ANI PHARMACEUTICALS INC
For the period ended Jun 30, 2025. Filed Aug 8, 2025.
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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.
Jun 30, 2025 · Filed Aug 8, 2025
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 2025-03-31; filed 2025-05-09.
0001023024-25-000046
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 109 previous paragraphs and 136 current paragraphs.
68 unchanged; 35 reworded; 18 added; 6 removed; 0 previous and 15 current paragraphs rearranged.
Tables are not compared: 8 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 (18)
Current report
Results of NEW DAY Study
Current report
On July 23, 2025, we announced results from the NEW DAY clinical trial of ILUVIEN for use in patients with DME. The results were presented in a paper-on-demand presentation by Michael A. Singer, M.D. for the American Society of Retina Specialists (ASRS) Annual Scientific Meeting. On July 23, 2025, the Company issued a press release describing the results of the NEW DAY clinical trial of ILUVIEN. On the same date, the Company filed a Current Report on Form 8-K that incorporated the press release by reference therein.
Current report
•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 report
•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 report
Other Expense, net
Current report
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 report
RESULTS OF OPERATIONS FOR THE SIX MONTHS ENDED JUNE 30, 2025 AND 2024
Current report
Net Revenues
Current report
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 report
•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 report
•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 report
•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 report
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 report
Other Operating Expenses, net
Current report
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 report
•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 report
Other Expense, net
Current report
Income Tax Expense
Removed paragraphs (6)
Previous report
Restructuring
Previous report
On February 15, 2024, ANI Pharmaceuticals Canada, Inc., a wholly owned subsidiary of the Company, entered into an agreement with 1540700 Ontario Limited for the sale of ANI’s Oakville, Ontario former manufacturing site (the “Property”) for a total purchase price of $19.2 million Canadian Dollars, or approximately $14.2 million, based on the exchange rate at closing. During February 2024, and in accordance with the Agreement, the Buyer deposited a total of approximately $1.9 million Canadian Dollars, or approximately $1.4 million in refundable deposits in escrow as part of the total purchase price.
Previous report
On March 28, 2024 the Company completed the sale of the Property. After payment of commissions, taxes, and other related costs of approximately $0.7 million, the Company received a net cash amount of approximately $13.5 million at closing. The gain on the sale of the Property was approximately $5.3 million, recorded in the unaudited condensed consolidated statements of operations.
Previous report
•Net revenues for brands portfolio of pharmaceutical products were $25.1 million during the three months ended March 31, 2025, a decrease of $0.6 million compared to $25.7 million for the same period in 2024, driven by a net decrease in volume. During the first quarter of both 2025 and 2024, and portions of the fourth quarter of 2024, we were successful in supplying incremental volume in markets that were experiencing supply chain disruptions for competing products. Incremental volume achieved toward the end of 2024 continued into the first half of the first quarter of 2025. The timing, magnitude and persistence of such market share gains are inherently difficult to predict and they may not persist in future reporting periods.
Previous report
•Research and development expenses during the three months ended March 31, 2025 totaled approximately $10.6 million which was consistent with the same period in the prior year.
Previous report
Other (Expense) Income, net
Reworded paragraphs (35)
Previous wording
ANI Pharmaceuticals, Inc. and its consolidated subsidiaries (together, “ANI,” the “Company,” “we,” “us,” or “our”) is a diversified bio-pharmaceutical company committed to its missionof “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing innovative and high quality therapeutics.
Current wording
ANI Pharmaceuticals, Inc. and its consolidated subsidiaries (together, “ANI,” the “Company,” “we,” “us,” or “our”) is a diversified bio-pharmaceutical company committed to its mission of “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing innovative and high quality therapeutics.
Previous wording
On September 16, 2024, the Company completed itspreviously 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”).
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 ofproducing 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. In February 2024, our Canadian subsidiary entered into an agreement for the purchase and sale of the Oakville site, for a purchase price of $19.2 million Canadian Dollars, or approximately $14.2 million, based on the exchange rate at closing. The sale closed on March 28, 2024 (see Note 4 “Restructuring Canada Operations” to the notes to the condensed consolidated financial statements (unaudited)).
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. 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.
Previous wording
In September 2024, we acquired ILUVIEN and YUTIQ in connection with the acquisition of Alimera. The acquisition of Alimera is anticipated to strengthen our Rare Disease business and expands our footprint beyond the U.S. with the addition of Alimera’s direct marketing operations located in Germany, the United Kingdom, Portugal, and Ireland, as well as its partnerships in Europe, Asia, and the Middle East. ILUVIEN and YUTIQ are a durable franchise with high barriers to genericization which the Company believes have a clear role for patients in need of alternative therapeutic options. ANI sees the potential to unlock significant additional growth for the ILUVIEN and YUTIQ franchise through commercial synergies and execution. Importantly, the addition of Alimera expands the reach of the ophthalmology sales team and we believe there will be significant overlap between high potential prescribers of Cortrophin Gel, ILUVIEN, and YUTIQ.
Current wording
In September 2024, we acquired ILUVIEN and YUTIQ (the "Retina Franchise") in connection with the acquisition of Alimera. The acquisition of Alimera is anticipated to strengthen our Rare Disease business and expands our footprint beyond the U.S. with the addition of Alimera’s direct marketing operations located in Germany, the United Kingdom, Portugal, and Ireland, as well as its partnerships in Europe, Asia, and the Middle East. We believe that the Retina Franchise is durable with high barriers to genericization and a clear role for patients in need of alternative therapeutic options. ANI sees the potential to unlock significant additional growth for the Retina Franchise through commercial synergies and execution. Importantly, the addition of Alimera expands the reach of the ophthalmology sales team and we believe there will be significant overlap between high potential prescribers of Cortrophin Gel and the Retina Franchise.
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 plans to market ILUVIEN for chronic NIU-PS in addition to its current indication of diabetic macular edema ("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.
Current 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.
Previous wording
Additionally, on February 28, 2025, the FDA approved a prefilled syringe format for Cortrophin Gel. This new presentation will be available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options through Cortrophin Gel’s established specialty pharmacy network during the second quarter of 2025. The prefilled syringe reduces administration steps for patients using Cortrophin Gel, which remains available in 5 mL and 1 mL vials.
Current wording
Additionally, on February 28, 2025, the FDA approved a prefilled syringe format for Cortrophin Gel. This new presentation became available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options through Cortrophin Gel’s established specialty pharmacy network during the second quarter of 2025. The prefilled syringe reduces administration steps for patients using Cortrophin Gel, which remains available in 5 mL and 1 mL vials.
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, Lithobid, Vancocin, Inderal LA, Inderal XL, InnoPran XL, Oxistat, and Veregen. 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, 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.
Previous wording
The Company incurred approximately $0.9 million and zero transaction and integration costs during the three months ended March 31, 2025 and 2024, related to the Merger Agreement, all of which were expensed. 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 $0.2 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.
Previous wording
Impacts to our first 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 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.
Previous wording
Net revenues for the three months ended March 31, 2025 were$197.1 million compared to$137.4 million for the same period in 2024, an increase of 43.4%, primarily as a result of the following:
Current 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:
Previous wording
•Net revenues from Rare Disease and Brands, includes rare disease and brands portfolio of pharmaceutical products was $94.1 million during the three months ended March 31, 2025, an increase of $31.5 million, compared to $62.6 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 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.
Previous wording
•Net revenues for rare disease pharmaceutical products were $69.0 million during the three months ended March 31, 2025, an increase of $32.0 million from $36.9 million for the same period in 2024. This increase was driven by a full quarter of sales from ILUVIEN and YUTIQ, as a result of the acquisition of Alimera on September 16, 2024, and increased volume of Cortrophin Gel from overall ACTH market growth and share growth.
Current 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.
Previous wording
•Net revenues for generic and other pharmaceutical products were $103.0 million during the three months ended March 31, 2025, an increase of 37.7% compared to $74.8 million for the same period in 2024, primarily a result of the following:
Current wording
•Net revenues for Generic and Other pharmaceutical products were $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:
Previous wording
•Net revenues from royalties and other pharmaceuticals was down modestly between the three months ended March 31, 2025, compared to the same time in the prior year.
Current wording
•Net revenues from royalties and other pharmaceuticals was down modestly for the three months ended June 30, 2025, compared to the same time in the prior year.
Previous wording
For the three months ended March 31, 2025, cost of sales increased to $73.0 million from $49.2 million for the same period in 2024, an increase of $23.9 million, or 48.6%. 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.
Current 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.
Previous wording
Cost of sales, as a percentage of net revenues, increased to 37.1% from 35.8% for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to a shift in product mix year over year and an increase in sales of products that bear a royalty payable.
Current 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.
Previous wording
For the three months ended March 31, 2025, other operating expenses, net increased to $97.9 million from $68.0 million for the same period in 2024, an increase of $29.9 million, or 44.0%, primarily as a result of the following factors:
Current 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:
Previous wording
•Selling, general, and administrative expenses increased from $48.0 million to $76.5 million, an increase of $28.5 million, or 59.4%, 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 in our business.
Current wording
•Selling, general, and administrative expenses increased from $52.8 million to $81.8 million, an increase of $29.0 million, or 54.8%, 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 wording
•Depreciation and amortization expense was $22.9 million for the three months ended March 31, 2025, compared to $14.7 million for the same period in 2024 an increase of approximately $8.2 million, primarily related to the amortization expense of the acquired intangible assets of 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 $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.
Previous wording
•We recognized again of $12.1 million for the three months ended March 31, 2025 for the contingent consideration fair value adjustment, which consisted of three components: the changes in fair value of (1) the Novitium contingent consideration; (2) the Alimera contingent value rights; and (3) the accrued Alimera licensor payments.
Current wording
•We recognized losses of $1.3 million for the three months ended June 30, 2025 for the contingent consideration fair value adjustment, which consisted of two components: the changes in fair value of (1) the Novitium contingent consideration; and (2) the accrued Alimera licensor payments. We recorded losses in fair value of approximately $0.9 million related to the increase in the expected future payments related to Novitium contingent consideration, and $0.4 million related to the passage of time related to expected future payments of the accrued licensor payments.
Previous wording
•We recorded an unrealized loss on our investment in equity securities of approximately$0.9 million for the three months ended March 31, 2025, compared to an unrealized gain of 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 recorded an unrealized gain on our investment in equity securities of approximately $0.3 million for the three months ended June 30, 2025, compared to an unrealized loss 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.
Previous wording
•Interest expense, for the three months ended March 31, 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 $0.9 million is primarily attributable to decrease in bank interest rates and overall cash balance during the three months ended March 31, 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 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.
Previous wording
•Other income (expense), net, for thethree months ended March 31, 2025 consists primarily of foreign exchange gains and losses related to our international entities.
Current 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.
Previous wording
•Generic pharmaceutical products net revenues were $98.7 million during the three months ended March 31, 2025, an increase of $28.5 million overthe 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 will run until late June, increased volumes from the benefit of new product launches during the first quarter 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, Ketoconazole, L-Glutamine, Methylphenidate ER, Promethazine HCL, 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 $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.
Previous wording
During the three months ended March 31, 2025, approximately 22%, of our raw material inventory purchases were from one domestic supplier. During the three months ended March 31, 2024, approximately 25%, of our raw material inventory purchases were from one domestic supplier.
Current 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.
Previous wording
•We recorded a gain in fair value of approximately $9.9 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 $0.8 million related to the increase in the expected future payments related to Novitium contingent consideration.
Current 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.
Previous wording
•We recognized a gain related to the sale of the former Oakville, Ontario manufacturing site of approximately $5.3 million during thethree months ended March 31, 2024. There was no comparable sale during thethree months ended March 31, 2025.
Current wording
•We recognized a gain related to the sale of the former Oakville, Ontario manufacturing site of approximately $5.3 million during the six months ended June, 2024. There was no comparable sale during the six months ended June 30, 2025.
Previous wording
For thethree months ended March 31, 2025, we recognized total other expense of $6.2 million as compared to total other income of $5.0 million for the same period in 2024.
Current wording
For the six months ended June 30, 2025, we recognized total other expense, net of $9.6 million as compared to total other expense of $2.4 million for the same period in 2024.
Previous wording
For the three months ended March 31, 2025, we recognized an income tax expense of approximately $4.3 million, an effective tax rate of 21.5% of pre-tax income reported in the period, as well as the net effect of certain discrete items for the three months ended March 31, 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 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.
Previous wording
For thethree months ended March 31, 2024, we recognized an income tax expense of $7.1 million. The Company's effective tax rate was 28.1% after discrete items for thethree months ended March 31, 2024. The effective tax rate differed from the federal statutory rate of 21% primarily due to state taxes, stock based compensation, tax on the sale of the Oakville, Ontario manufacturing site, and recording of a withholding tax liability on the proceeds of the sale.
Current wording
For thesix months ended June 30, 2024, the Company recognized an income tax expense of$7.1 million. The Company’s effective tax rate was 30.9% after discrete items for thesix 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, tax on the sale of the Oakville, Ontario manufacturing site, and recording of a withholding tax liability on the proceeds of the sale, and non-deductible expenses related to the 2024 business combination.
Previous wording
On September 16, 2024 (the “Closing Date”) the Company drew the full $325.0 million of Term Loan A principal on September 16, 2024, with proceeds used to finance the acquisition of Alimera, including fees, costs and expenses incurred in connection with the transaction. As of March 31, 2025, the TLA Revolver remains undrawn, and $75.0 million is available for borrowing, subject to certain conditions. The TLA and the TLA Revolver mature on September 16, 2029. The New Credit Facility contains certain contingent acceleration clauses, none of which have been triggered as of March 31, 2025. The cash interest rate and effective rate under the Term Loan A was approximately 6.92% at March 31, 2025.
Current wording
On September 16, 2024 (the “Closing Date”) the Company drew the full $325.0 million of Term Loan A principal on September 16, 2024, with proceeds used to finance the acquisition of Alimera, including fees, costs and expenses incurred in connection with the transaction. As of June 30, 2025, the TLA Revolver remains undrawn, and $75.0 million is available for borrowing, subject to certain conditions. The TLA and the TLA Revolver mature on September 16, 2029. The New Credit Facility contains certain contingent acceleration clauses, none of which have been triggered as of June 30, 2025. The cash interest rate and effective rate under the Term Loan A was approximately 6.92% and 7.29%, respectively, at June 30, 2025.
Previous wording
On August 13, 2024 (the “Closing Date” or “Issue Date”), the Company completed an offering of $316.3 million aggregate principal amount of Notes. The Notes were issued pursuant to an indenture (the “Indenture”) dated as of August 13, 2024 between the Company and U.S. Bank Trust Company, National Association (“Trustee”). The Notes are due September 1, 2029, unless earlier repurchased, redeemed, or converted. The Notes will accrue interest at a rate of 2.25% per annum, payable semi-annually in arrears on March 1 and September 1 of each year, beginning on March 1, 2025. After deducting the initial purchasers’ discounts and commissions of approximately $9.5 million, but before deducting the Company’s offering expenses, the net proceeds to the Company from the offering of the Notes was approximately $306.8 million. After payment of the cost of entering into the Capped Call Transactions (as defined below), the Company used the remainder of the net proceeds from the Notes offering, together with cash on hand, to repay the Company’s existing senior secured credit agreement, dated as of November 19, 2021, by and among the Company, certain of the Company’s subsidiaries, as guarantors, Truist Bank, as administrative agent and other parties thereto, as amended, in the amount of 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. In connection with the issuance of the Convertible Senior Notes, the Company recorded a loss on debt extinguishment in the unaudited consolidated statement of operations for the three months ended September 30, 2024, amounting to approximately $7.5 million, comprised of the write-off unamortized deferred financing fees.
Current wording
On August 13, 2024 (the “Closing Date” or “Issue Date”), the Company completed an offering of $316.3 million aggregate principal amount of Notes. The Notes were issued pursuant to an indenture (the “Indenture”) dated as of August 13, 2024 between the Company and U.S. Bank Trust Company, National Association (“Trustee”). The Notes are due September 1, 2029, unless earlier repurchased, redeemed, or converted. The Notes will accrue interest at a rate of 2.25% per annum, payable semi-annually in arrears on March 1 and September 1 of each year, beginning on March 1, 2025. After deducting the initial purchasers’ discounts and commissions of approximately $9.5 million, but before deducting the Company’s offering expenses, the net proceeds to the Company from the offering of the Notes was approximately $306.8 million. After payment of the cost of entering into the Capped Call Transactions (as defined below), the Company used the remainder of the net proceeds from the Notes offering, together with cash on hand, to repay the Company’s existing senior secured credit agreement, dated as of November 19, 2021, by and among the Company, certain of the Company’s subsidiaries, as guarantors, Truist Bank, as administrative agent and other parties thereto, as amended, in the amount of 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.
Previous wording
Net cash provided by operating activities was $35.0 million for the three months ended March 31, 2025, compared to net cash provided by operating activities of $18.3 million during the same period in 2024, an increase of $16.7 million. The increase in cash provided by operating activities primarily resulted from our net income of $15.7 million adjusted for non-cash items, and an increase in our working capital accounts driven by the growth of our business.
Current wording
Net cash provided by operating activities was $110.8 million for the six months ended June 30, 2025, compared to net cash provided by operating activities of $35.7 million during the same period in 2024, an increase of $75.1 million. The increase in cash provided by operating activities primarily resulted from our net income of $24.2 million adjusted for non-cash items, and an increase in our working capital accounts driven by the growth of our business.
Previous wording
Net cash used in investing activities for the three months ended March 31, 2025 was $19.8 million, principally due to the payment for the exercise of the Buy-Out Option of approximately $17.3 million and capital expenditures of approximately $2.5 million. Net cash provided by investing activities for the three months ended March 31, 2024 was $8.9 million, principally due to the proceeds received from the sale of the Oakville, Ontario manufacturing site in March 2024 of approximately $13.5 million offset by capital expenditures of approximately $4.6 million.
Current wording
Net cash used in investing activities for the six months ended June 30, 2025 was $26.8 million, principally due to the payment for the exercise of the Buy-Out Option and purchase of other intangible assets of approximately $20.3 million and capital expenditures of approximately $6.5 million. Net cash provided by investing activities for the six months ended June 30, 2024 was $4.5 million, principally due to the proceeds received from the sale of the Oakville, Ontario manufacturing site in March 2024 of approximately $13.5 million offset by capital expenditures of approximately $9.0 million.
Previous wording
Net cash used in financing activities for the three months ended March 31, 2025 was $9.9 million, principally resulting from $10.0 million of treasury stock purchases for restricted stock vests, a principal payment on our New Credit Facility of $2.0 million, offset by proceeds received from stock option exercises and ESPP purchases. Net cash used in financing activities for the three months ended March 31, 2024 was $19.7 million, principally resulting from $12.5 million paid to the Company Members of Novitium, $8.7 million of treasury stock purchased related to restricted stock vests, $0.8 million principal payments on the Term Facility, and $0.4 million convertible preferred stock dividends paid, offset by $2.6 million from proceeds from stock option exercises and ESPP purchases.
Current wording
Net cash used in financing activities for the six months ended June 30, 2025 was $11.7 million, principally resulting from $10.6 million of treasury stock purchases for restricted stock vests, principal payments on our New Credit Facility of $4.1 million, offset by proceeds received from stock option exercises and ESPP purchases. Net cash used in financing activities for the six months ended June 30, 2024 was $21.2 million, principally resulting from $12.5 million paid to the Company Members of Novitium, $10.0 million of treasury stock purchased related to restricted stock vests, $1.5 million principal payments on the Term Facility, and $0.8 million convertible preferred stock dividends paid, offset by $3.6 million from proceeds from stock option exercises and ESPP purchases.
Rearranged current paragraphs (15)
Current report — wording carried from elsewhere
•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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
For the three months ended June 30, 2025, we recognized an income tax expense of approximately $2.0 million, an effective tax rate of 18.8% of pre-tax income reported in the period, as well as the net effect of certain discrete items for the three months ended June 30, 2025 which impact our income tax expense in the period in which they occur. Discrete items during the second quarter of 2025 relate predominately to favorable return to provision adjustments attributable to certain foreign tax returns filed during the quarter.
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
"n/m" - not meaningful percentage due to the acquisition of ILUVIEN and YUTIQ in the third quarter of 2024.
Current report — wording carried from elsewhere
•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 report — wording carried from elsewhere
•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 report — wording carried from elsewhere
Cost of Sales (Excluding Depreciation and Amortization)
Current report — wording carried from elsewhere
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 report — wording carried from 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.
Current report — wording carried from elsewhere
•Depreciation and amortization expense was $46.2 million for the six months ended June 30, 2025, compared to $29.4 million for the same period in 2024, an increase of approximately $16.8 million, primarily related to the amortization expense of the acquired intangible assets, ILUVIEN and YUTIQ, which amounted to approximately $16.4 million for the six months ended June 30, 2025. These assets were acquired on September 16, 2024 from Alimera.
Current report — wording carried from elsewhere
•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 report — wording carried from elsewhere
•Interest expense, net for the six 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 $1.7 million is primarily attributable to decrease in bank interest rates and overall cash balance during the six 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 report — wording carried from elsewhere
•Other income (expense), net, for the six months ended June 30, 2025 consists primarily of foreign exchange gains and losses related to our international entities.
Current report — wording carried from elsewhere
In connection with the issuance of the Convertible Senior Notes, the Company recorded a loss on debt extinguishment in the unaudited consolidated statement of operations for thethree months ended September 30, 2024, amounting to approximately $7.5 million, comprised of the write-off unamortized deferred financing fees.