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ANI PHARMACEUTICALS INC

For the period ended Sep 30, 2025. Filed Nov 7, 2025.

View on SEC.gov

About 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, 2025 · Filed Nov 7, 2025

ANIP$67.41-3.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-08.

0001023024-25-000082

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-07.

0001023024-25-000108

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 136 previous paragraphs and 143 current paragraphs.

71 unchanged; 58 reworded; 13 added; 4 removed; 3 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 (13)

Current report

On March 8, 2021, concurrently with the acquisition of Novitium, and as financing for a portion of the acquisition, the Company entered into an Equity Commitment and Investment Agreement with Ampersand 2020 Limited Partnership (the “PIPE Investor”), pursuant to which the PIPE Investor purchased 25,000 shares of Series A Convertible Preferred Stock (the “PIPE Shares”), for a purchase price of $1,000 per share and an aggregate purchase price of $25.0 million on November 19, 2021. The PIPE Shares were classified as mezzanine equity because the shares were mandatorily redeemable for cash upon a change in control, an event that was not solely within the Company’s control.

Current report

The PIPE Shares accrued dividends at 6.50% per year on a cumulative basis, payable in cash or in-kind, and participated, on a pro-rata basis, in any dividends that would be declared with respect to the Company's common stock. The PIPE Shares were convertible into common shares at the conversion price of $41.4662 (i) beginning two years after their issuance date, at the election of ANI, if the volume-weighted average price of the common stock for any 20 trading days out of 30 consecutive trading days exceeds 170% of the conversion price, or (ii) at any time after issuance, at the election of the PIPE Investor.

Current report

On August 14, 2025, the PIPE Investor converted 5,000 PIPE Shares into 120,580 shares of common stock based on the conversion price of $41.4662 per share. On September 26, 2025, pursuant to the notice dated September 22, 2025, the Company elected mandatory conversion of the remaining 20,000 outstanding PIPE Shares into 482,320 shares of common stock based on the conversion price of $41.4662 per share, as the conditions for conversion had been satisfied. There were no shares of Series A convertible preferred stock outstanding as of September 30, 2025.

Current report

•Selling, general, and administrative expenses decreased from $79.1 million to $76.7 million, a slight decrease of approximately $2.4 million, primarily driven by the decrease of approximately $9.3 million in transaction and integration costs and $14.5 of severance and equity payments related to the Alimera acquisition, offset by increased costs associated with Rare Disease sales and marketing efforts of approximately $10 million and increase in legal costs of approximately $4 million, and other expenses related to the growth of our business.

Current report

•We recognized a loss related to the disposal of certain manufacturing equipment of approximately $0.3 million during the three months ended September 30, 2025. There was no comparable disposals during the three months ended September 30, 2024.

Current report

•We recognized an impairment charge related to a definite-lived intangible asset of approximately $0.8 million during the three months ended September 30, 2025. There was no comparable intangible asset impairment charge in the three months ended September 30, 2024.

Current report

•In the prior year period, we recorded a loss on debt extinguishment of approximately $7.5 million, comprised of the write-off unamortized deferred financing fees related to the Credit Facility. On August 13, 2024, the Company entered into the 2.25% Convertible Senior Notes due 2029 (as described in Note 7 “2.25% Convertible Senior Notes” to the Notes to Condensed Consolidated Financial Statements). The proceeds of the 2.25% Convertible Senior Notes were used to repay the Truist Credit Facility in its entirety, approximately $294.0 million, comprised of $292.5 million of unpaid principal, $1.2 million in accrued and unpaid interest, and $0.3 million of legal fees. There was no comparable transaction in the three months ended September 30, 2025.

Current report

RESULTS OF OPERATIONS FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2025 AND 2024

Current report

•We recognized an impairment charge related to one definite-lived intangible asset of approximately $0.8 million during the nine months ended September 30, 2025. There was no comparable intangible asset impairment charge in the nine months ended September 30, 2024.

Current report

•We recorded a loss on debt extinguishment of approximately $7.5 million, comprised of the write-off unamortized deferred financing fees related to the Credit Facility. On August 13, 2024, the Company entered into the 2.25% Convertible Senior Notes due 2029 (as described in Note 7 “2.25% Convertible Senior Notes” to the Notes to Condensed Consolidated Financial Statements). The proceeds of the 2.25% Convertible Senior Notes were used to repay the infrastructure Credit Facility in its entirety, approximately $294.0 million, comprised of $292.5 million of unpaid principal, $1.2 million in accrued and unpaid interest, and $0.3 million of legal fees. There was no comparable transaction in the nine months ended September 30, 2025.
Removed paragraphs (4)
Reworded paragraphs (58)

Previous wording

On September 16, 2024, the Company completed its previously announced acquisition of Alimera Sciences, Inc., a Delaware corporation, pursuant to the terms of the Agreement and Plan of Merger, dated as of June 21, 2024 (the “Merger Agreement”), by and among the Company, Alimera and ANIP Merger Sub INC., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”). Pursuant to the Merger Agreement, Merger Sub merged with and into Alimera, with Alimera surviving the merger as a wholly owned subsidiary of the Company (the “Merger”). In connection with the Merger, the Company added a 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”).

Current wording

On September 16, 2024, the Company completed its previously announced acquisition of Alimera Sciences, Inc., a Delaware corporation, pursuant to the terms of the Agreement and Plan of Merger, dated as of June 21, 2024 (the “Merger Agreement”), by and among the Company, Alimera and ANIP Merger Sub INC., a Delaware corporation and wholly owned subsidiary of the Company (“Merger Sub”). Pursuant to the Merger Agreement, Merger Sub merged with and into Alimera, with Alimera surviving the merger as a wholly owned subsidiary of the Company (the “Merger”). In connection with the Merger, the Company added a 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., refer below for further information related to the expanded label.

Previous wording

Our three pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota, and one is located in East Windsor, New Jersey, are together capable of producing oral solid dose products, as well as semi-solids, liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment. We ceased operations at our subsidiary in Oakville, Ontario, Canada as of March 31, 2023. This action was part of ongoing initiatives to capture operational synergies following our acquisition of Novitium Pharma LLC (“Novitium”) in November 2021. We have fully completed the transition of the products manufactured or packaged in Oakville to one of our three U.S. based manufacturing sites.

Current wording

Our three pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota, and one is located in East Windsor, New Jersey, are together capable of producing oral solid dose products, as well as semi-solids, liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment.

Previous wording

During March 2025, the FDA approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye ("NIU-PS"). The Company is currently marketing ILUVIEN for chronic NIU-PS in addition to its current indication of DME in the U.S. ILUVIEN is already approved for both DME and NIU-PS outside the U.S., including in seventeen European countries. In order to support the transition to ILUVIEN, in July 2024, the Company extended its partnership with Alliance Medical Products, Inc., a subsidiary of Siegfried Holding AG ("Siegfried"), its long-term supplier for ILUVIEN, through 2029, and contracted with Siegfried to upgrade equipment on the existing manufacturing line and significantly expand capacity through the addition of a second manufacturing line. During the second quarter of 2025, we transitioned promotional efforts in the U.S. from YUTIQ to ILUVIEN with its combined label of DME and NIU-PS.

Current wording

During March 2025, the FDA approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) to include an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye ("NIU-PS") in addition to the then current indication of DME. The Company is currently marketing ILUVIEN for both indications in the U.S. ILUVIEN was already approved for both DME and NIU-PS outside the U.S., including in seventeen European countries. In order to support the transition to ILUVIEN, in July 2024, the Company extended its partnership with Alliance Medical Products, Inc., a subsidiary of Siegfried Holding AG ("Siegfried"), its long-term supplier for ILUVIEN, through 2029, and contracted with Siegfried to upgrade equipment on the existing manufacturing line and significantly expand capacity through the addition of a second manufacturing line. During the second quarter of 2025, we transitioned promotional efforts in the U.S. from YUTIQ to ILUVIEN with its combined label of DME and NIU-PS.

Previous wording

We have grown our brands portfolio of products through acquisition. We have acquired the NDAs for and market Atacand, Atacand HCT, Arimidex, Casodex, Inderal LA, Inderal XL, InnoPran XL, Lithobid, Oxistat, Vancocin, and Veregen. During the second quarter, we commercialized two 505(b)(2) products acquired from Novitium, Tezruly and Inzirqo. We are innovating in our go-to-market strategy through creative partnerships and a sales force for these products.

Current wording

We have grown our brands portfolio of products through acquisition. We have acquired the NDAs for and market Atacand, Atacand HCT, Arimidex, Casodex, Inderal LA, Inderal XL, InnoPran XL, Inzirqo, Lithobid, Oxistat, Vancocin, and Veregen. We are innovating in our go-to-market strategy through creative partnerships and a sales force for these products.

Previous wording

The Company incurred approximately $0.2 million and $1.1 million transaction and integration costs during the three and six months ended June 30, 2025, related to the Merger Agreement, all of which were expensed. The Company incurred approximately $3.5 million of transaction costs during the three and six months ended June 30, 2024. See Note 3 “Business Combination” to the notes to the condensed consolidated financial statements (unaudited) for further information on the acquisition.

Current wording

The Company incurred approximately $0.4 million and $1.6 million of transaction and integration costs during the three and nine months ended September 30, 2025, related to the Merger Agreement, all of which were expensed. The Company incurred approximately $13.2 million of transaction and integration costs during the nine months ended September 30, 2024. See Note 3 “Business Combination” to the notes to the condensed consolidated financial statements (unaudited) for further information on the acquisition.

Previous wording

Impacts to our second quarter 2025 and 2024 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 2025 and 2024 results of operations, including to net revenues, operating expenses, interest and other expense, net, and income taxes are described below. The following table summarizes our results of operations for the periods indicated:

Previous wording

"n/m" - not meaningful percentage due to the acquisition of ILUVIEN and YUTIQ in the third quarter of 2024.

Current wording

"N/M" - not meaningful percentage due to the acquisition of ILUVIEN and YUTIQ on September 16, 2024.

Previous wording

Net revenues for the three months ended June 30, 2025 were $211.4 million compared to $138.0 million for the same period in 2024, an increase of 53.1%, primarily as a result of the following:

Current wording

Net revenues for the three months ended September 30, 2025 were $227.8 million compared to $148.3 million for the same period in 2024, an increase of 53.6%, primarily as a result of the following:

Previous wording

•Net revenues from Rare Disease and Brands, includes rare disease and brands portfolio of pharmaceutical products was $117.2 million during the three months ended June 30, 2025, an increase of $57.9 million, compared to $59.2 million, for the same period in 2024.

Current wording

•Net revenues from Rare Disease and Brands, includes rare disease and brands portfolio of pharmaceutical products were $129.1 million during the three months ended September 30, 2025, an increase of $63.5 million, compared to $65.6 million, for the same period in 2024.

Previous wording

•Net revenues for Rare Disease pharmaceutical products were $104.0 million during the three months ended June 30, 2025, an increase of $54.8 million from $49.2 million for the same period in 2024. This increase was driven by increased volume of Cortrophin Gel from overall ACTH market growth and share growth, and a full quarter of sales from ILUVIEN and YUTIQ, as a result of the acquisition of Alimera on September 16, 2024.

Current wording

•Net revenues for Rare Disease pharmaceutical products were $118.5 million during the three months ended September 30, 2025, an increase of $62.0 million from $56.4 million for the same period in 2024. This increase was driven by increased volume of Cortrophin Gel from overall ACTH market growth and share growth, and a full quarter of sales from ILUVIEN, as a result of the acquisition of Alimera on September 16, 2024.

Previous wording

•Net revenues for our Brands portfolio of pharmaceutical products were $13.2 million during the three months ended June 30, 2025, an increase of $3.2 million compared to $10.0 million for the same period in 2024, driven by a net increase in demand for certain products during a portion of the second quarter, and we anticipate a return to a more normalized level during the second half of the year.

Current wording

•Net revenues for our Brands portfolio of pharmaceutical products were $10.7 million during the three months ended September 30, 2025, an increase of $1.5 million compared to $9.2 million for the same period in 2024, driven by a net increase in demand for certain products during the third quarter.

Previous wording

•Net revenues for Generic and Other pharmaceutical products were $94.2 million during the three months ended June 30, 2025, an increase of 19.5% compared to $78.8 million for the same period in 2024, primarily a result of the following:

Current wording

•Net revenues for Generic and Other pharmaceutical products were $98.7 million during the three months ended September 30, 2025, an increase of 19.3% compared to $82.7 million for the same period in 2024, primarily a result of the following:

Previous wording

•Generic pharmaceutical products net revenues were $189.0 million during the six months ended June 30, 2025, an increase of $44.8 million over the prior year. This increase was driven by the late 2024 launch of Prucalopride Tablets, which was launched with CGT designation and corresponding 180 day exclusivity that expired in late June, increased volumes from the benefit of new product launches during the first half of 2025, along with annualization of new product launches that occurred during 2024. The Company launched a total of 17 new products in 2024. From a product perspective, the increase was principally driven by revenues from year over year increases in products such as Candesartan, Colestipol, Estradiol, Ketoconazole, L-Glutamine, Prucalopride, Thyroid, among others. We currently anticipate that revenues from Generic pharmaceutical products will be lower in the second half of 2025 compared to the first half of 2025 due to the expiry of exclusivity for Prucalopride and resultant expected competition.

Current wording

•Generic pharmaceutical products net revenues were $94.4 million during the three months ended September 30, 2025, an increase of $16.2 million over the prior year. This increase was driven by a partnered product launched in the third quarter, increased volumes from the benefit of of new product launches during 2025, along with annualization of new product launches that occurred during 2024. These gains were somewhat tempered by net decreases in products that were launched prior to 2024. The Company launched a total of 17 new products in 2024. From a product perspective, the increase was principally driven by revenues from year over year increases in products such as Estradiol, Ketoconazole, Nitazoxanide, Promethazine HCL and Dextromehorphan HBM, Prucalopride, and the partnered product launched in the third quarter, among others. We currently anticipate that revenues from Generic pharmaceutical products will be lower in the fourth quarter compared to that in the third quarter of 2025 due to expected competition on certain products.

Previous wording

For the three months ended June 30, 2025, cost of sales increased to $74.6 million from $57.7 million for the same period in 2024, an increase of $16.9 million, or 29.3%. 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.

Current wording

For the three months ended September 30, 2025, cost of sales increased to $93.4 million from $63.1 million for the same period in 2024, an increase of $30.3 million, or 48.1%. 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, decreased to 35.3% from 41.8% for the three months ended June 30, 2025, compared to the same period in 2024, primarily due to a shift in product mix year over year.

Current wording

Cost of sales, as a percentage of net revenues, decreased to 41.0% from 42.5% for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to the non-recurrence of $3.2 million of the inventory step-up related to the acquisition of Alimera.

Previous wording

During the three months ended June 30, 2025, no single vendor represented more than 10% of our raw inventory purchases. During the three months ended June 30, 2024, approximately 27% of our raw material inventory purchases were from one domestic supplier.

Current wording

During the three months ended September 30, 2025, approximately 21% of our raw material inventory purchases were from one domestic supplier. During the three months ended September 30, 2024, no single vendor represented more than 10% of our raw material inventory purchases.

Previous wording

For the six months ended June 30, 2025, total other operating expenses, net increased to $220.8 million from $143.1 million for the same period in 2024, an increase of $77.6 million, or 54.2%, primarily as a result of the following factors:

Current wording

For the three months ended September 30, 2025, total other operating expenses, net decreased to $98.2 million from $105.8 million for the same period in 2024, a decrease of $7.6 million, or 7.2%, primarily as a result of the following factors:

Previous wording

•Research and development expenses during the three months ended June 30, 2025 increased from $7.3 million to $16.5 million, an increase of 126.6% or $9.2 million, primarily due to a higher level of activity and timing associated with ongoing and new projects to support future growth of Rare Disease and Generics in the three months ended June 30, 2025.

Current wording

•Research and development expenses during the three months ended September 30, 2025 increased from $10.1 million to $12.3 million, an increase of 21.5% or $2.2 million, primarily due to a higher level of activity and timing associated with ongoing and new projects to support future growth of Rare Disease and Generics in the three months ended September 30, 2025.

Previous wording

•Depreciation and amortization expense was $23.3 million for the three months ended June 30, 2025, compared to $14.7 million for the same period in 2024 an increase of approximately $8.6 million, primarily related to the amortization expense of the acquired intangible assets, ILUVIEN and YUTIQ, which amounted to approximately $8.2 million for the quarter. These assets were acquired on September 16, 2024 from Alimera.

Current wording

•Depreciation and amortization expense was $22.6 million for the three months ended September 30, 2025, compared to $15.7 million for the same period in 2024 an increase of approximately $6.9 million, primarily related to the full quarter of amortization expense of ILUVIEN, which amounted to approximately $8.2 million for the current quarter, compared to $1.4 million of amortization expense for only a portion of the quarter in the prior year. These assets were acquired on September 16, 2024 from Alimera.

Previous wording

•We recognized a gain of $10.8 million for the six months ended June 30, 2025 for the contingent consideration fair value adjustment, which consisted of three components: the changes in fair value of (1) the accrued Alimera licensor payments; (2) the Alimera contingent value rights; and (3) the Novitium contingent consideration. We recorded a gain in fair value of approximately $9.5 million related to the decrease in expected future payments of the accrued licensor payments and a decrease in fair value of $3.0 million related to the Alimera contingent value rights, which was offset by a loss of approximately $1.7 million related to the increase in the expected future payments related to Novitium contingent consideration.

Current wording

•We recognized a gain of $14.5 million for the three months ended September 30, 2025 for the contingent consideration fair value adjustments, which consisted of three components: the gain in fair value related to (1) the accrued Alimera licensor payments, (2) the Novitium contingent consideration, and (3) the contingent value rights related to the acquisition of Alimera. We recorded a gain in fair value related to the adjustment of future cash flows and a related decrease in the expected future payments of approximately $7.4 million related to the accrued licensor fees, a gain in fair value of approximately $4.6 million related related to Novitium contingent consideration, and a gain of approximately $2.5 million related to the contingent value rights.

Previous wording

For the three months ended June 30, 2025, we recognized total other expense, netof$3.4 million as compared to $7.5 million for the same period in 2024.

Current wording

For the three months ended September 30, 2025, we recognized total other expense, netof$2.4 million as compared to $11.0 million for the same period in 2024.

Previous wording

•We recorded an unrealized loss on our investment in equity securities of approximately $0.6 million for the six months ended June 30, 2025, compared to an unrealized gain in the same period in 2024, which is based on the mark to market to fair value of equity securities held in CG Oncology as of the balance sheet date.

Current wording

•We reco rded an unrealized gain on our investment in equity securities of approximately $3.1 million for the three months ended September 30, 2025, compared to an unrealized gain in the same period in 2024, which is based on the mark to market to fair value of equity securities held in CG Oncology as of the balance sheet date, and an increase of the trading price of the securities.

Previous wording

•Interest expense, net for the three months ended June 30, 2025 consists primarily of coupon interest expense on borrowings under our outstanding debt and amortization of deferred financings costs on these debt instruments, interest income earned on our bank balances, and interest earned on our interest rate swap. The increase in interest expense, net, of $0.8 million is primarily attributable to decreased bank interest rates and overall cash balance during the three months ended June 30, 2025 as compared to prior year, offset partially by favorable interest rates on the New Credit Facility and Convertible Notes.

Current wording

•Interest expense, net for the three months ended September 30, 2025 consists primarily of coupon interest expense on borrowings under our outstanding debt and amortization of deferred financings costs on these debt instruments, and interest income earned on our bank balances. The increase in interest expense, net, of $2.4 million is primarily attributable to an increase in interest expense related to our New Credit Agreement of $0.6 million and Convertible Senior Notes of $0.8 million, an increase in amortization of deferred financing fees of $0.2 million, and a decrease in interest earned on bank balances of approximately $0.4 million during the three months ended September 30, 2025 as compared to prior year.

Previous wording

•Other income (expense), net, for the three months ended June 30, 2025 consists primarily of foreign exchange gains and losses related to our international entities.

Current wording

•Other expense, net, for the three months ended September 30, 2025 consists primarily of foreign exchange gains and losses related to our international entities.

Previous wording

Income tax expense consists of current and deferred components, which include changes in our deferred tax assets, our deferred tax liabilities, and our valuation allowance.

Current wording

Income tax expense (benefit) consists of current and deferred components, which include changes in our deferred tax assets, our deferred tax liabilities, and our valuation allowance.

Previous wording

For the six months ended June 30, 2025, we recognized an income tax expense of approximately $6.3 million, an effective tax rate of 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.

Current wording

For the three months ended September 30, 2025, we recognized an income tax expense of approximately $7.2 million, an effective tax rate of 21.3% of pre-tax income reported in the period, as well as the net effect 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.

Previous wording

For the three months ended June 30, 2024, we recognized an income tax expense of $0.0 million. The Company's effective tax rate was 0.0% after discrete items for the three months ended June 30, 2024. The effective tax rate differed from the federal statutory rate of 21% primarily due to state taxes, stock based compensation, and non-deductible expenses related to the pending business combination which were treated as a discrete item during the quarter which affects the estimated tax rate.

Current wording

For the three months ended September 30, 2024, we recognized an income tax benefit of $7.3 million. The Company's effective tax rate was 23.3% after discrete items for the three months ended September 30, 2024. The effective tax rate differed from the federal statutory rate of 21% primarily due to state taxes, stock based compensation, and non-deductible expenses related to the pending business combination which were treated as a discrete item during the quarter which affects the estimated tax rate.

Previous wording

"n/m" - not meaningful percentage due to the acquisition of ILUVIEN and YUTIQ in the third quarter of 2024.

Current wording

"N/M" - not meaningful percentage due to the acquisition of ILUVIEN and YUTIQ on September 16, 2024.

Previous wording

Net revenues for the six months ended June 30, 2025 were $408.5 million compared to $275.5 million for the same period in 2024, an increase of 48.3%, primarily as a result of the following:

Current wording

Net revenues for the nine months ended September 30, 2025 were $636.3 million compared to $423.8 million for the same period in 2024, an increase of 50.1%, primarily as a result of the following:

Previous wording

•Net revenues from Rare Disease and Brands, includes rare disease and brands portfolio of pharmaceutical products was $211.2 million during the six months ended June 30, 2025, an increase of $89.4 million, compared to $121.8 million, for the same period in 2024.

Current wording

•Net revenues from Rare Disease and Brands, includes rare disease and brands portfolio of pharmaceutical products were $340.4 million during the nine months ended September 30, 2025, an increase of $152.9 million, compared to $187.5 million, for the same period in 2024.

Previous wording

•Net revenues for Rare Disease pharmaceutical products were $172.9 million during the six months ended June 30, 2025, an increase of $86.8 million from $86.1 million for the same period in 2024. This increase was driven by increased volume of Cortrophin Gel from overall ACTH market growth and share growth and two full quarters of sales from ILUVIEN and YUTIQ, as a result of the acquisition of Alimera on September 16, 2024, and

Current wording

•Net revenues for Rare Disease pharmaceutical products were $291.4 million during the nine months ended September 30, 2025, an increase of $148.8 million from $142.6 million for the same period in 2024. This increase was driven by increased volume of Cortrophin Gel from overall ACTH market growth and share growth and three full quarters of sales from ILUVIEN and YUTIQ, as a result of the acquisition of Alimera on September 16, 2024.

Previous wording

•Net revenues for Brands portfolio of pharmaceutical products were $38.3 million during the six months ended June 30, 2025, an increase of $2.6 million compared to $35.7 million for the same period in 2024, driven by a net increase in demand for certain products, and we anticipate a return to a more normalized level during the second half of the year.

Current wording

•Net revenues for Brands portfolio of pharmaceutical products were $49.0 million during the nine months ended September 30, 2025, an increase of $4.1 million compared to $44.9 million for the same period in 2024, driven by a net increase in demand for certain products, and we anticipate a return to a more normalized level during Q4 of 2025.

Previous wording

•Net revenues for Generic and Other pharmaceutical products were $197.3 million during the six months ended June 30, 2025, an increase of 28.4% compared to $153.6 million for the same period in 2024, primarily a result of the following:

Current wording

•Net revenues for Generic and Other pharmaceutical products were $295.9 million during the nine months ended September 30, 2025, an increase of 25.2% compared to $236.3 million for the same period in 2024, primarily a result of the following:

Previous wording

•Generic pharmaceutical products net revenues were $90.3 million during the three months ended June 30, 2025, an increase of $16.3 million over the prior year. This increase was driven by the late 2024 launch of Prucalopride Tablets, which was launched with CGT designation and corresponding 180 day exclusivity that expired in late June 2025, increased volumes from the benefit of new product launches during the first half of 2025, along with annualization of new product launches that occurred during 2024. The Company launched a total of 17 new products in 2024. From a product perspective, the increase was principally driven by revenues from year over year increases in products such as Estradiol, Ketoconazole, L-Glutamine, Nitazoxanide, Prucalopride, among others. We currently anticipate that revenues from Generic pharmaceutical products will be lower in the second half of 2025 compared to the first half of 2025 due to the expiry of exclusivity for Prucalopride and resultant expected competition.

Current wording

•Generic pharmaceutical products net revenues were $283.4 million during the nine months ended September 30, 2025, an increase of $60.9 million over the prior year. This increase was driven by the late 2024 launch of Prucalopride Tablets, which was launched with CGT designation and corresponding 180 day exclusivity that expired in late June, increased volumes from the benefit of new product launches during the first three quarters of 2025, inclusive of a partnered generic product launched in Q3 2025, along with annualization of new product launches that occurred during 2024. The Company launched a total of 17 new products in 2024. From a product perspective, the increase was principally driven by revenues from year over year increases in products such as Candesartan, Estradiol, Ketoconazole, Kionex, L-Glutamine, Nitazoxanide, Promethazine HCL and Dextromehorphan HBM, Prucalopride, among others. We currently anticipate that revenues from Generic pharmaceutical products will be lower in the fourth quarter compared to that in the third quarter of 2025 due to expected competition on certain products.

Previous wording

•Net revenues from royalties and other pharmaceuticals was down modestly for the six months ended June 30, 2025, compared to the same time in the prior year.

Current wording

•Net revenues from royalties and other pharmaceuticals was down modestly for the nine months ended September 30, 2025, compared to the same period in the prior year.

Previous wording

For the six months ended June 30, 2025, cost of sales increased to $147.7 million from $106.9 million for the same period in 2024, an increase of $40.8 million, or 38.2%. 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.

Current wording

For the nine months ended September 30, 2025, cost of sales increased to $241.0 million from $169.9 million for the same period in 2024, an increase of $71.1 million, or 41.8%. 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 percen tage of net revenues, decreased to 36.1% from 38.8% for the six months ended June 30, 2025, compared to the same period in 2024, primarily due to a shift in product mix year over year.

Current wording

Cost of sales, as a percen tage of net revenues, decreased to 37.9% from 40.1% for the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to a shift in product mix year over year.

Previous wording

During the six months ended June 30, 2025, approximately 23% of our raw material inventory purchases were from one domestic supplier. During the six months ended June 30, 2024, approximately 24% of our raw material inventory purchases were from one domestic supplier.

Current wording

During the nine months ended September 30, 2025, approximately 22% of our raw material inventory purchases were from one domestic supplier. During the nine months ended September 30, 2024, approximately 17% of our raw material inventory purchases were from one domestic supplier.

Previous wording

For the three months ended June 30, 2025, total other operating expenses, net increased to $122.9 million from $75.2 million for the same period in 2024, an increase of $47.7 million, or 63.4%, primarily as a result of the following factors:

Current wording

For the nine months ended September 30, 2025, total other operating expenses, net increased to $318.9 million from $248.9 million for the same period in 2024, an increase of $70.0 million, or 28.1%, primarily as a result of the following factors:

Previous wording

•Research and development expenses increased to $27.1 million from $17.8 million, an increase of $9.3 million or 52.2%, primarily due to a higher level and timing of activity associated with ongoing and new projects to support future growth of Rare Disease and Generics in the six months ended June 30, 2025.

Current wording

•Research and development expenses increased to $39.4 million from $27.9 million, an increase of $11.5 million or 41.1%, primarily due to a higher level and timing of activity associated with ongoing and new projects to support future growth of Rare Disease and Generics in the nine months ended September 30, 2025.

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Current report — wording carried from elsewhere

Net Cash Used in Investing Activities
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Previous report — wording carried elsewhere

The following table summarizes our results of operations for the periods indicated:

Previous report — wording carried elsewhere

•Selling, general, and administrative expenses increased from $100.8 million to $158.3 million, an increase of $57.5 million, or 57.0%, due to increased employment related costs, investment in Rare Disease sales and marketing infrastructure including our new, larger ophthalmology sales and marketing team and activities, legal expenses, professional fees, and an overall increase in activities to support the growth of our business.

Previous report — wording carried elsewhere

Net Cash Used in Financing Activities