ANI PHARMACEUTICALS INC
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
ANIP$67.41-3.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-07.
0001023024-26-000069
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001023024-26-000078
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 113 previous paragraphs and 116 current paragraphs.
54 unchanged; 56 reworded; 5 added; 3 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 13 previous and 13 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
•We recognized losses related to the disposal of certain manufacturing equipment and an impairment charge related to one definite-lived intangible asset totaling approximately $1.1 million during the three months ended September 30, 2025. There were no similar items in the three months ended September 30, 2026.
Current report
For the three months ended September 30, 2025, our income tax expense was approximately $7.2 million. Our effective tax rate of 21.3% of pre-tax income for the period was determined based on our pre-tax income, statutory tax rates and the tax impacts of certain discrete items for the three months ended September 30, 2025, which impact our income tax expense in the period in which they occur. The effective tax rate differed from the federal statutory rate of 21% primarily due to excess tax benefits recognized upon settlement of stock-based compensation and non-taxable adjustments to the fair value of certain contingent liabilities related to the acquisition of Alimera.
Current report
RESULTS OF OPERATIONS FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2026 AND 2025
Current report
•We recognized losses related to the disposal of certain manufacturing equipment and an impairment charge related to one definite-lived intangible asset totaling approximately $1.1 million during the nine months ended September 30, 2025. There were no similar items during the nine months ended September 30, 2026.
Current report
In May 2026, our Board of Directors approved a share repurchase program authorizing us to repurchase up to $100.0 million of our common stock (the “Share Repurchase Program”). During the three months ended September 30, 2026, we repurchased 102,492 shares of our common stock for an aggregate purchase price of approximately $7.5 million, including direct costs, and approximately $92.5 million remained available for repurchase under the Share Repurchase Program as of September 30, 2026. In addition, from October 1, 2026 through November 2, 2026, we repurchased 173,143 shares of our common stock for an aggregate purchase price of approximately $12.5 million, including direct costs. The specific timing and amount of any future repurchases will depend on available capital resources, market conditions and other factors, and we are not obligated to repurchase any shares. See Note 9 “Stockholders’ Equity” in the notes to the unaudited condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report on Form 10-Q for further information.
Removed paragraphs (3)
Previous report
During the three months ended June 30, 2026 and 2025, no single vendor represented more than 10% of our raw inventory purchases.
Previous report
RESULTS OF OPERATIONS FOR THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025
Previous report
For the six months ended June 30, 2025, our income tax expense was approximately $6.3 million. Our effective tax rate was 20.6% of pre-tax income reported in the period, as well as the net effect of certain discrete items for the six months ended June 30, 2025 which impact our income tax expense in the period in which they occur. Discrete items are primarily related to excess tax benefits recognized upon settlement of stock'based compensation awards.
Reworded paragraphs (56)
Previous wording
ANI Pharmaceuticals is a diversified bio-pharmaceutical company. The Company’s mission is “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing therapeutics through its Rare Disease, Generics, and Brands businesses.
Current wording
ANI Pharmaceuticals is a diversified bio-pharmaceutical company. The Company’s mission is “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing therapeutics through its Rare Disease, Generics and Other, and Brands businesses.
Previous wording
On September 16, 2024, the Company acquired Alimera Sciences, Inc. (“Alimera”). In connection with the Merger, the Company addeda growing and durable franchise, ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg, which has received marketing authorization and reimbursement in the United States (“U.S.”) and 24 countries for the treatment of diabetic macular edema (“DME”) and YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, available in the U.S. for the treatment of non-infectious uveitis affecting the posterior segment of the eye (“NIU-PS”). Subsequent to the acquisition of Alimera, we expanded the label for ILUVIEN to include an indication for chronic NIU-PS in addition to its then-current indication in DME in the U.S.
Current wording
On September 16, 2024, the Company acquired Alimera Sciences, Inc. (“Alimera”). In connection with the acquisition of Alimera, the Company addeda growing and durable franchise, ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg, which has received marketing authorization and reimbursement in the United States (“U.S.”) and 24 countries for the treatment of diabetic macular edema (“DME”) and YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, available in the U.S. for the treatment of non-infectious uveitis affecting the posterior segment of the eye (“NIU-PS”). Subsequent to the acquisition of Alimera, we expanded the label for ILUVIEN to include an indication for chronic NIU-PS in addition to its then-current indication in DME in the U.S.
Previous wording
We acquired the NDAs for Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (“Cortrophin Gel”) and Cortrophin-Zinc TMin January 2016 and executed long-term supply agreements witha supplier of our primary raw material for corticotrophin API, a supplier of corticotrophin API with whom we have advanced the manufacture of commercial scale batches of API, and a Cortrophin Gel fill/finish contract manufacturer. On October 29, 2021, the U.S. Food and Drug Administration (“FDA”) approved the Company’s Supplemental New Drug Application (“sNDA”) for Cortrophin Gel for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (“MS”) and rheumatoid arthritis (“RA”), in addition to excess urinary protein due to nephrotic syndrome. Cortrophin Gel is an adrenocorticotropic hormone (“ACTH”), also known as purified corticotropin. On January 24, 2022, we announced the commercial launch of Cortrophin Gel in the U.S. as our foundational Rare Disease asset.
Current wording
We acquired the NDAs for Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (“Cortrophin Gel”) and Cortrophin-Zinc TMin January 2016 and executed long-term supply agreements witha supplier of our primary raw material for corticotropin API, a supplier of corticotropin API with whom we have advanced the manufacture of commercial scale batches of API, and a Cortrophin Gel fill/finish contract manufacturer. On October 29, 2021, the U.S. Food and Drug Administration (“FDA”) approved the Company’s Supplemental New Drug Application (“sNDA”) for Cortrophin Gel for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (“MS”) and rheumatoid arthritis (“RA”), in addition to excess urinary protein due to nephrotic syndrome. Cortrophin Gel is an adrenocorticotropic hormone (“ACTH”), also known as purified corticotropin. On January 24, 2022, we announced the commercial launch of Cortrophin Gel in the U.S. as our foundational Rare Disease asset.
Previous wording
During 2026, we are building a dedicated sales organization focused on acute gouty arthritis flares, an indication unique to Cortrophin Gel within the ACTH class. Our dedicated sales force will focus on the appropriate patient population through podiatry and primary care physicians, while our existing sales organization will continue to focus on appropriate acute gouty arthritis flare patients seen by rheumatologists and nephrologists.
Current wording
During 2026, we have built a dedicated sales organization focused on acute gouty arthritis flares, an indication unique to Cortrophin Gel within the ACTH class. Our dedicated sales force is focused on the appropriate patient population through podiatry and primary care physicians, while our existing sales organization will continue to focus on appropriate acute gouty arthritis flare patients seen by rheumatologists and nephrologists.
Previous wording
Impacts to our second quarter 2026 and 2025 results of operations, including to net revenues, operating expenses, interest and other expense, net, and income taxes are described below.
Current wording
Impacts to our third quarter 2026 and 2025 results of operations, including to net revenues, operating expenses, interest and other expense, net, and income taxes are described below.
Previous wording
(1)There were no sales of YUTIQ during the quarters ended March 31, 2026 and June 30, 2026, as the Company transitioned promotional efforts in the U.S. from YUTIQ to ILUVIEN, which has a combined label of DME and NIU-PS during the second quarter of 2025.
Current wording
(1)There were no sales of YUTIQ during the three months ended September 30, 2026 and 2025, as the Company transitioned U.S. promotional efforts from YUTIQ to ILUVIEN, which has a combined label of DME and NIU-PS as of the second quarter of 2025.
Previous wording
Net revenues for the three months ended June 30, 2026 were $266.0 million compared to $211.4 million for the same period in 2025, an increase of 25.9%, primarily as a result of the following:
Current wording
Net revenues for the three months ended September 30, 2026 were $290.8 million compared to $227.8 million for the same period in 2025, an increase of 27.6%, primarily as a result of the following:
Previous wording
•Net revenues from Rare Disease and Brands, which includes our Rare Disease and Brands portfolios of pharmaceutical products, royalties, and other revenues were $165.4 million during the three months ended June 30, 2026, an increase of $48.2 million, compared to $117.2 million for the same period in 2025.
Current wording
•Net revenues from Rare Disease and Brands, which includes our Rare Disease and Brands portfolios of pharmaceutical products, royalties, and other revenues were $182.3 million during the three months ended September 30, 2026, an increase of $53.2 million, compared to $129.1 million for the same period in 2025.
Previous wording
•Net revenues for Rare Disease pharmaceutical products were $135.8 million during the three months ended June 30, 2026, an increase of $31.9 million from $104.0 million for the same period in 2025. This increase was driven by increased volume of Cortrophin Gel from overall ACTH market growth and market share gains. ILUVIEN net revenues were $18.7 million in the second quarter, down 16% from the prior year period.
Current wording
•Net revenues for Rare Disease pharmaceutical products were $160.9 million during the three months ended September 30, 2026, an increase of $42.5 million from $118.5 million for the same period in 2025. This increase was driven by increased volume of Cortrophin Gel from overall ACTH market growth and market share gains, driven by both the contribution from the expansion to capture the opportunity in acute gouty arthritis flares and the existing specialty areas of Nephrology, Neurology, Rheumatology, Ophthalmology, and Pulmonology. ILUVIEN net revenues were $22.3 million during the three months ended September 30, 2026, an increase of $5.7 million compared to $16.6 million in the prior year period.
Previous wording
•Net revenues for Brands portfolio of pharmaceutical products were $11.8 million during the three months ended June 30, 2026, a decrease of $1.4 million compared to $13.2 million for the same period in 2025, driven by a net decrease in demand for certain products during the second quarter.
Current wording
•Net revenues for Brands portfolio of pharmaceutical products were $10.0 million during the three months ended September 30, 2026, a decrease of $0.7 million compared to $10.7 million for the same period in 2025, driven by a net decrease in demand for certain products during the third quarter.
Previous wording
•Net revenues for Brand royalties and other revenues during the three months ended June 30, 2026, includes royalties of approximately $9.7 million, and $8.0 million of revenue associated with development milestones satisfied over time, related to the Harmony Agreement.
Current wording
•Net revenues for Brand royalties and other revenues during the three months ended September 30, 2026, includes royalties of approximately $9.5 million and $2.0 million of revenue associated with achievement of development milestones satisfied over time related to the Harmony Agreement.
Previous wording
•Net revenues from Generics and Other, which includes our generic pharmaceutical products, sales of contract manufactured products, royalties on contract manufactured products, and other pharmaceutical services, were $100.7 million during the three months ended June 30, 2026, an increase of 6.8% compared to $94.2 million for the same period in 2025, primarily as a result of the following:
Current wording
•Net revenues from Generics and Other, which includes our generic pharmaceutical products, sales of contract manufactured products, royalties on contract manufactured products, and other pharmaceutical services, were $108.4 million during the three months ended September 30, 2026, an increase of 9.9% compared to $98.7 million for the same period in 2025, primarily as a result of the following:
Previous wording
•Generic pharmaceutical products net revenues were $204.5 million during the six months ended June 30, 2026, an increase of $15.5 million over the prior year. This increase was driven by a partnered product launched in the third quarter of 2025, and increased volumes from the benefit of new product launches during 2026. From a product perspective, in addition to the partnered product cited above, the increase was principally driven by revenues from year over year increases in products such as Vancomycin and MAS ER, among others, tempered by decreased sales of Prucalopride.
Current wording
•Generic pharmaceutical products net revenues were $104.5 million during the three months ended September 30, 2026, an increase of $10.1 million over the prior year. This increase was driven by increased volumes from the new product launches during 2026 and 2025 and revenue from existing products in the portfolio. From a product perspective, the increase was principally driven by year over year revenue increases in products such as Carbamazepine and Clomiphene, among others.
Previous wording
•Other generic net revenues were down modestly for the three months ended June 30, 2026, compared to the same time in the prior year due to fewer contract manufacturing shipments and lower royalties during the period.
Current wording
•Other generic net revenues were down modestly for the three months ended September 30, 2026, compared to the same time in the prior year due to fewer contract manufacturing shipments during the current period.
Previous wording
For the three months ended June 30, 2026, cost of sales increased to $100.2 million from $74.6 million for the same period in 2025, an increase of $25.5 million, or 34.2%. The increase is primarily due to significant net growth in sales volumes of pharmaceutical products and significant growth of royalty bearing products, including Cortrophin Gel, and other products in our portfolio.
Current wording
For the three months ended September 30, 2026, cost of sales increased to $111.5 million from $93.4 million for the same period in 2025, an increase of $18.1 million, or 19.4%. The increase is primarily due to significant net growth in sales volumes of pharmaceutical products and significant growth of royalty bearing products, including Cortrophin Gel, and other products in our portfolio.
Previous wording
Cost of sales, as a percentage of net revenues, increased to 37.6% from 35.3% for the three months ended June 30, 2026, compared to the same period in 2025, primarily due to a shift in product mix year over year and an increase in sales of products that bear a royalty payable, and the non-recurrence of prior year sales from Prucalopride. These effects were somewhat tempered by the revenue recognized under the Harmony Agreement.
Current wording
Cost of sales, as a percentage of net revenues, decreased to 38.4% from 41.0% for the three months ended September 30, 2026, compared to the same period in 2025, primarily due to a favorable shift in product mix year over year in conjunction with revenue recognized under the Harmony Agreement, tempered by an increase in sales of products that bear a royalty payable.
Previous wording
For the three months ended June 30, 2026, total other operating expenses, net increased to $125.4 million from $122.9 million for the same period in 2025, an increase of $2.6 million, or 2.1%, primarily as a result of the following factors:
Current wording
For the three months ended September 30, 2026, total other operating expenses, net increased to $126.9 million from $98.2 million for the same period in 2025, an increase of $28.7 million, or 29.2%, primarily as a result of the following factors:
Previous wording
•Research and development expenses during the six months ended June 30, 2026 decreased from $27.1 million to $25.3 million, a decrease of approximately $1.8 million, primarily due to timing of activity associated with ongoing and new projects to support future growth of Rare Disease and Generics.
Current wording
•Research and development expenses during the three months ended September 30, 2026 increased from $12.3 million to $13.0 million, an increase of approximately $0.7 million, primarily due to timing of activity associated with ongoing and new projects to support future growth of Rare Disease and Generics.
Previous wording
•Selling, general, and administrative expenses increased from $81.8 million to $91.7 million, primarily resulting from increased investment in Rare Disease sales and marketing infrastructure, related to our expansion of the Rare Disease team which is targeting opportunities in acute gouty arthritis, and an overall increase in activities to support the growth of our business, tempered by lower legal costs, compared to the same period in 2025.
Current wording
•Selling, general, and administrative expenses increased from $76.7 million to $94.9 million, an increase of approximately $18.2 million, primarily resulting from increased investment in Rare Disease sales and marketing infrastructure, related to our expansion of the Rare Disease team which is targeting opportunities in acute gouty arthritis, and an overall increase in activities to support the growth of our business, tempered by lower legal costs, compared to the same period in 2025.
Previous wording
•Depreciation and amortization expense was $19.6 million for the three months ended June 30, 2026, compared to $23.3 million for the same period in 2025, a decrease of approximately $3.6 million, primarily related to certain definite-lived intangibles that have been fully amortized during 2025.
Current wording
•Depreciation and amortization expense was $19.6 million for the three months ended September 30, 2026, compared to $22.6 million for the same period in 2025, a decrease of approximately $3.1 million, primarily related to certain definite-lived intangibles that have been fully amortized during 2025.
Previous wording
•We recognized a net gain of approximately $0.6 million for the three months ended June 30, 2026 related to changes in our contingent consideration liabilities, which are measured at fair value. The net gain resulted from the adjustment of future forecasted cash flows and includes primarily: (1) a $0.5 million reduction related to the Alimera contingent value rights; and (2) a $0.1 million decrease in contingent consideration related to the Novitium acquisition.
Current wording
•We recognized a net gain of approximately $0.5 million for the three months ended September 30, 2026 related to changes in our contingent consideration liabilities, which are measured at fair value. The net gain resulted from the adjustment of future forecasted cash flows and includes primarily: (1) a $0.3 million reduction related to the Alimera contingent value rights; and (2) a $0.2 million decrease in contingent consideration related to the Novitium acquisition.
Previous wording
For the three months ended June 30, 2026, we recognized total other expense, net of $3.4 million as compared to total other expense, net of $3.4 million for the same period in 2025.
Current wording
For the three months ended September 30, 2026, we recognized total other expense, net of $3.3 million as compared to total other expense, net of $2.4 million for the same period in 2025.
Previous wording
•We recorded an unrealized gain on investment in equity securities of approximately $6.5 million for the six months ended June 30, 2026, compared to an unrealized loss of approximately $0.6 million in the same period in 2025, which is based on the mark to market fair value of equity securities held in CG Oncology as of the balance sheet date.
Current wording
•We recorded an unrealized loss on investment in equity securities of approximately $35.0 thousand for the three months ended September 30, 2026, compared to an unrealized gain of approximately $3.1 million in the same period in 2025, which is based on the mark to market fair value of equity securities held in CG Oncology as of the balance sheet date.
Previous wording
•Interest expense, net for the three months ended June 30, 2026 consists primarily of coupon interest expense on borrowings under our outstanding debt and amortization of deferred financing costs on these debt instruments, interest income earned on our bank balances, and interest earned on our interest rate swap. Interest income earned on our bank balances increased approximately $1.2 million and interest expense related to our outstanding debt decreased approximately $0.8 million resulting in an increase of interest income of approximately $2.0 million. This impact was partially offset by a decrease of interest earned on our interest rate swap of approximately $0.2 million, compared to the same period in the prior year.
Current wording
•Interest expense, net for the three months ended September 30, 2026 consists primarily of coupon interest expense on borrowings under our outstanding debt and amortization of deferred financing costs on these debt instruments, interest income earned on our bank balances, and interest earned on our interest rate swap. Interest income earned on our bank balances increased approximately $1.0 million, interest expense related to our outstanding debt decreased approximately $0.7 million, and capitalized interest related to construction in progress increased approximately $0.2 million resulting in a decrease in interest expense, net, of approximately $2.0 million. This impact was partially offset by a decrease of interest earned on our interest rate swap of approximately $0.2 million, compared to the same period in the prior year.
Previous wording
•Other (expense) income, net, for the three months ended June 30, 2026 and 2025 consists primarily of unrealized foreign exchange gains and losses related to our Alimera UK subsidiary.
Current wording
•Other expense, net, for the three months ended September 30, 2026 and 2025 consists primarily of unrealized foreign exchange gains and losses related to our Alimera UK subsidiary.
Previous wording
For the six months ended June 30, 2026, our income tax expense was approximately $23.1 million. Our effective tax rate of 29.9% of pre-tax income for the current year was determined based on our pre-tax income, statutory tax rates and the tax impacts of certain discrete items for the six months ended June 30, 2026, which impact our income tax expense in the period in which they occur. The effective tax rate differed from the federal statutory rate of 21% primarily due to state taxes and disallowed officers’ compensation partially offset by excess tax benefits recognized upon settlement of stock-based compensation.
Current wording
For the three months ended September 30, 2026, our income tax expense was approximately $13.9 million. Our effective tax rate of 28.3% of pre-tax income for the current period was determined based on our pre-tax income, statutory tax rates and the tax impacts of certain discrete items for the three months ended September 30, 2026, which impact our income tax expense in the period in which they occur. The effective tax rate differed from the federal statutory rate of 21% primarily due to state taxes and disallowed officers’ compensation.
Previous wording
(1)There were no sales of YUTIQ during the quarters ended March 31, 2026 and June 30, 2026, as the Company transitioned promotional efforts in the U.S. from YUTIQ to ILUVIEN, which had a combined label of DME and NIU-PS during the second quarter of 2025.
Current wording
(1)There were no sales of YUTIQ during the nine months ended September 30, 2026, as the Company transitioned U.S. promotional efforts from YUTIQ to ILUVIEN, which has a combined label of DME and NIU-PS as of the second quarter of 2025.
Previous wording
Net revenues for the six months ended June 30, 2026 were $503.5 million compared to $408.5 million for the same period in 2025, an increase of 23.3%, primarily as a result of the following:
Current wording
Net revenues for the nine months ended September 30, 2026 were $794.3 million compared to $636.3 million for the same period in 2025, an increase of 24.8%, primarily as a result of the following:
Previous wording
•Net revenues from Rare Disease and Brands, which includes our Rare Disease and Brands portfolios of pharmaceutical products, royalties, and other revenues were $293.6 million during the six months ended June 30, 2026, an increase of $82.4 million, compared to $211.2 million for the same period in 2025.
Current wording
•Net revenues from Rare Disease and Brands, which includes our Rare Disease and Brands portfolios of pharmaceutical products, royalties, and other revenues were $476.0 million during the nine months ended September 30, 2026, an increase of $135.6 million, compared to $340.4 million for the same period in 2025.
Previous wording
•Net revenues for Rare Disease pharmaceutical products were $230.2 million during the six months ended June 30, 2026, an increase of $57.3 million from $172.9 million for the same period in 2025. This increase was driven by increased volume of Cortrophin Gel from overall ACTH market growth and market share gains. Net revenues for ILUVIEN were down modestly for the six months ended June 30, 2026, compared to the same time in the prior year.
Current wording
•Net revenues for Rare Disease pharmaceutical products were $391.1 million during the nine months ended September 30, 2026, an increase of $99.8 million from $291.4 million for the same period in 2025. This increase was driven by increased volume of Cortrophin Gel from overall ACTH market growth and market share gains, driven by both the contribution from the expansion to capture the opportunity in acute gouty arthritis flares and the existing specialty areas of Nephrology, Neurology, Rheumatology, Ophthalmology, and Pulmonology. Net revenues for ILUVIEN were $60.2 million during the nine months ended September 30, 2026, an increase of $5.2 million from $55.0 million compared to the prior year period.
Previous wording
•Net revenues for Brands portfolio of pharmaceutical products were $24.1 million during the six months ended June 30, 2026, a decrease of $14.2 million compared to $38.3 million for the same period in 2025, driven by a net decrease in demand for certain products during the first half of 2026, compared to the same time in the prior year.
Current wording
•Net revenues for Brands portfolio of pharmaceutical products were $34.1 million during the nine months ended September 30, 2026, a decrease of $14.9 million compared to $49.0 million for the same period in 2025, driven by a net decrease in demand for certain products, compared to the same time in the prior year.
Previous wording
•Net revenues for Brand royalties and other revenues during the six months ended June 30, 2026, includes a $15.0 million upfront payment, associated royalties of approximately $16.3 million, and $8.0 million of revenue associated with development milestones satisfied over time, related to the Harmony Agreement.
Current wording
•Net revenues for Brand royalties and other revenues during the nine months ended September 30, 2026, includes a $15.0 million upfront payment, associated royalties of approximately $25.7 million, and $10.0 million of revenue associated with achievement of development milestones satisfied over time, related to the Harmony Agreement.
Previous wording
•Net revenues from Generics and Other, which includes our generic pharmaceutical products, sales of contract manufactured products, royalties on contract manufactured products, and other pharmaceutical services, were $209.9 million during the six months ended June 30, 2026, an increase of $12.6 million compared to $197.3 million for the same period in 2025, primarily as a result of the following:
Current wording
•Net revenues from Generics and Other, which includes our generic pharmaceutical products, sales of contract manufactured products, royalties on contract manufactured products, and other pharmaceutical services, were $318.3 million during the nine months ended September 30, 2026, an increase of $22.4 million compared to $295.9 million for the same period in 2025, primarily as a result of the following:
Previous wording
•Generic pharmaceutical products net revenues were $99.1 million during the three months ended June 30, 2026, an increase of $8.8 million over the prior year. This increase was driven by a partnered product launched in the third quarter of 2025, and increased volumes from the benefit of new product launches during 2026. From a product perspective, in addition to the partnered product cited above, the increase was principally driven by revenues from year over year increases in products such as MAS ER, Vancomycin, among others.
Current wording
•Generic pharmaceutical products net revenues were $308.9 million during the nine months ended September 30, 2026, an increase of $25.6 million over the prior year. This increase was driven by increased volumes from new product launches during 2026 and 2025 and revenue from existing products in the portfolio. From a product perspective, the increase was principally driven by year over year revenue increases in products such as Vancomycin, among others.
Previous wording
•Other generic net revenues was down modestly for the six months ended June 30, 2026, compared to the same time in the prior year due to fewer contract manufacturing shipments during the period.
Current wording
•Other generic net revenues were down for the nine months ended September 30, 2026, compared to the same time in the prior year due to fewer contract manufacturing shipments during the period.
Previous wording
For the six months ended June 30, 2026, cost of sales increased to $193.7 million from $147.7 million for the same period in 2025, an increase of $46.1 million, or 31.2%. The increase is primarily due to significant net growth in sales volumes of pharmaceutical products and significant growth of royalty bearing products, including Cortrophin Gel, and other products in our portfolio.
Current wording
For the nine months ended September 30, 2026, cost of sales increased to $305.3 million from $241.0 million for the same period in 2025, an increase of $64.2 million, or 26.6%. The increase is primarily due to significant net growth in sales volumes of pharmaceutical products and significant growth of royalty bearing products, including Cortrophin Gel, and other products in our portfolio.
Previous wording
Cost of sales, as a percentage of net revenues, increased to 38.5% from 36.1% for the six months ended June 30, 2026, compared to the same period in 2025, primarily due to a shift in product mix year over year, an increase in sales of products that bear a royalty payable, and the non-recurrence of prior year sales from Prucalopride. These effects were somewhat tempered by the revenue recognized under the Harmony Agreement.
Current wording
Cost of sales, as a percentage of net revenues, increased to 38.4% from 37.9% for the nine months ended September 30, 2026, compared to the same period in 2025, primarily due to a shift in product mix year over year, an increase in sales of products that bear a royalty payable, and the non-recurrence of prior year sales from Prucalopride. These effects were somewhat tempered by the revenue recognized under the Harmony Agreement.
Previous wording
During the six months ended June 30, 2026, approximately 23% of our raw material inventory purchases were from one domestic supplier. During the six months ended June 30, 2025, approximately 23% of our raw material inventory purchases were from one domestic supplier.
Current wording
During the nine months ended September 30, 2026, approximately 26% of our raw material inventory purchases were from one domestic supplier. During the nine months ended September 30, 2025, approximately 22% of our raw material inventory purchases were from one domestic supplier.
Previous wording
For the six months ended June 30, 2026, total other operating expenses, net increased to $230.4 million from $220.8 million for the same period in 2025, an increase of $9.7 million, or 4.4%, primarily as a result of the following factors:
Current wording
For the nine months ended September 30, 2026, total other operating expenses, net increased to $357.3 million from $318.9 million for the same period in 2025, an increase of $38.4 million, or 12.0%, primarily as a result of the following factors:
Previous wording
•Research and development expenses during the three months ended June 30, 2026 decreased from $16.5 million to $14.7 million, a decrease of approximately $1.8 million, primarily due to timing of activity associated with ongoing and new projects to support future growth of Rare Disease and Generics.
Current wording
•Research and development expenses during the nine months ended September 30, 2026 decreased from $39.4 million to $38.3 million, a decrease of approximately $1.1 million, primarily due to timing of activity associated with ongoing and new projects to support future growth of Rare Disease and Generics.
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Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
During the three months ended September 30, 2026, approximately 22% of our raw inventory purchases were from one domestic supplier. During the three months ended September 30, 2025, approximately 21% of our raw inventory purchases were from one domestic supplier.