Earnings release
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ANI Pharmaceuticals Reports Third Quarter 2026 Financial Results November 5, 2026 Quarterly net revenues of $290.8 million, an increase of 27.6% year-over-year Purified Cortrophin® Gel net revenues of $138.7 million, an increase of 36.1% year-over-year Quarterly GAAP net income available to common shareholders of $35.1 million; quarterly adjusted non-GAAP EBITDA of $83.3 million, an increase of 39.8% year-over-year Diluted GAAP income per share of $1.51 and adjusted non-GAAP diluted earnings per share of $2.70 Narrows 2026 total company revenue guidance to $1,085 - $1,125 million, revises Cortrophin Gel revenue guidance to $480 - $500 million and raises both adjusted non-GAAP EBITDA to $290 - $300 million, and adjusted non-GAAP diluted earnings per share to $9.37 to $9.71 Announced offer to acquire Egetis Therapeutics, expanding the scope and scale of ANI’s Rare Disease business Repurchased $20 million in common stock year-to-date PRINCETON, N.J., Nov. 05, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the third quarter ended September 30, 2026. “In the third quarter, ANI delivered strong financial results, while advancing our transformation into a leading Rare Disease company,” said Nikhil Lalwani, President and CEO of ANI. “Cortrophin Gel delivered solid growth, driven by momentum from the gout expansion and continued progress in our existing specialties, while our Generics business continued to outperform. We also executed on our capital allocation strategy by repurchasing shares and expanding the scope and scale of our Rare Disease business through our offer to acquire Egetis Therapeutics. This acquisition would add an FDA-approved rare disease therapy with significant long-term growth potential, that is poised to address the unmet need of patients with MCT8 deficiency who have no other approved treatment options.” “As we head into the end of the year, we are focused on delivering our 2026 financial guidance and advancing the proposed acquisition of Egetis toward closing. We are also executing multiple operational and strategic initiatives to achieve approximately 40% year-over-year growth in 2026 for Cortrophin and capture the significant multi-year growth opportunity ahead,” he concluded. Third Quarter and Recent Business Highlights: Rare Disease Cortrophin Gel: Cortrophin Gel net revenues were $138.7 million for the third quarter of 2026, an increase of 36.1% over the same period in 2025. Year-over-year growth in the third quarter of 2026 was driven by momentum from the gout expansion and continued progress in the existing specialty areas of Nephrology, Neurology, Rheumatology, Ophthalmology, and Pulmonology. Leading indicators of demand in the gout expansion remained strong, with new gout patient cases doubling quarter- over-quarter and an approximately 67% increase in the number of new prescribers. However, revenue conversion was slower than expected in both existing specialties and gout, due to capacity constraints in the Company’s specialty pharmacy network. The Company is expanding its specialty pharmacy network and patient support capabilities to accelerate the conversion of strong demand into patients on therapy. ILUVIEN: ILUVIEN® net revenues were $22.3 million for the third quarter of 2026, an increase of 34.1% over the same period in 2025 due to increased volumes and phasing of international shipments. The Company announced 6- and 24-month topline data from the Phase 4 open-label single-arm SYNCHRONICITY clinical trial in chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) and presented select secondary endpoint analyses highlighting durable efficacy at the American Academy of Ophthalmology annual conference in October 2026. Generics Generics net revenues were $104.5 million in the third quarter of 2026, an increase of 10.7% over the same period in 2025, driven by strong market demand for our existing products and new product launches in 2025 and 2026. Launched 16 new Generics products year-to-date. Brand Royalties and Other Revenues
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The Company recognized $11.5 million of revenue under the Harmony Agreement, comprised of $9.5 million of royalties on net sales of pitolisant-based products for the third quarter of 2026 and $2.0 million of revenue associated with the achievement of certain development milestones. In addition, the Company will continue to earn low single digit royalties on net sales of pitolisant-based products. Brands Brands net revenues were $10.0 million for the third quarter of 2026, a decrease of 6.5% compared to the same period in 2025, reflecting a net decrease in demand for certain products. Corporate Highlights Offer to Acquire Egetis Therapeutics AB On November 5, 2026, ANI announced a recommended public offer to acquire the shares in Egetis Therapeutics AB (‘Egetis’) for SEK 11.25 per share, representing a 27% premium to the 60-day VWAP, as well as the convertible debt and the warrants issued by Egetis. The Offer, if consummated, would add EMCITATE® (tiratricol), the first and only approved treatment in the U.S. and Europe for peripheral thyrotoxicosis associated with MCT8 deficiency, a rare genetic disorder, supported by Orphan Drug exclusivity and patent protection into 2045. The value of the Offer, including outstanding incentive programs, amounts to approximately SEK 5.6 billion or approximately $5601 million. On November 4, 2026, Egetis announced that it had entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $190.0 million (USD). Upon the closing of the PRV sale, former owners of Rare Thyroid Therapeutics International AB (RTTI) will receive an earn-out of their share under agreements governing Egetis’ acquisition of RTTI. The consideration in the Offer fully reflects the net value of the PRV on the terms of that sale. When adjusted for the estimated PRV net proceeds, the enterprise value reflected in the deal is approximately $4341 million. The Board of Directors of Egetis unanimously recommends that Egetis’ shareholders and the holder of the convertible and the warrants accept the Offer. In addition, shareholders representing in total approximately 42 percent of the total number of outstanding shares in Egetis, have undertaken to accept the Offer, under certain conditions. The Offer is subject to customary closing conditions, including that the Offer is accepted by shareholders representing at least 90 percent of the outstanding shares in Egetis, and that ANI receives necessary regulatory approvals. The Offer is financed in full through a combination of cash on hand and new debt financing provided by JPMorgan Chase Bank, N.A., on terms customary for financing of public offers on the Swedish market. The acceptance period in the offer is expected to commence on or around November 20, 2026 and to expire on or around December 18, 2026. For information in relation to the Offer, please refer to the formal offer announcement available on www.biopharma-offer.com. Share Repurchase Program Effective on May 8, 2026, ANI’s board of directors authorized a share repurchase program to repurchase up to $100.0 million of the Company’s common stock. During the third quarter of 2026, the Company repurchased 102,492 shares for approximately $7.5 million. From October 1 through November 2, 2026, ANI repurchased an additional 173,143 shares for approximately $12.5 million. In total, through November 2, 2026, ANI has repurchased 275,635 shares under the share repurchase program for approximately $20.0 million. Third Quarter 2026 Financial Results Three Months Ended September 30, (in thousands) 2026 2025 Change % Change Rare Disease and Brands Cortrophin Gel $ 138,655 $ 101,850 $ 36,805 36.1% ILUVIEN(1) 22,254 16,600 5,654 34.1% Rare Disease total net revenues $ 160,909 $ 118,450 $ 42,459 35.8% Brands 9,978 10,675 (697) (6.5) % Brand royalties and other revenues 11,460 — 11,460 N/M Rare Disease and Brands total net revenues $ 182,347 $ 129,125 $ 53,222 41.2% Generics and Other Generic pharmaceutical products 104,455 94,375 10,080 10.7% Other generic revenues 3,975 4,313 (338) (7.8) % Generics and Other total net revenues $ 108,430 $ 98,688 $ 9,742 9.9% Total net revenues $ 290,777 $ 227,813 $ 62,964 27.6% (1) There were no sales of YUTIQ during the three months ended September 30, 2026 and 2025, as the Company transitioned U.S. promotional efforts from YUTIQ to ILUVIEN, which has a combined label of DME and NIU-PS as of the second quarter of 2025. All comparisons are made versus the same period in 2025 unless otherwise stated. Total net revenues for the third quarter of 2026 were $290.8 million, an increase of 27.6% over the prior year period. Net revenues for Rare Disease, which includes Cortrophin Gel and ILUVIEN, increased 35.8% to $160.9 million. Cortrophin Gel net revenues increased 36.1% to $138.7 million and ILUVIEN net revenues increased 34.1% to $22.3 million. Growth for Cortrophin Gel was driven primarily by
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increased volume. Net revenues for Brands decreased 6.5% to $10.0 million driven by a net decrease in demand for certain products. Net revenues from Brand royalties and other revenues include $2.0 million of revenue associated with the achievement of development milestones and royalties of approximately $9.5 million, related to the Harmony Agreement. Net revenues for Generic pharmaceutical products increased 10.7% to $104.5 million driven by strong market demand for our existing products and new product launches in 2025 and 2026. On a GAAP basis, gross margin increased from 59.0% to 61.6%, while on a non-GAAP basis, gross margin increased from 59.2% to 61.8%. Both increases were primarily due to a favorable shift in product mix year over year in conjunction with revenue recognized under the Harmony Agreement, tempered by an increase in sales of products that bear a royalty payable. On a GAAP basis and a non-GAAP basis, research and development expenses increased 5.6% to $13.0 million and 4.7% to $12.3 million, respectively, driven by timing associated with ongoing and new projects to support future growth of our Rare Disease and Generics businesses. On a GAAP basis, selling, general, and administrative expenses increased 23.8% to $94.9 million, while on a non-GAAP basis, selling, general, and administrative expenses increased 32.4% to $84.2 million. Both comparisons include expense related to expansion of the Rare Disease team, which is targeting opportunities in acute gouty arthritis, and an overall increase in activities to support the growth of our business. On a GAAP basis, the Company reported net income available to common shareholders of $35.1 million, or $1.51 per diluted share, for the third quarter of 2026 compared to $26.3 million, or $1.13 per diluted share, in the prior year period. On a non-GAAP basis, the Company reported adjusted diluted earnings per share of $2.70 for the third quarter of 2026 compared to $2.04 in the prior year period. Adjusted non-GAAP EBITDA for the third quarter of 2026 was $83.3 million, an increase of 39.8% from the third quarter of 2025, driven by increased net revenues and gross profit. For reconciliations of adjusted non-GAAP metrics, including non-GAAP research and development expenses, non-GAAP selling, general and administrative expenses, adjusted non-GAAP EBITDA, non-GAAP gross margin, and adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measures, please see Table 3, Table 4, and Table 5 below, respectively. Liquidity As of September 30, 2026, the Company had $420.8 million in unrestricted cash and cash equivalents, $304.5 million in net accounts receivable and $616.9 million in principal value of outstanding debt (inclusive of the Company’s senior convertible notes). The Company generated cash flow from operations of $198.8 million on a year to date basis. Full Year 2026 Financial Guidance Revised Full Year 2026 Guidance Previous Full Year 2026 Guidance 2025 Actual Growth Net Revenue (Total Company) $1,085 million - $1,125 million $1,080 million - $1,140 million $883 million 23% - 27% Cortrophin Gel Net Revenue $480 million - $500 million $520 million - $540 million $348 million 38% - 44% ILUVIEN Net Revenue $80 million - $85 million $78 million - $83 million $75 million 7% - 14% Adjusted Non-GAAP EBITDA $290 million - $300 million $285 million - $300 million $230 million 26% - 31% Adjusted Non-GAAP Diluted EPS $9.37 - $9.71 $9.19 - $9.69 $7.89 19% - 23% ANI expects full year total company adjusted non-GAAP gross margin between 60.3% and 61.0% and anticipates between approximately 21.5 million and 21.8 million shares outstanding for the purpose of calculating full year adjusted non-GAAP diluted EPS. The Company now expects its annual U.S. GAAP effective tax rate to be between 27% and 29% and will continue to tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share utilizing a tax rate of 26%. Conference Call The Company’s management will host a conference call and webcast today, Thursday, November 5, 2026, at 8:00 a.m. ET to discuss its third quarter 2026 results and the proposed Egetis Therapeutics acquisition. To join the conference call, please dial +1(833) 630-1956 (U.S. and Canada) or +1(412) 317-1837 (International callers). Please reference the “ANI Pharmaceuticals Third Quarter 2026 Earnings Call.” To view the webcast, please click here. Links to access the webcast will also be available on the “Events & Presentations” page of the Company’s website at https://www.anipharmaceuticals.com, under the “Investors” section. A replay of the event will remain accessible for up to one year. Non-GAAP Financial Measures Adjusted non-GAAP EBITDA ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance. Adjusted non-GAAP EBITDA is defined as net income, excluding tax expense, interest expense, net, other expense (income), net, depreciation and
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amortization expense, non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized gain (loss) on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expenses, and certain other items that vary in frequency and impact on ANI’s results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided below. ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted non-GAAP EBITDA guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results. Adjusted non-GAAP Net Income ANI’s management considers adjusted non-GAAP net income to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP net income when analyzing Company performance. Adjusted non-GAAP net income is defined as net income available to common shareholders, plus the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP net income should be considered in addition to, but not in lieu of, net income reported under GAAP. A reconciliation of adjusted non-GAAP net income to the most directly comparable GAAP financial measure is provided below. Adjusted non-GAAP Diluted Earnings per Share ANI’s management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP diluted earnings per share when analyzing Company performance. Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding exclude certain dilutive shares related to the senior convertible notes as they are intended to be covered by our capped call transactions. Our outstanding capped call transactions are intended to fully offset the dilutive effect of the senior convertible notes recognized in the calculation of GAAP diluted EPS, and therefore 121,000 shares and 119,000 shares, for the three and nine months ended September 30, 2026, respectively, have been excluded from the calculation of Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding. Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP diluted earnings per share should be considered in addition to, but not in lieu of, diluted earnings (loss) per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure is provided below. ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted non-GAAP diluted earnings per share guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results. Other non-GAAP metrics ANI’s management considers non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses to be financial indicators of ANI’s operating performance, providing investors and analysts with useful measures of operating results unaffected by non-cash stock-based compensation expense, M&A transaction and integration expenses, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses when analyzing Company performance. Non-GAAP research and development expenses is defined as research and development expenses, excluding non-cash stock-based compensation expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Non-GAAP selling, general, and administrative expenses is defined as selling, general, and administrative expenses, excluding non-cash stock-based compensation expense, M&A transaction and integration expenses, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Each of adjusted non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses should be considered in addition to, but not in lieu of, research and development expenses, and selling, general, and administrative expenses reported under GAAP, respectively. A reconciliation of each of non-GAAP research and development expenses and non-GAAP selling, general and administrative expenses to the most
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directly comparable GAAP financial measure is provided below. ANI’s management also considers non-GAAP gross margin to be a financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses non-GAAP gross margin when analyzing Company performance. Non-GAAP gross margin is defined as adjusted non-GAAP net revenues less non-GAAP cost of sales (excluding depreciation and amortization) divided by non-GAAP net revenues. Non-GAAP cost of sales is defined as cost of sales (excluding depreciation and amortization), excluding non-cash stock-based compensation expense and certain other items that vary in frequency and impact on ANI’s results of operations. Non-GAAP gross margin should be considered in addition to, but not in lieu of, gross margin reported under GAAP. ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted non-GAAP gross margin guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results. About ANI ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit https://www.anipharmaceuticals.com/. Forward-Looking Statements To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s strategy; its expectations regarding its future operations, financial position or revenues, including its 2026 financial guidance; the public offer to the shareholders of Egetis Therapeutics and statements related to the potential acquisition of Egetis Therapeutics, including the potential addition of EMCITATE to the Company’s asset portfolio through the proposed acquisition and the anticipated timing and expenses related to the acquisition; the anticipated sales potential of EMCITATE; the Company’s expectations regarding its share repurchase program; the results and timing of the Company’s preclinical studies, clinical trials, regulatory submissions and regulatory approvals; the commercialization and anticipated sales of the Company’s products, including current and planned product launches and any additional product launches from the Company’s generic pipeline; the Company’s estimates of the market opportunity and addressable patient populations for its products; the execution capabilities of the Company’s sales representatives for acute gouty arthritis for Cortrophin Gel; the Company’s anticipated growth opportunities, including for Cortrophin Gel and ILUVIEN; the Company’s positioning for continued shareholder value creation; anticipated R&D developments and clinical trial advances; and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates. Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of the Company’s approved products, including Cortrophin Gel and ILUVIEN, to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; the Company’s ability to complete or achieve any or all of the intended benefits of acquisitions and investments, in a timely manner or at all; delays and disruptions in the production of the Company’s approved products; increased costs and potential loss of revenues if the Company needs to change suppliers due to the limited number of suppliers for its raw materials, active pharmaceutical ingredients, excipients, and other materials; delays and disruptions in the production of the Company’s approved products as a result of its reliance on single source third party contract manufacturing supply for certain of its key products, including Cortrophin Gel and ILUVIEN; delays or failure to obtain or maintain approvals by the FDA of the Company’s products; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies; risks that the Company may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of the Company’s products from both domestic and overseas sources due to supply chain disruptions or for any other reason, including increased costs due to tariffs or macroeconomic disruptions; the ability of the Company’s manufacturing partners to meet its product demands and timelines; the impact of changes or fluctuations in exchange rates; the Company’s ability to develop, license or acquire, and commercialize new products; the Company’s obligations in agreements under which it licenses, develops or commercializes rights to products or technology from third parties and its ability to maintain such licenses; the level of competition the Company faces and the legal, regulatory and/or legislative strategies employed by its competitors to prevent or delay competition from generic alternatives to branded products; the Company’s ability to protect its intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which the Company is, or may become, a party; the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; the Company’s ability to maintain the services of its key executives and other personnel; and general business and economic conditions, such as inflationary pressures and geopolitical conditions. More detailed information on these and additional factors that could affect the Company’s actual results is included in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, and other periodic reports, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Relations: Irina Koffler, Vice President, Investor Relations T: 917-734-7387 E: Irina.koffler@anipharmaceuticals.com Media Relations:
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Argot Partners T: 212-600-1494 E: ani@argotpartners.com SOURCE: ANI Pharmaceuticals, Inc. FINANCIAL TABLES FOLLOW ANI Pharmaceuticals, Inc. and Subsidiaries Table 1: US GAAP Statements of Operations (unaudited, in thousands, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2026 2025 2026 2025 Net Revenues $ 290,777 $ 227,813 $ 794,283 $ 636,306 Operating Expenses 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 Other (expense) income, net 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 — (344) — (1,157) Net Income Available to Common Shareholders $ 35,149 $ 26,273 $ 89,352 $ 49,690 Basic and Diluted Income Per Share: Basic Income Per Share $ 1.54 $ 1.19 $ 3.94 $ 2.26 Diluted Income Per Share $ 1.51 $ 1.13 $ 3.86 $ 2.15 Basic Weighted-Average Shares Outstanding 21,212 20,074 21,095 19,840 Diluted Weighted-Average Shares Outstanding 21,675 21,093 21,598 20,911 ANI Pharmaceuticals, Inc. and Subsidiaries Table 2: US GAAP Balance Sheets (unaudited, in thousands) September 30, 2026 December 31, 2025 Current Assets Cash and cash equivalents $ 420,758 $ 285,585 Restricted cash 35 36
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Accounts receivable, net 304,450 281,082 Inventories 136,411 143,067 Prepaid expenses and other current assets 25,577 34,216 Investment in equity securities 15,590 9,131 Total Current Assets 902,821 753,117 Non-current Assets Property and equipment, net 81,552 62,476 Deferred tax assets, net 74,668 69,072 Intangible assets, net 433,109 479,526 Goodwill 62,480 62,480 Other non-current assets 13,031 13,706 Total Assets $ 1,567,661 $ 1,440,377 Current Liabilities Accounts payable $ 74,415 $ 62,583 Accrued royalties 66,054 48,497 Accrued compensation and related expenses 34,950 37,897 Accrued government rebates 56,635 43,154 Returned goods reserve 45,648 49,504 Accrued expenses and other 18,674 16,970 Income taxes payable 8,979 2,239 Current debt, net 23,362 17,268 Total Current Liabilities 328,717 278,112 Non-current Liabilities Debt, net 274,314 291,840 Convertible notes, net 309,556 307,927 Contingent consideration 7,836 9,610 Other non-current liabilities 10,125 12,164 Total Liabilities $ 930,548 $ 899,653 Stockholders’ Equity Common Stock 3 3 Class C Special Stock — — Preferred Stock — — Treasury stock (62,212) (33,249) Additional paid-in capital 634,239 596,036 Retained earnings (Accumulated deficit) 66,253 (23,099) Accumulated other comprehensive (loss) income, net of tax (1,170) 1,033 Total Stockholders’ Equity 637,113 540,724 Total Liabilities and Stockholders’ Equity $ 1,567,661 $ 1,440,377 ANI Pharmaceuticals, Inc. and Subsidiaries Table 3: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation (unaudited, in thousands) Reconciliation of certain adjusted non-GAAP accounts: Net Revenues Cost of sales (excluding depreciation and amortization) Selling, general, and administrative Research and development Three Months Ended September 30, Three Months Ended September 30, Three Months Ended September 30, Three Months Ended September 30, Three Months Ended September 30, 2026 2025 2026 2025 2026 2025 2026 2025 2026 2025 Net Income $ 35,149 $ 26,617 As reported: $290,777 $227,813 $111,531 $ 93,389 $ 94,862 $ 76,656 $ 12,997 $12,304 Add/(Subtract): Interest expense, net 3,056 4,727
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Other expense, net 241 853 Income tax expense 13,892 7,183 Depreciation and amortization 19,552 22,632 Contingent consideration fair value adjustment (538) (14,470) Unrealized loss (gain) on investment in equity securities 35 (3,140) Intangible asset impairment charge — 767 Loss on disposal of assets — 295 Stock-based compensation 11,631 9,691 Stock-based compensation — — (543) (516) (10,435) (8,660) (653) (515) M&A transaction and integration expenses (33) 599 M&A transaction and integration expenses — — — — 33 (599) — — Litigation expenses 310 3,847 Litigation expenses — — — — (310) (3,847) — — Adjusted non-GAAP EBITDA $ 83,295 $ 59,601 As adjusted: $290,777 $227,813 $110,988 $ 92,873 $ 84,150 $ 63,550 $ 12,344 $11,789 Reconciliation of certain adjusted non-GAAP accounts: Net Revenues Cost of sales (excluding depreciation and amortization) Selling, general, and administrative Research and development Nine Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, Nine Months Ended September 30, 2026 2025 2026 2025 2026 2025 2026 2025 2026 2025 Net Income $ 89,352 $ 50,847 As reported: $794,283 $636,306 $305,271 $241,041 $260,178 $234,955 $38,344 $39,403 Add/(Subtract): Interest expense, net 10,461 15,649 Other expense (income), net 1,360 (1,084) Income tax expense 37,007 13,465 Depreciation and amortization 60,111 68,804 Contingent consideration fair value adjustment (1,342) (25,285)
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Unrealized gain on investment in equity securities (6,459) (2,551) Intangible asset impairment charge — 767 Loss on disposal of assets — 295 Stock-based compensation 33,228 28,161 Stock-based compensation — — (1,590) (1,296) (29,745) (25,241) (1,893) (1,624) M&A transaction and integration expenses 268 3,216 M&A transaction and integration expenses — — — — (268) (3,216) — — Litigation expenses and settlement proceeds (6,098) 12,038 Litigation expenses and settlement proceeds — — — — 6,098 (12,038) — — Severance — 105 Severance — — — — — (105) — — Adjusted non-GAAP EBITDA $217,888 $164,427 As adjusted: $794,283 $636,306 $303,681 $239,745 $236,263 $194,355 $36,451 $37,779 ANI Pharmaceuticals, Inc. and Subsidiaries Table 4: US GAAP Gross Margin to Non-GAAP Gross Margin Reconciliation (unaudited, in thousands) Three Months Ended September 30, Nine Months Ended September 30, 2026 2025 2026 2025 GAAP net revenues $ 290,777 $ 227,813 $ 794,283 $ 636,306 GAAP cost of sales (excluding depreciation and amortization) 111,531 93,389 305,271 241,041 GAAP gross profit $ 179,246 $ 134,424 $ 489,012 $ 395,265 Stock-based compensation 543 516 1,590 1,296 Non-GAAP gross profit $ 179,789 $ 134,940 $ 490,602 $ 396,561 GAAP gross margin 61.6% 59.0% 61.6% 62.1% Non-GAAP gross margin 61.8% 59.2% 61.8% 62.3% ANI Pharmaceuticals, Inc. and Subsidiaries Table 5: Adjusted non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per Share Reconciliation (unaudited, in thousands, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2026 2025 2026 2025 Net Income Available to Common Shareholders $ 35,149 $ 26,273 $ 89,352 $ 49,690 Add/(Subtract): Non-cash interest expense 43 225 397 736 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 Unrealized loss (gain) on investment in equity securities 35 (3,140) (6,459) (2,551) Intangible asset impairment charge — 767 — 767 Stock-based compensation 11,631 9,691 33,228 28,161 M&A transaction and integration expenses (33) 599 268 3,216 Litigation expenses and settlement proceeds 310 3,847 (6,098) 12,038 Severance — — — 105
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Other expense (income) 166 794 1,269 (1,215) Less: Estimated tax impact of adjustments (8,103) (5,522) (21,157) (22,118) Adjusted non-GAAP Net Income Available to Common Shareholders (1) $ 58,212 $ 41,991 $ 149,569 $ 112,643 Diluted Weighted-Average Shares Outstanding 21,675 21,093 21,598 20,911 Adjusted Diluted Weighted-Average (2) Shares Outstanding 21,554 20,591 21,479 20,318 Adjusted non-GAAP Diluted Earnings per Share $ 2.70 $ 2.04 $ 6.96 $ 5.54 (1) Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistributed earnings to participating securities. (2) Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding exclude certain dilutive shares related to the senior convertible notes as they are intended to be covered by our capped call transactions. Our outstanding capped call transactions are intended to fully offset the dilutive effect of the senior convertible notes recognized in the calculation of GAAP diluted EPS, and therefore 121,000 shares and 119,000 shares, for the three and nine months ended September 30, 2026, respectively, have been excluded from the calculation of Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding. ________________ 1 Calculated utilizing 30 trading day average USD to SEK exchange rate of 9.9471 as of November 3, 2026.
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ANI Pharmaceuticals Announces Offer to Acquire Egetis Therapeutics, Expanding the Scope and Scale of Its Rare Disease Business November 5, 2026 Egetis Therapeutics’ lead asset, EMCITATE®, is the first and only approved treatment in U.S. and Europe for peripheral thyrotoxicosis associated with MCT8 deficiency, a rare genetic disorder, impacting approximately 1 in 70K males Supported by ANI’s proven track record in Rare Disease, EMCITATE® has potential to reach over $300 million in peak sales in its approved indication, with U.S. and EU Orphan Drug Exclusivity and patent protection into 2045 Combines ANI’s resources, Rare Disease expertise, and infrastructure with Egetis’ commercialization and clinical development capabilities The Offer reflects a purchase price of SEK 11.25 per share representing a 27% premium to the 60-day VWAP of shares of Egetis and total value of approximately SEK 5.6 billion, or $560M 1 U.S.; and an enterprise value of approximately $434 1 million when adjusted for estimated proceeds of Egetis’ sale of its Rare Pediatric Disease Priority Review Voucher The acquisition is unanimously recommended by Egetis’ Board, and supported by shareholders in Egetis controlling approximately 42 percent of the shares ANI will release 3Q 2026 earnings results at 6:50 am ET and host conference call today at 8:00 am ET PRINCETON, N.J., Nov. 05, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (“ANI” or the “Company”) announces a recommended public offer to acquire Egetis Therapeutics AB (publ) (“Egetis”) (the “Offer”). Egetis is a commercial-stage pharmaceutical company focused on developing and delivering innovative therapies for patients with rare diseases with significant unmet medical need. Egetis’ lead product, EMCITATE®, was approved by the European Commission on February 12, 2025, and by the U.S. Food and Drug Administration (FDA) on September 28, 2026, as the first and only approved treatment of peripheral thyrotoxicosis in adults and pediatric patients with MCT8 deficiency (Allan–Herndon–Dudley syndrome). “This proposed acquisition further accelerates our transformation with a substantial majority of our revenues expected to be derived from higher margin rare disease products by decade’s end and supports our mission of serving vulnerable patient populations with unmet medical needs,” said Nikhil Lalwani, President and Chief Executive Officer of ANI. “We have followed the Egetis team closely, and we have been deeply impressed by their commitment to patients with MCT8 deficiency and to the families who care for them.” Mr. Lalwani added, “The proposed transaction reflects the disciplined execution of the strategy we have consistently outlined: adding differentiated, durable commercial Rare Disease assets that leverage our existing expertise and infrastructure. The acquisition of Egetis would strengthen our Rare Disease portfolio and development capabilities. By leveraging our resources and the groundwork laid by Egetis, we estimate peak sales potential for EMCITATE® of over $300 million in its approved indication coupled with durable protection into 2045, bolstering our long-term growth and profitability profile. We believe that ANI is well-positioned to successfully bring EMCITATE® to patients and caregivers.” Strategic Rationale Advances ANI’s mission of “Serving Patients, Improving Lives”: EMCITATE® addresses MCT8 deficiency, a devastating ultra-rare disease marked by severe lifelong morbidity and substantial caregiver burden, furthering ANI’s commitment to bringing innovative therapies to patients with significant unmet need. Accelerates ANI’s strategic transformation into a leading Rare Disease company: The proposed transaction expands the scope and scale of ANI’s Rare Disease business by broadening the Company’s commercial footprint and adding EMCITATE®, a commercial product with over $300 million in peak sales potential in its approved indication. Introduces a new growth driver with durable runway into 2045: As the first and only FDA-approved treatment of peripheral thyrotoxicosis associated with MCT8 deficiency, EMCITATE® has significant growth potential that ANI plans to unlock with its resources, commercial capabilities, and infrastructure. EMCITATE ®’s durability is supported by New Chemical Entity exclusivity, Orphan Drug exclusivity in both the U.S. and Europe, and an Orange Book-listed patent offering protection into mid-2045. Leverages ANI’s resources and existing Rare Disease expertise and infrastructure: ANI intends to build on Egetis’ U.S. commercial launch preparations by leveraging its resources, extensive experience in Rare Disease, and existing medical affairs, patient access and reimbursement support.
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Strengthens ANI’s clinical development capabilities: The proposed transaction adds a proven research and development team with an ongoing clinical program to evaluate tiratricol in resistance to thyroid hormone beta (RTH-beta). Diversifies ANI’s revenue base and enhances its long-term growth and profitability profile. Transaction Details On November 5, 2026, ANI announced a recommended public offer to acquire the shares in Egetis for SEK 11.25 per share, representing a 27% premium to the 60-day VWAP, as well as the convertible debt and the warrants issued by Egetis. The value of the Offer, including outstanding incentive programs, amounts to approximately SEK 5.6 billion or approximately $5601 million. On November 4, 2026, Egetis announced that it had entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $190.0 million (USD). Upon the closing of the PRV sale, former owners of Rare Thyroid Therapeutics International AB (RTTI) will receive an earn-out of their share under agreements governing Egetis’ acquisition of RTTI. The consideration in the Offer fully reflects the net value of the PRV on the terms of that sale. When adjusted for the estimated PRV net proceeds, the enterprise value reflected in the deal is approximately $4341 million. The Board of Directors of Egetis unanimously recommends that Egetis’ shareholders and the holder of the convertible and the warrants accept the Offer. In addition, shareholders representing in total approximately 42 percent of the total number of outstanding shares in Egetis, have undertaken to accept the Offer, under certain conditions. The Offer is subject to customary closing conditions, including that the Offer is accepted by shareholders representing at least 90 percent of the outstanding shares in Egetis, and that ANI receives necessary regulatory approvals. The Offer is financed in full through a combination of cash on hand and new debt financing provided by JPMorgan Chase Bank, N.A., on terms customary for financing of public offers on the Swedish market. The acceptance period in the offer is expected to commence on or around November 20, 2026 and to expire on or around December 18, 2026. For information in relation to the Offer, please refer to the formal offer announcement available on www.biopharma-offer.com. Advisors For ANI Pharmaceuticals, Jefferies LLC is serving as sole financial advisor and Ropes & Gray LLP and Mannheimer Swartling Advokatbyrå AB are serving as legal counsel. For Egetis Therapeutics, Centerview Partners is serving as sole financial advisor, and Vinge is serving as legal counsel. Conference Call ANI will host a conference call and webcast today, Thursday, November 5, 2026, at 8:00 a.m. ET to discuss the acquisition and third quarter 2026 financial results. To join the conference call, please dial +1(833) 630-1956 (U.S. and Canada) or +1(412) 317-1837 (International callers). To view the webcast and accompanying slides, please click here. Links to access the webcast will also be available on the “Events & Presentations” page of the Company’s website at https://www.anipharmaceuticals.com, under the “Investors” section. A replay of the event will remain accessible for up to one year. About ANI Pharmaceuticals, Inc. ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit https://www.anipharmaceuticals.com. Forward-Looking Statements To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the public offer to acquire Egetis; the Company’s strategy and ability to transform into a leading Rare Disease company; the Company’s expectations regarding its future operations; the commercialization and anticipated sales of EMCITATE® and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates. Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the Company’s ability to complete or achieve any or all of the intended benefits of the proposed acquisition of Egetis, in a timely manner or at all; regulatory approvals required for the transaction not being timely obtained, if obtained at all; the Egetis business experiencing disruptions due to transaction-related uncertainties or other factors; the Company being unable to successfully implement integration strategies; the ability of EMCITATE® and the Company’s approved products, including Cortrophin Gel and ILUVIEN, to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies; the Company’s ability to develop, license or acquire, and commercialize new products; the Company’s ability to protect its intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; and general business and economic conditions, such as inflationary pressures, and geopolitical conditions.
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More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, and other periodic reports, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Important information to U.S. shareholders The Offer described in this press release is made for the shares, the convertible loan 2023:1 (the “Convertible”) and the warrants 2023/2033:1 (the “Warrants”) of Egetis, a Swedish public limited liability company, and is subject to Swedish disclosure and procedural requirements, which may be different from those of the United States. The Offer is made in the United States pursuant to Section 14(e) of the U.S. Securities Exchange Act of 1934, as amended and Regulation 14E thereunder, to the extent applicable, and otherwise in compliance with the disclosure and procedural requirements of Swedish law, including with respect to withdrawal rights, the Offer timetable, notices of extensions, announcements of results, settlement procedures (including as regards to the time when payment of the consideration is rendered) and waivers of conditions, which may be different from requirements or customary practices in relation to U.S. domestic tender offers. Shareholders and the holder of the Convertible and the Warrants domiciled in the United States (the “U.S. Holders”) are encouraged to consult with their own advisors regarding the Offer. Egetis’ financial statements and all financial information included herein, or any other documents relating to the Offer, have been or will be prepared in accordance with IFRS and may not be comparable to the financial statements or financial information of companies in the United States or other companies whose financial statements are prepared in accordance with U.S. generally accepted accounting principles. It may be difficult for Egetis’ shareholders and the holder of the Convertible and the Warrants to enforce their rights and any claims they may have arising under the U.S. federal or U.S. state securities laws in connection with the Offer, since Egetis is located in Sweden, and some or all of its officers and directors may be residents of countries other than the United States. Egetis’ shareholders and the holder of the Convertible and the Warrants may not be able to sue Egetis or its officers or directors in a non-U.S. court for violations of U.S. securities laws. Further, it may be difficult to compel Egetis and its affiliates to subject themselves to the jurisdiction or judgment of a U.S. court. To the extent permissible under applicable law or regulations, ANI and its affiliates or its brokers and its brokers' affiliates (acting as agents for ANI or its affiliates, as applicable) may from time to time and during the pendency of the Offer, and other than pursuant to the Offer, directly or indirectly purchase or arrange to purchase shares of Egetis outside the United States, or any securities that are convertible into, exchangeable for or exercisable for such shares. These purchases may occur either in the open market at prevailing prices or in private transactions at negotiated prices, and information about such purchases will be disclosed by means of a press release or other means reasonably calculated to inform U.S. Holders of such information, to the extent required by applicable laws and regulations. In addition, the financial advisors to ANI may also engage in ordinary course trading activities in securities of Egetis, which may include purchases or arrangements to purchase such securities as long as such purchases or arrangements comply with the applicable laws and regulations. Any information about such purchases will be announced in Swedish and in a non-prevailing English translation available to the U.S. Holders through relevant electronic media if, and to the extent, such announcement is required under applicable Swedish or U.S. law, rules or regulations. The receipt of cash pursuant to the Offer by a U.S. Holder may be a taxable transaction for U.S. federal income tax purposes and under applicable U.S. state and local, as well as foreign and other, tax laws. Each shareholder is urged to consult an independent professional adviser regarding the tax consequences of accepting the Offer. Neither ANI nor any of its affiliates and their respective directors, officers, employees or agents or any other person acting on their behalf in connection with the Offer shall be responsible for any tax effects or liabilities resulting from acceptance of this Offer. NEITHER THE U.S. SECURITIES AND EXCHANGE COMMISSION NOR ANY U.S. STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED THE OFFER, MADE ANY COMMENTS UPON THE MERITS OR FAIRNESS OF THE OFFER, MADE ANY COMMENT UPON THE ADEQUACY OR COMPLETENESS OF THIS PRESS RELEASE OR MADE ANY COMMENT ON WHETHER THE CONTENT IN THIS PRESS RELEASE IS CORRECT OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENCE IN THE UNITED STATES. For purposes of this section "United States" and "U.S." means the United States of America (its territories and possessions, all states of the United States of America and the District of Columbia). Information about the Offer Information regarding the Offer is made available at: www.biopharma-offer.com. ANI Pharmaceuticals Contacts Investor Relations: Irina Koffler, Vice President, Investor Relations T: 917-734-7387 E: Irina.koffler@anipharmaceuticals.com Media Relations: Argot Partners T: 212-600-1494 E: ani@argotpartners.com SOURCE: ANI Pharmaceuticals, Inc. ________________________ 1 Calculated utilizing 30 trading day average USD to SEK exchange rate of 9.9471 as of November 3, 2026.