ELITE PHARMACEUTICALS INC /NV/ 10-Q

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion of our financial condition and results of operations for the nine months ended December 31, 2022 and 2021 should be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements that are included elsewhere in this report. Our discussion includes forward-looking statements based upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth under Item 1A. Risk Factors appearing in our Annual Report on Form 10-K for the year ended March 31, 2022. We use words such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions to identify forward-looking statements. Unless expressly indicated or the context requires otherwise, the terms “Elite”, the “Company”, “we”, “us”, and “our” refer to Elite Pharmaceuticals, Inc. and subsidiary. Background Elite Pharmaceuticals, Inc., a Nevada corporation (the “Company”, “Elite”, “Elite Pharmaceuticals”, the “registrant”, “we”, “us” or “our”) was incorporated on October 1, 1997 under the laws of the State of Delaware, and its wholly-owned subsidiary, Elite Laboratories, Inc. (“Elite Labs”), was incorporated on August 23, 1990 under the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of Nevada. We are a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, using proprietary know-how and technology for the manufacture of generic pharmaceuticals. Our strategy includes developing generic versions of controlled-release drug products with high barriers to entry. We occupy manufacturing, warehouse, laboratory and office space at 165 Ludlow Avenue and 135 Ludlow Avenue in Northvale, NJ (the “Northvale Facility”) . The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States Drug Enforcement Agency (“DEA”) registered facility for research, development and manufacturing. We are also party to an operating lease for office space at Pompano Beach, Florida (the “Pompano Office Lease”). Strategy We focus our efforts on the following areas: (i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New Drug Applications (“ANDAs”); (ii) development of additional generic pharmaceutical products; (iii) development of the other products in our pipeline including the products with our partners; (iv) commercial exploitation of our products either by license and the collection of royalties, or through the manufacture of our formulations; and (v) development of new products and the expansion of our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations. Our focus is on the development of various types of drug products, including generic drug products which require ANDAs as well as branded drug products which require New Drug Applications (“NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Drug Price Competition Act”). We believe that our business strategy enables us to reduce its risk by having a diverse product portfolio that includes generic products in various therapeutic categories and to build collaborations and establish licensing agreements with companies with greater resources thereby allowing us to share costs of development and improve cash-flow. 1 Recent Developments Pyros Agreement During the nine months ended December 31, 2022, the Company entered into an agreement with Pyros Pharmaceuticals, Inc. (“Pyros”) pursuant to which the Company sold to Pyros its rights in and to the Company’s approved abbreviated new drug applications (ANDAs) for its generic Sabril drug. The Company sold its rights to Pyros for $1,000,000, which was recorded as gain on sale of ANDA during the nine months ended December 31, 2022. There is no further action required by the Company regarding the rights which would affect future periods. In conjunction with the sale of its Product to Pyros, the Company executed a Manufacturing and Supply agreement (the “Pyros Agreement”) with Pyros. Under the terms of the Pyros Agreement, the Company will receive an agreed-upon price per drug for the manufacturing and packaging of Sabril over a term of three years. Revenue per the Pyros Agreement will be recognized as control of the manufactured and supplied drugs is transferred to Pyros (at the time of delivery). Notice of Termination of License, Supply and Distribution Agreement On September 14, 2022, the Company has provided written notice pursuant to Section 8.2 of the License, Supply and Distribution Agreement between the Company and Elite Laboratories, Inc. and Epic Pharma, Inc. dated November 21, 2020 (“the Epic Agreement”) that the Company and Elite Laboratories, Inc. are now providing notice of termination of the Epic Agreement, with such termination to be effective March 31, 2023. Commercial Products We own, license, contract manufacture or have contractual rights to receive royalties from the following products currently approved for commercial sale: Product Branded Product Equivalent Therapeutic Category Launch Date Phentermine HCl 37.5mg tablets (“Phentermine 37.5mg”) Adipex-P® Bariatric April 2011 Phendimetrazine Tartrate 35mg tablets (“Phendimetrazine 35mg”) Bontril® Bariatric November 2012 Phentermine HCl 15mg and 30mg capsules (“Phentermine 15mg” and “Phentermine 30mg”) Adipex-P® Bariatric April 2013 Naltrexone HCl 50mg tablets (“Naltrexone 50mg”) Revia® Addiction Treatment September 2013 Isradipine 2.5mg and 5mg capsules (“Isradipine 2.5mg” and “Isradipine 5mg”) n/a Cardiovascular January 2015 Oxycodone HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets (“OXY IR 5mg”, “Oxy IR 10mg”, “Oxy IR 15mg”, “OXY IR 20mg” and “Oxy IR 30mg”) Roxycodone® Pain March 2016 Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine 100mg”) Surmontil® Antidepressant May 2017 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets (“Amphetamine IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine IR 12.5mg”, “Amphetamine IR 15mg”, “Amphetamine IR 20mg” and “Amphetamine IR 30mg”) Adderall® Central Nervous System (“CNS”) Stimulant April 2019 Dantrolene Sodium Capsules 25mg, 50mg and 100mg (“Dantrolene 25mg”, “Dantrolene 50mg”, “Dantrolene 100mg”) Dantrium® Muscle Relaxant June 2019 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules (“Amphetamine ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine ER 20mg”, “Amphetamine ER 25mg”, and “Amphetamine ER 30mg”) Adderall XR® Central Nervous System (“CNS”) Stimulant March 2020 Loxapine Succinate 5mg, 10mg, 25mg and 50gm capsules (“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”, and Loxapine 50mg”) Loxapine® Antipsychotic May 2021 2 Approved Products Not Yet Commercialized Acetaminophen and Codeine Phosphate The Company received approval on September 10, 2019 from the FDA of an ANDA for a generic version of Tylenol® with Codeine (acetaminophen and codeine phosphate). Acetaminophen with codeine is a combination medication indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. The Company is not pursuing licensing deals for any opioids at this time and, in light of the current market and litigation around opioid products, the Company has no plans to commercialize this product at this time. The Company received approval on June 27, 2022 from the FDA of an ANDA for a generic version of Sabril® (Vigabatrin USP) 500 mg powder for solution packet. Vigabatrin is an antiepileptic drug indicated for refractory complex partial seizures and used as an adjunctive therapy in patients who have inadequately responded to several alternative treatments. We are evaluating potential commercial opportunities. The Company received approval on April 4, 2022 from the FDA of an ANDA for a generic version of Doxycycline (doxycycline hyclate) 100mg tablets. Doxycycline hyclate is an antibiotic that is used to treat a wide variety of bacterial infections. This product was co-developed and co-owned by Elite and Praxgen Pharmaceuticals LLC, formerly SunGen Pharma LLC. We are evaluating potential commercial opportunities. Critical Accounting Policies and Estimates The preparation of the unaudited condensed consolidated financial statements and related disclosures in conformity with GAAP, and our discussion and analysis of the Company’s financial condition and operating results require our management to make judgments, assumptions and estimates that affect the amounts reported in the Company’s unaudited condensed consolidated financial statements and accompanying notes. Management bases its estimates on historical experience and on various other assumptions it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates and such differences may be material. There were no significant changes during the nine months ended December 31, 2022 to the items that we disclosed as our significant accounting policies and estimates described in “Note 1, Summary of Significant Accounting Policies” to the Company’s financial statements as contained in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2022. Results of Operations The following set forth our results of operations for the periods presented. The period-to-period comparison of financial results is not necessarily indicative of future results. Three months ended December 31, 2022 compared to December 31, 2021 Revenue, Cost of revenue and Gross profit: For the Three Months Ended December 31, Change 2022 2021 Dollars Percentage Manufacturing fees $ 7,798,159 $ 7,667,674 $ 130,485 2 % Licensing fees 1,451,907 1,307,140 144,767 11 % Total revenue 9,250,066 8,974,814 275,252 3 % Cost of manufacturing 4,330,841 4,957,150 (626,309 ) (13 )% Gross profit $ 4,919,225 $ 4,017,664 $ 901,561 22 % Gross profit - percentage 53 % 45 % Total revenues for the three-month period ended December 31, 2022 increased by $0.28 million or 3%, to $9.25 million, as compared to $8.97 million, for the corresponding period of the prior year, primarily due to the increased sales of Amphetamine IR Tablets and Amphetamine ER Capsules during the three month period ended December 31, 2022 as compared to the comparable period of the prior fiscal year. Manufacturing fees increased by $0.13 million, or 2%, primarily due to increased sales of Amphetamine IR Tablets and Amphetamine ER Capsules during the three month period ended December 31, 2022 as compared to the comparable period of the prior fiscal year. Licensing fees increased by $0.14 million, or 11%. This increase is primarily due to licensing fees earned from the sale of Amphetamine ER Capsules and Amphetamine IR Tablets during the three months ended December 31, 2022 as compared to the comparable period of the prior fiscal year. Costs of revenue consists of manufacturing and assembly costs. Our costs of revenue decreased by $0.63 million or 13%, to $4.33 million as compared to $4.96 million for the corresponding period in the prior fiscal year. This decrease was due in large part to an improved margin on products sold during the three months ended December 31, 2022, as compared to the comparable period of the prior fiscal year. 3 Our gross profit margin was 53% during the three months ended December 31, 2022 as compared to 45% during the comparable period of the prior fiscal year. Operating expenses: For the Three Months Ended December 31, Change 2022 2021 Dollars Percentage Operating expenses: Research and development $ 1,443,361 $ 956,628 $ 486,733 51 % General and administrative 1,186,049 929,547 256,502 28 % Non-cash compensation 13,030 3,630 9,400 259 % Depreciation and amortization 317,685 296,559 21,126 7 % Total operating expenses $ 2,960,125 $ 2,186,364 $ 773,761 35 % Operating expenses consist of research and development costs, general and administrative costs, non-cash compensation and depreciation and amortization expenses. Operating expenses from the three months ended December 31, 2022 increased by $0.8 million, or 35%, to $3.0 million as compared to $2.2 million for the corresponding period in the prior fiscal year. Research and development costs during the three months ended December 31, 2022 were $1.4 million, an increase of $0.5 million, or 51%, from approximately $1.0 million of such costs for the comparable period of the prior year. The increase was a result of the timing and nature of product development activities during the three month period ended December 31, 2022 as compared to the comparable period of the prior fiscal year. General and administrative expenses during the three months ended December 31, 2022 were $1.2 million, an increase of $0.3 million, or 28% from $0.9 million of such costs for the comparable period of the prior year due to increased spending in payroll and professional expense. Non-cash compensation expense during the three months ended December 31, 2022 and December 31, 2021 was less than $0.1 million. Depreciation and amortization expenses during the three months ended December 31, 2022 were $0.3 million, which was virtually unchanged from $0.3 million in such costs for the comparable period of the prior fiscal year. As a result of the foregoing, our income from operations during the three months ended December 31, 2022 was $2.0 million, compared to income from operations of $1.8 million for the comparable period of the prior fiscal year. Other income (expense): For the Three Months Ended December 31, Change 2022 2021 Dollars Percentage Other income (expense): Change in fair value of derivative instruments $ 372,894 $ 489,500 $ (116,606 ) (24 )% Interest expense and amortization of debt issuance costs (322,681 ) (37,400 ) (285,281 ) 763 % Gain on sale of ANDA 1,000,000 — 1,000,000 100 % Interest income 15 13 2 15 % Other (expense) income, net $ 1,050,228 $ 452,113 $ 598,115 132 % 4 Other income (expense) for the three months ended December 31, 2022 was $1.1 million, an increase of $0.6 million from the other income (expense) of $0.5 million for the comparable period of the prior fiscal year. The increase was due to the gain on sale of ANDA, offset by an increase in interest expense and amortization of debt issuance costs during the three months ended December 31, 2022. Please note that the change in the fair value of derivative instruments is determined in large part by the change in the closing price of the Company’s Common Stock as of the end of the period, as compared to the closing price at the beginning of the period, with a strong inverse relationship between the fair value of our derivatives instruments and decreases in the closing price of the Company’s Common Stock. Please see Note 11 to the Unaudited Condensed Consolidated Financial Statements above. The increase in interest expense was primarily attributable to the increased interest payments related to the loan and mortgage the Company obtained from East West Bank. As a result of the foregoing, our net income before the net benefit from sale of net operating loss credits for the three months ended December 31, 2022 was $3.0 million, compared to net income $2.3 million for the comparable period of the prior fiscal year. Nine months ended December 31, 2022 compared to December 31, 2021 Revenue, Cost of revenue and Gross profit: For the Nine Months Ended December 31, Change 2022 2021 Dollars Percentage Manufacturing fees $ 21,312,663 $ 20,639,421 $ 673,242 3 % Licensing fees 4,200,888 3,950,623 250,265 6 % Total revenue 25,513,551 24,590,044 923,507 4 % Cost of manufacturing 12,360,935 13,209,430 (848,495 ) (6 )% Gross profit $ 13,152,616 $ 11,380,614 $ 1,772,002 16 % Gross profit - percentage 52 % 46 % Total revenues for the nine months period ended December 31, 2022 increased by $0.9 million or 4%, to $25.5 million, as compared to $24.6 million, for the corresponding period of the prior year, primarily due to the increased sales of Amphetamine IR Tablets and Amphetamine ER Capsules during the nine months ended December 31, 2022 as compared to the comparable period of the prior fiscal year. Manufacturing fees increased by $0.7 million, or 3%, primarily due to increased sales of Amphetamine IR Tablets and Amphetamine ER Capsules during the nine months ended December 31, 2022 as compared to the comparable period of the prior fiscal year. Licensing fees increased by $0.3 million, or 6%. This increase is primarily due to licensing fees earned from the sale of Amphetamine ER Capsules and Amphetamine IR Tablets during the nine months ended December 31, 2022 as compared to the comparable period of the prior fiscal year. Costs of revenue consists of manufacturing and assembly costs. Our costs of revenue decreased by $0.8 million or 6%, to $12.4 million as compared to $13.2 million for the corresponding period in the prior fiscal year. This decrease was due to an improved margin on products sold during the nine months ended December 31, 2022, as compared to the comparable period of the prior fiscal year. Our gross profit margin was 52% during the nine months ended December 31, 2022 as compared to 46% during the comparable period of the prior fiscal year. 5 Operating expenses: For the Nine Months Ended December 31, Change 2022 2021 Dollars Percentage Operating expenses: Research and development $ 3,775,107 $ 3,312,540 $ 462,567 14 % General and administrative 4,356,752 2,930,126 1,426,626 49 % Non-cash compensation 24,325 10,617 13,708 129 % Depreciation and amortization 933,531 908,297 25,234 3 % Total operating expenses $ 9,089,715 $ 7,161,580 $ 1,928,135 27 % Operating expenses consist of research and development costs, general and administrative costs, non-cash compensation and depreciation and amortization expenses. Operating expenses for the nine months ended December 31, 2022 increased by $1.9 million, or 27%, to $9.1 million as compared to $7.2 million for the corresponding period in the prior fiscal year. Research and development costs during the nine months ended December 31, 2022 were $3.8 million, an increase of $0.5 million, or 14%, from approximately $3.3 million of such costs for the comparable period of the prior year. The increase was a result of the timing and nature of product development activities during the nine months ended December 31, 2022 as compared to the comparable period of the prior fiscal year. General and administrative expenses for the nine months ended December 31, 2022 were $4.4 million, an increase of $1.4 million, or 49% from $2.9 million of such costs for the comparable period of the prior year due to increased spending in payroll and professional expense. Non-cash compensation expense for the nine months ended December 31, 2022 and December 31, 2021 was less than $0.1 million. Depreciation and amortization expenses from the nine months ended December 31, 2022 were $0.9 million, which was virtually unchanged from $0.9 million in such costs for the comparable period of the prior fiscal year. As a result of the foregoing, our income from operations during the nine months ended December 31, 2022 was $4.1 million, compared to income from operations of $4.2 million for the comparable period of the prior fiscal year. Other income (expense): For the Nine Months Ended December 31, Change 2022 2021 Dollars Percentage Other income (expense): Change in fair value of derivative instruments $ 561,070 $ 1,523,394 $ (962,324 ) (63 )% Interest expense and amortization of debt issuance costs (782,221 ) (126,376 ) (655,845 ) 519 % Gain on sale of ANDA 1,000,000 — 1,000,000 100 % Interest income 187 77 110 143 % Other (expense) income, net $ 779,036 $ 1,397,095 $ (618,059 ) (44 )% Other income (expense) for the nine months ended December 31, 2022 was $0.8 million, a decrease of $0.6 million from $1.4 million for the comparable period of the prior fiscal year. The decrease was due to decreased income relating to changes in the fair value of our outstanding derivative warrants and increased interest expense and amortization of debt issuance costs, offset by the gain on sale of ANDA during the nine months ended December 31, 2022. Please note that the change in the fair value of derivative instruments is determined in large part by the change in the closing price of the Company’s Common Stock as of the end of the period, as compared to the closing price at the beginning of the period, with a strong inverse relationship between the fair value of our derivatives instruments and decreases in the closing price of the Company’s Common Stock. Please see Note 11 to the Unaudited Condensed Consolidated Financial Statements above. As a result of the foregoing, our net income before the net benefit from sale of net operating loss credits for the nine months ended December 31, 2022 was $4.8 million, compared to net income $5.6 million for the comparable period of the prior fiscal year. Liquidity and Capital Resources Capital Resources December 31, 2022 March 31, 2022 Change Current assets $ 33,164,840 $ 18,861,389 $ 14,303,451 Current liabilities $ 6,654,362 $ 6,694,241 $ (39,879 ) Working capital $ 26,510,478 $ 12,167,148 $ 14,343,330 Our working capital (total current assets less total current liabilities) increased by $14.3 million from $12.2 million as of March 31, 2022 to $26.5 million as of December 31, 2022, with such increase being primarily related to the cash proceeds of $14.6 million from the new loan during the nine months ended December 31, 2022. 6 Summary of Cash Flows: For the Nine Months Ended December 31, 2022 2021 Net cash provided by operating activities $ 370,021 $ 4,902,978 Net cash used in investing activities $ (5,200,407 ) $ (234,387 ) Net cash provided by (used in) financing activities $ 14,204,231 $ (572,889 ) Net cash provided by operating activities for the nine months ended December 31, 2022 was $0.4 million, which included net income of $4.8 million and increases in non-cash expenses totaling $0.9 million, offset by net changes in assets and liabilities totaling $5.3 million. Net cash used in investing activities for the nine months ended December 31, 2022 was comprised of purchases of property and equipment of approximately $5.2 million. Net cash provided by financing activities was $14.2 million for the nine months ended December 31, 2022 which proceeds from loan issuances totaling $14.6 million, offset by loan payments totaling $0.2 million. Lincoln Park Capital – July 8, 2020 Purchase Agreement On July 8, 2020, the Company entered into a purchase agreement (the “2020 LPC Purchase Agreement”), and a registration rights agreement, with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park has committed to purchase up to $25.0 million of the Company’s Common Stock, $0.001 par value per share, from time to time over the term of the 2020 LPC Purchase Agreement, at the Company’s direction. During the nine months ended December 31, 2022 and December 31, 2021, respectively, there were no shares sold to Lincoln Park pursuant to the 2020 LPC Purchase Agreement. In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Purchase Agreement. The Company did not issue any shares of its Common Stock pursuant to the 2020 LPC Purchase Agreement during the nine months ended December 31, 2021. In addition, there were no shares issued to Lincoln Park as additional commitment shares, pursuant to the 2020 LPC Agreement. ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK As a smaller reporting company, we are not required to provide the information required by this Item.