ANI Pharmaceuticals (NASDAQ: ANIP) targets ~$1.1B in 2026 revenue
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
ANI Pharmaceuticals furnished an updated investor presentation outlining strong growth plans and refreshed 2026 guidance. The company now projects $1.08–$1.14 billion in 2026 total net revenue, implying mid‑20% year-over-year growth, with its Rare Disease business expected to contribute about 60% of sales.
Lead asset Cortrophin Gel is forecast to generate $540–$575 million in 2026 revenue and approximately 60% growth, supported by expansion into acute gouty arthritis flares and other underpenetrated indications. ILUVIEN is guided to $78–$83 million, while Generics continue to provide strong cash flow.
For 2026, ANI targets adjusted non-GAAP EBITDA of $285–$300 million and adjusted non-GAAP diluted EPS of $9.19–$9.69. In Q1 2026, total net revenues reached $237.5 million and adjusted non-GAAP EBITDA was $63.0 million, reflecting solid top- and bottom-line growth. The board also authorized a $100 million share repurchase program, and the company reported cash of $311 million and net leverage of roughly 1.3x as of March 31, 2026.
Positive
- Raised 2026 guidance with strong growth outlook: Total 2026 net revenue guidance increased to $1.08–$1.14 billion and adjusted non-GAAP EBITDA to $285–$300 million, implying robust top- and bottom-line expansion versus prior ranges.
- Rapid expansion of higher-margin Rare Disease business: Rare Disease revenue is expected to reach $540–$575 million in 2026 and represent about 60% of total revenues, led by approximately 60% year-over-year growth in Cortrophin Gel.
- Solid balance sheet and shareholder return: Cash of $311 million and net leverage of roughly 1.3x as of March 31, 2026 support both growth initiatives and a newly authorized $100 million share repurchase program.
Negative
- None.
Insights
ANI raises 2026 guidance, leans into Rare Disease growth and returns cash via buybacks.
ANI Pharmaceuticals is signaling a faster growth trajectory, lifting 2026 guidance to $1.08–$1.14B in net revenue and $285–$300M in adjusted non-GAAP EBITDA. Rare Disease, led by Cortrophin Gel, is expected to account for about 60% of 2026 revenue, marking a strategic mix shift away from reliance on generics.
Cortrophin Gel guidance of $540–$575M for 2026 with roughly +60% year-over-year growth shows management’s confidence in underpenetrated indications such as acute gouty arthritis flares, nephrology and neurology. ILUVIEN’s $78–$83M target and the Harmony Biosciences royalty deal add incremental branded revenue streams, while generics continue to fund R&D through strong cash flow.
Financially, the company posted Q1 2026 revenues of $237.5M and adjusted non-GAAP EBITDA of $63.0M. With cash of $311M, net leverage around 1.3x, and a newly authorized $100M share repurchase program, ANI has flexibility for both capital returns and further Rare Disease investment. Future disclosures in 2026 filings will show whether execution tracks the raised guidance ranges.
8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
2026 net revenue guidance: $1.08–$1.14B
2026 adjusted EBITDA guidance: $285–$300M
2026 Cortrophin Gel revenue: $540–$575M
+5 more
8 metrics
2026 net revenue guidance
$1.08–$1.14B
Total company net revenue guidance for full year 2026
2026 adjusted EBITDA guidance
$285–$300M
Adjusted non-GAAP EBITDA target for 2026
2026 Cortrophin Gel revenue
$540–$575M
Cortrophin Gel net revenue guidance for 2026
2026 ILUVIEN revenue
$78–$83M
ILUVIEN net revenue guidance for 2026
Q1 2026 total net revenues
$237.5M
Total net revenues for quarter ended Q1 2026
Q1 2026 adjusted EBITDA
$63.0M
Adjusted non-GAAP EBITDA for Q1 2026
Share repurchase authorization
$100M
Board-authorized share repurchase program
Cash balance and leverage
$311M; ~1.3x
Cash and net leverage as of March 31, 2026
Key Terms
Adjusted non-GAAP EBITDA, Adjusted non-GAAP diluted earnings per share, Non-GAAP gross margin, share repurchase program, +2 more
6 terms
Adjusted non-GAAP EBITDA financial
"Adjusted non-GAAP EBITDA is defined as net income, excluding tax expense, interest expense, net, other expense (income), net, depreciation and amortization expense..."
Adjusted non-GAAP EBITDA is a company’s earnings measure that starts with profit before interest, taxes, depreciation and amortization and then removes one-time items or other costs management says obscure ongoing performance. Investors use it like a tuned-up odometer — it aims to show the business’s underlying cash-generating ability by stripping out irregular or non-cash charges, which helps compare results across periods and companies but can vary depending on what adjustments are included.
Non-GAAP gross margin financial
"ANI’s management also considers non-GAAP gross margin to be a financial indicator of ANI’s operating performance..."
Non-GAAP gross margin is a measure of a company's profitability that shows how much money it makes from sales after subtracting the direct costs of producing its products or services, but without applying certain accounting adjustments required by standard rules. It helps investors understand the company's core earning ability by excluding items like one-time expenses or accounting changes. This metric provides a clearer picture of ongoing business performance beyond official financial reports.
capped call transactions financial
"Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding excludes certain dilutive shares related to the convertible senior notes as they are intended to be covered by our capped call transactions."
Capped call transactions are agreements where investors buy options that give them the chance to benefit if a stock's price goes up, but with a limit on how much they can gain. This helps protect them from paying too much if the stock's price rises a lot, similar to having a maximum limit on a reward. They matter because they help investors manage risk while still allowing some upside potential.
ACTH market medical
"Overall ACTH market growth driven by continued expansion into key indications"
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported): May 13, 2026
(Exact name of registrant as specified in its charter)
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Registrant's telephone number, including area code: (609 ) 759-1810
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging Growth Company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 7.01 | Regulation FD Disclosure | ||||
On May 13, 2026, ANI Pharmaceuticals, Inc. (the “Company”) published an updated investor presentation to the investor relations section of its website. The Company may use the updated investor presentation in various meetings with investors and analysts from time to time. A copy of the investor presentation is attached as Exhibit 99.1 hereto and incorporated herein by reference.*
| Item 9.01 | Exhibits | ||||
(d)Exhibits
| Exhibit No. | Description | ||||
| 99.1 | Investor Presentation, dated May 2026 | ||||
| 104 | Cover Page Interactive Data File (embedded with the Inline XBRL document) | ||||
*The information in Item 7.01 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: May 13, 2026 | ANI PHARMACEUTICALS, INC. | |||||||
| By: | /s/ Stephen P. Carey | |||||||
| Name: | Stephen P. Carey | |||||||
| Title: | Senior Vice President Finance and Chief Financial Officer | |||||||
© 2026 ANI Pharmaceuticals, Inc. 1 Corporate Presentation May 2026
© 2026 ANI Pharmaceuticals, Inc. 2 Disclaimers Forward-Looking Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The guidance included herein was provided on the Company's earnings conference call on May 8, 2026. Investors accessing this presentation subsequent to May 8, 2026 are cautioned that the Company is neither reconfirming this guidance as of any date subsequent to May 8, 2026 nor assuming any obligation to update or revised such guidance. Any statements that are not historical facts, including statements about our expectations, beliefs, plans, objectives, assumptions or future events or performance are forward-looking statements. These statements are often, but are not always, made through the use of words or phrases such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These statements may include, but are not limited to, statements concerning our planned future operations, strategies and growth potential; our strategy and future operations, including with respect to our share repurchase program; our future financial position and performance, including our expectations regarding our forecasted revenue (including revenue from licensing, royalties and sales) and our forecasted adjusted non-GAAP EBITDA and adjusted non-GAAP gross margin, as well as our estimates of our expenses and capital requirements; our development pipeline, including the structure, focus, success, cost and timing of our development activities, including nonclinical studies and clinical trials, and the reporting of data from those activities; expected timeframes for the submission of new drug applications, abbreviated new drug applications, or supplemental new drug applications to the U.S. Food and Drug Administration (the “FDA”) and the number of product launches we expect to be able to complete in a given timeframe; our expectations regarding the size of patient populations, market acceptance and clinical utility of our products and product candidates, if approved; anticipated growth opportunities for Cortrophin Gel and ILUVIEN; and the commercialization and potential anticipated sales of our products. Uncertainties and risks may cause our 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 our approved products, including Cortrophin Gel and ILUVIEN, to achieve commercialization at levels of market acceptance that will allow us to maintain profitability; ou r manufacturing capabilities and our ability to comply with significant regulations with respect to the manufacture of our products or, where applicable, our reliance on third parties to do the same; supply chain and inventory expectations, and our and our partners’ ability to meet anticipated demand; 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”); increased costs and potential loss of revenues if we need to change suppliers due to the limi ted number of suppliers for our raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in the production of our approved products as a result of our reliance on single source third party contract manufacturing supply for certain of our key products, including Cortrophin Gel and ILUVIEN; the success of competing therapies that are or may become available; our strategic initiatives, including acquisitions, strategic alliances and collaborations, and our ability to realize the intended benefits of such initiatives; our ability to attract and retain key personnel; our expectations and uncertainties regarding future pricing, coverage and reimbursement for our products; the impact of new or modified laws or regulations, and the application or implementation thereof; our ability to obtain, protect and enforce our intellectual property; and 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. Any forward-looking statements in this presentation are based on the reasonable beliefs of our management as well as assumptions made by and information currently available to our management. Forward-looking statements are inherently subject to known and unknown risks, uncertainties and other factors, some of which cannot be predicted or quantified, that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that might cause such a difference include, but are not limited to, those risks and uncertainties that are described in the Company’s most recent Annual Report on Form 10-K, any subsequent quarterly reports filed by the Company on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Such statements are based on management’s expectations as of the date of this presentation and involve many risks and uncertainties that could cause our actual results, events or circumstances to differ materially from those expressed or implied in our forward-looking statements. We undertake no obligation to update any forward-looking statements made in this presentation to reflect events or circumstances after the date of this presentation or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
© 2026 ANI Pharmaceuticals, Inc. 3 Presentation of financial information 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 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 within the Appendix. ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted 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 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 excludes certain dilutive shares related to the convertible senior notes as they are intended to be covered by our capped call transactions. Our outstanding capped call transactions are intended to offset the dilutive effect of the convertible senior notes recognized in the calculation of GAAP diluted EPS in this reporting period in full, and therefore shares have been excluded from the calculation of the 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 within the Appendix. ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted 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 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 cost of sales is defined as cost of sales (excluding depreciation and amortization), excluding non-cash stock-based compensation expense, amortization of certain purchase price adjustments, and certain other items that vary in frequency and impact on ANI’s results of operations. 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 and Non-GAAP gross margin should be considered in addition to, but not in lieu of, cost of sales and 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, 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.”
© 2026 ANI Pharmaceuticals, Inc. 4 ~$1.1B Total net revenue in 2026 A profitable, high-growth biopharmaceutical organization transforming into a leading Rare Disease company • Projecting ~$1.1B in total net revenue in 2026 • 44% YoY increase in 2025 • 26% YoY increase in 2026(1) • Rare Disease business is primary focus • Expected to represent ~60% of total revenues in 2026 • Lead asset, Cortrophin Gel, expected to provide substantial, durable multi-year growth opportunity • Generics business delivering strong cash flows enabled by superior R&D capabilities, operational execution, and U.S. manufacturing 1. Percent change calculated using the midpoint of 2026 financial guidance ranges provided by the Company on May 8, 2026. RARE D ISEASE BRA N D S G E N E R I C S ANI’s virtuous cycle of growth
© 2026 ANI Pharmaceuticals, Inc. 5 Proven track record of delivering top- and bottom-line growth Adjusted Non-GAAP EBITDA ($ millions)(1)Total Company Net Revenues ($ millions) 1. Adjusted Non-GAAP EBITDA is a Non-GAAP financia l measure. See Appendix for a reconciliation to the most directly comparable GAAP financial metr ic. 2. 2022-2026 CAGR calcu lated using the midpoint of full year 2026 guidance provided by the Company on May 8, 2026. 3. Based on 2026 financial guidance provided by the Company on May 8, 2026. $316 $487 $614 $883 $1,080-$1,140 2022 2023 2024 2025 2026E +37% CAGR(2) $56 $134 $156 $230 $285-$300 2022 2023 2024 2025 2026E +51% CAGR(2) (3) (3)
© 2026 ANI Pharmaceuticals, Inc. 6 ACCELERATE ANI’S TRANSFORMATION INTO A LEADING RARE DISEASE COMPANY Cortrophin Gel 2026 priorities to drive long-term growth and value creation • Maximize multi-year growth opportunity by addressing significant unmet need across indications • Build on momentum in underpenetrated specialty indications in nephrology, neurology, rheumatology, ophthalmology and pulmonology • Recently onboarded majority of commercial team for acute gouty arthritis flares • Advance Phase 4 trial to establish further evidence supporting Cortrophin Gel in acute gouty arthritis flares • Continue to evaluate opportunities to enhance patient convenience ILUVIEN • Return to growth by leveraging the commercial and patient access initiatives established in 2025 CONTINUED EXCELLENCE IN GENERICS BUSINESS EXECUTE DISCIPLINED CAPITAL ALLOCATION STRATEGY • Leverage superior R&D capabilities, operational execution, U.S. manufacturing footprint, and business development expertise to continue expanding cash generation • On track to Maintain current cadence of 10-15 launches annually • Explore opportunities to expand scope and scale of Rare Disease business • Investing in dedicated organization for Cortrophin Gel in gout • Invest high single-digit percentage of Generics revenue into R&D
© 2026 ANI Pharmaceuticals, Inc. 7 Q1 2026 and recent business highlights 1. Totals may not sum due to rounding. 2. Adjusted Non-GAAP EBITDA is a Non-GAAP financia l measure. See Appendix for a reconciliation to the most directly comparable GAAP financial metr ic. 3. Includes Cortrophin Gel, ILUVIEN, Brands, and Brand royalties and other revenues. 4. Includes Generic pharmaceutical products and other generic revenues. • Strong top- and bottom-line growth supported by solid performance across each business unit • Continued momentum in demand for Cortrophin Gel • Monetized innovative IP, creating new stream of royalty revenue • Raising 2026 financial guidance for total net revenues and adjusted EBITDA • Board authorized new $100M share repurchase program $94.1 $128.2 $103.0 $109.2 1Q25 1Q26 +20% $197.1 $237.5 $50.7 $63.0 1Q25 1Q26 Adjusted Non-GAAP EBITDA ($M)(2) +24% Total Net Revenues ($M)(1) Rare Disease and Brands(3) Generics and Other(4)
© 2026 ANI Pharmaceuticals, Inc. 8 Establishing collaborations to drive future value for our stakeholders Out-licensed intellectual property to Harmony Biosciences in January 2026 Harmony to utilize IP to expand its intellectual property estate for pitolisant and to develop a novel formulation Low single digit royalties on pitolisant-based products $10M payment upon achievement of certain development milestones; expected to be achieved in 2Q26 and 3Q26 $15M upfront license fee recognized in 1Q26
© 2026 ANI Pharmaceuticals, Inc. 9 1. Adjusted Non-GAAP EBITDA, Adjusted Non-GAAP Diluted EPS, and Adjusted Non-GAAP Gross Margin are Non-GAAP f inancial measures. 2. For full year 2026 guidance, Adjusted Non-GAAP Diluted EPS is defined as adjusted Non-GAAP net income divided by the diluted weighted average shares outstanding during the period ("Non-GAAP Adjusted Diluted Weighted- Average Shares Outstanding"). Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding excludes certain dilut ive shares related to the senior convertible notes as they are intended to be covered by our capped call transactions. 3. Blended royalty rate due to Merck for Cortrophin Gel net sales expected to be in high-20 percent range in 2026. 4. Does not assume any share repurchases in 2026. 5. Based on 2026 f inancial guidance provided by the company on May 8, 2026 YoY Growth $1,055 - $1,115 22 - 29% $540 - $575 55 - 65% $78 - $83 4 - 11% $275 - $290 24 - 31% $8.83 - $9.34 16 - 23% Metric ($ millions, except EPS) Net Revenue (Total Company) Cortrophin Gel Net Revenue ILUVIEN Net Revenue Adjusted Non-GAAP EBITDA(1) Adjusted Non-GAAP Diluted EPS(1)(2) Prior 2026 Guidance 2026 Financial Guidance5 Reflects significant top- and bottom-line growth 2026 adjusted non-GAAP gross margin expected to be 59.9% - 60.9%(3) $1,080 - $1,140 $540 - $575 $78 - $83 $285 - $300 $9.19 - $9.69 Current 2026 Guidance Anticipates 21.5M – 21.8M shares outstanding for the purpose of calculating full year 2026 adjusted non-GAAP diluted EPS(4)
© 2026 ANI Pharmaceuticals, Inc. 10 Rare Disease Business
© 2026 ANI Pharmaceuticals, Inc. 11 Rare Disease business represents primary driver of growth; expected to account for ~60% of revenues in 2026 1. Percent change calculated based on the midpoint of 2026 financial guidance range provided by the Company on May 8, 2026. 2. Alimera acquisition occurred in September 2024; ILUVIEN revenue only represents partial year of ownership. 3. Represents 2026 financial guidance ranges provided by the Company on May 8, 2026. Rare Disease Net Revenues ($ millions) $198 $348 $540 - $575 $32 $75 $78 - $83 2022 2023 2024 2025 2026E $230 $423 $42 $112 $618 - $658 (3) Cortrophin Gel ILUVIEN +84% +51%(1) (2)
© 2026 ANI Pharmaceuticals, Inc. 12 Cortrophin Gel: lead rare disease asset Acceleration in momentum across new patient starts and dispensed volumes Potential for strong multi-year growth as key indications are significantly underpenetrated Broad growth across all targeted specialties: rheumatology, nephrology, neurology, pulmonology and ophthalmology Prescribing in acute gouty arthritis flares expected to be a key growth driver in 2026; represents ~18% of total utilization
© 2026 ANI Pharmaceuticals, Inc. 13 2021 2022 2023 2024 2025 $594M $558M $537M $684M $1.0B ACTH MARKET SALES -6% -4% +27%YoY Growth +50% Acthar Gel Purified Cortrophin® Gel >$1.3B +30% 2026(1) Overall ACTH market growth driven by continued expansion into key indications • Expect continued strong multi- year growth potential driven by large market opportunity as key indications remain significantly underpenetrated • Proven ability to reach new HCPs and patients with approximately half of Cortrophin Gel prescribers naive to the ACTH category before prescribing Cortrophin Gel 1. Based on the sum of 2026 Cortrophin Gel net revenue guidance and Keenova Therapeutics’ 2026 guidance for Acthar Gel per its fourth quarter 2025 earnings release (March 31, 2026). +24% CAGR
© 2026 ANI Pharmaceuticals, Inc. 14 Diagnosed ~9,900,0001 ~500,000 addressable annual flares ~285,000 addressable patients Acute Gout Flares Cortrophin Gel has strong multi-year growth potential with addressable patient populations across indications significantly under-penetrated ~36% receive treatment annually2 1.5 – 2 average flares per year3 ~8% receive an injectable flare treatment4 Diagnosed ~750,0005 Multiple Sclerosis Flares 1-2.2 average flares per year6,7 25% of patients do not respond to a steroid8 Diagnosed ~1,600,0009 Rheumatoid Arthritis 17-25% experience a flare annually10,11 Up to 30% of patients do not respond to a steroid12 Diagnosed ~35,00020 Nephrotic Syndrome (proteinuria reduction) 12.5% – 20% of patients do not respond to a steroid21,22 Diagnosed ~175,00013-15 Sarcoidosis 25-42.5% of patients are treated13,16 10-25% of patients require a second line therapy17-19 ~300,000 addressable annual flares ~187,500 addressable patients ~100,000 addressable annual flares ~480,000 addressable patients ~10,000 addressable patients ~6,000 addressable patients * A ll re ferences provided in appendix. Addressable patient populations shared for select ind ications.
© 2026 ANI Pharmaceuticals, Inc. 15 $42 $112 $198 $348 $540 - $575 2022 2023 2024 2025 2026E Cortrophin Gel Net Revenues ($ millions) Investing in Cortrophin Gel to build momentum in 2026 and beyond 1. Year-over-year growth calculated based on the midpoint of 2026 financial guidance range provided by the Company on May 8, 2026. 2. Represents 2026 financial guidance provided by the Company on May 8, 2026. (2) +76% +60%(1) Investing in high ROI commercial initiatives • Focus efforts to continue momentum established in Nephrology, Neurology, Rheumatology and Pulmonology as the ACTH market expands • Expanding rare disease organization by ~90-people dedicated to gout that targets primary care and podiatrist offices, full organization expansion completed and operational by the end of June 2026 • Realizing synergies with integrated ophthalmology team Generating scientific and clinical evidence • Advancing Phase 4 clinical trial of Cortrophin Gel in acute gouty arthritis flares • Robust pipeline of investigator-initiated trials across disease states • Continued investment in preclinical data and publications Enhancing convenience • Launched Pre-Filled Syringe in 2025 • Continuing to evaluate opportunities to enhance patient convenience
© 2026 ANI Pharmaceuticals, Inc. 16 Capturing sizable additional opportunity in gout through commercial organization expansion * A ll re ferences provided in appendix. Addressable patient populations shared for select ind ications. • Focus on most severe patients: ~285,000 who are currently treated with injectables for their flares • Need for new treatments for those patients not well served by first line options • Co-morbidities may limit certain treatment options • Only approved ACTH therapy to treat acute gouty arthritis flares • In 2025, ran successful pilots across 10 territories in primary care and podiatry • Prefilled syringe and subcutaneous option for Cortrophin self- administration enables flare readiness, unlike most injectable options • Rare Disease commercial organization expansion targeting high priority PCPs and podiatrists who see most severe acute gouty arthritis patients to be in the field by end of 2Q26 • Majority of commercial team has been onboarded Diagnosed ~9,900,0001 Acute Gout Flares ~36% receive treatment annually2 1.5 – 2 average flares per year3 Large underpenetrated market opportunity Successful track record in Gout Our approach to serving more patients ~8% receive an injectable flare treatment4 ~285,000 patients ~500,000 addressable annual flares
© 2026 ANI Pharmaceuticals, Inc. 17 ILUVIEN is a long-acting ocular therapy approved for DME and chronic NIU-PS 36-months of continuous therapy via CONTINUOUS MICRODOSING of fluocinolone acetonide (FAc) in patients with retinal disease Diabetic Macular Edema (DME): • Chronic disease that is the leading cause of vision loss in diabetic patients; ~4% of diabetic patients develop clinically significant macular edema • >50,000 patients in the U.S. are not well served by anti-VEGF therapy; <5,000 patient starts annually for DME in the U.S. • Strong global clinical evidence in DME supported by NEW DAY study results Chronic non-infectious uveitis affecting the posterior segment (NIU-PS): • Inflammation of the eye that can lead to pain, visual impairment, and vision loss • >75,000 patients in the U.S. are candidates for treatment, and steroids are the standard of care; <5,000 patient starts annually for NIU-PS in the U.S.
© 2026 ANI Pharmaceuticals, Inc. 18 Returning ILUVIEN to growth by leveraging established commercial and patient access initiatives NEW DAY study results in DME published in Ophthalmology Expect to present SYNCHRONICITY trial results in NIU-PS at medical meeting in 3Q 2026 Growing use of alternative access channels to navigate market access challenges for Medicare patients
© 2026 ANI Pharmaceuticals, Inc. 19 Generics Business
© 2026 ANI Pharmaceuticals, Inc. 20 $210 $269 $301 $384 2022 2023 2024 2025 Robust, diversified pipeline and new product launch execution • Robust pipeline in place with goal to deliver ~10-15 new product launches annually; 6 products launched YTD; ANI holds #2 CGT filing position • Invest high single-digit percentage of Generics revenue into Generics R&D to support business • Diversified portfolio of ~125 product families and largest product expected to account for less than approximately 6% of Generics revenues in 2026 Strong operational backbone with a focus on cost efficiency • Three U.S. based manufacturing sites with strong GMP track record; all sites currently in VAI or NAI status • Manufactured and supplied over 2.5 billion doses of therapeutics in last 12 months(1) • Systematic approach to reducing raw materials and finished goods costs and lean corporate spend Generics business driving strong cash flow generation with superior R&D capabilities, U.S. manufacturing footprint, and operational excellence Generics Net Revenues2 ($ millions) +12% +28% 1. Per IQVIA NSP Sales data - MAT December 2025 data. 2. Reflects generic pharmaceutical products.
© 2026 ANI Pharmaceuticals, Inc. 21 U.S. Manufacturing Footprint
© 2026 ANI Pharmaceuticals, Inc. 22 United States 93% Europe 2% India 2% Others 3% United States 48% Europe 26% India 18% China 5% Others 3% Over 90% of ANI’s revenues come from finished goods manufactured in the U.S.; ~95% of revenues from products sold in the U.S. API by Country of Origin Finished Goods (FG) by Country of Origin % of Revenues % of Revenues ~95% of revenues from products sold in the U.S. NOTE: Statistics on this slide based upon in ternal analysis utilizing estimated / projected fu ll year 2025 Revenue, procurement, manufacturing and other data as prepared June 2025
© 2026 ANI Pharmaceuticals, Inc. 23 U.S.-based manufacturing footprint with strong GMP track record Baudette, MN 130k sf Baudette, MN Containment Facility - 47k sf East Windsor, NJ 120k sf Facility Overview and Capabilities • Manufacturing, packaging, warehouse • Schedule CII vault & CIII cage space • Lab space - R&D/analytical testing • Solutions, suspensions, topicals, tablets, capsules, and powder for suspension • DEA-licensed for Schedule II controlled substances • Manufacturing, packaging, warehouse • Low-humidity suite for moisture-sensitive compounds • Fully-contained high potency facility for hormone, steroid, and oncolytic products • DEA Schedule III capability • 100K ft2 of manufacturing, packaging, lab, warehouse, and administrative space • 20K ft2 expansion added 15 new manufacturing suites and new QC lab • Solid oral tablets and capsules, liquid suspensions and solutions, powder for oral suspension, controlled substances as well as containment & nano-milling • API development & low volume production Annual Capacity • Solid Dose ~2.5BN doses • Liquid Unit ~23MM doses • Liquids ~20MM bottles • Powder ~4MM bottles • Tablets ~2.5BN doses • Capsules ~150MM doses • Blisters ~ 45MM doses • Tablets & Capsules ~3.0BN doses • Packaged Units ~20MM units • Liquids ~10MM bottles • Powder ~ 2MM bottles ; Semi Solids GMP Five FDA inspections since 2013 Latest FDA inspection – December 2024 Current site status: VAI Seven DEA inspections since 2013 Latest DEA inspection – August 2023 Current site status: VAI Seven FDA inspections since 2017, Four DEA inspections since 2016 Latest FDA inspection – January 2024 Current site status: NAI status (zero 483s)
© 2026 ANI Pharmaceuticals, Inc. 24 Summary
© 2026 ANI Pharmaceuticals, Inc. 25 ANI well positioned to deliver long-term growth and value creation • Rare Disease expected to represent ~60% of total revenue in 2026 • Lead asset, Cortrophin Gel, expected to deliver +60% YoY growth in 2026 with substantial, multi-year growth opportunity(1) • Strong Generics cash flows further enables investments in Rare Disease business VIRTUOUS CYCLE OF GROWTH DRIVES TRANSFORMATION INTO A LEADING RARE DISEASE COMPANY 1. Based on the midpoint of 2026 financial guidance ranges provided by the Company on May 8, 2026. 2. Adjusted Non-GAAP EBITDA is a Non-GAAP financia l measure. 3. Based on trailing twelve months adjusted Non-GAAP EBITDA of $242M. Accelerate transformation into leading Rare Disease company Continued excellence in Generics R&D and operations Execute disciplined capital allocation strategy FINANCIAL STRENGTH 2026 STRATEGIC PRIORITIES Cash as of 3/31/26 $311M Net leverage as of 3/31/26(3) ~1.3x Projected 2026 total revenues(1) ~$1.1B Projected 2026 adjusted non- GAAP EBITDA(1)(2) ~$293M 27% YoY26% YoY
© 2026 ANI Pharmaceuticals, Inc. 26 Appendix
© 2026 ANI Pharmaceuticals, Inc. 27 Adjusted Non-GAAP EBITDA calculation and US GAAP to Non-GAAP reconciliation
© 2026 ANI Pharmaceuticals, Inc. 28 Adjusted Non-GAAP diluted earnings per share calculation and US GAAP to Non-GAAP reconciliation 1. Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistr ibuted earnings to participating securities. 2. Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding exclude certain dilutive shares rela ted 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 offset the dilutive effect of the senior convertible notes recognized in the calculation of GAAP diluted EPS in this repor ting per iod in full, and therefore 239,000 shares for the three months ended March 31, 2026, have been excluded from the calculation of the Non-GAAP Adjusted Diluted Weighted-Average Shares outstanding.
© 2026 ANI Pharmaceuticals, Inc. 29 References for Cortrophin Gel Addressable Patient Population Gout 1. Singh G, Lingala B, Mithal A. Gout and hyperuricaemia in the USA: prevalence and trends. Rheumatology (Oxford). 2019 Dec 1;58(12):2177-2180. doi: 10.1093/rheumatology/kez196. PMID: 31168609 2. Thorpe K. Partnership to fight chronic disease. May 21, 2018 3. Singh JA, Morlock A, Morlock R. Gout Flare Burden in the United States: A Multiyear Cross‐Sectional Survey Study. ACR Open Rheumatology. 2025 Jan;7(1):e11759, ANI claims data analysis (data on file), Proudman C, et al. Arthritis Res Ther. 2019;21:132. 4. Based on ANI claims analysis Multiple Sclerosis 5. Hittle M, Culpepper WJ, Langer-Gould A, Marrie RA, Cutter GR, Kaye WE, Wagner L, Topol B, LaRocca NG, Nelson LM, Wallin MT. Population-based estimates for the prevalence of multiple sclerosis in the United States by race, ethnicity, age, sex, and geographic region. JAMA neurology. 2023 Jul 1;80(7):693-701. 6. Nazareth TA, Rava AR, Polyakov JL, Banfe EN, Waltrip II RW, Zerkowski KB, Herbert LB. Relapse prevalence, symptoms, and health care engagement: patient insights from the Multiple Sclerosis in America 2017 survey. Multiple sclerosis and related disorders. 2018 Nov 1;26:219-34. 7. Oleen-Burkey M, Castelli-Haley J, Lage MJ, Johnson KP. Burden of a multiple sclerosis relapse: the patient’s perspective. The Patient-Patient-Centered Outcomes Research. 2012 Mar;5(1):57-69. 8. Wynn D, Goldstick L, Bauer W, Zhao E, Tarau E, Cohen JA, Robertson D, Miller A. Results from a multicenter, randomized, double‐blind, placebo‐controlled study of repository corticotropin injection for multiple sclerosis relapse that did not adequately respond to corticosteroids. CNS Neuroscience & Therapeutics. 2022 Mar;28(3):364-71. Rheumatoid Arthritis 9. Evaluate Pharma, Evaluate Epi USA Population Insight 10. Bachman K. et al. J Rheumatol. 2018;45(11):1515-1521 11. Oh YJ, Moon KW. Predictors of flares in patients with rheumatoid arthritis who exhibit low disease activity: A nationwide cohort study. Journal of Clinical Medicine. 2020 Oct 7;9(10):3219. 12. Chikanza IC, Kozaci DL. Corticosteroid resistance in rheumatoid arthritis: molecular and cellular perspectives. Rheumatology. 2004 Nov 1;43(11):1337-45. Sarcoidosis 13. Baughman RP, et al. Ann Am Thorac Soc. 2016;13(8):1244-1252 14. Gerke AK, Judson MA, Cozier YC, Culver DA, Koth LL. Disease burden and variability in sarcoidosis. Annals of the American Thoracic Society. 2017 Dec;14(Supplement 6):S421-8. 15. Nam HH, Washington A, Butt M, Maczuga S, Guck D, Yanosky JD, Helm MF. The prevalence and geographic distribution of sarcoidosis in the United States. JAAD international. 2022 Dec 1;9:30-2. 16. Sangani R, Bosch NA, Govender P, Scarpato B, Walkey AJ, Newman J, Law AC, Gillmeyer KR, Shankar DA. Sarcoidosis treatment patterns in the United States: 2016-2022. Chest. 2025 Apr 1;167(4):1099-106. 17. ANI primary market research 2023 18. El Jammal T, Jamilloux Y, Gerfaud-Valentin M, Valeyre D, Sève P. Refractory sarcoidosis: a review. Therapeutics and clinical risk management. 2020 Apr 17:323-45. 19. Mahmood K, Butt NI, Ashfaq F, Younus R. Refractory Sarcoidosis. Journal of Ayub Medical College Abbottabad. 2023 Jul 9;35(3):479-81. Nephrotic Syndrome 20. Evaluate Pharma, Evaluate Epi USA Population Insight 21. Bensimhon AR, Williams AE, Gbadegesin RA. Treatment of steroid-resistant nephrotic syndrome in the genomic era. Pediatric nephrology. 2019 Nov;34(11):2279-93. / 22. Ghedira-Besbes L, Mallek A, Guediche MN. Idiopathic nephrotic syndrome in children: report of 57 cases. La Tunisie Medicale. 2003 Sep 1;81(9):702-8.
FAQ
What 2026 revenue guidance did ANI Pharmaceuticals (ANIP) provide?
ANI Pharmaceuticals guided to total 2026 net revenue of $1.08–$1.14 billion, up from prior guidance of $1.055–$1.115 billion. This reflects expected year-over-year growth of roughly the mid‑20% range, driven mainly by expansion in its Rare Disease portfolio.
How important is the Rare Disease business to ANI Pharmaceuticals’ 2026 plan?
The Rare Disease segment is expected to be ANI’s primary growth driver, contributing about 60% of total 2026 revenues. Cortrophin Gel and ILUVIEN together are guided to $618–$658 million in revenue, significantly shifting the company’s mix toward branded rare disease therapies.
What are ANI Pharmaceuticals’ 2026 targets for Cortrophin Gel and ILUVIEN?
For 2026, ANI expects Cortrophin Gel net revenue of $540–$575 million and ILUVIEN net revenue of $78–$83 million. Cortrophin Gel is projected to deliver roughly 60% year-over-year growth as it expands in underpenetrated indications like acute gouty arthritis flares.
What profitability guidance did ANI Pharmaceuticals give for 2026?
ANI targets 2026 adjusted non-GAAP EBITDA of $285–$300 million and adjusted non-GAAP diluted EPS of $9.19–$9.69. The company also expects adjusted non-GAAP gross margin between 59.9% and 60.9%, supported by a larger Rare Disease contribution.
How did ANI Pharmaceuticals perform in Q1 2026?
In Q1 2026, ANI reported total net revenues of $237.5 million and adjusted non-GAAP EBITDA of $63.0 million. Both metrics increased versus the prior-year quarter, with growth supported by Rare Disease products and the Generics segment’s continued cash generation.
What capital allocation actions did ANI Pharmaceuticals announce?
ANI’s board authorized a new $100 million share repurchase program and the company plans to invest a high single-digit percentage of Generics revenue into R&D. As of March 31, 2026, ANI held $311 million in cash and had net leverage of roughly 1.3x.
What is ANI Pharmaceuticals’ collaboration with Harmony Biosciences?
ANI out-licensed intellectual property to Harmony Biosciences in January 2026, receiving a $15 million upfront license fee recognized in Q1 2026. The deal includes low single‑digit royalties on pitolisant-based products and $10 million in development milestone payments expected across 2Q and 3Q 2026.