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ANI Pharmaceuticals Reports Record Fourth Quarter and Full Year 2025 Financial Results and Reaffirms 2026 Financial Guidance

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ANI Pharmaceuticals (Nasdaq: ANIP) reported record Q4 2025 net revenue of $247.1M (+29.6% YoY) and full‑year revenue of $883.4M (+43.8% YoY). Cortrophin Gel drove Rare Disease growth with Q4 revenue of $111.4M (+87.6%) and full‑year $347.8M (+75.6%).

The company posted Q4 GAAP EPS $1.18 and adjusted non‑GAAP diluted EPS $2.33, record adjusted EBITDA of $65.4M Q4 and $229.8M full year, and reaffirmed 2026 guidance targeting >$1B revenue and adjusted EBITDA $275M–$290M.

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Positive

  • Total revenue +43.8% YoY to $883.4M in 2025
  • Cortrophin Gel revenue +75.6% YoY to $347.8M in 2025
  • Record adjusted non‑GAAP EBITDA of $229.8M for 2025
  • Generics revenue +27.6% YoY to $384.1M in 2025
  • Q4 GAAP EPS $1.18 and adjusted non‑GAAP EPS $2.33

Negative

  • Brands revenue down 5.3% to $61.3M for 2025
  • GAAP debt principal of $629.1M as of Dec 31, 2025
  • Non‑GAAP gross margin declined to 59.6% in Q4 2025

Market Reaction – ANIP

+7.58% $83.00
15m delay 1 alert
+7.58% Since News
$83.00 Last Price
+$122M Valuation Impact
$1.73B Market Cap
447 Volume

Following this news, ANIP has gained 7.58%, reflecting a notable positive market reaction. The stock is currently trading at $83.00. This price movement has added approximately $122M to the company's valuation.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Q4 2025 Net Revenue: $247.1 million 2025 Net Revenue: $883.4 million 2025 Cortrophin Gel Revenue: $347.8 million +5 more
8 metrics
Q4 2025 Net Revenue $247.1 million Record quarterly net revenues, up 29.6% year-over-year
2025 Net Revenue $883.4 million Record full year net revenues, up 43.8% year-over-year
2025 Cortrophin Gel Revenue $347.8 million Full year Cortrophin Gel net revenues, up 75.6% year-over-year
Q4 2025 GAAP EPS $1.18 Quarterly diluted GAAP income per share
Q4 2025 Adj. EPS $2.33 Quarterly adjusted non-GAAP diluted earnings per share
Q4 2025 Adj. EBITDA $65.4 million Record quarterly adjusted non-GAAP EBITDA, up 30.6% year-over-year
Cash & Equivalents $285.6 million Unrestricted cash and cash equivalents as of December 31, 2025
Outstanding Debt $629.1 million Principal value of outstanding debt including senior convertible notes

Market Reality Check

Price: $77.15 Vol: Volume 181,552 vs 20-day ...
low vol
$77.15 Last Close
Volume Volume 181,552 vs 20-day average 321,718 suggests trading activity was below recent norms ahead of this earnings release. low
Technical Shares at $77.15 trade below the 200-day MA of $79.58 and about 22.46% below the 52-week high, while sitting 42.61% above the 52-week low.

Peers on Argus

Pre-news, ANIP was up 1.11% while peers were mixed: ALVO +1.96%, SUPN +0.27%, bu...

Pre-news, ANIP was up 1.11% while peers were mixed: ALVO +1.96%, SUPN +0.27%, but INDV, AMRX, and HCM were down. With gains and losses split, ANIP’s move appears more company-specific than sector-driven.

Common Catalyst At least one peer (AMRX) also reported earnings today, but broader same-direction sector momentum was not evident.

Previous Earnings Reports

5 past events · Latest: Feb 13 (Neutral)
Same Type Pattern 5 events
Date Event Sentiment Move Catalyst
Feb 13 Earnings call timing Neutral +0.9% Scheduled Q4 and full-year 2025 results release and conference call details.
Nov 07 Q3 2025 earnings Positive +0.2% Record Q3 revenues and EBITDA with raised 2025 revenue and EPS guidance.
Oct 24 Earnings call timing Neutral -0.7% Announcement of Q3 2025 earnings release date and investor call logistics.
Aug 08 Q2 2025 earnings Positive +18.1% Record Q2 revenue and EBITDA, strong Cortrophin Gel growth, raised guidance.
Aug 01 Earnings call timing Neutral +0.9% Notice of upcoming Q2 2025 earnings release and management conference call.
Pattern Detected

Earnings-related and conference-announcement headlines have generally coincided with modestly positive single-day moves, with one notably strong rally on preliminary 2025 results and 2026 guidance.

Recent Company History

Over the last several quarters, ANI has repeatedly highlighted record results and raised guidance. Q2 and Q3 2025 earnings showed strong Rare Disease growth, led by Cortrophin Gel, and prompted higher full-year outlooks. Preliminary full-year 2025 results and 2026 guidance on Jan 12, 2026 also coincided with a double‑digit move. Today’s detailed Q4 and full-year 2025 report and reaffirmed 2026 guidance build directly on that earlier preliminary update and the company’s rare disease–focused strategy.

Historical Comparison

+3.9% avg move · Past earnings and related announcements for ANIP have produced average one-day moves of about 3.87%,...
earnings
+3.9%
Average Historical Move earnings

Past earnings and related announcements for ANIP have produced average one-day moves of about 3.87%, with stronger reactions when guidance was raised or new records were highlighted.

Across recent quarters, ANIP’s earnings cycle has shown a pattern of record revenues, expanding Rare Disease contribution led by Cortrophin Gel, and progressively higher full-year guidance, culminating in preliminary 2025 results and 2026 guidance before this detailed Q4/full-year report.

Market Pulse Summary

The stock is up +7.6% following this news. A strong positive reaction aligns with ANI’s pattern of f...
Analysis

The stock is up +7.6% following this news. A strong positive reaction aligns with ANI’s pattern of favorable responses to robust earnings and guidance updates. The company reported record Q4 and full-year 2025 revenues and adjusted EBITDA, with Cortrophin Gel and Rare Disease driving growth, and reaffirmed its 2026 guidance. Historically, similar updates, such as on Jan 12, 2026 and Q2 2025, have coincided with sizable gains, though past rallies eventually faced normal consolidation.

Key Terms

adjusted non-gaap ebitda, gaap, non-gaap, senior convertible notes, +4 more
8 terms
adjusted non-gaap ebitda financial
"Record quarterly and full year adjusted non-GAAP EBITDA of $65.4 million and $229.8 million..."
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.
gaap financial
"Quarterly and full year GAAP net income available to common shareholders of $27.5 million..."
GAAP, or Generally Accepted Accounting Principles, are a set of standardized rules and guidelines that companies follow when preparing their financial statements. They ensure consistency, transparency, and comparability across different companies, making it easier for investors to understand and compare financial information accurately. This helps investors make informed decisions based on trustworthy and uniform financial reports.
non-gaap financial
"On a non-GAAP basis, gross margin decreased from 63.5% to 59.6%..."
Non-GAAP refers to financial measures that companies use to show their earnings or performance without including certain expenses or income that are often added back to give a different picture. It matters because it can make a company's results look better or more favorable, but it may also hide important costs, so investors need to look at both GAAP (official rules) and non-GAAP numbers to get a full understanding.
senior convertible notes financial
"...$629.1 million in principal value of outstanding debt (inclusive of our senior convertible notes)."
A senior convertible note is a loan a company issues that ranks near the top of payment priority and can be exchanged for the company’s stock under preset terms. Think of it as an IOU that promises interest payments and first dibs on repayments if assets are liquidated, but also gives the lender the option to become an owner later; investors watch these for repayment safety, interest income, and potential stock dilution.
rule 10b5-1 trading plan regulatory
"The transaction was executed under a pre-arranged Rule 10b5-1 trading plan adopted on June 16, 2025."
A Rule 10b5-1 trading plan is a pre-arranged schedule that allows company insiders to buy or sell stock at specific times, even if they have inside information. It helps prevent accusations of unfair trading by making these transactions look planned and transparent, rather than sneaky or illegal.
restricted stock financial
"shares were withheld to cover tax liabilities tied to vesting of previously granted restricted stock awards..."
Shares granted to an individual that carry limits on transfer or sale until certain conditions are met, such as staying with the company for a set time or hitting performance targets. Think of them as a locked gift that gradually opens; for investors they matter because they affect how many shares may enter the market later, signal management incentives and potential dilution, and reveal confidence in future company performance.
tax-withholding disposition financial
"shares of common stock were disposed of at $76.70 per share as a tax-withholding disposition tied to restricted stock vesting."
A tax-withholding disposition is an event or transaction—such as selling or transferring securities, exercising options, or receiving compensation—that triggers a requirement to hold back part of the payment and remit it to tax authorities. It matters to investors because it reduces the cash they receive immediately and can change the timing and amount of taxable income, like a cashier taking a portion of your sale proceeds to pay taxes before you get the rest.
capped call transactions financial
"Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding excludes certain dilutive shares... 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.

AI-generated analysis. Not financial advice.

  • Record quarterly and full year net revenues of $247.1 million and $883.4 million, up 29.6% and 43.8% year-over-year, respectively
  • Total Rare Disease quarterly and full year net revenue of $131.3 million and $422.6 million, up 50.8% and 84.1% year-over-year, respectively
    • Quarterly and full year Purified Cortrophin® Gel net revenues of $111.4 million and $347.8 million, up 87.6% and 75.6% year-over-year, respectively
    • Quarterly and full year ILUVIEN® and YUTIQ® net revenues of $19.8 million and $74.9 million, respectively(1)
  • Quarterly and full year GAAP net income available to common shareholders of $27.5 million and $77.2 million, respectively
  • Record quarterly and full year adjusted non-GAAP EBITDA of $65.4 million and $229.8 million, up 30.6% and 47.3% year-over-year, respectively
  • Quarterly diluted GAAP income per share of $1.18 and adjusted non-GAAP diluted earnings per share of $2.33; full year diluted GAAP income per share of $3.32 and adjusted non-GAAP diluted earnings per share of $7.89

PRINCETON, N.J., Feb. 27, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the fourth quarter and year ended December 31, 2025.

“2025 was a year of significant growth for our Rare Disease and Generics businesses, which drove expansion to both our top- and bottom-line,” said Nikhil Lalwani, President and CEO of ANI. “We are building on this momentum as we continue to focus on our key 2026 priority of accelerating our transformation into a leading Rare Disease company, supported by strong execution in Generics and disciplined capital deployment.”

Mr. Lalwani continued, “We see a significant multi-year growth opportunity for Cortrophin Gel as we expand in underpenetrated specialty indications and launch a dedicated organization for acute gouty arthritis flares. With a proven track record, we expect to deliver more than $1 billion in revenue in 2026, with Rare Disease representing approximately 60% of total revenue, while continuing to fulfill our purpose of Serving Patients, Improving Lives.”

(1) NIU-PS indication was merged into the ILUVIEN label in mid-2025; full-year 2025 results include YUTIQ revenue

Fourth Quarter and Recent Business Highlights:

Rare Disease

  • Cortrophin Gel:
    • Cortrophin Gel net revenues were $111.4 million for the fourth quarter of 2025, an increase of 87.6% over the same period in 2024. Cortrophin Gel net revenues were $347.8 million for full year 2025, an increase of 75.6% over the same period in 2024.
    • Growth in both periods was driven by record new patient starts, continued momentum across target indications, the expanded sales force for neurology, rheumatology and nephrology, and synergies from the combined ophthalmology sales force.
    • Prescribing for acute gouty arthritis flares, for which Cortrophin Gel is the only approved ACTH therapy, remained a significant growth driver, representing over 15% of Cortrophin Gel use.
    • In January, the Company announced a planned expansion of its Rare Disease organization by ~90 people to capture the unique opportunity for Cortrophin Gel in acute gouty arthritis flares. The expanded organization is expected to deploy in mid-2026 and target appropriate patients in Podiatry and Primary Care.
  • ILUVIEN:
    • ILUVIEN net revenues were $19.8 million for the fourth quarter of 2025 and $74.9 million for full year 2025.
    • The Company continues to execute commercial and patient access initiatives established in 2025, including strategic investments in marketing and medical affairs, expanded multi-indication coverage to streamline care, growth of alternative access channels, and strengthened commercial execution.

Generics

  • Generics net revenues were $100.8 million in the fourth quarter of 2025, an increase of 28.2% over the same period in 2024. The increase was driven by continued strength in the partnered generic launch that commenced in the second half of the third quarter of 2025. Generics net revenues were $384.1 million for full year 2025, an increase of 27.6% year-over-year, reflecting the Company’s strong R&D capabilities, execution, and steady cadence of new product launches.

Brands

  • Brands net revenues were $12.3 million for the fourth quarter of 2025, a decrease of 37.9% over the same period in 2024. Brands net revenues were $61.3 million for full year 2025, a decrease of 5.3% year-over-year. Both periods reflect a normalization in demand for certain products.

Fourth Quarter 2025 Financial Results

  Three Months Ended December 31,    
(in thousands)  2025  2024 Change % Change
Rare Disease and Brands        
Cortrophin Gel $111,431 $59,400 $52,031  87.6%
ILUVIEN(2)  19,843  27,643  (7,800) (28.2)%
Rare Disease total net revenues $131,274 $87,043 $44,231  50.8%
Brands  12,315  19,842  (7,527) (37.9)%
Rare Disease and Brands total net revenues $143,589 $106,885 $36,704  34.3%
Generics and Other        
Generic pharmaceutical products  100,760  78,600  22,160  28.2%
Royalties and other pharmaceutical services  2,711  5,089  (2,378) (46.7)%
Generics and Other total net revenues $103,471 $83,689 $19,782  23.6%
Total net revenues $247,060 $190,574 $56,486  29.6%

(2) NIU-PS indication was merged into the ILUVIEN label in mid-2025; fourth quarter 2024 results include YUTIQ revenue

All comparisons are made versus the same period in 2024 unless otherwise stated.

Total net revenues for the fourth quarter of 2025 were $247.1 million, an increase of 29.6% over the prior year period.

Net revenues for Rare Disease, which includes Cortrophin Gel and ILUVIEN, increased 50.8% to $131.3 million. Cortrophin Gel net revenues increased 87.6% to $111.4 million driven by increased volume. ILUVIEN net revenues were $19.8 million.

Net revenues for Brands decreased 37.9% to $12.3 million driven by normalization in demand for certain products.

Net revenues for Generic pharmaceutical products increased 28.2% to $100.8 million driven by continued strength in the partnered generic launch that commenced in the third quarter of 2025 and contribution from new product launches.

On a GAAP basis, gross margin increased from 57.9% to 59.4%, driven by the non-recurrence of costs of goods related to Alimera purchase accounting. On a non-GAAP basis, gross margin decreased from 63.5% to 59.6%, primarily due to higher sales of royalty bearing products, including Cortrophin Gel and a partnered generic product that launched in the third quarter, and lower Brands revenues.

On a GAAP basis and non-GAAP basis, research and development expenses decreased 26.3% to $12.3 million and 27.5% to $11.7 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 and non-GAAP basis, selling, general, and administrative expenses increased 18.7% to $82.8 million and 28.1% to $70.2 million, respectively, due to increased employment related costs, investment in Rare Disease sales and marketing infrastructure including the Company’s new, larger ophthalmology sales and marketing team and activities, legal expenses, and an overall increase in activities to support the growth of our business.

On a GAAP basis, the Company reported net income attributable to common shareholders of $27.5 million, or $1.18 per diluted share, for the fourth quarter of 2025 compared to net loss of $10.7 million, or $0.55 per diluted share, in the prior year period. On a non-GAAP basis, the Company reported adjusted diluted earnings per share of $2.33 for the fourth quarter of 2025 compared to $1.63 in the prior year period.

Adjusted non-GAAP EBITDA for the fourth quarter of 2025 was $65.4 million, an increase of 30.6% from the fourth quarter of 2024, driven by increased net revenues and gross profit.

For reconciliations of adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 3 and Table 4 below, respectively.

Liquidity

As of December 31, 2025, the Company had $285.6 million in unrestricted cash and cash equivalents, $281.1 million in net accounts receivable and $629.1 million in principal value of outstanding debt (inclusive of our senior convertible notes). The Company generated cash flow from operations of $185.2 million in 2025.

Full Year 2026 Financial Guidance:

The Company reaffirms its full year 2026 financial guidance.

 Full Year 2026
Guidance
2025 ActualGrowth
Net Revenue (Total Company)$1,055 million - $1,115 million$883 million19% - 26%
Cortrophin Gel Net Revenue$540 million - $575 million$348 million55% - 65%
ILUVIEN Net Revenue$78 million - $83 million$75 million4% - 11%
Adjusted Non-GAAP EBITDA$275 million - $290 million$230 million20% - 26%
Adjusted Non-GAAP Diluted EPS$8.83 - $9.34$7.8912% - 18%
    

ANI expects full year total company adjusted non-GAAP gross margin between 59.3% and 60.3%. The Company will continue to tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share as a tax rate of 26%, unless the item being adjusted is not tax deductible in whole or in part.

The Company anticipates approximately 21.5 million and 21.8 million shares outstanding for the purpose of calculating full year adjusted non-GAAP diluted EPS and expects its annual U.S. GAAP effective tax rate to be between 26% and 28%.

Conference Call

The Company’s management will host a conference call today to discuss its fourth quarter and fiscal year ended December 31, 2025 results.

DateFriday, February 27, 2026
Time8:00 a.m. ET
Toll free (U.S.)800-274-8461
Conference ID5230834
Webcast (live and replay)www.anipharmaceuticals.com, under the “Investors” section
  

The live and archived webcast and accompanying slide presentation will be accessible from the Company’s website at www.anipharmaceuticals.com, under the Investors section under Events and Presentations. The replay of the webcast will be accessible for 12 months following the event.

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 (loss), excluding tax expense (benefit), interest expense, net, other (income) expense, 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, loss (gain) on disposal of assets, intangible asset impairment charges, litigation expenses related to certain matters, amortization of certain purchase price adjustments, severance expense, 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 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, litigation expenses related to certain matters, amortization of certain purchase price adjustments, 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 (loss), 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, loss (gain) on disposal of assets, intangible asset impairment charges, litigation expenses related to certain 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, loss (gain) on disposal of assets, intangible asset impairment charges, litigation expenses related to certain 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 2029 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 2029 convertible senior notes recognized in the calculation of GAAP diluted EPS in this reporting period in full, and therefore 588,000 shares and 692,000 shares for the three and twelve months ended December 31, 2025, have been excluded from the calculation of the Non-GAAP Adjusted Diluted Weighted-Average Shares outstanding, respectively.

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 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, litigation expenses related to certain matters, inventory step-up amortization, 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, severance 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, litigation expenses related to certain 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 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, inventory step-up amortization, 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 gross margin should be considered in addition to, but not in lieu of, gross margin reported under GAAP.

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 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 Company’s strategy; its expectations regarding its future operations, financial position or revenues, including 2026 financial guidance; the commercialization and potential sales of the Company’s products, including current and planned product launches and any additional product launches from the Company’s generic pipeline; expansion plans for the Rare Disease business, including with respect to the planned expansion of the Company’s sales force for acute gouty arthritis, and with respect to the transformation of ANI into a leading rare disease company; anticipated growth opportunities for Cortrophin Gel and ILUVIEN; 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, expedients, 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, and the focus of the current U.S. presidential administration, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; 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; 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; the potential impact of new U.S. tax legislation on the Company’s business; and general business and economic conditions, such as inflationary pressures, geopolitical conditions.

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.

Investor Relations:
Courtney Mogerley, Argot Partners
T: 646-368-8014
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 December 31, Twelve Months Ended December 31,
  2025   2024   2025   2024 
Net Revenues$247,060  $190,574  $883,366  $614,376 
        
Operating Expenses       
Cost of sales (excluding depreciation and amortization) 100,269   80,280   341,310   250,210 
Research and development 12,261   16,646   51,664   44,581 
Selling, general, and administrative 82,790   69,719   317,745   249,636 
Depreciation and amortization 22,613   22,600   91,417   67,731 
Contingent consideration fair value adjustment (5,727)  (1,893)  (31,012)  (619)
Loss (gain) on disposal of assets 87      382   (5,347)
Intangible asset impairment charge    7,600   767   7,600 
        
Total Operating Expenses, net 212,293   194,952   772,273   613,792 
        
Operating income (loss) 34,767   (4,378)  111,093   584 
        
Other Expense, net       
Unrealized gain (loss) on investment in equity securities 273   (1,991)  2,824   6,307 
Interest expense, net (4,411)  (6,015)  (20,060)  (17,602)
Other income (expense), net 850   (1,378)  1,934   (4,033)
Loss on extinguishment of debt          (7,468)
        
Income (Loss) Before Income Tax Expense (Benefit) 31,479   (13,762)  95,791   (22,212)
        
Income tax expense (benefit) 3,989   (3,486)  17,454   (3,690)
        
Net Income (Loss)$27,490  $(10,276) $78,337  $(18,522)
        
Dividends on Series A Convertible Preferred Stock    (406)  (1,157)  (1,625)
        
Net Income (Loss) Available to Common
Shareholders
$27,490  $(10,682) $77,180  $(20,147)
        
Basic and Diluted Income (Loss) Per Share:       
Basic Income (Loss) Per Share$1.24  $(0.55) $3.50  $(1.04)
Diluted Income (Loss) Per Share$1.18  $(0.55) $3.32  $(1.04)
        
Basic Weighted-Average Shares Outstanding 20,686   19,445   20,053   19,318 
Diluted Weighted-Average Shares Outstanding 21,774   19,445   21,228   19,318 
                


ANI Pharmaceuticals, Inc. and Subsidiaries
Table 2: US GAAP Balance Sheets
(unaudited, in thousands)
    
 December 31,
2025
 December 31,
2024
    
Current Assets   
Cash and cash equivalents$285,585  $144,861 
Restricted cash 36   33 
Accounts receivable, net 281,082   221,726 
Inventories 143,067   136,782 
Prepaid income taxes 11,027   772 
Prepaid expenses and other current assets 23,189   17,975 
Investment in equity securities 9,131   6,307 
Total Current Assets 753,117   528,456 
Non-current Assets   
Property and equipment, net 62,476   56,863 
Deferred tax assets, net of deferred tax liabilities and valuation allowance 69,072   85,106 
Intangible assets, net 479,526   541,834 
Goodwill 62,480   59,990 
Derivatives and other non-current assets 13,706   12,220 
Total Assets$1,440,377  $1,284,469 
Current Liabilities   
Income taxes payable$1,291  $5,622 
Income taxes payable - foreign 948   1,899 
Current debt, net of deferred financing costs 17,268   9,172 
Accounts payable 62,583   45,656 
Accrued royalties 48,497   22,626 
Accrued compensation and related expenses 37,897   37,725 
Accrued government rebates 43,154   18,714 
Returned goods reserve 49,504   39,274 
Current contingent consideration 167   29 
Accrued expenses and other 16,803   13,735 
Total Current Liabilities 278,112   194,452 
Non-current Liabilities   
Non-current debt, net of deferred financing costs and current component 291,840   309,108 
Non-current convertible notes, net of deferred financing costs 307,927   305,812 
Non-current contingent consideration, net of current 9,610   19,825 
Accrued licensor payments due    20,961 
Other non-current liabilities 12,164   5,781 
Total Liabilities$899,653  $855,939 
Mezzanine Equity   
Convertible Preferred Stock, Series A    24,850 
Stockholders’ Equity   
Common Stock 3   2 
Class C Special Stock     
Preferred Stock     
Treasury stock (33,249)  (21,040)
Additional paid-in capital 596,036   519,653 
Accumulated deficit (23,099)  (100,279)
Accumulated other comprehensive income, net of tax 1,033   5,344 
Total Stockholders’ Equity 540,724   403,680 
Total Liabilities, Mezzanine Equity, and Stockholders’ Equity$1,440,377  $1,284,469 
        


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 December 31,   Three Months Ended December 31, Three Months Ended December 31, Three Months Ended December 31, Three Months Ended December 31,
   2025   2024     2025  2024  2025   2024   2025   2024   2025   2024 
Net Income (Loss) $27,490  $(10,276) As reported: $247,060 $190,574 $100,269  $80,280  $82,790  $69,719  $12,261  $16,646 
                       
Add/(Subtract):                      
Interest expense, net  4,411   6,015                   
Other (income) expense, net  (850)  1,378                   
Income tax expense (benefit)  3,989   (3,486)                  
Depreciation and amortization  22,613   22,600                   
Contingent consideration fair value adjustment  (5,727)  (1,893)                  
Unrealized (gain) loss on investment in equity securities  (273)  1,991                   
Intangible asset impairment charge     7,600                   
Loss on disposal of assets  87                      
Stock-based compensation  9,768   7,061  Stock-based compensation      (507)  (367)  (8,741)  (6,233)  (520)  (461)
M&A transaction and integration expenses  607   5,965  M&A transaction and integration expenses            (607)  (5,965)      
Litigation expenses  3,241   1,657  Litigation expenses            (3,241)  (1,657)      
Inventory step-up amortization     10,375  Inventory step-up amortization         (10,375)            
Severance     1,057  Severance               (1,057)      
Adjusted non-GAAP EBITDA $65,356  $50,044  As adjusted: $247,060 $190,574 $99,762  $69,538  $70,201  $54,807  $11,741  $16,185 
                                         


        Reconciliation of certain adjusted non-GAAP accounts:
        Net Revenues Cost of sales (excluding depreciation and amortization) Selling, general, and administrative Research and development
  Twelve Months Ended December 31,   Twelve Months Ended December 31, Twelve Months Ended December 31, Twelve Months Ended December 31, Twelve Months Ended December 31,
   2025   2024     2025  2024  2025   2024   2025   2024   2025   2024 
Net Income (Loss) $78,337  $(18,522) As reported: $883,366 $614,376 $341,310  $250,210  $317,745  $249,636  $51,664  $44,581 
                       
Add/(Subtract):                      
Interest expense, net  20,060   17,602                   
Other (income) expense, net  (1,934)  4,033                   
Loss on extinguishment of debt     7,468                   
Income tax expense (benefit)  17,454   (3,690)                  
Depreciation and amortization  91,417   67,731                   
Contingent consideration fair value adjustment  (31,012)  (619)                  
Unrealized gain on investment in equity securities  (2,824)  (6,307)                  
Intangible asset impairment charge  767   7,600                   
Loss (gain) on disposal of assets  382   (5,347)                  
Stock-based compensation  37,929   29,344  Stock-based compensation      (1,803)  (1,277)  (33,982)  (26,533)  (2,144)  (1,534)
M&A transaction and integration expenses  3,823   20,163  M&A transaction and integration expenses            (3,823)  (20,163)      
Litigation expenses  15,278   6,395  Litigation expenses            (15,278)  (6,395)      
Inventory step-up amortization     13,599  Inventory step-up amortization         (13,599)            
Severance  105   6,365  Severance            (105)  (6,365)      
Equity payout     10,190  Equity payout               (9,171)     (1,019)
Adjusted non-GAAP EBITDA $229,782  $156,005  As adjusted: $883,366 $614,376 $339,507  $235,334  $264,557  $181,009  $49,520  $42,028 
                                         


ANI Pharmaceuticals, Inc. and Subsidiaries
Table 4: Adjusted non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per Share Reconciliation
(unaudited, in thousands, except per share amounts)
    
 Three Months Ended December 31, Twelve Months Ended December 31,
  2025   2024   2025   2024 
Net Income (Loss) Available to Common Shareholders$27,490  $(10,682) $77,180  $(20,147)
        
Add/(Subtract):       
Non-cash interest expense 238   232   974   149 
Depreciation and amortization 22,613   22,600   91,417   67,731 
Contingent consideration fair value adjustment (5,727)  (1,893)  (31,012)  (619)
Loss (gain) on disposal of assets 87      382   (5,347)
Unrealized (gain) loss on investment in equity securities (273)  1,991   (2,824)  (6,307)
Intangible asset impairment charge    7,600   767   7,600 
Stock-based compensation 9,768   7,061   37,929   29,344 
M&A transaction and integration expenses 607   5,965   3,823   20,163 
Litigation expenses 3,241   1,657   15,278   6,395 
Inventory step-up amortization    10,375      13,599 
Severance    1,057   105   6,365 
Equity payout          10,190 
Loss on extinguishment of debt          7,468 
Other (income) expense (878)  1,335   (2,093)  3,869 
Less:       
Estimated tax impact of adjustments (7,716)  (15,021)  (29,834)  (38,154)
        
Adjusted non-GAAP Net Income Available to Common Shareholders(1)$49,450  $32,277  $162,092  $102,299 
Diluted Weighted-Average       
Shares Outstanding 21,774   19,445   21,228   19,318 
Adjusted Diluted Weighted-Average(2)       
Shares Outstanding 21,186   19,785   20,536   19,668 
        
Adjusted non-GAAP       
Diluted Earnings per Share$2.33  $1.63  $7.89  $5.20 

(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 excludes certain dilutive shares related to the 2029 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 2029 convertible senior notes recognized in the calculation of GAAP diluted EPS in this reporting period in full, and therefore approximately 588,000 shares and 692,000 shares for the three and twelve months ended December 31, 2025, have been excluded from the calculation of the Non-GAAP Adjusted Diluted Weighted-Average Shares outstanding, respectively.


FAQ

What were ANI Pharmaceuticals' Q4 2025 and full‑year 2025 revenues (ANIP)?

Q4 2025 revenue was $247.1 million; full‑year 2025 revenue was $883.4 million. According to the company, revenue rose 29.6% in Q4 and 43.8% for the year driven by Rare Disease and Generics sales.

How much did Cortrophin Gel contribute to ANI's 2025 results (ANIP)?

Cortrophin Gel generated $111.4 million in Q4 and $347.8 million for 2025. According to the company, growth was driven by new patient starts, expanded specialty sales, and traction in acute gouty arthritis flares.

What guidance did ANI (ANIP) reaffirm for full‑year 2026 revenue and EBITDA?

ANI reaffirmed 2026 revenue guidance of $1,055M–$1,115M and adjusted EBITDA of $275M–$290M. According to the company, guidance reflects continued Rare Disease expansion and generics execution.

What were ANI's Q4 2025 earnings per share figures (ANIP)?

Q4 2025 GAAP diluted EPS was $1.18; adjusted non‑GAAP diluted EPS was $2.33. According to the company, adjusted EPS excludes certain non‑cash and transaction items to show operating performance.

How strong was ANI's cash, receivables, and debt position at year‑end 2025 (ANIP)?

As of Dec 31, 2025 ANI held $285.6M cash, $281.1M net receivables, and $629.1M principal debt. According to the company, cash and 2025 operating cash flow supported investments and growth initiatives.
Ani Pharmaceutic

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