Ani Pharmaceuticals reports $290.78 million revenue for Q3 2026

Cover page 4 changes

3 unchanged paragraphs

For the quarterly period ended June September 30, 2026

23 unchanged paragraphs

Indicate by check mark whether whe ther the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of July 31, October 29, 2026, there were 22,959,488 22,718,931 shares of common stock and 10,864 shares of class C special stock of the registrant outstanding.

2 unchanged paragraphs

For the Quarterly Period Ended June September 30, 2026

1 unchanged paragraph

Exhibits 6 changes

2 unchanged paragraphs

• statements concerning the timing and impact of our proposed acquisition of Egetis Therapeutics AB ("Egetis");

• the ability to close our proposed acquisition of Egetis on a timely basis or at all;

3 unchanged paragraphs

• our plans with respect to the timing and amount of any repurchases of our common stock under our share repurchase program;

5 unchanged paragraphs

• selling and marketing strategies and associated costs to support the sales of our branded products, including Purified Cortrophin® Gel (Repository Corticotropin Injection USP) ("Cortrophin Gel"), and ILUVIEN® ("ILUVIEN"), and EMCITATE® if we complete our acquisition of Egetis;

1 unchanged paragraph

• our strategic initiatives, including acquisitions, strategic alliances and collaborations, such as our proposed acquisition of Egetis, and our ability to realize the intended benefits of such initiatives;

4 unchanged paragraphs

• general economic, industry, geopolitical and market conditions, such as military conflict or war, inflation and financial institution instability, or the impact of global pandemics on our business, and the risks of fluctuations in foreign currency exchange rates.

3 unchanged paragraphs

Financial statements 238 changes

3 unchanged paragraphs

Cash and cash equivalents $ 360,212 420,758 $ 285,585

1 unchanged paragraph

Inventories 143,149 143,067

Accounts receivable, net 274,469 304,450 281,082

Inventories 136,411 143,067

Prepaid expenses and other current assets 31,942 25,577 34,216

Investment in equity securities 15,626 15,590 9,131

Total Current Assets 825,433 902,821 753,117

Property and equipment, net 73,223 81,552 62,476

Deferred tax assets, net 71,495 74,668 69,072

Intangible assets, net 449,857 433,109 479,526

1 unchanged paragraph

Other non-current assets 11,624 13,031 13,706

Total Assets $ 1,494,112 1,567,661 $ 1,440,377

1 unchanged paragraph

Accounts payable $ 73,830 $ 62,583

Accrued royalties 55,830 48,497

Accounts payable $ 74,415 $ 62,583

Accrued royalties 66,054 48,497

Accrued compensation and related expenses 27,154 34,950 37,897

Accrued government rebates 41,392 56,635 43,154

Returned goods reserve 44,013 45,648 49,504

Accrued expenses and other 16,575 18,674 16,970

Income taxes payable 3,532 8,979 2,239

Current debt, net 21,329 23,362 17,268

Total Current Liabilities 283,655 328,717 278,112

1 unchanged paragraph

Debt, net 280,155 291,840

Contingent consideration 8,546 9,610

Total Liabilities $ 896,900 $ 899,653

Debt, net 274,314 291,840

Convertible notes, net 309,009 309,556 307,927

Contingent consideration 7,836 9,610

Other non-current liabilities 15,535 10,125 12,164

Total Liabilities $ 930,548 $ 899,653

2 unchanged paragraphs

Common Stock, $ 0.0001 par value, 66,000,000 shares authorized; 23,853,338 23,897,035 shares issued and 22,961,423 22,890,380 shares outstanding at June September 30, 2026; 23,112,577 shares issued and 22,491,281 shares outstanding at December 31, 2025

Class C Special Stock, $ 0.0001 par value, 781,281 shares authorized; 10,864 shares issued and outstanding at June September 30, 2026 and December 31, 2025, respectively

Preferred Stock, $ 0.0001 par value, 1,666,667 shares authorized; 0 shares issued and outstanding at June September 30, 2026 and December 31, 2025, respectively

Treasury stock, 891,915 1,006,655 shares of common stock, at cost, at June September 30, 2026 and 621,296 shares of common stock, at cost, at December 31, 2025 ( 53,817 62,212 ) ( 33,249 )

Additional paid-in capital 620,249 634,239 596,036

Retained earnings (Accumulated deficit) 31,104 66,253 ( 23,099 )

Accumulated other comprehensive (loss) income, net of tax ( 327 1,170 ) 1,033

Total Stockholders' Equity 597,212 637,113 540,724

Total Liabilities and Stockholders' Equity $ 1,494,112 1,567,661 $ 1,440,377

4 unchanged paragraphs

Three Months Ended June 30, Six Months Ended June 30,

Net Revenues $ 266,044 $ 211,371 $ 503,506 $ 408,493

Cost of sales (excluding depreciation and amortization) 100,158 74,615 193,740 147,652

Research and development 14,747 16,535 25,347 27,099

Selling, general, and administrative 91,661 81,771 165,316 158,299

Depreciation and amortization 19,640 23,281 40,559 46,172

Contingent consideration fair value adjustment ( 622 ) 1,277 ( 804 ) ( 10,815 )

Total Operating Expenses, net 225,584 197,479 424,158 368,407

Operating income 40,460 13,892 79,348 40,086

Three Months Ended September 30, Nine Months Ended September 30,

Net Revenues $ 290,777 $ 227,813 $ 794,283 $ 636,306

Cost of sales (excluding depreciation and amortization) 111,531 93,389 305,271 241,041

Research and development 12,997 12,304 38,344 39,403

Selling, general, and administrative 94,862 76,656 260,178 234,955

Depreciation and amortization 19,552 22,632 60,111 68,804

Contingent consideration fair value adjustment ( 538 ) ( 14,470 ) ( 1,342 ) ( 25,285 )

Loss on disposal of assets — 295 — 295

Intangible asset impairment charge — 767 — 767

Total Operating Expenses, net 238,404 191,573 662,562 559,980

Operating income 52,373 36,240 131,721 76,326

1 unchanged paragraph

Unrealized gain (loss) on investment in equity securities 741 332 6,494 ( 589 )

Interest expense, net ( 3,636 ) ( 5,438 ) ( 7,405 ) ( 10,922 )

Other (expense) income, net ( 468 ) 1,739 ( 1,119 ) 1,937

Income Before Income Tax Expense 37,097 10,525 77,318 30,512

Income tax expense 12,386 1,976 23,115 6,282

Net Income $ 24,711 $ 8,549 $ 54,203 $ 24,230

Net Income Available to Common Shareholders $ 24,711 $ 8,142 $ 54,203 $ 23,417

Unrealized (loss) gain on investment in equity securities ( 35 ) 3,140 6,459 2,551

Interest expense, net ( 3,056 ) ( 4,727 ) ( 10,461 ) ( 15,649 )

Other (expense) income, net ( 241 ) ( 853 ) ( 1,360 ) 1,084

Income Before Income Tax Expense 49,041 33,800 126,359 64,312

Income tax expense 13,892 7,183 37,007 13,465

Net Income $ 35,149 $ 26,617 $ 89,352 $ 50,847

Dividends on Series A Convertible Preferred Stock — ( 407 344 ) — ( 813 1,157 )

Net Income Available to Common Shareholders $ 35,149 $ 26,273 $ 89,352 $ 49,690

1 unchanged paragraph

Basic Income Per Share $ 1.09 $ 0.37 $ 2.40 $ 1.07

Diluted Income Per Share $ 1.05 $ 0.36 $ 2.32 $ 1.05

Basic Weighted-Average Shares Outstanding 21,158 19,834 21,036 19,721

Diluted Weighted-Average Shares Outstanding 21,915 20,308 21,785 20,177

Basic Income Per Share $ 1.54 $ 1.19 $ 3.94 $ 2.26

3 unchanged paragraphs

1 unchanged paragraph

3 unchanged paragraphs

7 unchanged paragraphs

1 unchanged paragraph

3 unchanged paragraphs

8 unchanged paragraphs

1 unchanged paragraph

3 unchanged paragraphs

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

2 unchanged paragraphs

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

and 158 more changes in the filing

Note 1: BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS 1 change

12 unchanged paragraphs

In September 2025, the FASB issued ASU 2025-06, Intangibles - Goodwill and Other - Internal-Use Software , which amends the guidance in ASC 350-40, Intangibles-Goodwill and Other-Internal-Use Software . The amendments modernize the recognition and disclosure framework for internal-use software costs, removing the previous "development stage" model and introducing a more judgment-based approach. ASU 2025-06 is effective for fiscal years beginning after December 15, 2027, and for interim periods within those annual reporting periods, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2025-06 will have on the consolidated financial statements and disclosures and anticipates disclosing any impact of the adoption in the Annual Report on Form 10-K for the fiscal year ended December 31, 2026. 2028.

2 unchanged paragraphs

Note 2: REVENUE RECOGNITION AND RELATED ALLOWANCES 91 changes

8 unchanged paragraphs

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2 unchanged paragraphs

Cortrophin Gel $ 117,126 $ 81,647 $ 192,245 $ 134,497

Cortrophin Gel $ 138,655 $ 101,850 $ 330,900 $ 236,347

1 unchanged paragraph

Rare Disease total net revenues $ 135,844 $ 103,963 $ 230,218 $ 172,922

Brands 11,813 13,195 24,141 38,318

Rare Disease and Brands total net revenues $ 165,388 $ 117,158 $ 293,630 $ 211,240

Generic pharmaceutical products $ 99,051 $ 90,297 $ 204,453 $ 188,975

Other generic revenues 1,605 3,916 5,423 8,278

Generics and Other total net revenues 100,656 94,213 209,876 197,253

Total net revenues $ 266,044 $ 211,371 $ 503,506 $ 408,493

Rare Disease total net revenues $ 160,909 $ 118,450 $ 391,127 $ 291,372

Brands 9,978 10,675 34,119 48,993

Brand royalties and other revenues 17,731 11,460 — 39,271 $ 50,731 —

Rare Disease and Brands total net revenues $ 182,347 $ 129,125 $ 475,977 $ 340,365

Generic pharmaceutical products $ 104,455 $ 94,375 $ 308,908 $ 283,350

Other generic revenues 3,975 4,313 9,398 12,591

Generics and Other total net revenues 108,430 98,688 318,306 295,941

Total net revenues $ 290,777 $ 227,813 $ 794,283 $ 636,306

(1) There were no sales of YUTIQ during the quarters nine months ended March 31, 2026 and June September 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 as of the second quarter of 2025.

In the six nine months ended June September 30, 2026, all of the Company's revenue was recognized at a point in time, except for the revenue recognized under the Harmony Agreement (as defined below). Revenue is recognized at a point in time when the performance obligations in the Company's contracts with customers have been satisfied, generally when control of the products is transferred to the customer. The Company estimates and recognizes royalty revenue as the related sales occur, and recognizes milestone revenue as the milestones are achieved.

In January 2026, Novitium Pharma LLC ("Novitium"), a subsidiary of the Company, entered into an IP license agreement ("Harmony Agreement") with Harmony Biosciences LLC ("Harmony"), which includes an exclusive license to intellectual property that will expand the intellectual property estate of Harmony, as well as a co-exclusive license, with which Harmony and Novitium intend to develop a novel formulation of pitolisant in broad central nervous system indications outside of sleep/wake. Under the Harmony Agreement, the Company received an upfront license fee of $ 15.0 million, which was recognized as revenue within the condensed consolidated statements of operations for the three months ended March 31, 2026. In addition, the Company earns low-single digit royalties on net sales of pitolisant-based products. The Company recognized royalty revenue of $ 9.7 9.5 million and $ 16.3 25.7 million in the three and six nine months ended June September 30, 2026, respectively. In addition, the Company expects to receive recognized an aggregate of $ 10.0 million upon the achievement of certain development milestones that were satisfied over time. During the three and six nine months ended June September 30, 2026, the Company recognized $ 8.0 2.0 million and $ 10.0 million of revenue associated with the achievement of the development milestones, and expects to recognize the remaining revenue during the third quarter of 2026. respectively.

2 unchanged paragraphs

The following table summarizes activity in the unaudited condensed consolidated balance sheets for accruals and allowances for the six nine months ended June September 30, 2026 and 2025, respectively:

4 unchanged paragraphs

Accruals 330,581 32,910 22,737 40,730 17,134

Credits/Payments ( 337,311 ) ( 18,758 ) ( 13,328 ) ( 38,902 ) ( 17,090 )

Balance at June 30, 2025 $ 98,900 $ 32,866 $ 48,683 $ 21,416 $ 6,302

Accruals 493,008 53,983 30,977 62,159 26,199

Credits/Payments ( 496,765 ) ( 35,665 ) ( 20,246 ) ( 58,645 ) ( 25,495 )

Balance at September 30, 2025 $ 101,873 $ 37,032 $ 50,005 $ 23,102 $ 6,962

1 unchanged paragraph

Accruals 360,498 37,148 18,892 46,410 18,760

Credits/Payments ( 409,412 ) ( 38,910 ) ( 24,383 ) ( 46,770 ) ( 20,224 )

Balance at June 30, 2026 (1) $ 94,538 $ 41,392 $ 44,013 $ 28,553 $ 7,169

Accruals 562,890 64,306 28,095 73,886 29,749

Credits/Payments ( 586,235 ) ( 50,825 ) ( 31,951 ) ( 72,483 ) ( 30,279 )

Balance at September 30, 2026 (1) $ 120,107 $ 56,635 $ 45,648 $ 30,316 $ 8,103

(1) Accounts receivable, net in the unaudited condensed consolidated balance sheet at June September 30, 2026 includes $ 94.5 120.1 million of Chargebacks, $ 19.0 21.4 million of Administrative Fees and Other Rebates and $ 7.2 8.1 million of Prompt Payment Discounts. Accrued expenses and other in the unaudited condensed consolidated balance sheet at June September 30, 2026 includes $ 9.5 8.9 million of Administrative Fees and Other Rebates.

2 unchanged paragraphs

During the three and six months ended June 30, 2026, there were three customers that accounted for 10% or more of net revenues. During the three and six months ended June 30, 2025, there were three and four customers, respectively, that accounted for 10% or more of net revenues. As of June 30, 2026, accounts receivable from three customers totaled 56 % of accounts receivable, net.

Three Months Ended June 30, Six Months Ended June 30,

Customer 1 14 % 18 % 15 % 21 %

Customer 2 9 % 9 % 9 % 10 %

Customer 3 12 % 11 % 14 % 12 %

Customer 4 24 % 20 % 21 % 18 %

The three customers custome rs that accounted for 10% or more of net revenues during the three and six nine months ended June September 30, 2026 and the three and four customers, respectively, that accounted for 10% or more of net revenues during the three and six months ended June 30, 2025 each represent the total percentage of net revenues as follows:

Three Months Ended September 30, Nine Months Ended September 30,

Customer 1 13 % 13 % 14 % 19 %

Customer 2 8 % 7 % 9 % 9 %

Customer 3 11 % 17 % 13 % 14 %

Customer 4 26 % 26 % 23 % 21 %

Customer 1 represented approximately 21 % and 24 % of the total accounts receivable as of September 30, 2026 and December 31, 2025, respectively. Customer 2 represented approximately 15 % and 14 % of the total accounts receivable as of September 30, 2026 and December 31, 2025, respectively. Customer 3 represented approximately 18 % and 21 % of the total accounts receivable as of September 30, 2026 and December 31, 2025, respectively. Customer 4 represented approximately 13 % and 19 % of the total accounts receivable as of September 30, 2026 and December 31, 2025, respectively.

7 unchanged paragraphs

On September 16, 2024 (the "2024 Credit Agreement Closing Date"), ANIP drew the full $ 325.0 million of Term Loan A principal, with proceeds used to finance the acquisition of Alimera, including fees, costs and expenses incurred in connection with the acquisition. As of June September 30, 2026, $ 74.9 million is available for borrowing under the TLA Revolver. The TLA and the TLA Revolver mature on September 16, 2029. The 2024 Credit Facility contains certain contingent acceleration clauses that could result in an earlier maturity date, none of which have been triggered as of June September 30, 2026.

The cash interest rate and effective rate under the Term Loan A was approximately 6.24 6.29 % and 6.61 6.65 % per annum at June September 30, 2026, respectively.

The 2024 Credit Facility is secured by a lien on substantially all of the Company's and its principal domestic subsidiary's assets and any future domestic subsidiary guarantors' assets. The 2024 Credit Facility is subject to customary financial and nonfinancial covenants. As of June September 30, 2026, the Company was in compliance with all covenants associated with the 2024 Credit Facility.

The Company is required to make quarterly principal payments, beginning on December 31, 2024, in the amount of (i) 0.625 % of the original principal amount of the Term Loan A on each quarterly payment date on or prior to the one year anniversary of the 2024 Credit Agreement Closing Date, (ii) 1.25 % of the original principal amount of the Term Loan A on each quarterly payment date following the one year anniversary of the 2024 Credit Agreement Closing Date, and (iii) 1.875 % of the original principal amount of the Term Loan A on each quarterly payment date following the three year anniversary of the 2024 Credit Agreement Closing Date and with the remaining unpaid principal amount due on the maturity date of the Term Loan A. A commitment fee accrues on the unutilized commitments under the TLA Revolver and, from and after the date that is two months after the closing date of the 2024 Credit Agreement, the TLA at a per annum rate equal between 0.25 % and 0.40 % depending on the Company's first lien net leverage ratio.

1 unchanged paragraph

(in thousands) June 30,

(in thousands) June 30,

Debt, net $ 280,155 $ 291,840

The carrying value of the current and non-current components of the Term Loan A as of June September 30, 2026 and December 31, 2025 are:

(in thousands) September 30,

Current borrowing on debt $ 22,344 24,375 $ 18,281

Deferred financing costs ( 1,015 1,013 ) ( 1,013 )

Current debt, net $ 21,329 23,362 $ 17,268

(in thousands) September 30,

Non-current borrowing on debt $ 282,344 276,250 $ 294,531

Deferred financing costs ( 2,189 1,936 ) ( 2,691 )

Debt, net $ 274,314 $ 291,840

The contractual maturity of the Term Loan A is as follows for the years ended ending December 31:

1 unchanged paragraph

Three Months Ended June 30, Six Months Ended June 30,

Amortization of deferred financing costs ( 854 ) ( 828 ) ( 1,697 ) ( 1,647 )

Interest expense ( 7,498 ) ( 8,222 ) ( 15,049 ) ( 16,329 )

Interest and dividend income on bank balances 2,636 1,458 5,272 2,778

Interest income 3,862 2,784 7,644 5,407

Interest expense, net $ ( 3,636 ) $ ( 5,438 ) $ ( 7,405 ) $ ( 10,922 )

2026 (remainder of the year) $ 10,157 6,094

The following table sets forth the components of total interest expense, net recognized in the accompanying unaudited condensed consolidated statements of operations for the three and six nine months ended June September 30, 2026 and 2025:

Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2026 2025 2026 2025

Contractual coupon interest expense, 2024 Credit Agreement $ ( 4,865 4,948 ) $ ( 5,615 5,662 ) $ ( 9,794 14,742 ) $ ( 11,144 16,806 )

Contractual coupon interest expense, Convertible Notes ( 1,779 ) ( 1,779 ) ( 3,558 5,337 ) ( 3,538 5,317 )

Amortization of deferred financing costs ( 860 ) ( 838 ) ( 2,557 ) ( 2,484 )

Interest expense ( 7,587 ) ( 8,279 ) ( 22,636 ) ( 24,607 )

Capitalized interest related to Construction in Progress 219 89 360 154 320 115 680 269

8 unchanged paragraphs

1 unchanged paragraph

3 unchanged paragraphs

and 11 more changes in the filing

Note 6: EARNINGS PER SHARE 17 changes

1 unchanged paragraph

For periods of net income, and when the effects are not anti-dilutive, the Company calculates diluted earnings per share by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive shares of common stock, consisting of shares issuable upon conversion of the Company's senior convertible Notes, common stock options, shares to be purchased under the 2016 Employee Stock Purchase Plan ("ESPP"), and performance stock units, using the more dilutive of the treasury stock or the two-class method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share.

1 unchanged paragraph

Earnings per share for the three and six nine months ended June September 30, 2026 and 2025 are calculated for basic and diluted earnings per share as follows:

1 unchanged paragraph

Net income available to common shareholders $ 24,711 $ 8,142 $ 24,711 $ 8,142 $ 54,203 $ 23,417 $ 54,203 $ 23,417

Earnings allocated to participating securities ( 1,711 ) ( 819 ) ( 1,656 ) ( 802 ) ( 3,774 ) ( 2,368 ) ( 3,653 ) ( 2,319 )

Net income available to common shareholders $ 23,000 $ 7,323 $ 23,055 $ 7,340 $ 50,429 $ 21,049 $ 50,550 $ 21,098

Basic Weighted-Average Shares Outstanding 21,158 19,834 21,158 19,834 21,036 19,721 21,036 19,721

Diluted Weighted-Average Shares Outstanding 21,915 20,308 21,785 20,177

Earnings per share $ 1.09 $ 0.37 $ 1.05 $ 0.36 $ 2.40 $ 1.07 $ 2.32 $ 1.05

Three Months Ended June September 30, Three Months Ended June September 30, Six Nine Months Ended June September 30, Six Nine Months Ended June September 30, (in thousands, except per share amounts) 2026 2025 2026 2025 2026 2025 2026 2025

Net income available to common shareholders $ 35,149 $ 26,273 $ 35,149 $ 26,273 $ 89,352 $ 49,690 $ 89,352 $ 49,690

Earnings allocated to participating securities ( 2,430 ) ( 2,483 ) ( 2,382 ) ( 2,374 ) ( 6,210 ) ( 4,860 ) ( 6,075 ) ( 4,634 )

Net income available to common shareholders $ 32,719 $ 23,790 $ 32,767 $ 23,899 $ 83,142 $ 44,830 $ 83,277 $ 45,056

Basic Weighted-Average Shares Outstanding 21,212 20,074 21,212 20,074 21,095 19,840 21,095 19,840

Dilutive effect of convertible senior notes, common stock options, ESPP, and performance stock units 757 474 749 456 463 1,019 503 1,071

Diluted Weighted-Average Shares Outstanding 21,675 21,093 21,598 20,911

Earnings per share $ 1.54 $ 1.19 $ 1.51 $ 1.13 $ 3.94 $ 2.26 $ 3.86 $ 2.15

The number of shares of potentially dilutive securities excluded from the computation of diluted earnings per share was 1.6 million and 2.3 1.6 million for the three months ended June September 30, 2026 and 2025, respectively, because including them would have been anti-dilutive. The number of shares of potentially dilutive securities excluded from the computation of diluted earnings per share was 1.6 million and 2.4 2.1 million for the six nine months ended June September 30, 2026 and 2025, respectively, because including them would have been anti-dilutive.

Note 7: INVENTORIES 9 changes

1 unchanged paragraph

Raw materials $ 77,769 $ 84,106

Finished goods 61,182 55,988

Inventories $ 143,149 $ 143,067

(in thousands) June September 30, 2026 December 31, 2025

Raw materials $ 71,540 $ 84,106

Work-in-progress 4,198 5,104 2,973

Finished goods 59,767 55,988

Inventories $ 136,411 $ 143,067

1 unchanged paragraph

Raw materials are sourced for products, including active pharmaceutical ingredients ("API"), from both domestic and international suppliers. Generally, only a single source of API is qualified for use in each product due to the cost and time required to validate a second source of supply. As a result, the Company is dependent upon its cur rent current vendors to reliably supply the API required for on-going product manufacturing. During the three months ended June 30, 2026, no single vendor represented more than 10% As of our raw inventory purchases. During the six months ended June September 30, 2026 approximately 23 % of the Company's raw material inventory purchases were from one domestic supplier. During the three months ended June 30, 2025, no single vendor represented more than 10% of our raw inventory purchases. During the six months ended June 30, and December 31, 2025, approximately 23 26 % and 17 % of the Company's raw material inventory purchases were from one domestic supplier, respectively.

Note 8: GOODWILL AND INTANGIBLE ASSETS 14 changes

As of June September 30, 2026, the Company has assigned its goodwill in three reporting units, Generics and Other, Brands, and Rare Disease reporting units. The Company's goodwill is assigned to Generics and Other and Rare Disease reporting units. There have been no events or changes in circumstances that would have reduced the fair value of the reporting units below their carrying value during the three and six nine months ended June September 30, 2026, and 2025, respectively, and as a result, no impairment charges have been recognized.

1 unchanged paragraph

(in thousands) Gross Carrying

June September 30, 2026 December 31, 2025 Remaining Weighted Average (in thousands) Gross Carrying

3 unchanged paragraphs

Acquired ANDAs intangible assets $ 214,417 215,017 $ ( 158,199 163,534 ) $ 56,218 51,483 $ 214,260 $ ( 147,511 ) $ 66,749 3.3 3.2 years

NDAs and product rights 679,804 ( 294,946 305,828 ) 384,858 373,976 673,554 ( 271,818 ) 401,736 9.8 9.6 years

Marketing and distribution rights 17,157 ( 16,676 16,917 ) 481 240 17,157 ( 16,195 ) 962 0.5 0.2 years

Customer relationships 24,900 ( 16,600 17,490 ) 8,300 7,410 24,900 ( 14,821 ) 10,079 2.3 2.1 years

Total Intangible Assets, net $ 936,278 936,878 $ ( 486,421 503,769 ) $ 449,857 433,109 $ 929,871 $ ( 450,345 ) $ 479,526 8.8 8.7 years

(1) Weighted average amortization period as of June September 30, 2026.

1 unchanged paragraph

There were no impairment charges during the three and six months ended June 30, 2026 and 2025.

For the six months ended June 30, During January 2026, the Company acquired approximately $ 6.3 million of acquired definite-lived intangible assets consisting of product rights, patents, know-how, and trade secrets that were capitalized pursuant to the Patent Purchase Agreement between Nuray Chemicals Private Limited ("Nuray") and the Company.

Amortization expense for definite-lived intangibles was $ 17.4 17.3 million and $ 36.1 53.4 million for the three and six nine months ended June September 30, 2026, respectively. Amortization expense for definite-lived intangibles was $ 21.1 20.4 million and $ 41.8 62.2 million for the three and six nine months ended June September 30, 2025, respectively.

During the year ended December 31, 2025, $ 15.8 million was reclassified from indefinite-lived In-Process Research & Development ("IPR&D") to definite-lived NDAs and product rights related to the commercialization of certain products, and will be amortized over ten years . As of June September 30, 2026 and December 31, 2025 there was no IPR&D on the unaudited condensed consolidated balance sheets.

There were no impairment charges during the three and nine months ended September 30, 2026. The Company recognized approximately $ 0.8 million of impairment charges during the three and nine months ended September 30, 2025, related to one product for which the Company ceased commercialization.

Note 9: STOCKHOLDERS' EQUITY 9 changes

1 unchanged paragraph

The Company is authorized to issue up to 66.0 million shares of common stock with a par value of $ 0.0001 per share, 0.8 million shares of class C special stock with a par value of $ 0.0001 per share, and 1.7 million shares of undesignated preferred stock with a par value of $ 0.0001 per share at June September 30, 2026.

There were 23.9 million shares of common stock issued and 23.0 22.9 million shares of common stock outstanding as of June September 30, 2026 and 23.1 million shares of common stock issued and 22.5 million shares of common stock outstanding as of December 31, 2025.

Share Repurchase Program

In May 2026, the Company's Board of Directors approved a share repurchase program authorizing the Company to repurchase up to $ 100.0 million of the Company's common stock (the "Share Repurchase Program"). Under the Share Repurchase Program, the Company is authorized to repurchase shares from time to time, at management's discretion, through open market purchases, privately-negotiated transactions or otherwise in accordance with applicable federal securities laws, including through Rule 10b5-1 trading plans and under Rule 10b-18 of the Exchange Act. The specific timing and amount of repurchases, if any, will vary based on available capital resources and other financial and operational performance, market conditions, securities law limitations, and other factors. The repurchases will be made using the Company's cash resources. The Company is not obligated to repurchase any shares under the Share Repurchase Program. Treasury stock purchases are accounted for under the cost method whereby the entire cost of the acquired stock is recorded as treasury stock, including any direct costs incurred to acquire such stock. Repurchases of common stock are accounted for as of the trade date, and are held as treasury stock until they are retired or re-issued.

During the three months ended September 30, 2026, the Company repurchased 102,492 shares of its common stock for an aggregate purchase price of approximately $ 7.5 million, including direct costs associated with the repurchases. As of September 30, 2026, 6,600 of such shares had not yet settled, and the purchase price of approximately $ 0.5 million with respect to these shares is included within Accounts payable on the unaudited condensed consolidated balance sheet.

1 unchanged paragraph

There were 10,864 shares of class C special stock issued and outstanding as of June September 30, 2026 and December 31, 2025. Each share of class C special stock entitles its holder to one vote per share. Each share of class C special stock is exchangeable, at the option of the holder, for one share of the Company's common stock, at an exchange price of $ 90.00 per share, subject to adjustment upon certain capitalization events. Holders of class C special stock are not entitled to receive dividends or to participate in the distribution of the Company's assets upon liquidation, dissolution, or winding-up the Company. The holders of class C special stock have no cumulative voting, preemptive, subscription, redemption, or sinking fund rights.

On March 8, 2021, concurrently with the entry into the merger agreement for 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 agreed to purchase 25,000 shares of the Company's 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 would not have been solely in the Company's control.

The PIPE Shares were classified as mezzanine equity because the shares were mandatorily redeemable for cash upon a change in control, an event that would not have been solely in the Company's control.

2 unchanged paragraphs

There were no shares of Series A convertible preferred stock outstanding as of June September 30, 2026 and December 31, 2025 .

Note 10: STOCK-BASED COMPENSATION 24 changes

3 unchanged paragraphs

As of June September 30, 2026, there are approximately 0.5 million shares of common stock available for issuance under the Amended and Restated ESPP.

1 unchanged paragraph

The Company held its 2026 Annual Meeting of Stockholders (the "2026 Annual Meeting") on May 21, 2026. During the 2026 Annual Meeting, the stockholders of the Company approved an amendment to the Amended 2022 Stock Plan (such amendment, the "2026 Stock Plan Amendment", and the Amended 2022 Stock Plan, after giving effect to the 2026 Stock Plan Amendment, the "Second Amended 2022 Stock Plan"). The 2026 Stock Plan Amendment authorized the issuance of an additional 962,000 shares pursuant to the Second Amended 2022 Stock Plan, which have been registered on a Form S-8 Registration Statement filed with the SEC on July 17, 2026. As of June September 30, 2026, approximately 2.2 million shares of common stock were available for issuance under the Second Amended 2022 Stock Plan.

3 unchanged paragraphs

Restricted stock awards ("RSAs") granted to employees generally vest over a period of four years . RSAs granted to non-officer directors generally vest over a period of one year . During the vesting period, the recipient of the RSA has full voting rights as a stockholder and would receive dividends, if declared, even though the restricted stock remains subject to transfer restrictions and will generally be forfeited upon termination of if the officer recipient is terminated prior to vesting. The fair value of each RSA is based on the market value of the Company's stock on the date of grant. Upon vesting, unrestricted shares of common stock are delivered to employees and directors.

1 unchanged paragraph

Restricted stock units ("RSUs") are typically granted to international employees of the Company under the Second Amended 2022 Stock Plan, and generally vest over a period of four years . Each RSU will entitle the recipient to receive one unrestricted share of common stock upon vesting. The fair value of each RSU is based on the market value of the Company's stock on the date of grant. The Company began granting RSUs to certain employees during the year ended December 31, 2025.

8 unchanged paragraphs

Performance of the Company was measured from January 1, 2023 to December 31, 2025. The MPRSUs and PRSUs exceeded the maximum growth rates as defined in the award agreements, resulting in a 200 % multiplier. The 2023 PSUs were included at 100 % of the estimated number of shares at the end of the three -year three-year performance period in the table below. As a result of the achievement of the 200 % target of the MPRSUs and PRSUs, an additional amount of 79,600 2023 PSUs were granted, and a total of 159,200 2023 PSUs were vested, and are reflected in the table below in "Granted" and "Options Exercised/RSAs Exercised/PSUs, RSAs, and PSUs RSUs Vested," respectively.

A summary of stock options (including Inducement Grants), RSA, RSU, and PSU activity under the Second Amended 2022 Stock Plan and Inducement Grants during the six nine months ended June September 30, 2026 is presented below:

2 unchanged paragraphs

Granted — 145 624 21

Forfeited — — ( 79 ) —

Outstanding/Unvested at June 30, 2026 332 216 1,537 38

Granted — 145 676 23

Options Exercised/PSUs, RSAs, and RSUs Vested ( 19 28 ) ( 159 ) ( 545 581 ) (1)

Forfeited — — ( 96 ) —

Outstanding/Unvested at September 30, 2026 323 216 1,536 40

(1) Includes 271,000 284,000 shares purchased from employees to cover employee income taxes related to income earned upon vesting of restricted stock. The shares purchased are held in treasury and the $ 20.6 21.5 million total purchase price for the shares is included in Treasury stock in the accompanying unaudited condensed consolidated balance sheets.

1 unchanged paragraph

Three Months Ended June 30, Six Months Ended June 30,

Cost of sales $ 552 $ 405 $ 1,047 $ 780

Research and development 616 583 1,240 1,109

Selling, general, and administrative 10,238 8,615 19,310 16,581

Total $ 11,406 $ 9,603 $ 21,597 $ 18,470

Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2026 2025 2026 2025

Cost of sales $ 543 $ 516 $ 1,590 $ 1,296

Research and development 653 515 1,893 1,624

Selling, general, and administrative 10,435 8,660 29,745 25,241

Total $ 11,631 $ 9,691 $ 33,228 $ 28,161

Note 11: INCOME TAXES 4 changes

1 unchanged paragraph

For the three months ended June September 30, 2026, the Company recognized an income tax expense of $ 12.4 13.9 million. The Company's effective tax rate was 33.4 28.3 % after discrete items for the three months ended June September 30, 2026. 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.

For the six three months ended June September 30, 2025, the Company recognized an income tax expense of $ 6.3 7.2 million. The Company's effective tax rate was 20.6 21.3 % after discrete items for the six three months ended June September 30, 2025. 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 awards. and non-taxable adjustments to the fair value of certain contingent liabilities related to the acquisition of Alimera.

For the six nine months ended June September 30, 2026, the Company recognized an income tax expense of $ 23.1 37.0 million. The Company's effective tax rate was 29.9 29.3 % after discrete items for the six nine months ended June September 30, 2026. 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.

For the three nine months ended June September 30, 2025, the Company recognized an income tax expense of $ 2.0 13.5 million. The Company's effective tax rate was 18.8 20.9 % after discrete items for the three nine months ended June September 30, 2025. 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, favorable return to provision adjustments attributable to certain foreign tax returns filed during the quarter. period, and non-taxable adjustments to the fair value of certain contingent liabilities related to the acquisition of Alimera.

Note 12: COMMITMENTS AND CONTINGENCIES 3 changes

The majority of the Company's leases as of June September 30, 2026 are classified as operating leases. Leases with an initial term of twelve months or less are not recorded on the balance sheet, and the Company does not separate lease and non-lease components of contracts. The Company's lease agreements do not provide for determination of the interest rate implicit in the lease. Therefore, the Company used a benchmark approach to derive an appropriate incremental borrowing rate. The Company's incremental borrowing rate is the rate of interest that the lessee would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company benchmarked itself against other companies of similar credit ratings and comparable quality and derived an incremental borrowing rate, which was used to discount its lease liabilities. Rent expense is recognized on a straight-line basis over the lease term. Operating lease ROU assets are included in other non-current assets and operating lease liabilities are included in accrued expenses and other and other non-current liabilities in the unaudited condensed consolidated balance sheets. The Company's lease agreements do not contain any material residual value guarantees or material restrictive covenants.

1 unchanged paragraph

The Company's products and facilities are subject to regulation by a number of federal, and state and foreign governmental agencies, such as the Drug Enforcement Administration ("DEA"), the FDA, the Centers for Medicare and Medicaid Services, the Central Drugs Standard Control Organization, the Narcotics Control Bureau ("NCB"), and India's Ministry of Health and Family Welfare. The FDA, in particular, maintains oversight of the formulation, manufacture, distribution, packaging, and labeling of all of ANI's products. The DEA and NCB maintain oversight over products that are considered controlled substances.

Four products, Esterified Estrogen with Methyltestosterone ("EEMT"), Opium Tincture, Thyroid Tablets, and Hyoscyamine, are marketed without approved NDAs or ANDAs. During the three and six nine months ended June September 30, 2026, net revenues from commercial sales of these products totaled $ 5.7 6.1 million and $ 11.9 18.0 million, respectively. During the three and six nine months ended June September 30, 2025, net revenues from commercial sales of these products totaled $ 6.1 6.0 million and $ 11.6 17.6 million, respectively.

Legal proceedings 157 changes

6 unchanged paragraphs

On March 4, 2024, ANI commenced a civil action against CG Oncology, Inc. f/k/a Cold Genesys, Inc. ("CG Oncology") in the Superior Court of the State of Delaware ("Delaware Action"). ANI's complaint alleges that, under an Assignment and Technology Transfer Agreement dated as of November 15, 2010 (the "November 2010 Agreement"), CG Oncology is liable to pay ANI a running royalty of 5 % of the worldwide net sales of cretostimogene made by CG Oncology or any affiliate or sublicensee thereof; and that in February 2024, CG Oncology wrongfully repudiated its royalty obligation to ANI. On April 2, 2024, CG Oncology filed an answer and counterclaim (the "CGON Answer and Counterclaim") and concurrently moved for judgment on the pleadings or, in the alternative, for partial summary judgment (the "Motion for Summary Judgment"). CG Oncology's Motion for Summary Judgment sought judgment declaring that the November 2010 Agreement does not "oblige CGON to pay royalties after expiration of the latest-running assigned patent." On April 25, 2024, ANI filed a reply to CG Oncology's counterclaims, denying any liability to CG Oncology and asserting additional counterclaims against CG Oncology ("Reply Counterclaims") for alleged breach of the November 2010 Agreement and, in the alternative, for unjust enrichment. On May 15, 2024, CG Oncology filed a reply to ANI's counterclaims, denying any liability to ANI and generally maintaining the positions taken in the CGON Answer and Counterclaim. On November 18, 2024, the court denied CG Oncology's Motion for Summary Judgment. On June 2, 2025, CG Oncology filed five motions for summary judgment seeking dismissal of all of ANI's claims and counterclaims, including breach of the royalty payment provision, breach of good faith performance, breach of the implied covenant of good faith, and in the alternative, unjust enrichment. Also on June 2, 2025, ANI filed a motion for partial summary judgment seeking dismissal of CG Oncology's counterclaims for unenforceability of the royalty payment provision under Brulotte, breach of good faith performance, breach of confidentiality and trade secret misappropriation. At a pretrial conference on July 16, 2025, the court granted CG Oncology's motion for partial summary judgment on its Brulotte counterclaim and affirmative defense, but allowed the case to proceed on ANI's counterclaim for unjust enrichment. The court also granted ANI's motion for partial summary judgment, dismissing CG Oncology's breach of confidentiality and trade secret misappropriation claims. The jury trial commenced in Delaware Superior Court on July 21, 2025. On July 29, 2025, a verdict was returned by the jury, finding that (1) the unenforceability of the royalty payment provision in the November 2010 Agreement did not affect the economic or legal substance of the transactions contemplated thereby in a manner that was materially adverse to ANI, and (2) awarding no damages to ANI on its unjust enrichment counterclaim. On August 12, 2025, ANI filed a motion for a new trial and for judgment as a matter of law. A hearing on the motions was held by the court on April 10, 2026. On July 16, 2026, the court denied ANI's motions. On August 17, 2026, ANI intends to filed a notice of appeal these decisions to the Delaware Supreme Court of the State of Delaware. On October 2, 2026, ANI filed its opening brief seeking judgment as a matter of law or, in the alternative, a new trial. On November 2, 2026, CG Oncology filed its answering brief. A hearing date has not been set by the court.

On March 6, 2024, a complaint was filed against ANI by Acella Pharmaceuticals, LLC ("Acella"), in the United States District Court for the District of Minnesota, asserting, among other things, false advertising under the Lanham Act, and unfair trade practices and false advertising under Minnesota law, relating to ANI's natural desiccated thyroid tablets USP. The complaint seeks injunctive relief, actual and consequential damages, disgorgement of profits, and attorneys' fees and costs. On June 7, 2024, ANI filed an amended answer to Acella's complaint, denying all claims, and asserting certain affirmative defenses, and counterclaims against Acella for false advertising of its thyroid product marketed as NP Thyroid® Tablets, under the Lanham Act, and for deceptive trade practices under Minnesota and Georgia law. ANI seeks injunctive relief, compensatory damages, punitive damages and attorneys' fees and costs. On April 15, 2026, ANI and Acella filed cross motions for summary judgment against each other's respective claims. The parties have been unable to reach a settlement to date. Fact and expert discovery are now closed. A hearing is set for was held on August 25, 2026 on the parties' cross motions for summary judgment, and the parties await a decision on those motions from the court. A trial date has not been set. ANI disputes any liability in this matter and continues to defend this lawsuit vigorously.

2 unchanged paragraphs

On April 20, 2026, Harmony Biosciences Management, Inc. ("Harmony Management"), along with Novitium, as exclusive licensor of certain intellectual property to Harmony Management (collectively, "plaintiffs"), including U.S. Patent No. 11,623,920 (the "920 Patent"), filed a lawsuit against AET Pharma US, Inc., AET Laboratories Private Limited, Alfred E. Tiefenbacher (GmbH & Co. KG) (collectively, "AET"), Sandoz Inc., Sandoz Private Limited, and Sandoz GmbH, alleging that the defendants' actions in connection with the filing of AET's ANDA No. 218892 infringe one or more claims of the 920 Patent. The case was filed in the United States District Court for the District of Delaware and assigned case no. 26-cv-00453-JLH.

On June 22, 2026, the defendants filed an answer to the complaint, along with counterclaims alleging various antitrust counterclaims against Harmony Management individually and against Harmony Management and Novitium plaintiffs jointly. On July 6, 2026, the parties stipulated that defendants Sandoz Private Limited and Sandoz GmbH be dismissed without prejudice, which stipulation was granted on July 7, 2026. On July 21, 2026, the defendants filed an amended answer updating the complaint to remove those parties. On August 13, 2026, plaintiffs filed a motion to bifurcate and stay the antitrust claims. On September 11, 2026, AET filed its opposition, and on October 2, 2026, plaintiffs filed their reply. On October 21, 2026, Judge Hall held a hearing on the pending motion. A decision has not yet been rendered by the court and discovery has commenced. On November 3, 2026, the court issued an order setting November 5, 2026 as the deadline by which plaintiffs must file any motion for a preliminary injunction seeking to prevent defendants from launching their ANDA product during the pendency of the 920 Patent litigation. A one-day preliminary injunction hearing is set for January 26, 2027.

On September 26, 2026, Harmony Management, along with Novitium, as exclusive licensor of certain intellectual property to Harmony Management, including U.S. Patent No. 11,945,788 (the "788 Patent"), filed a lawsuit against AET, Sandoz Inc. and Sandoz AG, alleging that the defendants' actions in connection with the filing of AET's ANDA No. 218892 infringe one or more claims of the 788 Patent. The case was filed in the United States District Court for the District of Delaware and assigned case no. 26-cv-1191-JLH. On October 26, 2026, plaintiffs voluntarily dismissed the 788 Patent lawsuit.

Novitium intends to continue to pursue this matter these matters and to vigorously defend the counterclaims along with Harmony Management.

1 unchanged paragraph

On April 22, 2026, Orphalan SA filed a lawsuit against Novitium, alleging that Novitium's actions in connection with the filing of Novitium's ANDA No. 218493 infringe one or more claims of U.S. Patent Nos. 10,988,436, 11,072,577, 12,358,861 and 12,358,862. The case was filed in the United States District Court for the District of Delaware and assigned case no. 1:99-mc-09999. 26-463-GBW. On June 22, 2026, Novitium filed its counterclaims and answer to the complaint. On July 10, 2026, Orphalan SA filed its answer to Novitium's counterclaims. On October 28, 2026, Orphalan SA filed an amended complaint, alleging that Novitium's actions in connection with the filing of Novitium's ANDA No. 218493 also infringe one or more claims of U.S. Patent No. 12,662,445.

4 unchanged paragraphs

On July 20, 2026, the Court entered a Joint Stipulation and Order of Consolidation that consolidated Civil Action No. 26-6568 and Civil Action No. 26-8641 into lead case Civil Action No. 2:26-cv-02044-JXN-JBC to become the In re Levoketoconazole Litigation. . On July 29, 2026, Novitium and ANI filed their answer and counterclaims.

2 unchanged paragraphs

Federal Court Multi District Litigation

Federal Court Multidistrict Litigation

4 unchanged paragraphs

In December 2023, the Keller Postman firm filed a large number of short form complaints that name generic defendants. Novitium is named in 29 of the short form complaints which reference the claims for the master complaint, but Novitium has not been served. ANI is not named. On February 1, 2024, the generic defendants filed an omnibus demurrer challenging the sufficiency of the Keller Postman complaints, largely on the basis of preemption. On April 23, 2024, the California court sustained the demurrer in part, dismissing all design defect claims against the generic defendants with prejudice on preemption grounds, but the court otherwise granted plaintiffs an opportunity for leave to amend their other claims against the generic defendants. Plaintiffs filed amended short form complaints on September 20, 2024 and defendants filed responses on October 6, 2024. One case naming Novitium (Shlitz) has had been set for trial to commence on October 19, 2026 and but the plaintiff has since agreed to dismiss Novitium from that case, which dismissal was filed on September 23, 2026. A second case naming Novitium (Rodriguez) is currently in discovery and has been set for trial to commence after June 2027.

2 unchanged paragraphs

The inputs used in measuring the fair value of cash and cash equivalents are considered to be Level 1 in accordance with the three-tier fair value hierarchy. The fair market values are based on period-end statements supplied by the various banks and brokers that held the majority of the Company's funds. The fair value of short-term financial instruments (primarily accounts receivable, prepaid expenses, accounts payable, accrued expenses, and other current liabilities) approximate their carrying values because of their short-term nature. The 2024 Credit Facility bears an interest rate that fluctuates with the changes in SOFR and because the variable interest rate approximates market borrowing rates available to the Company, the carrying value of the 2024 Credit Facility approximated its fair value at June September 30, 2026.

4 unchanged paragraphs

Three Months Ended June 30, Six Months Ended June 30,

Change in fair value ( 509 ) — ( 910 ) ( 3,000 )

Ending balance $ 518 $ 6,000 $ 518 $ 6,000

The fair value of the CVR liability is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The Company utilized a Monte Carlo simulation model to estimate the fair value of the CVR liability. For each simulated path of future revenue, the payments to the CVR holders were calculated based on the contractual terms of the rights. The average payments from all simulated paths were then discounted to present value at an estimated cost of debt. As a result of the decrease in forecast future revenue for 2026 and 2027, a corresponding decrease in the CVR liability was recorded. The fair value of the CVR liability was approximately $ 0.5 0.2 million as of June September 30, 2026, a decrease of approximately $ 0.9 1.2 million from $ 1.4 million as of December 31, 2025, and is classified within Other non-current liabilities in the Company's unaudited condensed consolidated balance sheets. There was no current liability recorded as of June September 30, 2026 as the Company does not expect to achieve the 2026 Milestone.

The following table presents the changes in the CVR liability balances classified as Level 3 for the three and six nine months ended June September 30, 2026 and 2025:

Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2026 2025 2026 2025

Beginning balance $ 1,027 518 $ 6,000 $ 1,428 $ 9,000

Change in fair value ( 333 ) ( 2,523 ) ( 1,243 ) ( 5,523 )

Ending balance $ 185 $ 3,477 $ 185 $ 3,477

Money market funds are readily convertible into cash and the net asset value of each fund on the last day of the reporting period is used to determine its fair value. Money market funds are included in Cash and cash equivalents within the unaudited condensed consolidated balance sheets, and are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. The Company does not adjust the quoted market price for such financial instruments. The fair value of the money market funds was approximately $ 269.5 342.2 million and $ 209.9 million, as of June September 30, 2026 and December 31, 2025, respectively.

The fair value of the interest rate swap is estimated based on the present value of projected future cash flows using the SOFR forward rate curve. (see Note 4 "2024 Credit Agreement" in The notes to the condensed consolidated financial statements (unaudited)). The model used to value the interest rate swap includes inputs of readily observable market data, a Level 2 input. The fair value of the interest rate swap was $ 1.1 0.6 million and $ 1.6 million as of June September 30, 2026 and December 31, 2025, respectively. The interest rate swap was classified as prepaid expenses and other current assets as of June September 30, 2026 in the unaudited condensed consolidated balance sheets, and other non-current assets as of December 31, 2025 in the condensed consolidated balance sheets.

1 unchanged paragraph

The Company currently holds 219,925 shares of common stock in CG Oncology, Inc. (Nasdaq: CGON) ("CG Oncology"). The Company accounts for its investment in CG Oncology equity securities as an equity investment with a readily determinable fair value, as the securities are publicly traded on the Nasdaq Global Select Market. The fair value of the equity securities is based on its closing price on the Nasdaq and is classified within Level 1 of the fair value hierarchy because the equity securities are valued using quoted market prices. The Company does not adjust the quoted market price for such financial instruments. The fair value of the CG Oncology equity securities as of June September 30, 2026 was approximately $ 15.6 million and $ 9.1 million as of December 31, 2025, based on a closing market price of $ 71.05 70.89 and $ 41.52 on June September 30, 2026 and December 31, 2025, respectively. The change in fair value of the equity securities is classified on the unaudited condensed consolidated statements of operations as unrealized gain (loss) gain on investment in equity securities, in the amounts of approximately $ 0.7 million 35 thousand and $ 6.5 million for the three and six nine months ended June September 30, 2026, respectively, and $ 0.3 3.1 million and $ 0.6 ) 2.6 million for the three and six nine months ended June September 30, 2025, respectively. Between 2013 and 2023, CG Oncology securities held by the Company were valued at zero under U.S. GAAP.

3 unchanged paragraphs

Pursuant to the terms of the Agreement and Plan of Merger related to the Novitium acquisition, dated as of March 8, 2021 ("Novitium Merger Agreement"), the Company owes 20 % of net profits generated by the sales of certain 505(b)(2) products (as defined in the Novitium Merger Agreement) to the holders of Novitium ownership interests ("Company Members") through the earlier to occur of (i) the sum of all such payments being equal to $ 21.5 million in the aggregate and (ii) the tenth anniversary of the FDA approval of the applicable 505(b)(2) product (the "505(b)(2) Earn-Out"). The payments are due on a quarterly basis, within 45 calendar days of each quarter end. During the three and six months ended June 30, 2026 and 2025, the Company has paid less than $ 0.1 million for payment of the 505(b)(2) Earn-Out to the Company Members, respectively.

The total fair value of the contingent consideration was approximately $ 8.5 8.3 million and $ 8.3 million as of June September 30, 2026 and December 31, 2025, respectively, and is classified within Accrued expenses and other and Other non-current liabilities Contingent consideration in the unaudited condensed consolidated balance sheets.

The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following significant unobservable inputs as of June September 30, 2026:

1 unchanged paragraph

Profit-based milestone payments Probability-weighted discounted cash flow Discount rate 12.0 13.0 %

1 unchanged paragraph

Three Months Ended June 30, Six Months Ended June 30,

Beginning balance $ 8,566 $ 11,655 $ 8,348 $ 10,854

Change in fair value ( 31 ) 917 187 1,718

The following table presents the changes in contingent consideration balances classified as Level 3 balances for the three and six nine months ended June September 30, 2026 and 2025:

Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2026 2025 2026 2025

Ending Beginning balance $ 8,455 $ 12,572 $ 8,455 8,348 $ 12,572 10,854

Payment of 505(b)(2) Earn-Out ( 80 77 ) ( 26 ) 80 ( 157 ) ( 26 )

Change in fair value ( 128 ) ( 4,581 ) 59 ( 2,863 )

Ending balance $ 8,250 $ 7,965 $ 8,250 $ 7,965

1 unchanged paragraph

On May 17, 2023, Alimera entered into the Product Rights Agreement (the "Product Rights Agreement") with EyePoint Pharmaceuticals US, Inc. ("EyePoint"), Product Rights Agreement which granted Alimera an exclusive and sublicensable right and license under EyePoint's and its affiliates' interest in certain of EyePoint's and its affiliates' intellectual property to develop, manufacture, sell, commercialize and otherwise exploit certain products, including YUTIQ, for the treatment and prevention of uveitis in the entire world, except Europe, the Middle East and Africa, where the Company already had such rights pursuant to an amended and restated license agreement (the "A&R Collaboration Agreement") with EyePoint, and except for China, Hong Kong, Macau, Taiwan, Brunei, Burma (Myanmar), Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, South Korea, Thailand and Vietnam, for which Ocumension holds a license from EyePoint. Pursuant to the A&R Collaboration Agreement, Alimera paid EyePoint an upfront payment of $ 75.0 million during the year ended December 31, 2024.

1 unchanged paragraph

Three Months Ended June 30, Six Months Ended June 30,

Ending balance $ — $ 11,428 $ — $ 11,428

Royalties are payable to EyePoint from 2025 to 2028 at 30 % of annual U.S. net sales of certain products (including YUTIQ and ILUVIEN) in excess of certain thresholds, beginning at $ 70.0 million in 2025, and increasing annually thereafter. The Company did not make any royalty payments during 2025 or the nine months ended September 30, 2026, as the minimum threshold of annual U.S. net sales that would trigger the requirement to make royalty payments was not met.

The following table presents the changes in accrued licensor payments balances classified as Level 3 balances for the three and six nine months ended June September 30, 2026 and 2025:

Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2026 2025 2026 2025

Beginning balance $ — $ 11,068 11,428 $ — $ 20,961

Change in fair value — 360 ( 7,366 ) 9,533 — ( 16,899 )

Ending balance $ — $ 4,062 $ — $ 4,062

The following table presents financial assets and liabilities accounted for at fair value on a recurring basis as of June September 30, 2026 and December 31, 2025, by level within the fair value hierarchy:

1 unchanged paragraph

Money Market Fund $ 269,466 $ 269,466 $ — $ —

Interest rate swap $ 1,124 $ — $ 1,124 $ —

June September 30, 2026 Level 1 Level 2 Level 3

Money Market Fund $ 342,243 $ 342,243 $ — $ —

Interest rate swap $ 618 $ — $ 618 $ —

CG Oncology - Investment in equity securities $ 15,626 15,590 $ 15,626 15,590 $ — $ —

Contingent consideration, Novitium $ 8,455 8,250 $ — $ — $ 8,455 8,250

Contingent Value Rights, Alimera $ 518 185 $ — $ — $ 518 185

8 unchanged paragraphs

On March 8, 2021, the Company entered into an Equity Commitment and Investment Agreement with the PIPE Investor, pursuant to which 25,000 PIPE Shares were purchased for $ 1,000 per share and an aggregate purchase price of $ 25.0 million on November 19, 2021. The former Chairman of the Company's Board of Directors and current Director, Patrick D. Walsh, is an operating partner of Ampersand Capital Partners, an affiliate of the PIPE Investor. During the quarter ended September 30, 2025, all PIPE Shares were converted to shares of common stock, and as such there were no PIPE Shares outstanding as of June September 30, 2026. Refer to Note 9 "Stockholders' Equity" to in the notes to the condensed consolidated financial statements (unaudited) for further information related to the conversion of the PIPE Shares.

In connection with the acquisition of Novitium, the Company entered into employment agreements with the two executives and founders of Novitium, Muthusamy Shanmugam, Head of R&D and COO of New Jersey Operations of ANI, and Chad Gassert, Senior Vice President, Corporate Development and Strategy of ANI, and both serve as executive officers of the Company. and Mr. Shanmugam also serves on the Company's Board of Directors. Mr. Shanmugam holds a minority interest in Scitus Pharma Services Private Limited ("Scitus"), which provides clinical research services to Novitium. Mr. Shanmugam holds interests in certain entities with which the Company conducts business, including a majority interest in SS Pharma LLC ("SS Pharma"), which acquires and supplies API to Novitium; a minority interest in Nuray, from which the Company acquired certain intangible assets; a majority interest in each of Esjay Pharma Private Limited and Esjay LLC (collectively, "Esjay"), which provides research and development services, certain finished goods, and certain consulting services to the Company; and a minority interest in each of SThree Chemicals Pvt Ltd and SThree Chemicals LLC (collectively, "SThree"), which acquires and supplies API to Novitium.

During the nine months ended September 30, 2026, the Company paid approximately $ 5.3 million of consideration for the acquisition of certain intangible assets to Nuray, and recorded $ 1.0 million as contingent consideration for the acquisition of certain intangible assets. During the three and nine months ended June September 30, 2026, the Company paid approximately $ 0.7 0.9 million and $ 1.6 million of royalty payments to Nuray, and respectively. The Company has accrued approximately $ 0.9 million of royalty payments due to Nuray for net sales related to the second third quarter of 2026.

1 unchanged paragraph

Three Months Ended June 30, Six Months Ended June 30,

Scitus $ 849 $ 906 $ 1,311 $ 1,932

SThree 1,689 3,403 3,752 4,329

Esjay 5,905 144 8,534 449

Total payments $ 9,157 $ 4,453 $ 19,561 $ 6,710

Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2026 2025 2026 2025

Scitus $ 1,404 $ 217 $ 2,715 $ 2,149

SThree 2,274 2,381 6,026 6,711

Esjay 4,637 2,485 13,171 2,934

Total payments $ 9,229 $ 5,083 $ 28,790 $ 11,794

As of June September 30, 2026, the outstanding balances due to Nuray, Scitus, Esjay, and SThree were $ 1.9 million, $ 0.9 0.7 million, $ 1.5 0.2 million, and $ 0.3 million 2.2 million, respectively. There were no payments to SS Pharma during the three and six nine months ended June September 30, 2026, and no outstanding balance due.

3 unchanged paragraphs

• Rare Disease and Brands – Consists of two reporting units, Rare Disease and Brands. The Rare Disease unit consists of operations related to the development, manufacture and marketing of proprietary branded pharmaceutical products, with a strategic focus on products used in the treatment of patients with rare disease conditions, and consists of including operations related to Cortrophin Gel and ILUVIEN (there were no sales of YUTIQ during the quarters nine months ended June September 30, 2026 and March 31, 2026), royalties, and other revenues. In addition, the Brands reporting unit includes a portfolio of approximately 20 branded products that are principally sold in highly genericized markets.

• Generics and Other – Consists of operations related to the development, manufacture, and marketing of generic pharmaceutical products including those sold through traditional wholesale and retail sales channels, sales of contract manufactured products, royalties on contract manufactured products, and other pharmaceutical services. As of June September 30, 2026, this reporting segment was comprised of over 135 138 product families.

3 unchanged paragraphs

Three Months Ended June September 30, 2026

1 unchanged paragraph

Net Revenues $ 100,656 $ 165,388 $ — $ 266,044

Research and Development expense 11,186 3,561 — 14,747

Selling, general, and administrative expense 1,578 60,719 29,364 91,661

Operating Income (Loss) $ 36,494 $ 52,348 $ ( 48,382 ) $ 40,460

Income (Loss) Before Income Tax Expense $ 36,494 $ 52,348 $ ( 51,745 ) $ 37,097

Net Revenues $ 108,430 $ 182,347 $ — $ 290,777

Cost of sales (excluding depreciation and amortization) 51,398 48,760 57,927 53,604 — 100,158 111,531

Research and Development expense 9,804 3,193 — 12,997

1 unchanged paragraph

and 77 more changes in the filing

MD&A 231 changes

1 unchanged paragraph

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.

On September 16, 2024, the Company acquired Alimera Sciences, Inc. ("Alimera"). In connection with the Merger, acquisition of Alimera, the Company added a growing and durable franchise, ILUVIEN (fluocinolon e 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.

5 unchanged paragraphs

We acquired the NDAs for Purified Cortrophin® Gel (Repository Corticotropin Injection USP) ("Cortrophin Gel") and Cortrophin-Zinc TM in January 2016 and executed long-term supply agreements with a supplier of our primary raw material for corticotrophin corticotropin API, a supplier of corticotrophin 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.

1 unchanged paragraph

During 2026, we are building 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 will focus 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.

14 unchanged paragraphs

Impacts to our second 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.

1 unchanged paragraph

Three Months Ended June 30, Six Months Ended June 30,

Net Revenues $ 266,044 $ 211,371 $ 503,506 $ 408,493

Cost of sales (excluding depreciation and amortization) 100,158 74,615 193,740 147,652

Research and development 14,747 16,535 25,347 27,099

Selling, general, and administrative 91,661 81,771 165,316 158,299

Depreciation and amortization 19,640 23,281 40,559 46,172

Contingent consideration fair value adjustment (622) 1,277 (804) (10,815)

Operating income 40,460 13,892 79,348 40,086

Unrealized gain (loss) on investment in equity securities 741 332 6,494 (589)

Interest expense, net (3,636) (5,438) (7,405) (10,922)

Other (expense) income, net (468) 1,739 (1,119) 1,937

Income Before Income Tax Expense 37,097 10,525 77,318 30,512

Income tax expense 12,386 1,976 23,115 6,282

Net Income $ 24,711 $ 8,549 $ 54,203 $ 24,230

Three Months Ended September 30, Nine Months Ended September 30, (in thousands) 2026 2025 2026 2025

Net Revenues $ 290,777 $ 227,813 $ 794,283 $ 636,306

Cost of sales (excluding depreciation and amortization) 111,531 93,389 305,271 241,041

Research and development 12,997 12,304 38,344 39,403

Selling, general, and administrative 94,862 76,656 260,178 234,955

Depreciation and amortization 19,552 22,632 60,111 68,804

Contingent consideration fair value adjustment (538) (14,470) (1,342) (25,285)

Loss on disposal of assets — 295 — 295

Intangible asset impairment charge — 767 — 767

Operating income 52,373 36,240 131,721 76,326

Unrealized (loss) gain on investment in equity securities (35) 3,140 6,459 2,551

Interest expense, net (3,056) (4,727) (10,461) (15,649)

Other (expense) income, net (241) (853) (1,360) 1,084

Income Before Income Tax Expense 49,041 33,800 126,359 64,312

Income tax expense 13,892 7,183 37,007 13,465

Net Income $ 35,149 $ 26,617 $ 89,352 $ 50,847

1 unchanged paragraph

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

1 unchanged paragraph

Cost of sales (excluding depreciation and amortization) 37.6 % 35.3 % 38.5 % 36.1 %

Research and development 5.5 % 7.8 % 5.0 % 6.6 %

Selling, general, and administrative 34.5 % 38.7 % 32.8 % 38.8 %

Depreciation and amortization 7.4 % 11.0 % 8.1 % 11.3 %

Operating income 15.2 % 6.6 % 15.8 % 9.8 %

Unrealized gain (loss) on investment in equity securities 0.3 % 0.2 % 1.3 % (0.1) %

Interest expense, net (1.4) % (2.6) % (1.5) % (2.7) %

Income Before Income Tax Expense 13.9 % 5.0 % 15.4 % 7.5 %

Income tax expense 4.7 % 0.9 % 4.6 % 1.5 %

Net Income 9.2 % 4.1 % 10.8 % 6.0 %

Cost of sales (excluding depreciation and amortization) 38.4 % 41.0 % 38.4 % 37.9 %

Research and development 4.5 % 5.4 % 4.8 % 6.2 %

Selling, general, and administrative 32.6 % 33.6 % 32.8 % 36.9 %

Depreciation and amortization 6.7 % 9.9 % 7.6 % 10.8 %

Contingent consideration fair value adjustment (0.2) % 0.6 (6.4) % (0.2) % (2.6) (4.0) %

Loss on disposal of assets — % 0.1 % — % — %

Intangible asset impairment charge — % 0.3 % — % 0.1 %

Operating income 18.0 % 16.1 % 16.6 % 12.1 %

Unrealized (loss) gain on investment in equity securities — % 1.4 % 0.8 % 0.4 %

Interest expense, net (1.1) % (2.1) % (1.3) % (2.5) %

Other (expense) income, net (0.2) (0.1) % 0.8 (0.4) % (0.2) % 0.5 0.2 %

Income Before Income Tax Expense 16.8 % 15.0 % 15.9 % 10.2 %

Income tax expense 4.8 % 3.2 % 4.7 % 2.1 %

Net Income 12.0 % 11.8 % 11.2 % 8.1 %

1 unchanged paragraph

RESULTS OF OPERATIONS FOR THE THREE MONTHS ENDED JUNE SEPTEMBER 30, 2026 AND 2025 (in thousands) 2026 2025 Change % Change

Three Months Ended September 30,

(in thousands) 2026 2025 Change % Change

1 unchanged paragraph

Cortrophin Gel $ 117,126 $ 81,647 $ 35,479 43.5 %

ILUVIEN and YUTIQ (1)

Rare Disease total net revenues $ 135,844 $ 103,963 $ 31,881 30.7 %

Brands 11,813 13,195 (1,382) (10.5) %

Brand royalties and other revenues 17,731 — 17,731 100.0 %

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

2 unchanged paragraphs

1 unchanged paragraph

2 unchanged paragraphs

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

2 unchanged paragraphs

and 162 more changes in the filing

Controls and procedures 2 changes

2 unchanged paragraphs

1 unchanged paragraph

and 2 more changes in the filing

Risk factors 25 changes

1 unchanged paragraph

and 25 more changes in the filing

Unregistered sales of stock 12 changes

2 unchanged paragraphs

1 unchanged paragraph

and 12 more changes in the filing

Other information 3 changes

2 unchanged paragraphs

and 3 more changes in the filing