: subject to examination in our major tax jurisdictions are:
United States – Federal, 2016 and forward, and State, 2013 and forward.
−Removed: Company did not record unrecognized tax positions for the three months ended June 30, 2022 and June 30, 2021.
+Added: The Company did not record unrecognized tax positions for the six months ended September 30, 2022.
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
and Preferred Shares
29 unchanged sentences
OF EARNINGS (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
−Removed: the Three Months Ended June 30,
−Removed: income - basic
−Removed: of dilutive instrument on net income
−Removed: income - diluted
−Removed: Weighted average
−Removed: shares of Common Stock outstanding - basic
+Added: For the Three Months Ended September 30,
+Added: For the Six Months Ended September 30,
+Added: Net income - basic
+Added: Effect of dilutive instrument on net income
( 1,033,894 )
+Added: Net income - diluted
+Added: Weighted average shares of Common Stock outstanding - basic
1,012,228,256
−Removed: effect of stock options and convertible securities
−Removed: average shares of Common Stock outstanding - diluted
1,011,281,988
1,011,762,632
+Added: 1,010,059,593
+Added: Dilutive effect of stock options and convertible securities
+Added: Weighted average shares of Common Stock outstanding - diluted
+Added: 1,012,228,256
+Added: 1,011,281,988
+Added: 1,011,762,632
+Added: 1,010,059,593
Net income per share
28 unchanged sentences
OF LIABILITIES MEASURED AT FAIR VALUE ON A RECURRING BASIS
−Removed: Value Measurement Using
−Removed: at Fair Value
−Removed: as of March 31, 2022
−Removed: in fair value of derivative instruments
−Removed: as of June 30, 2022
+Added: Amount at Fair
+Added: Fair Value Measurement Using
+Added: Balance as of March 31, 2022
+Added: Change in fair value of derivative instruments
+Added: Balance as of September 30, 2022
Note 11 for specific inputs used in determining fair value.
24 unchanged sentences
consisted of the following:
+Added: September 30, 2022
+Added: March 31, 2022
+Added: Finished goods
Work-in-progress
+Added: Raw materials
+Added: Inventory, net
PHARMACEUTICALS, INC.
4 unchanged sentences
OF PROPERTY AND EQUIPMENT
−Removed: building and improvements
−Removed: manufacturing, warehouse and transportation equipment
−Removed: equipment and software
−Removed: plant and equipment, gross
+Added: September 30, 2022
+Added: March 31, 2022
+Added: Land, building and improvements
+Added: Laboratory, manufacturing, warehouse and transportation equipment
+Added: Office equipment and software
+Added: Furniture and fixtures
+Added: Property and equipment, gross
Accumulated depreciation
1 unchanged sentence
( 13,348,565 )
−Removed: plant and equipment, net
−Removed: expense was $ 292,748
−Removed: and $ 309,157
−Removed: for the three months ended June 30, 2022 and June 30, 2021, respectively.
+Added: Property and equipment, net
+Added: expense was $ 316,007 and $ 295,491 for the three months ended September 30, 2022 and 2021, respectively.
+Added: and $ 608,755 and $ 604,648 for
+Added: the six months ended September 30, 2022 and 2021, respectively.
INTANGIBLE ASSETS
1 unchanged sentence
OF INTANGIBLE ASSETS
−Removed: application costs
−Removed: acquisition costs
−Removed: application costs *
−Removed: acquisition costs
−Removed: application costs were incurred in relation to the Company’s abuse deterrent opioid technology.
−Removed: Amortization of the patent
−Removed: costs will begin upon the issuance of marketing authorization by the FDA.
−Removed: Amortization will then be calculated on a straight-line
−Removed: basis through the expiry of the related patent(s).
+Added: September 30, 2022
+Added: Patent application costs
+Added: ANDA acquisition costs
+Added: March 31, 2022
+Added: Patent application costs *
+Added: ANDA acquisition costs
+Added: application costs were incurred in relation to the Company’s abuse deterrent opioid
+Added: Amortization of the patent costs will begin upon the issuance of marketing authorization
+Added: Amortization will then be calculated on a straight-line basis through the expiry
+Added: of the related patent(s).
PHARMACEUTICALS, INC.
2 unchanged sentences
ACCRUED EXPENSES
−Removed: of June 30, 2022 and March 31, 2022, the Company’s accrued expenses consisted of the following:
+Added: of September 30, 2022 and March 31, 2022, the Company’s accrued expenses consisted of the following:
OF ACCRUED EXPENSES
−Removed: and fees payable in common stock
−Removed: contract fees
−Removed: loan interest
−Removed: accrued expenses
−Removed: accrued expenses
+Added: September 30, 2022
+Added: March 31, 2022
+Added: Salaries and fees payable in common stock
+Added: Consultant contract fees
+Added: Director dues
+Added: EWB loan interest
+Added: Employee bonuses
+Added: Other accrued expenses
+Added: Total accrued expenses
August 2005, the Company issued NJEDA tax exempt Bonds with Series A Notes outstanding.
−Removed: The Company is required to maintain a debt
−Removed: service reserve.
−Removed: The debt service reserve is classified as restricted cash on the accompanying unaudited condensed consolidated
−Removed: balance sheets.
−Removed: The NJEDA Bonds require the Company to make an annual principal payment on September 1st based on the amount
−Removed: specified in the loan documents and semi-annual interest payments on March 1st and September 1st, equal to interest due on the
−Removed: 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 the
−Removed: original and refinanced bonds.
+Added: The Company is required to maintain a debt service
+Added: The debt service reserve is classified as restricted cash on the accompanying unaudited condensed consolidated balance sheets.
+Added: The NJEDA Bonds require the Company to make an annual principal payment on September 1st based on the amount specified in the loan documents
+Added: and semi-annual interest payments on March 1st and September 1st, equal to interest due on the outstanding principal.
+Added: The annual interest
+Added: rate on the Series A Note is 6.5 % .
+Added: The NJEDA Bonds are collateralized by a first lien on the Company’s facility and equipment acquired
+Added: with the proceeds of the original and refinanced bonds.
following tables summarize the Company’s bonds payable liability:
OF BONDS PAYABLE LIABILITY
−Removed: bonds payable
−Removed: Bonds - Series A Notes
+Added: September 30, 2022
+Added: March 31, 2022
+Added: Gross bonds payable
+Added: NJEDA Bonds - Series A Notes
Current portion of bonds payable (prior to deduction of bond offering costs)
−Removed: portion of bonds payable (prior to deduction of bond offering costs)
−Removed: offering costs
+Added: Long-term portion of bonds payable (prior to deduction of bond offering costs)
+Added: Bond offering costs
Accumulated amortization
−Removed: offering costs, net
−Removed: portion of bonds payable - net of bond offering costs
−Removed: portions of bonds payable
+Added: Bond offering costs, net
+Added: Current portion of bonds payable - net of bond offering costs
+Added: Current portions of bonds payable
Bonds offering costs to be amortized in the next 12 months
−Removed: portion of bonds payable, net of bond offering costs
−Removed: term portion of bonds payable - net of bond offering costs
−Removed: term portion of bonds payable
+Added: Current portion of bonds payable, net of bond offering costs
+Added: Long term portion of bonds payable - net of bond offering costs
+Added: Long term portion of bonds payable
Bond offering costs to be amortized subsequent to the next 12 months
−Removed: term portion of bonds payable, net of bond offering costs
−Removed: expense was $ 3,546
−Removed: for the three months ended June 30, 2022 and June 30, 2021, respectively.
−Removed: As of June 30, 2022 and March 31, 2022, interest payable
−Removed: and $ 7,367 ,
−Removed: respectively.
+Added: Long term portion of bonds payable, net of bond offering costs
+Added: expense was $ 3,539 and $ 3,545 for the three months ended September 30, 2022 and 2021, $ 7,085 and $ 7,090 for the six months ended September
+Added: 30, 2022 and 2021, respectively.
+Added: As of September 30, 2022 and March 31, 2022, interest payable was $ 6,744 and $ 7,367 , respectively.
PHARMACEUTICALS, INC.
1 unchanged sentence
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: of bonds for the next five years are as follows:
+Added: SCHEDULE OF MATURITIES OF BONDS FOR THE NEXT FIVE YEARS
+Added: Years ending March 31,
LOANS PAYABLE
−Removed: April 2, 2022, the Company and Elite Labs entered into a Loan and Security Agreement (the “EWB Loan Agreement”) with East West Bank (“EWB”).
−Removed: Pursuant to the EWB Loan Agreement, the Company and Elite Labs
−Removed: received one term loan for a principal amount of $ 12,000,000 (the “EWB Term Loan”) and a revolving line of credit up to $ 2,000,000 (the “EWB Revolver,”
+Added: April 2, 2022, the Company and Elite Labs entered into a Loan and Security Agreement (the “EWB Loan Agreement”) with East
+Added: West Bank (“EWB”).
+Added: Pursuant to the EWB Loan Agreement, the Company and Elite Labs received one term loan for a principal
+Added: amount of $ 12,000,000 (the “EWB Term Loan”) and a revolving line of credit up to $ 2,000,000 (the “EWB Revolver,”
together with the “EWB Term Loan,” the EWB Loans”), each of which shall be used for working capital.
−Removed: The EWB Term Loan bears interest at a rate of 6.48 % ( 1.73 % plus
−Removed: the prime rate (“Prime”)) and is repayable over five years , maturing on May 1, 2027 .
−Removed: The EWB Revolver bears interest at a rate of [ 5.65 % ( 0.87 % plus Prime)]
−Removed: and matures on May 1, 2027 .
−Removed: The total transaction costs associated with the EWB Loans incurred as of June 30, 2022, were $ 40,120 ,
−Removed: which are being amortized on a monthly basis over five years, beginning in April 2022.
−Removed: The EWB Loans are secured by a security interest
−Removed: in the personal property of the Company and Elite Labs.
+Added: The EWB Term Loan
+Added: bears interest at a rate of 7.98 % ( 1.73 % plus the prime rate (“Prime”)) and is repayable over five years , maturing on May
+Added: The EWB Revolver bears interest at a rate of ( 7.12 % ( 0.87 % plus Prime)) and matures on May 1, 2027 .
+Added: The total transaction costs
+Added: associated with the EWB Loans incurred as of September 30, 2022, were $ 40,120 , which are being amortized on a monthly basis over five
+Added: years, beginning in April 2022.
+Added: The EWB Loans are secured by a security interest in the personal property of the Company and Elite Labs.
The EWB Loan Agreement contains customary representations, warranties and covenants.
These covenants include, but are not limited to,
−Removed: maintaining maximum leverage ratios of 3.50 to 1.00,
−Removed: minimum liquidity of $5,000,000, minimum cash of $1,000,000, a fixed charge coverage ratio of 1.25 to 1.00 and restrictions on mergers or sales of assets and debt borrowings .
−Removed: As of June 30,
−Removed: 2022, the Company is in compliance with each financial covenant and the Company has not used any of the Revolving line of credit.
+Added: maintaining maximum leverage ratios of 3.50 to 1.00, minimum liquidity of $5,000,000, minimum cash of $1,000,000, a fixed charge coverage
+Added: ratio of 1.25 to 1.00 and restrictions on mergers or sales of assets and debt borrowings .
+Added: As of September 30, 2022, the Company is in
+Added: compliance with each financial covenant and the Company has not used any of the Revolving line of credit.
+Added: July 1, 2022, the EWB provided a mortgage loan (“EWB Mortgage Loan”) in the amount of $ 2.55 million for the purchase of the
+Added: property at 135-137 Ludlow Avenue, which was formerly a lease held by the Company.
+Added: The EWB Mortgage Loan matures in 10 years and bears
+Added: interest at a rate of 4.75% fixed for 5 years then adjustable at WSJP plus 0.5% with floor rate of 4.5% .
+Added: The total transaction costs
+Added: associated with the EWB Mortgage Loan incurred as of September 30, 2022, were $ 34,952 , which are being amortized on a monthly basis over
+Added: ten years, beginning in July 2022.
+Added: The EWB Mortgage Loan contains customary representations, warranties and covenants.
+Added: These covenants
+Added: include maintaining a minimum debt coverage ratio of 1.50 to 1.00 tested annually and a minimum trailing 12-month debt coverage ratio
+Added: of 1.50 to 1.00.
+Added: As of September 30, 2022, the Company was in compliance with each financial covenant .
payable consisted of the following:
OF LOANS PAYABLE
−Removed: and insurance financing loans payable, between 3.30 % and 12.02 % interest and maturing between October 2022 and April 2027
+Added: September 30, 2022
+Added: March 31, 2022
+Added: Equipment and insurance financing and mortgage loans payable, between 3.30 % and 12.02 % interest and maturing between October 2022 and June 2032
Current portion of loans payable
−Removed: portion of loans payable
−Removed: interest expense associated with the loans payable was $ 177,579
−Removed: for the three months ended June 30, 2022 and June 30, 2021, respectively.
+Added: Long-term portion of loans payable
+Added: interest expense associated with the loans payable was $ 83,686 and $ 17,001 for the three months ended September 30, 2022 and 2021, respectively,
+Added: and $ 261,265 and $ 35,598 for the six months ended September 30, 2022 and 2021, respectively.
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: principal payments for the next five years are as follows:
+Added: SCHEDULE OF LOAN PRINCIPAL PAYMENTS
+Added: Years ending March 31,
+Added: 2023 (excluding the six months ended September 30, 2022)
+Added: 2028 and thereafter
+Added: Total remaining principal balance
DEFERRED REVENUE
−Removed: revenues in the aggregate amount of $ 42,222 as of June 30, 2022, were comprised of a current component of $ 13,333 and a long-term component
−Removed: of $ 28,889 .
−Removed: Deferred revenues in the aggregate amount of $ 45,559 as of March 31, 2022, were comprised of a current component of $ 13,333
−Removed: and a long-term component of $ 32,226 .
−Removed: These line items represent the unamortized amounts of a $ 200,000 advance payment received for a
−Removed: TAGI Pharma (“TAGI”) licensing agreement with a fifteen-year term beginning in September 2010 and ending in August 2025 .
−Removed: These advance payments were recorded as deferred revenue when received and are earned, on a straight-line basis over the life of the
−Removed: The current component is equal to the amount of revenue to be earned during the 12-month period immediately subsequent to the
−Removed: balance sheet date and the long-term component is equal to the amount of revenue to be earned thereafter.
+Added: revenues in the aggregate amount of $ 38,889 as of September 30, 2022, were comprised of a current component of $ 13,333 and a long-term
+Added: component of $ 25,556 .
+Added: Deferred revenues in the aggregate amount of $ 45,559 as of March 31, 2022, were comprised of a current component
+Added: of $ 13,333 and a long-term component of $ 32,226 .
+Added: These line items represent the unamortized amounts of a $ 200,000 advance payment received
+Added: for a TAGI Pharma (“TAGI”) licensing agreement with a fifteen-year term beginning in September 2010 and ending in August
+Added: These advance payments were recorded as deferred revenue when received and are earned, on a straight-line basis over the life of
+Added: the licenses.
+Added: The current component is equal to the amount of revenue to be earned during the 12-month period immediately subsequent
+Added: to the balance sheet date and the long-term component is equal to the amount of revenue to be earned thereafter.
COMMITMENTS AND CONTINGENCIES
−Removed: Leases – 135 Ludlow Ave.
Company entered into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey (the
−Removed: “135 Ludlow Ave.
lease”) which began in 2010.
1 unchanged sentence
including a term that begins on January 1, 2022 and expires on December 31, 2026.
−Removed: 135 Ludlow Ave.
−Removed: modified lease property required significant leasehold improvements and qualifications, as a prerequisite, for its intended
−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.
+Added: The Ludlow Ave.
+Added: lease was terminated on July 1,
+Added: 2022, when the Company purchased the underlying property.
October 2020, the Company entered into an operating lease for office space in Pompano Beach, Florida (the “Pompano Office Lease”).
1 unchanged sentence
Pompano Office has a term of three years, ending on October 31, 2023 .
+Added: April 8, 2022, the Company entered into an Agreement for Sale and Purchase of Real Estate to purchase the building located at 135-137
+Added: Ludlow Avenue in Northvale, NJ.
+Added: The Company had leased the entire 35,000 square feet of floor space since 2014.
+Added: This property is occupied
+Added: by the Company’s Quality Assurance department, commercial manufacturing, packaging, and warehouse.
+Added: The closing of the Agreement
+Added: for Sale and Purchase of Real Estate occurred on July 1, 2022 (refer to Note 7).
Company assesses whether an arrangement is a lease or contains a lease at inception.
3 unchanged sentences
has elected to account for non-lease components associated with its leases and lease components as a single lease component.
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Company recognizes a right-of-use asset, which represents the Company’s right to use the underlying asset for the lease term, and
1 unchanged sentence
The present value of the lease payments is calculated using either the implicit interest rate in the lease or an incremental borrowing
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
expense is recorded on the straight-line basis.
−Removed: Rent expense under the leases for the three months ended June 30, 2022 and June 30,
−Removed: 2021 was $ 64,578 and
−Removed: $ 62,877 , respectively.
−Removed: Rent expense is recorded in general and administrative expense in the unaudited condensed consolidated statements of
+Added: Rent expense under the leases for the three months ended September 30, 2022 and 2021
+Added: was $ 6,330 and $ 62,877 , respectively, and $ 70,908 and $ 125,754 for the six months ended September 30, 2022 and 2021, respectively.
+Added: expense is recorded in general and administrative expense in the unaudited condensed consolidated statements of operations.
table below shows the future minimum rental payments, exclusive of taxes, insurance and other costs, under the Ludlow Ave.
1 unchanged sentence
OF FUTURE MINIMUM RENTAL PAYMENTS
−Removed: ending March 31,
−Removed: (excluding the three months ended June 30, 2022)
−Removed: future minimum lease payments
−Removed: value of lease payments
+Added: Years ending March 31,
+Added: 2023 (excluding the six months ended September 30, 2022)
+Added: Total future minimum lease payments
+Added: Present value of lease payments
Company has an obligation for the restoration of its leased facility and the removal or dismantlement of certain property and equipment
6 unchanged sentences
Upon settlement of the liability, the Company records either a gain or
−Removed: As of June 30, 2022, and March 31, 2022, the Company had a liability of $ 40,551 and $ 38,780 , respectively, recorded as other long-term
+Added: As of September 30, 2022, and March 31, 2022, the Company had a liability of $ 0 and $ 38,780 , respectively, recorded as other long-term
DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS
3 unchanged sentences
described in this note below.
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: summary of warrant activity is as follows:
−Removed: OF WARRANT ACTIVITY
−Removed: Average Exercise Price
−Removed: Average Exercise Price
−Removed: at beginning of period
−Removed: granted pursuant to the issuance of Series J convertible preferred shares
−Removed: exercised, forfeited and/or expired, net
−Removed: at end of period
−Removed: April 28, 2017, the Company entered into an Exchange Agreement with Nasrat Hakim (“Hakim”), the Chairman of the Board, President, and Chief Executive
−Removed: Officer of the Company, pursuant to which the Company issued to Hakim 24.0344 shares of its Series J Preferred and warrants to purchase
−Removed: an aggregate of 79,008,661 shares of its Common Stock (the “Series J Warrants” and, along with the Series J Preferred issued
−Removed: to Hakim, the “Securities”) in exchange for 158,017,321 shares of Common Stock owned by Hakim.
−Removed: The fair value of the Series
−Removed: J Warrants was determined to be $ 6,474,674 upon issuance at April 28, 2017.
+Added: The warrant share balance is 79,008,661 as of September 30, 2022, and March 31, 2022 with a weighted average
+Added: exercise price of $ 0.1521 as of September 30, 2022, and March 31, 2022.
+Added: April 28, 2017, the Company entered into an Exchange Agreement with Nasrat Hakim (“Hakim”), the Chairman of the Board, President,
+Added: and Chief Executive Officer of the Company, pursuant to which the Company issued to Hakim 24.0344 shares of its Series J Preferred and
+Added: warrants to purchase an aggregate of 79,008,661 shares of its Common Stock (the “Series J Warrants” and, along with the Series
+Added: J Preferred issued to Hakim, the “Securities”) in exchange for 158,017,321 shares of Common Stock owned by Hakim.
+Added: value of the Series J Warrants was determined to be $ 6,474,674 upon issuance at April 28, 2017.
Series J Warrants are exercisable for a period of 10 years from the date of issuance, commencing April 28, 2020.
7 unchanged sentences
J Warrants also provide for other standard adjustments upon the occurrence of certain customary events.
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
fair value of the Series J Warrants was calculated using a Black-Scholes model.
2 unchanged sentences
OF FAIR VALUE OF WARRANTS ISSUED
−Removed: value of the Company’s Common Stock
−Removed: Initial exercise
−Removed: term (in years)
−Removed: changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the three months ended June 30, 2022
+Added: September 30, 2022
+Added: March 31, 2022
+Added: Fair value of the Company’s Common Stock
+Added: Initial exercise price
+Added: Warrant term (in years)
+Added: Risk free rate
+Added: changes in warrants (Level 3 financial instruments) measured at fair value on a recurring basis for the six months ended September 30,
2022 were as follows:
OF CHANGES IN WARRANTS MEASURED AT FAIR VALUE ON A RECURRING BASIS
−Removed: at March 31, 2022
−Removed: in fair value of derivative financial instruments - warrants
−Removed: at June 30, 2022
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Balance at March 31, 2022
+Added: Change in fair value of derivative financial instruments – warrants
+Added: Balance at September 30, 2022
SHAREHOLDERS’ EQUITY
4 unchanged sentences
share, from time to time over the term of the 2020 LPC Purchase Agreement, at the Company’s direction.
−Removed: Company did not issue any shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the three months ended June 30,
+Added: Company did not issue any shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the six months ended September
In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Agreement.
−Removed: of June 30, 2022, the Company has issued an aggregate of 5,975,857 shares of Common Stock for net proceeds of $ 469,105 to Lincoln Park
−Removed: as initial commitment shares.
+Added: of September 30, 2022, the Company has issued an aggregate of 5,975,857 shares of Common Stock for net proceeds of $ 469,105 to Lincoln
+Added: Park as initial commitment shares.
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
STOCK-BASED COMPENSATION
5 unchanged sentences
the valuation of such shares being calculated on quarterly basis and equal to the average closing price of the Company’s Common
−Removed: of June 30, 2022, the Company accrued director’s fees totaling $ 112,500 , which will be paid via cash payments totaling $ 37,500
+Added: of September 30, 2022, the Company accrued director’s fees totaling $ 45,000 , which will be paid via cash payments totaling $ 15,000
and the issuance of 739,449 shares of Common Stock.
−Removed: The Company anticipates that these shares of Common Stock will be issued prior
−Removed: to the end of the current fiscal year.
+Added: The Company anticipates that these shares of Common Stock will be issued prior to
+Added: the end of the current fiscal year.
Employee/Consultant Compensation
3 unchanged sentences
and equal to the average closing price of the Company’s Common Stock.
−Removed: the three months ended June 30, 2022, the Company accrued salaries totaling $ 193,750 owed to the Company’s President and Chief
+Added: the six months ended September 30, 2022, the Company accrued salaries totaling $ 250,000 owed to the Company’s President and Chief
Executive Officer and certain other employees which will be paid via the issuance of 6,109,277 shares of Common Stock.
−Removed: of June 30, 2022, the Company owed its President and Chief Executive Officer and certain other employees’ salaries totaling $ 3,750,000
+Added: of September 30, 2022, the Company owed its President and Chief Executive Officer and certain other employees’ salaries totaling
$ 3,875,000 which will be paid via the issuance of 56,300,056 shares of Common Stock.
9 unchanged sentences
A summary of the activity of Company’s 2014 Stock Option Plan
−Removed: for the three months ended June 30, 2022 is as follows:
+Added: for the six months ended September 30, 2022 is as follows:
OF STOCK OPTION PLAN
Exercise Price
−Removed: Average Remaining Contractual
−Removed: Intrinsic Value
−Removed: at March 31, 2022
−Removed: at June 30, 2022
−Removed: at June 30, 2022
+Added: Weighted Average
+Added: Remaining Contractual
+Added: Aggregate Intrinsic
+Added: Outstanding at March 31, 2022
+Added: Outstanding at September 30, 2022
+Added: Exercisable at September 30, 2022
aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying awards
−Removed: and the quoted price of the Company’s Common Stock as of June 30, 2022 and March 31, 2022 of $ 0.09 and $ 0.10 , respectively.
−Removed: of June 30, 2022, there was $ 44,330 in unrecognized stock based compensation expense that will be recognized over 2.8 years.
+Added: and the quoted price of the Company’s Common Stock as of September 30, 2022 and March 31, 2022 of $ 0.10 and $ 0.10 , respectively.
+Added: of September 30, 2022, there was $ 38,357 in unrecognized stock based compensation expense that will be recognized over 2.5 years.
CONCENTRATIONS AND CREDIT RISK
−Removed: customer accounted for approximately 85 % of the Company’s revenues for the three months ended June 30, 2022.
−Removed: customer accounted for approximately 83 % of the Company’s revenues for the three months ended June 30, 2021.
−Removed: customers accounted for approximately 90 % of the Company’s accounts receivable as of June 30, 2022.
+Added: customers accounted for approximately 96 %
+Added: of the Company’s revenues for the six months ended September 30, 2022.
+Added: These two customers accounted for approximately 85 % and 11 % of revenues each, respectively.
+Added: customers accounted for approximately 95 % of the Company’s revenues for the six months ended September 30, 2021.
+Added: These two customers
+Added: accounted for approximately 85 % and 10 % of revenues each, respectively.
+Added: The same two customers accounted for 88 % and 9 % of revenues each,
+Added: respectively, for the three months ended September 30, 2021.
+Added: customers accounted for approximately 97 % of the Company’s accounts receivable as of September 30, 2022.
These two customers accounted
3 unchanged sentences
for approximately 78 % and 13 % of accounts receivable each, respectively.
−Removed: suppliers accounted for approximately 66 % of the Company’s purchases of raw materials for the three months ended June 30, 2022.
−Removed: These two suppliers accounted for approximately 56 % and 10 % of purchases each, respectively.
−Removed: suppliers accounted for approximately 52 % of the Company’s purchases of raw materials for the three months ended June 30, 2021.
−Removed: These two suppliers accounted for approximately 38 % and 14 % of purchases each, respectively.
+Added: supplier accounted for approximately 62 % of the Company’s purchases of raw materials for the six months ended September 30, 2022.
+Added: supplier accounted for approximately 61 % of the Company’s purchases of raw materials for the six months ended September 30, 2021.
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEGMENT RESULTS
8 unchanged sentences
decision maker to make decisions regarding the allocation of resources to and the financial performance of the reporting segments.
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
information by operating segment is not presented below since the chief operating decision maker does not review this information by
3 unchanged sentences
OF SELECTED INFORMATION FOR REPORTABLE SEGMENTS
−Removed: the Three Months Ended June 30,
−Removed: Income by Segment
−Removed: Income by Segment
+Added: For the Three Months Ended September 30,
+Added: For the Six Months Ended September 30,
+Added: Operating Income by Segment
+Added: Operating income by Segment
table below reconciles the Company’s operating income by segment to income from operations before provision for income taxes as
1 unchanged sentence
OF OPERATING LOSS BY SEGMENT TO (LOSS) INCOME FROM OPERATIONS
−Removed: the Three Months Ended June 30,
−Removed: income by segment
−Removed: unallocated costs
−Removed: expense and amortization of debt issuance costs
−Removed: and amortization expense
−Removed: non-cash items
−Removed: in fair value of derivative instruments
−Removed: from operations before income taxes
+Added: For the Three Months Ended September 30,
+Added: For the Six Months Ended September 30,
+Added: Operating income by segment
+Added: Corporate unallocated costs
+Added: ( 1,086,925 )
+Added: ( 1,570,128 )
+Added: Interest income
+Added: Interest expense and amortization of debt issuance costs
+Added: Depreciation and amortization expense
+Added: Significant non-cash items
+Added: Change in fair value of derivative instruments
+Added: Income from operations before income taxes
RELATED PARTY AGREEMENTS WITH MIKAH PHARMA, LLC
−Removed: December 3, 2018, the Company executed a development agreement with Mikah Pharma, LLC (“Mikah”), pursuant to which Mikah and the Company will collaborate
−Removed: to develop and commercialize generic products including formulation development, analytical method development, bioequivalence
−Removed: studies and manufacture of development batches of generic products.
−Removed: Mikah was founded in 2009 by Hakim, a related party and the Company’s President, Chief Executive Officer and
−Removed: Chairman of the Board.
−Removed: As of March 31, 2021, the Company has incurred costs which are
−Removed: in excess of advanced payments received to date from Mikah.
−Removed: This balance due from Mikah was offset, in full, against accrued
−Removed: interest due and owing to Mikah pursuant to the Secured Promissory Note, dated May 15, 2017, issued by the Company to Mikah.
+Added: December 3, 2018, the Company executed a development agreement with Mikah Pharma LLC (“Mikah”), pursuant to which Mikah and
+Added: the Company will collaborate to develop and commercialize generic products including formulation development, analytical method development,
+Added: bioequivalence studies and manufacture of development batches of generic products.
+Added: Mikah was founded in 2009 by Hakim, a related party
+Added: and the Company’s President, Chief Executive Officer and Chairman of the Board.
+Added: As of March 31, 2021, the Company has incurred
+Added: costs which are $ 238,451 in excess of advanced payments received to date from Mikah.
+Added: This balance due from Mikah was offset, in full,
+Added: against accrued interest due and owing to Mikah pursuant to the Secured Promissory Note, dated May 15, 2017, issued by the Company to
+Added: PHARMACEUTICALS, INC.
+Added: AND SUBSIDIARY
+Added: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
May 2020, SunGen Pharma LLC (“SunGen”), pursuant to an asset purchase agreement, assigned its rights and obligations under
12 unchanged sentences
Initially two generic products were identified for the parties to develop.
−Removed: PHARMACEUTICALS, INC.
−Removed: AND SUBSIDIARY
−Removed: TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Company’s effective tax rate and income tax expense for the three months ended June 30, 2022 was $ 0 .
−Removed: The Company has evaluated its deferred tax assets, specifically its net operating loss carryovers, for realizability and has
−Removed: provided a valuation allowance on the majority of its deferred tax assets.
−Removed: The valuation allowance is the reason that the effective
−Removed: tax rate and income tax expense are different than the statutory rate of 21 %.
+Added: Company’s effective tax rate was 11.5 % and income tax expense for the six months ended September 30, 2022 was $ 11,587 .
+Added: The Company’s
+Added: effective tax rate was 10.75 % and income tax expense was $ 4,000 for the six months ended September 30, 2021.
+Added: The Company has evaluated its
+Added: deferred tax assets, specifically its net operating loss carryovers, for realizability and has provided a valuation allowance on the
+Added: majority of its deferred tax assets.
+Added: The valuation allowance is the reason that the effective tax rate and income tax expense are different
+Added: than the statutory rate of 21 % .
COVID-19 UPDATE
22 unchanged sentences
and Supply Chain
−Removed: the three months ended June 30, 2022, and as of the date of this Quarterly Report on Form 10-Q, the Company has not experienced material,
+Added: the six months ended September 30, 2022, and as of the date of this Quarterly Report on Form 10-Q, the Company has not experienced material,
detrimental issues related to COVID-19 in its manufacturing, supply chain, quality assurance and regulatory compliance activities, and
8 unchanged sentences
SUBSEQUENT EVENTS
−Removed: April 8, 2022, the Company entered into an Agreement for Sale and Purchase of Real Estate to purchase the building located at 135-137
−Removed: Ludlow Avenue in Northvale, NJ.
−Removed: The Company had leased the entire 35,000
−Removed: square feet of floor space since 2014.
−Removed: This property
−Removed: is occupied by the Company’s Quality Assurance department, commercial manufacturing, packaging, and warehouse.
−Removed: The closing of the
−Removed: Agreement for Sale and Purchase of Real Estate occurred on July 1, 2022.
−Removed: July 1, 2022, the EWB provided a mortgage loan in the amount of $ 2.55
−Removed: million for the purchase of the above property.
−Removed: The mortgage loan matures in 10
−Removed: years and bears
−Removed: interest at a rate of 4.75% fixed for 5 years then adjustable at WSJP plus 0.5% with floor rate of 4.5% .
+Added: November 2, 2022, in a press release, the Company reported positive results from pivotal fed and fasted bioequivalence studies for an
+Added: undisclosed extended-release generic drug product in a class of medications called dopamine agonists.
+Added: The results indicate that the generic
+Added: product is bioequivalent to the branded product.
+Added: studies were single-dose crossover comparative bioavailability studies in healthy male and female volunteers in both the fed and fasting
+Added: The results indicate that the generic product is bioequivalent to the branded
+Added: The Company is compiling the data for this product to file an Abbreviated New
+Added: Drug Application with the US Food and Drug Administration.
+Added: November 10, 2022, in an 8-K, the Company reported the termination of the License, Supply, and Distribution Agreement with Lannett Company,
+Added: Inc for Vigabatrin, 500 mg.
+Added: effective as of November 9, 2022.
+Added: marketing rights will return at that time to Elite.
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.