MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
−Removed: following discussion of our financial condition and results of operations for the six months ended September 30, 2025 and 2024 should
+Added: following discussion of our financial condition and results of operations for the nine months ended December 31, 2025 and 2024 should
be read in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements that are included
24 unchanged sentences
occupy manufacturing, warehouse, laboratory and office space at 135, 144 and 165 Ludlow Avenue in Northvale, NJ (the “Northvale
−Removed: The Northvale Facility operates under Current Good Manufacturing Practice and is a United States
−Removed: Drug Enforcement Agency registered facility for research, development, and manufacturing.
−Removed: We are also party to an
−Removed: operating lease for office space at Pompano Beach, Florida.
+Added: The Northvale Facility operates under Current Good Manufacturing Practice and is a United States Drug Enforcement Agency
+Added: registered facility for research, development, and manufacturing.
+Added: We are also party to an operating lease for office space at Pompano
+Added: Beach, Florida.
focus our efforts on the following areas:
28 unchanged sentences
The Company is compiling the data for this product to file an ANDA with the FDA.
−Removed: On November 12, 2025,
−Removed: the Company announced that it received approval from the FDA for an ANDA for a generic version of Requip XL ® (Ropinirole
−Removed: Extended-Release Tablets USP), with strengths of 2mg, 4mg, 6mg, 8mg and 12mg tablets.
−Removed: Ropinirole belongs to a class of drugs known as
−Removed: non-ergoline dopamine agonist used to treat symptoms of Parkinson’s disease.
−Removed: This product will be marketed and sold under the Elite
−Removed: Laboratories, Inc.
+Added: November 12, 2025, the Company announced that it received approval from the FDA for an ANDA for a generic version of Requip XL ®
+Added: (Ropinirole Extended-Release Tablets USP), with strengths of 2mg, 4mg, 6mg, 8mg and 12mg tablets.
+Added: Ropinirole belongs to a class of drugs
+Added: known as non-ergoline dopamine agonist used to treat symptoms of Parkinson’s disease.
+Added: This product will be marketed and sold under
+Added: the Elite Laboratories, Inc.
own, license, contract manufacture or have contractual rights to receive royalties from the following products currently approved for
1 unchanged sentence
Product Equivalent
−Removed: HCl 37.5mg tablets (“Phentermine 37.5mg”)
−Removed: Phendimetrazine
−Removed: Tartrate 35mg tablets (“Phendimetrazine 35mg”)
−Removed: HCl 15mg and 30mg capsules (“Phentermine 15mg” and “Phentermine 30mg”)
−Removed: HCl 50mg tablets (“Naltrexone 50mg”)
−Removed: 2.5mg and 5mg capsules (“Isradipine 2.5mg” and “Isradipine 5mg”)
+Added: Phentermine HCl 37.5mg tablets (“Phentermine
+Added: Phendimetrazine Tartrate 35mg tablets (“Phendimetrazine
+Added: November 2012
+Added: Phentermine HCl 15mg and 30mg capsules (“Phentermine
+Added: 15mg” and “Phentermine 30mg”)
+Added: Naltrexone HCl 50mg tablets (“Naltrexone
+Added: September 2013
+Added: Isradipine 2.5mg and 5mg capsules (“Isradipine
+Added: 2.5mg” and “Isradipine 5mg”)
Cardiovascular
−Removed: Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine
+Added: Trimipramine Maleate Immediate Release 25mg,
+Added: 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine 100mg”)
Antidepressant
−Removed: Dextroamphetamine
−Removed: Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg,
−Removed: 20mg and 30mg tablets (“Amphetamine IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine
−Removed: IR 12.5mg”, “Amphetamine IR 15mg”, “Amphetamine IR 20mg” and “Amphetamine IR 30mg”)
−Removed: Nervous System (“CNS”) Stimulant
−Removed: Sodium Capsules 25mg, 50mg and 100mg (“Dantrolene 25mg”, “Dantrolene 50mg”, “Dantrolene 100mg”)
−Removed: Dextroamphetamine
−Removed: Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and
−Removed: 30mg capsules (“Amphetamine ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine
−Removed: ER 20mg”, “Amphetamine ER 25mg”, and “Amphetamine ER 30mg”)
−Removed: Nervous System (“CNS”) Stimulant
−Removed: Succinate 5mg, 10mg, 25mg and 50gm capsules (“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”,
−Removed: and Loxapine 50mg”)
+Added: Dextroamphetamine Saccharate, Amphetamine Aspartate,
+Added: Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets (“Amphetamine
+Added: IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine IR 12.5mg”, “Amphetamine
+Added: IR 15mg”, “Amphetamine IR 20mg” and “Amphetamine IR 30mg”)
+Added: Central Nervous System
+Added: (“CNS”) Stimulant
+Added: Dantrolene Sodium Capsules 25mg, 50mg and 100mg
+Added: (“Dantrolene 25mg”, “Dantrolene 50mg”, “Dantrolene 100mg”)
+Added: Muscle Relaxant
+Added: Dextroamphetamine Saccharate, Amphetamine Aspartate,
+Added: Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules (“Amphetamine
+Added: ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine ER 20mg”, “Amphetamine
+Added: ER 25mg”, and “Amphetamine ER 30mg”)
+Added: Central Nervous System
+Added: (“CNS”) Stimulant
+Added: Loxapine Succinate 5mg, 10mg, 25mg and 50gm
+Added: capsules (“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”, and Loxapine 50mg”)
Antipsychotic
−Removed: Sodium 2.5mg tablets (“Methotrexate 2.5mg”)
+Added: Methotrexate Sodium 2.5mg tablets (“Methotrexate
Antimetabolite
−Removed: Acetaminophen
−Removed: and Codeine Phosphate 300mg/15mg, 300mg/30mg, 300mg/60mg tablets (“APAP Codeine 300mg/15mg”, “APAP Codeine 300mg/30mg”,
−Removed: and “APAP Codeine 300mg/60mg”)
−Removed: Acetaminophen
−Removed: and Hydrocodone Bitartrate 325mg/2.5mg, 325mg/5mg, 325mg/7.5mg and 325mg/10mg tablets (“APAP Hydrocodone 325mg/2.5mg”,
−Removed: “APAP Hydrocodone 325mg/5mg”, APAP Hydrocodone 325mg/7.5mg and APAP Hydrocodone 325mg/10mg”)
−Removed: Lisdexamfetamine
−Removed: Dimesylate 10mg, 20mg, 30mg, 40mg, 50mg, 60mg and 70mg capsules (“Lisdex 10mg”, “Lisdex 20mg”, “Lisdex
−Removed: 30mg”, “Lisdex 40mg”, “Lisdex 50mg”, “Lisdex 60mg” and “Lisdex 70mg”)
−Removed: Hydrochloride and Acetaminophen 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets (“Oxy APAP 5/325”, “Oxy APAP 7.5/325”
−Removed: and “Oxy APAP 10/325”)
+Added: Acetaminophen and Codeine Phosphate 300mg/15mg,
+Added: 300mg/30mg, 300mg/60mg tablets (“APAP Codeine 300mg/15mg”, “APAP Codeine 300mg/30mg”, and “APAP Codeine
+Added: Tylenol® with
+Added: Acetaminophen and Hydrocodone Bitartrate 325mg/2.5mg,
+Added: 325mg/5mg, 325mg/7.5mg and 325mg/10mg tablets (“APAP Hydrocodone 325mg/2.5mg”, “APAP Hydrocodone 325mg/5mg”,
+Added: APAP Hydrocodone 325mg/7.5mg and APAP Hydrocodone 325mg/10mg”)
+Added: December 2024
+Added: Lisdexamfetamine Dimesylate 10mg, 20mg, 30mg,
+Added: 40mg, 50mg, 60mg and 70mg capsules (“Lisdex 10mg”, “Lisdex 20mg”, “Lisdex 30mg”, “Lisdex
+Added: 40mg”, “Lisdex 50mg”, “Lisdex 60mg” and “Lisdex 70mg”)
+Added: December 2024
+Added: Oxycodone Hydrochloride and Acetaminophen 5mg/325mg,
+Added: 7.5mg/325mg and 10mg/325mg tablets (“Oxy APAP 5/325”, “Oxy APAP 7.5/325” and “Oxy APAP 10/325”)
Under FDA Review
44 unchanged sentences
Hydrochloride Tablets
−Removed: to the Nostrum Asset Purchase Agreement, dated June 17, 2024, by and between the Company and Nostrum Laboratories Inc.,
−Removed: the Company acquired all rights in and to the approved ANDA for Methadone Hydrochloride Tablets and a royalty-free, non-exclusive perpetual
−Removed: license to use the manufacturing technology, proprietary information, processes, techniques, protocols, methods, know-how and improvements
−Removed: necessary or used to manufacture this product.
+Added: to the Nostrum Asset Purchase Agreement, dated June 17, 2024, by and between the Company and Nostrum Laboratories Inc., the Company acquired
+Added: all rights in and to the approved ANDA for Methadone Hydrochloride Tablets and a royalty-free, non-exclusive perpetual license to use
+Added: the manufacturing technology, proprietary information, processes, techniques, protocols, methods, know-how and improvements necessary
+Added: or used to manufacture this product.
Extended-Release Tablets USP
10 unchanged sentences
part of standard operating practices, the Company, from time to time, as relevant, conducts evaluations of all ANDAs owned, consisting,
−Removed: without limitation, of ANDAs acquired or approved prior to the quarter ended September 30, 2025 and ANDAs acquired or approved during the
−Removed: quarter ended September 30, 2025.
−Removed: Such evaluations include, without limitation, costs and benefits analyses relating to each ANDA owned, with
−Removed: such costs including those fees required under the FDA’s Generic Drug User Fee Amendment which is significantly influenced by the
−Removed: number of ANDAs owned, and other costs and benefits taking into consideration various specific market factors for each ANDA.
−Removed: with a cost/benefit profile not consistent with management criteria for continuation are identified for disposition and effort is made
−Removed: to determine the optimal course of action to achieve disposition of the ANDA.
−Removed: The Company did not discontinue or transfer an ANDAs during the quarter ended September 30, 2025.
+Added: without limitation, of ANDAs acquired or approved prior to the quarter ended December 31, 2025 and ANDAs acquired or approved during
+Added: the quarter ended December 31, 2025.
+Added: Such evaluations include, without limitation, costs and benefits analyses relating to each ANDA
+Added: owned, with such costs including those fees required under the FDA’s Generic Drug User Fee Amendment which is significantly influenced
+Added: by the number of ANDAs owned, and other costs and benefits taking into consideration various specific market factors for each ANDA.
+Added: ANDAs with a cost/benefit profile not consistent with management criteria for continuation are identified for disposition and effort
+Added: is made to determine the optimal course of action to achieve disposition of the ANDA.
+Added: The Company did not discontinue or transfer an
+Added: ANDAs during the quarter ended December 31, 2025.
Accounting Estimates
38 unchanged sentences
any deferred tax assets that it determines will not be realizable in the future.
−Removed: On July 4, 2025, tax
−Removed: legislation known as the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States.
−Removed: The Company has evaluated the
−Removed: impact of U.S.
−Removed: tax law changes introduced by OBBBA on our consolidated financial statements and the impact to the current year’s
−Removed: financial statements is not material.
of Operations
2 unchanged sentences
necessarily indicative of future results.
−Removed: months ended September 30, 2025 compared to the three months ended September 30, 2024
+Added: months ended December 31, 2025 compared to the three months ended December 31, 2024
Cost of manufacturing and Gross profit:
−Removed: the Three Months Ended
−Removed: Manufacturing
+Added: the Three Months Ended December 31,
+Added: Manufacturing fees
+Added: Licensing fees
+Added: Total revenue
Cost of manufacturing
−Removed: profit - percentage
−Removed: revenues for the three months ended September 30, 2025 increased by $17.4 million or 92%, to $36.3 million, as compared to $18.9 million,
+Added: Gross profit - percentage
+Added: revenues for the three months ended December 31, 2025 increased by $17.2 million or 120%, to $31.6 million, as compared to $14.4 million,
for the corresponding period of the prior year.
Manufacturing
−Removed: fees revenue increased by $18.0 million, or 99%, to $36.2 million primarily due to revenues relating to increased revenues from the Elite label products that were commercialized in both the current period and comparable
−Removed: period of the prior year as well as sales of new products, including,
−Removed: without limitation, the Lisdexamfetamine products, which were commercially launched subsequent to the comparable period of the prior
−Removed: year and are expected to continue in periods subsequent to September 30, 2025.
−Removed: fees revenue decreased by $529,705, or 81%.
−Removed: This decrease is primarily due to the Company’s transitioned focus on marketing of
−Removed: the Elite label products, which does not result in license fee revenues.
−Removed: The Company’s last remaining licensing agreement
−Removed: expired in accordance with its terms on September 10, 2025.
−Removed: Accordingly, other than minimal residual licensing fees that may be
−Removed: received prospectively, there is no contractual framework in place for achieving license fees revenues going forward.
+Added: fees revenue increased by $17.6 million, or 128%, to $31.4 million primarily due to increased revenues from the Elite label products
+Added: that were commercialized in both the current period and comparable period of the prior year as well as sales of new products, including,
+Added: without limitation, the Lisdexamfetamine and Elite labeled Naltrexone products, which were commercially launched subsequent to the comparable
+Added: period of the prior year and are expected to continue in periods subsequent to December 31, 2025.
+Added: fees revenue decreased by $0.4 million, or 67%.
+Added: This decrease is primarily due to the Company’s transitioned focus on marketing
+Added: of the Elite label products, which does not result in license fee revenues.
of manufacturing consists of manufacturing and assembly costs.
1 unchanged sentence
million as compared to $8.2 million for the corresponding period in the prior fiscal year.
−Removed: This increase was due to an increased volume
−Removed: of products sold during the three months ended September 30, 2025, as compared to the comparable period of the prior fiscal year, as
−Removed: gross profit margin was 39% during the three months ended September 30, 2025 as compared to 43% during the comparable period of the
−Removed: prior fiscal year.
−Removed: The decrease is primarily due to sales in the current quarter consisting of a higher proportion of indirect sales
−Removed: through wholesalers, which yield lower gross profit margins as compared to direct sales to pharmaceutical chains, as
−Removed: compared to the proportion of indirect sales through wholesalers achieved during the comparable period of the prior
−Removed: the Three Months Ended
+Added: These costs have a strong positive correlation
+Added: with manufacturing operation and the increase was due to an increased volume of products sold during the three months ended December
+Added: 31, 2025, as compared to the comparable period of the prior fiscal year, as noted above.
+Added: gross profit margin was 41% during the three months ended December 31, 2025 as compared to 43% during the comparable period of the prior
+Added: The decrease is primarily due to sales in the current quarter consisting of a higher proportion of indirect sales through
+Added: wholesalers, which yield lower gross profit margins as compared to direct sales to pharmaceutical chains, as compared to the proportion
+Added: of indirect sales through wholesalers achieved during the comparable period of the prior year.
+Added: the Three Months Ended December 31,
Operating expenses:
−Removed: and development
−Removed: and administrative
+Added: General and administrative
+Added: Non-cash compensation
and amortization
operating expenses
−Removed: expenses for the three months ended September 30, 2025 increased by $1.1 million, or 24%, to $5.9 million as compared to $4.7 million
−Removed: for the corresponding period in the prior fiscal year, largely due to an increase in general and administrative costs of $1.8 million,
−Removed: offset by a decrease in research and development expenses of $0.6 million
−Removed: and development costs during the three months ended September 30, 2025 were $1.4 million, a decrease of $0.6 million, or 30%, from
−Removed: approximately $2.0 million of such costs for the comparable period of the prior year.
−Removed: The decrease was the result of more laboratory
−Removed: resources being allocated to supporting commercial operations as well as the number, timing and nature of product development
−Removed: activities during the three months ended September 30, 2025, as compared to the comparable period of the prior fiscal
−Removed: and administrative expenses for the three months ended September 30, 2025 were $4.0 million, an increase of $1.8 million or approximately
−Removed: 77% from the comparable period of the prior fiscal year.
−Removed: This increase is due to largely due to increased human resource costs resulting from increased headcounts
−Removed: as well as increased costs of financial, tax and other regulatory compliance costs as compared to the comparable period of the prior
−Removed: compensation expense for the three months ended September 30, 2025 and 2024 was less than $0.1 million.
−Removed: and amortization expenses from the three months ended September 30, 2025 were $0.4 million, essentially flat as compared to $0.4 million
+Added: $ (1,081,299 )
+Added: expenses for the three months ended December 31, 2025 decreased by $1.1 million, or 22%, to $3.9 million as compared to $5.0 million
+Added: for the corresponding period in the prior fiscal year, largely due to decreases in research and development and general and
+Added: administrative expenses of $0.8 million and $0.3 million, respectively.
+Added: and development costs during the three months ended December 31, 2025 were $1.0 million, a decrease of $0.8 million, or 42%, from approximately
+Added: $1.8 million of such costs for the comparable period of the prior year.
+Added: The decrease was the result of more laboratory resources being
+Added: allocated to supporting commercial operations as well as the number, timing and nature of product development activities during the three
+Added: months ended December 31, 2025, as compared to the comparable period of the prior fiscal year.
+Added: and administrative expenses for the three months ended December 31, 2025 were $2.5 million, a decrease of $0.3 million or
+Added: approximately 9% from the comparable period of the prior fiscal year.
+Added: This decrease was due primarily to higher facility utilization
+Added: resulting in increased overhead absorption as compared to the comparable period of the prior fiscal year, which had a lower than baseline sell side quantity demand that has not reoccurred.
+Added: compensation expense for the three months ended December 31, 2025 and 2024 was less than $0.1 million.
+Added: and amortization expenses from the three months ended December 31, 2025 were $0.4 million, essentially flat as compared to $0.4 million
for the comparable period in the prior fiscal year.
−Removed: a result of the foregoing, our income from operations during the three months ended September 30, 2025 was $8.2 million, compared to
−Removed: income from operations of $3.5 million for the comparable period of the prior fiscal year.
+Added: a result of the foregoing, our income from operations during the three months ended December 31, 2025 was $9.0 million, compared to income
+Added: from operations of $1.1 million for the comparable period of the prior fiscal year.
income (expense):
−Removed: the Three Months Ended
+Added: the Three Months Ended December 31,
Other income (expenses):
−Removed: in fair value of derivative financial instruments - warrants
+Added: Change in fair
+Added: value of derivative financial instruments - warrants
$ (11,729,368 )
−Removed: expense and amortization of debt issuance costs
+Added: Interest expense and amortization
+Added: of debt issuance costs
+Added: Interest income
income (expenses), net
$ (11,750,575 )
−Removed: income (expenses) for the three months ended September 30, 2025 was $7.5 million, an increase in net other income
−Removed: of $20.5 million from a net other (expense) of $13.0 million for the comparable period of the prior fiscal year.
−Removed: The increase in net
−Removed: other income was primarily due to an increase of $20.3 million relating to the change in fair value of derivative financial instruments
−Removed: and a decrease in interest expense of $0.2 million, as compared to the comparable period of the prior year.
+Added: other income (expenses) for the three months ended December 31, 2025 was $11.8 million, an increase in net other income of $23.6 million
+Added: from a net other (expense) of $11.8 million for the comparable period of the prior fiscal year.
+Added: The increase in net other income was
+Added: primarily due to an increase of $23.5 million relating to the change in fair value of derivative financial instruments and an increase
+Added: in interest income of $0.1 million, as compared to the comparable period of the prior year.
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 relationship
−Removed: between changes in the closing price of the Company’s Common Stock and other income or (expense) being recorded.
−Removed: The decrease in
−Removed: interest expense is primarily related to the Company servicing a lesser principal amount of loans payable during the three months
−Removed: ended September 30, 2025 as compared to the comparable period of the prior year.
−Removed: a result of the foregoing, our net income before income taxes for the three months ended September 30, 2025 was $15.7 million, compared
+Added: Common Stock as of the end of the period, as compared to the closing price at the beginning of the period.
+Added: There is a strong inverse
+Added: relationship between changes in the closing price of the Company’s Common Stock and other income or (expense) being recorded.
+Added: closing price of the Company’s Common Stock at the end of the three months ended December 31, 2025 was lower than the closing price
+Added: of the Company’s Common Stock at the beginning of the three months ended December 31, 2025, resulting in the recording of other
+Added: income from the change in fair value of warrant derivative instruments.
+Added: The closing price of the Company’s Common Stock at the
+Added: end of the comparable period of the prior year was higher than the closing price of the Company’s Common Stock at the beginning
+Added: of the comparable period of the prior year, resulting in the recording of other expenses from the change in fair value of warrant derivative
+Added: increase in interest income is primarily due to higher interest rates being earned on the Company’s cash balances as compared to
+Added: the comparable period of the prior year.
+Added: a result of the foregoing, our net income before income taxes for the three months ended December 31, 2025 was $20.8 million, compared
to net loss before income taxes of $10.7 million for the comparable period of the prior fiscal year.
−Removed: months ended September 30, 2025 compared to the six months ended September 30, 2024
+Added: months ended December 31, 2025 compared to the nine months ended December 31, 2024
Cost of manufacturing and Gross profit:
−Removed: the Six Months Ended
−Removed: Manufacturing
+Added: the Nine Months Ended December 31,
+Added: Manufacturing fees
+Added: $ 107,357,701
+Added: Licensing fees
+Added: Total revenue
Cost of manufacturing
−Removed: profit - percentage
−Removed: revenues for the six months ended September 30, 2025 increased by $38.8 million or 103%, to $76.5 million, as compared to $37.7 million,
+Added: Gross profit - percentage
+Added: revenues for the nine months ended December 31, 2025 increased by $56.1 million or 108%, to $108.1 million, as compared to $52.0 million,
for the corresponding period of the prior year.
Manufacturing
−Removed: fees revenue increased by $39.3 million, or 107%, primarily due to revenues relating to increased revenues from the Elite label products that were commercialized in both the current period and comparable
−Removed: period of the prior year as well as sales of new products, including, without limitation,
−Removed: the Lisdexamfetamine products, which were commercially launched subsequent to the comparable period of the prior year and are expected to continue in periods subsequent to September 30, 2025.
+Added: fees revenue increased by $57.0 million, or 113%, primarily due to increased revenues from the Elite label products that were commercialized
+Added: in both the current period and comparable period of the prior year as well as sales of new products, including, without limitation, the
+Added: Lisdexamfetamine and Elite labeled Naltrexone products, which were commercially launched subsequent to the comparable period of the prior
+Added: year and are expected to continue in periods subsequent to December 31, 2025.
fees revenue decreased by $0.9 million, or 53%.
−Removed: This decrease is primarily due to the Company’s transitioned focus on
−Removed: marketing of the Elite label, which does not result in license fee revenues.
−Removed: The Company’s last remaining licensing agreement
−Removed: expired in accordance with its terms on September 10, 2025.
−Removed: Accordingly, other than minimal residual licensing fees that may be
−Removed: received prospectively, there is no contractual framework in place for achieving license fees revenues going forward.
+Added: This decrease is primarily due to the Company’s transitioned focus on marketing
+Added: of the Elite label, which does not result in license fee revenues.
of manufacturing consists of manufacturing and assembly costs.
−Removed: Our cost of manufacturing increased by $14.2 million or 68%, to $35.2 million
−Removed: as compared to $21.0 million for the corresponding period in the prior fiscal year.
−Removed: This increase was due to an increased volume of products
−Removed: sold during the six months ended September 30, 2025, as compared to the comparable period of the prior fiscal year, as noted above.
−Removed: gross profit margin was 54% during the six months ended September 30, 2025 as compared to 44% during the comparable period of the prior
−Removed: The increase is primarily due to sales achieved during the current quarter being comprised of a greater proportion of higher
−Removed: margin products as compared to sales achieved during the comparable period of the prior year and sales during the six month period ended September 30, 2025 consisting of a greater proportion of direct
−Removed: sales to pharmaceutical chains, which yield higher gross profit margins as compared to indirect sales to wholesalers, as compared to the
−Removed: comparable period of the prior year.
−Removed: It should be noted that the higher gross profit percentage during the six months ended September 30,
−Removed: 2025 is higher that that of the three months ended September 30, 2025, as per above, with such being due to the latter half of the
−Removed: six month period ended September 30, 2025 consisting of an increased proportion of indirect sales through wholesalers, as compared
−Removed: to the former half of the six month period ended September 30, 2025.
−Removed: the Six Months Ended
+Added: Our cost of manufacturing increased by $24.6 million or 84%, to $53.9
+Added: million as compared to $29.3 million for the corresponding period in the prior fiscal year.
+Added: These costs have a strong positive correlation
+Added: with manufacturing operations and the increase was due to an increased volume of products sold during the nine months ended December
+Added: 31, 2025, as compared to the comparable period of the prior fiscal year, as noted above.
+Added: gross profit margin was 50% during the nine months ended December 31, 2025 as compared to 44% during the comparable period of the prior
+Added: The increase is primarily due to sales achieved during the current period being comprised of a greater proportion of higher
+Added: margin products as compared to sales achieved during the comparable period of the prior year and sales during the nine months ended December
+Added: 31, 2025 consisting of a greater proportion of direct sales to pharmaceutical chains, which yield higher gross profit margins as compared
+Added: to indirect sales to wholesalers, as compared to the comparable period of the prior year.
+Added: It should be noted that the gross profit
+Added: percentage during the nine months ended December 31, 2025 is higher than that of the three months ended December 31, 2025, as per above,
+Added: with such being due to the latter half of the nine months ended December 31, 2025 consisting of an increased proportion of indirect sales
+Added: through wholesalers, as compared to the former half of the nine months ended December 31, 2025.
+Added: the Nine Months Ended December 31,
Operating expenses:
−Removed: and development
$ (1,822,488 )
−Removed: and administrative
+Added: General and administrative
+Added: Non-cash compensation
and amortization
operating expenses
−Removed: expenses for the six months ended September 30, 2025 increased by $2.1 million, or 22%, to $11.4 million as compared to $9.3 million
+Added: expenses for the nine months ended December 31, 2025 increased by $1.0 million, or 7%, to $15.3 million as compared to $14.3 million
for the corresponding period in the prior fiscal year, largely due to an increase in general and administrative expenses of $2.9 million,
−Removed: offset by a decrease in research and development expenses of $1.1 million.
−Removed: and development costs during the six months ended September 30, 2025 were $3.1 million, a decrease of $1.1 million, or 26%, from
−Removed: approximately $4.1 million of such costs for the comparable period of the prior year.
−Removed: The decrease was the result of more laboratory
−Removed: resources being allocated to supporting commercial operations as well as the number, timing and nature of product development
−Removed: activities during the six months ended September 30, 2025, as compared to the comparable period of the prior fiscal year.
−Removed: and administrative expenses for the six months ended September 30, 2025 were $7.4 million as compared to $4.2 million for the corresponding
−Removed: period in the prior fiscal year, an increase of $3.2 million or approximately 75% .
−Removed: This increase is largely due to increased human resource costs resulting
−Removed: from increased headcounts as well as increased costs of financial, tax and other regulatory compliance as compared to the comparable
−Removed: period of the prior year.
−Removed: compensation expense for the six months ended September 30, 2025 and 2024 was less than $0.1 million.
−Removed: and amortization expenses from the six months ended September 30, 2025 were $0.8 million, essentially flat from $0.8 million for the
+Added: partially offset by a decrease in research and development expenses of $1.8 million.
+Added: and development costs during the nine months ended December 31, 2025 were $4.1 million, a decrease of $1.8 million, or 31%, from approximately
+Added: $5.9 million of such costs for the comparable period of the prior year.
+Added: The decrease was the result of more laboratory resources being
+Added: allocated to supporting commercial operations as well as the number, timing and nature of product development activities during the nine
+Added: months ended December 31, 2025, as compared to the comparable period of the prior fiscal year.
+Added: General and administrative expenses for the nine months ended December 31,
+Added: 2025 were $9.9 million as compared to $7.0 million for the corresponding period in the prior fiscal year, an increase of $2.9 million
+Added: or approximately 42%.
+Added: This increase is due primarily to legal and consulting costs incurred during first six months of the fiscal year
+Added: ended March 31, 2026 and related to strategic company objectives, as well as increased costs of current expected credit loss expenses
+Added: and third party legal and regulatory compliance subject matter experts as compared to the comparable period of the prior fiscal year.
+Added: Non-cash compensation expense for the nine months ended December 31, 2025
+Added: and 2024 was less than $0.2 million.
+Added: and amortization expenses from the nine months ended December 31, 2025 were $1.2 million, essentially flat from $1.3 million for the
comparable period of the prior year.
−Removed: a result of the foregoing, our income from operations during the six months ended September 30, 2025 was $29.9 million, compared to income
+Added: a result of the foregoing, our income from operations during the nine months ended December 31, 2025 was $38.9 million, compared to income
from operations of $8.4 million for the comparable period of the prior fiscal year.
−Removed: income (expense):
−Removed: the Six Months Ended
+Added: (expense) income:
+Added: the Nine Months Ended December 31,
Other (expense) income:
−Removed: in fair value of derivative financial instruments - warrants
+Added: Change in fair
+Added: value of derivative financial instruments - warrants
$ (2,772,513 )
$ (27,267,016 )
−Removed: expense and amortization of debt issuance costs
−Removed: (expense) income, net
+Added: Interest expense and amortization
+Added: of debt issuance costs
+Added: Interest income
$ (2,966,547 )
$ (27,770,848 )
−Removed: (expense) income for the six months ended September 30, 2025 was a net other expense of $14.8 million, a decrease of $1.2 million from
−Removed: a net other expense of $16.0 million for the comparable period of the prior fiscal year.
+Added: other (expense) income for the nine months ended December 31, 2025 was a net other expense of $3.0 million, a decrease of $24.8 million
+Added: from a net other expense of $27.8 million for the comparable period of the prior fiscal year.
The decrease was primarily due to a decrease
−Removed: in other expenses of $0.9 million relating to the change in fair value of derivative instruments and a decrease in interest expense and
−Removed: amortization debt issuance costs of $0.3 million.
−Removed: The change in the fair value of derivative instruments is determined in large part
−Removed: 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
−Removed: at the beginning of the period, with a strong inverse relationship between changes in the closing price of the Company’s Common
−Removed: Stock and other income or (expense) being recorded.
−Removed: The decrease in interest expense is primarily related to the Company servicing a
−Removed: lesser principal amount of loans payable during the six months ended September 30, 2025 as compared to the comparable period of the prior
−Removed: a result of the foregoing, our net income before income taxes for the six months ended September 30, 2025 was $15.1 million, compared
+Added: in other expenses of $24.5 million relating to the change in fair value of derivative instruments, a decrease in interest expense and
+Added: amortization debt issuance costs of $0.3 million, and an increase in interest income of $0.1 million.
+Added: change in the fair value of derivative instruments is determined in large part by the change in the closing price of the Company’s
+Added: Common Stock as of the end of the period, as compared to the closing price at the beginning of the period.
+Added: There is a strong inverse
+Added: relationship between changes in the closing price of the Company’s Common Stock and other income or (expense) being recorded.
+Added: closing price of the Company’s Common Stock at December 31, 2025 was higher than at March 31, 2025, resulting in the recording
+Added: of other expenses from the change in fair value of warrant derivative instruments for the nine month period.
+Added: The closing price of the
+Added: Company’s Common Stock at the end of the comparable period of the prior year was higher than the closing price of the Company’s
+Added: Common Stock at the beginning of the comparable period of the prior year, resulting in the recording of other expenses from the change
+Added: in fair value of warrant derivative instruments.
+Added: decrease in interest expense is primarily related to the Company servicing a lesser principal amount of loans payable during the nine
+Added: months ended December 31, 2025 as compared to the comparable period of the prior year
+Added: increase in interest income is primarily due to higher interest rates being earned on the Company’s higher cash balances as compared
+Added: to the comparable period of the prior year.
+Added: a result of the foregoing, our net income before income taxes for the nine months ended December 31, 2025 was $36.0 million, compared
to net loss before income taxes of $19.3 million for the comparable period of the prior fiscal year.
and Capital Resources
−Removed: $ (1,166,919 )
+Added: Current assets
+Added: Current liabilities
+Added: Working capital
working capital (total current assets less total current liabilities) increased by $37.7 million from $45.9 million as of March 31,
−Removed: to $75.1 million as of September 30, 2025, with such increase being primarily related to the increase cash, finished goods inventory
−Removed: and accounts receivable, associated with increased customer orders and shipments during the six months ended September 30, 2025 and a
−Removed: decrease in current liabilities during the same period.
+Added: 2025 to $83.6 million as of December 31, 2025, with such increase being primarily related to the increase in cash, finished goods
+Added: inventory and accounts receivable, associated with increased customer orders and shipments during the nine months ended December 31,
+Added: 2025 and partially offset by an increase in current liabilities during the same period.
of Cash Flows:
−Removed: the Six Months Ended
−Removed: Net cash provided
−Removed: by operating activities
−Removed: Net cash used in investing
+Added: the Nine Months Ended December 31,
+Added: Net cash provided by operating
+Added: Net cash used in investing activities
$ (1,645,722 )
−Removed: Net cash used in financing
+Added: Net cash used in financing activities
$ (4,280,787 )
−Removed: cash provided by operating activities for the six months ended September 30, 2025 was $19.9 million, which included, without limitation,
−Removed: net income of $7.8 million, increased by fair value of derivative financial instruments - warrants of $14.6
−Removed: million, and other non-cash expenses of $1.9 million, deferred tax expenses of $6.6 million, and reduced by increases in operating assets
−Removed: and liabilities totaling $11.0 million.
−Removed: cash used in investing activities for the six months ended September 30, 2025 was comprised of purchases of property and equipment of
+Added: cash provided by operating activities for the nine months ended December 31, 2025 was $14.6 million, which included, without limitation,
+Added: net income of $26.4 million, increased by fair value of derivative financial instruments - warrants of $2.8 million, and other non-cash
+Added: expenses of $2.6 million, deferred tax expenses of $8.0 million, and reduced by increases in operating assets and liabilities totaling
+Added: $25.2 million.
+Added: cash used in investing activities for the nine months ended December 31, 2025 was comprised of purchases of property and equipment of
approximately $0.5 million.
−Removed: cash used in financing activities was $4.2 million for the six months ended September 30, 2025 compared to net cash used in financing
−Removed: activities of $0.5 million for the corresponding period of the prior year.
−Removed: Net cash used in financing activities consisted primarily
−Removed: of payments of bond and loan principal totaling $4.1 million and payments on principal on finance lease obligations of $0.2 million.
−Removed: Net cash used in financing activities of $0.5 million during the prior fiscal year was due to payments of bond and loan principal
−Removed: totaling $0.3 million and payments on principal on finance lease obligations of $0.2 million.
+Added: cash used in financing activities was $4.3 million for the nine months ended December 31, 2025 compared to net cash used in
+Added: financing activities of $0.7 million for the corresponding period of the prior year.
+Added: Net cash used in financing activities consisted
+Added: primarily of payments of bond and related party loan principal totaling $4.1 million and payments on principal on finance lease
+Added: obligations of $0.3 million, offset by proceeds received from the exercise of stock options of $0.2 million.
+Added: Net cash used in
+Added: financing activities of $0.7 million during the prior fiscal year was due to payments of bond and loan principal totaling $0.4
+Added: million and payments on principal on finance lease obligations of $0.2 million.
July 1, 2022, East West Bank (“EWB”) provided a mortgage loan (“EWB Mortgage Loan”) in the amount of $2.55 million
3 unchanged sentences
rate of 4.5%.
−Removed: The total transaction costs associated with the EWB Mortgage Loan incurred as of September 30, 2025, were $13,251, which
+Added: The total transaction costs associated with the EWB Mortgage Loan incurred as of December 31, 2025, were $13,251, which
are being amortized on a monthly basis over ten years, beginning in July 2022.
3 unchanged sentences
trailing 12-month debt coverage ratio of 1.50 to 1.00.
−Removed: As of September 30, 2025, and through the date of filing of this Quarterly Report
+Added: As of December 31, 2025, and through the date of filing of this Quarterly Report
on Form 10-Q, the Company was not aware of the existence of any violations of financial covenants included in the EWB Mortgage Loan.
13 unchanged sentences
issue costs of $354,454 were paid from the proceeds of the NJEDA Bonds and are being amortized over the life of the NJEDA bonds.
−Removed: of bond issuance costs amounted to $7,089 for the six months ended September 30, 2025.
+Added: of bond issuance costs amounted to $10,634 for the nine months ended December 31, 2025.
NJEDA Bonds require the Company to make an annual principal payment on September 1st of varying amounts as specified in the loan documents
10 unchanged sentences
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.