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ANI Pharmaceuticals Reports Record Second Quarter 2026 Financial Results

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ANI Pharmaceuticals (Nasdaq: ANIP) reported record second quarter 2026 net revenues of $266.0 million, up 25.9% year-over-year, driven by Rare Disease and Generics. Cortrophin Gel net revenues rose 43.5% to $117.1 million, while Generics revenues increased 9.7% to $99.1 million. ILUVIEN revenues declined 16.1% to $18.7 million and Brands declined 10.5% to $11.8 million, partially offset by $17.7 million of brand royalties and other revenues from the Harmony Agreement.

GAAP net income available to common shareholders was $24.7 million with diluted EPS of $1.05. Adjusted non-GAAP EBITDA was $71.6 million, up 32.4%, and adjusted diluted EPS was $2.21. ANI reaffirmed 2026 total net revenue guidance of $1.08–$1.14 billion and adjusted non-GAAP EBITDA of $285–$300 million, while revising Cortrophin Gel 2026 revenue guidance to $520–$540 million. The company ended June 30, 2026 with $360.2 million in cash and cash equivalents and generated $115.0 million in year-to-date operating cash flow.

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Positive

  • Total Q2 2026 net revenues $266.0 million, up 25.9% YoY
  • Cortrophin Gel Q2 revenues $117.1 million, up 43.5% YoY
  • Adjusted non-GAAP EBITDA $71.6 million in Q2, up 32.4% YoY
  • GAAP diluted EPS $1.05 vs. $0.36 prior year; adjusted EPS $2.21 vs. $1.80
  • Cash and cash equivalents $360.2 million; operating cash flow $115.0 million YTD
  • 2026 total net revenue guidance reaffirmed at $1.08–$1.14 billion

Negative

  • ILUVIEN Q2 revenues $18.7 million, down 16.1% YoY
  • Brands Q2 revenues $11.8 million, down 10.5% YoY
  • GAAP gross margin fell to 62.4% from 64.7% YoY
  • Adjusted non-GAAP gross margin fell to 62.6% from 64.9% YoY
  • Cortrophin Gel 2026 guidance cut to $520–$540 million from $540–$575 million

News Explained

At June 30, the company reported $360.2 million cash alongside $620.9 million of outstanding debt.

ANI Pharmaceuticals reported results for the quarter ended June 30, 2026; the material holder-related change is a board authorization, effective May 8, 2026, allowing the company to repurchase up to $100.0 million of common stock through May 2029.

The release reports $17.7 million of Harmony Agreement revenue, including $9.7 million in royalties and $8.0 million for development work completed during the quarter. The remaining development work is expected to be completed in the third quarter, when ANI expects to recognize an additional $2.0 million of milestone revenue.

At June 30, 2026, ANI reported $620.9 million of principal-value outstanding debt and $274.5 million of net accounts receivable.

The Cortrophin Gel expansion to podiatrists and primary-care physicians for acute gout was fully operational by the end of June. Over 95% of representatives had generated multiple new patient cases, and more than one-third of prescribers had initiated at least two cases.

The next specified clinical-information milestone is detailed SYNCHRONICITY results and additional analyses at a medical conference in the fourth quarter of 2026.

Market Reaction – ANIP

-6.15% $77.55
15m delay
-6.15% Vs previous close
$77.55 Last Price
$74.39 $85.00 Day Range
$1.70B Market Cap
1.4x Rel. Volume

Following this news, ANIP has declined 6.15%, reflecting a notable negative market reaction. Our momentum scanner has triggered 9 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $77.55.

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Market Context

Earnings-tag history averaged a -1.23% 24-hour move, adding caution to the current results assessmen...
Analysis

Earnings-tag history averaged a -1.23% 24-hour move, adding caution to the current results assessment. Revenue growth and Cortrophin momentum were offset by ILUVIEN and margin declines, while net insider selling remained a risk factor.

Key Figures

Quarterly net revenues: $266.0 million Cortrophin Gel revenue: $117.1 million GAAP net income: $24.7 million +5 more
8 metrics
Quarterly net revenues $266.0 million Second quarter 2026; up 25.9% year-over-year
Cortrophin Gel revenue $117.1 million Second quarter 2026; up 43.5% year-over-year
GAAP net income $24.7 million Quarterly net income available to common shareholders
Adjusted EBITDA $71.6 million Second quarter 2026; up 32.4% year-over-year
GAAP diluted EPS $1.05 Second quarter 2026
Adjusted diluted EPS $2.21 Second quarter 2026; non-GAAP
Total revenue guidance $1,080-$1,140 million Full-year 2026 guidance
Adjusted EBITDA guidance $285-$300 million Full-year 2026 non-GAAP guidance

Previous Earnings Reports

5 past events · Latest: Jul 24 (Neutral)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 24 Earnings scheduling Neutral -1.1% Scheduled discussion of second-quarter financial results and webcast details
May 08 First-quarter earnings Positive -2.4% Reported quarterly growth, raised full-year guidance, and authorized share repurchases
Apr 24 Earnings scheduling Neutral +0.7% Scheduled first-quarter results release and management conference call
Feb 27 Fourth-quarter earnings Positive -4.2% Reported record quarterly and annual results while reaffirming annual guidance
Feb 13 Earnings scheduling Neutral +0.9% Scheduled fourth-quarter and full-year results release before market open

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Tag-specific history showed negative 24-hour reactions for the two recent financial-results announcements despite positive reported results.

Key Terms

adjusted non-gaap ebitda, gaap, phase 4, single-arm
4 terms
adjusted non-gaap ebitda financial
"Quarterly adjusted non-GAAP EBITDA of $71.6 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 GAAP net income available to common shareholders"
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.
View in glossary
phase 4 medical
"6-month topline data from the Phase 4 open-label"
Phase 4 is the stage after a drug or vaccine has been approved and is sold to the public, where regulators and companies keep watching how it performs in the real world to detect rare side effects, long‑term effects, or differences in effectiveness across different groups. Think of it as ongoing quality control for a product already on shelves; results can prompt label changes, safety warnings, sales impacts or recalls, all of which matter to investors evaluating risk and future revenue.
single-arm medical
"Phase 4 open-label single-arm SYNCHRONICITY clinical trial"
A single-arm study is a clinical trial that gives all participants the same treatment and does not include a separate comparison group or placebo. Think of it like testing a new recipe by serving it to diners without offering a control dish — you can see how people respond, but you can’t directly compare results to another option. For investors, single-arm trials can speed development and reduce cost but leave more uncertainty about how a treatment stacks up against existing therapies and how regulators will view the evidence.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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  • Quarterly net revenues of $266.0 million, an increase of 25.9% year-over-year
  • Purified Cortrophin® Gel net revenues of $117.1 million, an increase of 43.5% year-over-year
  • Quarterly GAAP net income available to common shareholders of $24.7 million; Quarterly adjusted non-GAAP EBITDA of $71.6 million, an increase of 32.4% year-over-year
  • Diluted GAAP income per share of $1.05 and adjusted non-GAAP diluted earnings per share of $2.21
  • Reaffirming 2026 guidance for total net revenue of $1,080 - $1,140 million and adjusted non-GAAP EBITDA of $285 - $300 million

PRINCETON, N.J., Aug. 07, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the second quarter ended June 30, 2026.

“In the second quarter, we delivered outstanding financial results, while we implemented the largest Rare Disease sales force expansion in our history,” said Nikhil Lalwani, President and CEO of ANI. “Leading indicators from our gout expansion for Cortrophin Gel are very positive, with the team rapidly delivering a large funnel of new patient cases, with significant breadth and depth of prescribing. The encouraging initial trends we are seeing from the gout expansion, and the continued momentum in our existing specialties, further support our conviction in Cortrophin Gel’s sizable multi-year growth opportunity.”

“We are reaffirming our full year 2026 total net revenue guidance of $1,080 - $1,140 million and adjusted non-GAAP EBITDA of $285 - $300 million. Based on our results in the first half of 2026, we are modestly adjusting our Cortrophin Gel net revenue guidance to $520 - $540 million, reflecting 50-55% growth for the full year. Our solid track record of commercial execution and prudent capital allocation combined with our strong balance sheet position us well for continued shareholder value creation,” he concluded.

Second Quarter and Recent Business Highlights:

Rare Disease

  • Cortrophin Gel:
    • Cortrophin Gel net revenues were $117.1 million for the second quarter of 2026, an increase of 43.5% over the same period in 2025. Year-over-year growth in the second quarter of 2026 was driven primarily by the existing specialty areas of Nephrology, Neurology, Ophthalmology, Pulmonology and Rheumatology. Momentum for the existing specialties has continued into the third quarter with a record number of new cases initiated in July.
    • ANI’s organization expansion to reach podiatrists and primary care physicians for Cortrophin Gel in acute gouty arthritis flares was fully operational as of the end of June, as planned.
    • The Company’s key demand metrics of the gout expansion have been very positive to date, with over 95% of the reps generating multiple new patient cases and over a third of the prescribers initiating two or more cases, and the Company has seen balanced demand from both podiatrists and primary care physicians.
    • The gout expansion targets an estimated addressable market of approximately 285,000 patients, the majority of whom are treated by podiatrists and primary care physicians.


  • ILUVIEN:
    • ILUVIEN® net revenues were $18.7 million for the second quarter of 2026, a decrease of 16.1% over the same period in 2025 based primarily on timing of international shipments.
    • The Company announced 6-month topline data from the Phase 4 open-label single-arm SYNCHRONICITY clinical trial in chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) and anticipates announcing the detailed results and additional analyses at a key medical conference attended by retina specialists in the fourth quarter of 2026.

Generics

  • Generics net revenues were $99.1 million in the second quarter of 2026, an increase of 9.7% over the same period in 2025, driven by new product launches, including the partnered generic launch that commenced in the third quarter of 2025.
  • Launched 12 new Generics products year-to-date, and on track for at least 15 new product launches in 2026.

Brand Royalties and Other Revenues

  • The Company recognized $17.7 million of revenue under the Harmony Agreement, comprised of $9.7 million of royalties on net sales of pitolisant-based products for the second quarter of 2026, and $8.0 million based upon work completed in the quarter toward the achievement of certain development milestones. The balance of the development work is expected to be completed in the third quarter of 2026, at which time the Company will recognize an additional $2.0 million in development milestone revenue. In addition, the Company will continue to earn low single digit royalties on net sales of pitolisant-based products.

Brands

  • Brands net revenues were $11.8 million for the second quarter of 2026, a decrease of 10.5% over the same period in 2025, reflecting a normalization in demand for certain products.

Corporate Highlights

  • Effective on May 8, 2026, ANI’s board of directors authorized a share repurchase program to repurchase up to $100.0 million in common stock through May 2029.

Second Quarter 2026 Financial Results

  Three Months Ended June 30,    
(in thousands)  2026  2025 Change % Change
Rare Disease and Brands        
Cortrophin Gel $117,126 $81,647 $35,479  43.5%
ILUVIEN and YUTIQ(1)  18,718  22,316  (3,598) (16.1)%
Rare Disease total net revenues $135,844 $103,963 $31,881  30.7%
Brands  11,813  13,195  (1,382) (10.5)%
Brand royalties and other revenues  17,731    17,731  100.0%
Rare Disease and Brands total net revenues $165,388 $117,158 $48,230  41.2%
Generics and Other        
Generic pharmaceutical products  99,051  90,297  8,754  9.7%
Other generic revenues  1,605  3,916  (2,311) (59.0)%
Generics and Other total net revenues $100,656 $94,213 $6,443  6.8%
Total net revenues $266,044 $211,371 $54,673  25.9%

(1) There were no sales of YUTIQ during the quarter ended June 30, 2026, as the Company transitioned promotional efforts in the U.S. from YUTIQ to ILUVIEN, which has a combined label of DME and NIU-PS during the second quarter of 2025.

All comparisons are made versus the same period in 2025 unless otherwise stated.

Total net revenues for the second quarter of 2026 were $266.0 million, an increase of 25.9% over the prior year period.

Net revenues for Rare Disease, which includes Cortrophin Gel and ILUVIEN, increased 30.7% to $135.8 million. Cortrophin Gel net revenues increased 43.5% to $117.1 million and ILUVIEN net revenues decreased 16.1% to $18.7 million. Growth for Cortrophin was driven primarily by increased volume while ILUVIEN was impacted by timing of shipments in certain international markets.

Net revenues for Brands decreased 10.5% to $11.8 million driven by normalization in demand for certain products.

Net revenues from Brand royalties and other revenues include $8.0 million of revenue recognized upon work completed in the quarter toward the achievement of certain development milestones and royalties of approximately $9.7 million, related to the Harmony Agreement.

Net revenues for Generic pharmaceutical products increased 9.7% to $99.1 million driven by continued strength in the partnered generic launch that commenced in the third quarter of 2025, contribution from new product launches and commercial and operational outperformance.

On a GAAP basis, gross margin decreased from 64.7% to 62.4%, while on a non-GAAP basis, gross margin decreased from 64.9% to 62.6%. Both decreases were primarily due to higher sales of royalty bearing products, including Cortrophin Gel and a partnered generic product that launched in the third quarter of 2025, and the non-recurrence of prior year revenues from Prucalopride. These effects were somewhat tempered by the revenue recognized under the Harmony Agreement.

On a GAAP basis and a non-GAAP basis, research and development expenses decreased 10.8% to $14.7 million and 11.4% to $14.1 million, respectively, driven by timing associated with ongoing and new projects to support future growth of our Rare Disease and Generics businesses.

On a GAAP basis, selling, general, and administrative expenses increased 12.1% to $91.7 million, while on a non-GAAP basis, selling, general, and administrative expenses increased 20.2% to $80.7 million. Both comparisons include incremental expense related to the initial marketing and recruitment expense of our expansion of the Rare Disease team, which is targeting opportunities in acute gouty arthritis, and an overall increase in activities to support the growth of our business.

On a GAAP basis, the Company reported net income attributable to common shareholders of $24.7 million, or $1.05 per diluted share, for the second quarter of 2026 compared to $8.1 million, or $0.36 per diluted share, in the prior year period. On a non-GAAP basis, the Company reported adjusted diluted earnings per share of $2.21 for the second quarter of 2026 compared to $1.80 in the prior year period.

Adjusted non-GAAP EBITDA for the second quarter of 2026 was $71.6 million, an increase of 32.4% from the second quarter of 2025, driven by increased net revenues and gross profit.

For reconciliations of adjusted non-GAAP metrics, including non-GAAP gross margin, non-GAAP research and development expenses, non-GAAP selling, general and administrative expenses, adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measures, please see Table 3, Table 4, and Table 5 below, respectively.

Liquidity

As of June 30, 2026, the Company had $360.2 million in unrestricted cash and cash equivalents, $274.5 million in net accounts receivable and $620.9 million in principal value of outstanding debt (inclusive of the Company’s senior convertible notes). The Company generated cash flow from operations of $115.0 million on a year to date basis.

Full Year 2026 Financial Guidance

 Revised Full Year 2026
Guidance
Previous Full Year 2026 Guidance2025 ActualGrowth
Net Revenue (Total Company)$1,080 million - $1,140 million$1,080 million - $1,140 million$883 million22% - 29%
Cortrophin Gel Net Revenue$520 million - $540 million$540 million - $575 million$348 million50% - 55%
ILUVIEN Net Revenue$78 million - $83 million$78 million - $83 million$75 million4% - 11%
Adjusted Non-GAAP EBITDA$285 million - $300 million$285 million - $300 million$230 million24% - 31%
Adjusted Non-GAAP Diluted EPS$9.19 - $9.69$9.19 - $9.69$7.89
16% - 23%
     

ANI expects full year total company adjusted non-GAAP gross margin between 59.9% and 60.9% and anticipates approximately 21.5 million and 21.8 million shares outstanding for the purpose of calculating full year adjusted non-GAAP diluted EPS. The Company expects its annual U.S. GAAP effective tax rate to be between 26% and 28% and will continue to tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share utilizing a tax rate of 26%.

Conference Call

The Company’s management will host a conference call and webcast today, Friday, August 7, at 8:00 a.m. ET to discuss its second quarter 2026 results.

To view the webcast, please click here. Links to access the webcast and conference call will also be available on the “Events & Presentations” page of the Company’s website at https://www.anipharmaceuticals.com, under the “Investors” section. A replay of the event will remain accessible for up to one year.

Non-GAAP Financial Measures

Adjusted non-GAAP EBITDA

ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.

Adjusted non-GAAP EBITDA is defined as net income, excluding tax expense, interest expense, net, other expense (income), net, depreciation and amortization expense, non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized gain (loss) on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expenses, and certain other items that vary in frequency and impact on ANI’s results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided below.

ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted EBITDA guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.

Adjusted non-GAAP Net Income

ANI’s management considers adjusted non-GAAP net income to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP net income when analyzing Company performance.

Adjusted non-GAAP net income is defined as net income, plus the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP net income should be considered in addition to, but not in lieu of, net income reported under GAAP. A reconciliation of adjusted non-GAAP net income to the most directly comparable GAAP financial measure is provided below.

Adjusted non-GAAP Diluted Earnings per Share

ANI’s management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP diluted earnings per share when analyzing Company performance.

Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding exclude certain dilutive shares related to the senior convertible notes as they are intended to be covered by our capped call transactions. Our outstanding capped call transactions are intended to fully offset the dilutive effect of the senior convertible notes recognized in the calculation of GAAP diluted EPS, and therefore 340,000 shares and 345,000 shares, for the three and six months ended June 30, 2026, respectively, have been excluded from the calculation of Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding.

Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP diluted earnings per share should be considered in addition to, but not in lieu of, diluted earnings (loss) per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure is provided below.

ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted diluted earnings per share guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.

Other non-GAAP metrics

ANI’s management considers non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses to be financial indicators of ANI’s operating performance, providing investors and analysts with useful measures of operating results unaffected by non-cash stock-based compensation expense, M&A transaction and integration expenses, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations.

Management uses adjusted non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses when analyzing Company performance. Non-GAAP research and development expenses is defined as research and development expenses, excluding non-cash stock-based compensation expense, and certain other items that vary in frequency and impact on ANI’s results of operations.

Non-GAAP selling, general, and administrative expenses is defined as selling, general, and administrative expenses, excluding non-cash stock-based compensation expense, M&A transaction and integration expenses, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations.

Each of adjusted non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses should be considered in addition to, but not in lieu of, research and development expenses, and selling, general, and administrative expenses reported under GAAP, respectively.

A reconciliation of each of non-GAAP research and development expenses and non-GAAP selling, general and administrative expenses to the most directly comparable GAAP financial measure is provided below.

ANI’s management also considers non-GAAP gross margin to be a financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses non-GAAP gross margin when analyzing Company performance.

Non-GAAP gross margin is defined as adjusted non-GAAP net revenues less non-GAAP cost of sales (excluding depreciation and amortization) divided by non-GAAP net revenues. Non-GAAP 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 https://www.anipharmaceuticals.com/.

Forward-Looking Statements

To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the Company’s strategy; its expectations regarding its future operations, financial position or revenues, including its 2026 financial guidance; its expectations regarding its share repurchase program; the results and timing of the Company’s preclinical studies, clinical trials, regulatory submissions and regulatory approvals; the commercialization and anticipated sales of the Company’s products, including current and planned product launches and any additional product launches from the Company’s generic pipeline; the Company’s estimates of the market opportunity and addressable patient populations for its products; the expansion and execution capabilities of the Company’s sales force for acute gouty arthritis for Cortrophin Gel; the Company’s anticipated growth opportunities, including for Cortrophin Gel and ILUVIEN; the Company’s positioning for continued shareholder value creation; anticipated R&D developments and clinical trial advances; and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of the Company’s approved products, including Cortrophin Gel and ILUVIEN, to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; the Company’s ability to complete or achieve any or all of the intended benefits of acquisitions and investments, in a timely manner or at all; delays and disruptions in the production of the Company’s approved products; increased costs and potential loss of revenues if the Company needs to change suppliers due to the limited number of suppliers for its raw materials, active pharmaceutical ingredients, excipients, and other materials; delays and disruptions in the production of the Company’s approved products as a result of its reliance on single source third party contract manufacturing supply for certain of its key products, including Cortrophin Gel and ILUVIEN; delays or failure to obtain or maintain approvals by the FDA of the Company’s products; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies; risks that the Company may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of the Company’s products from both domestic and overseas sources due to supply chain disruptions or for any other reason, including increased costs due to tariffs or macroeconomic disruptions; the ability of the Company’s manufacturing partners to meet its product demands and timelines; the impact of changes or fluctuations in exchange rates; the Company’s ability to develop, license or acquire, and commercialize new products; the Company’s obligations in agreements under which it licenses, develops or commercializes rights to products or technology from third parties and its ability to maintain such licenses; the level of competition the Company faces and the legal, regulatory and/or legislative strategies employed by its competitors to prevent or delay competition from generic alternatives to branded products; the Company’s ability to protect its intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which the Company is, or may become, a party; the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; the Company’s ability to maintain the services of its key executives and other personnel; and general business and economic conditions, such as inflationary pressures, 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:
Irina Koffler, Vice President, Investor Relations
T: 917-734-7387
E: Irina.koffler@anipharmaceuticals.com

Media Relations:
Argot Partners
T: 212-600-1494
E: ani@argotpartners.com

SOURCE: ANI Pharmaceuticals, Inc.

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 June 30, Six Months Ended June 30,
  2026   2025   2026   2025 
Net Revenues$266,044  $211,371  $503,506  $408,493 
        
Operating Expenses       
Cost of sales (excluding depreciation and amortization) 100,158   74,615   193,740   147,652 
Research and development 14,747   16,535   25,347   27,099 
Selling, general, and administrative 91,661   81,771   165,316   158,299 
Depreciation and amortization 19,640   23,281   40,559   46,172 
Contingent consideration fair value adjustment (622)  1,277   (804)  (10,815)
        
Total Operating Expenses, net 225,584   197,479   424,158   368,407 
        
Operating income 40,460   13,892   79,348   40,086 
        
Other (expense) income, net       
Unrealized gain (loss) on investment in equity securities 741   332   6,494   (589)
Interest expense, net (3,636)  (5,438)  (7,405)  (10,922)
Other (expense) income, net (468)  1,739   (1,119)  1,937 
        
Income Before Income Tax Expense 37,097   10,525   77,318   30,512 
        
Income tax expense 12,386   1,976   23,115   6,282 
        
Net Income$24,711  $8,549  $54,203  $24,230 
        
Dividends on Series A Convertible Preferred Stock    (407)     (813)
        
Net Income Available to Common Shareholders$24,711  $8,142  $54,203  $23,417 
        
Basic and Diluted Income Per Share:       
Basic Income Per Share$1.09  $0.37  $2.40  $1.07 
Diluted Income Per Share$1.05  $0.36  $2.32  $1.05 
        
Basic Weighted-Average Shares Outstanding 21,158   19,834   21,036   19,721 
Diluted Weighted-Average Shares Outstanding 21,915   20,308   21,785   20,177 



ANI Pharmaceuticals, Inc. and Subsidiaries
Table 2: US GAAP Balance Sheets
(unaudited, in thousands)
    
 June 30,
2026
 December 31,
2025
Assets   
Current Assets   
Cash and cash equivalents$360,212  $285,585 
Restricted cash 35   36 
Accounts receivable, net 274,469   281,082 
Inventories 143,149   143,067 
Prepaid expenses and other current assets 31,942   34,216 
Investment in equity securities 15,626   9,131 
Total Current Assets 825,433   753,117 
Non-current Assets   
Property and equipment, net 73,223   62,476 
Deferred tax assets, net 71,495   69,072 
Intangible assets, net 449,857   479,526 
Goodwill 62,480   62,480 
Other non-current assets 11,624   13,706 
Total Assets$1,494,112  $1,440,377 
Liabilities and Stockholders’ Equity   
Current Liabilities   
Accounts payable$73,830  $62,583 
Accrued royalties 55,830   48,497 
Accrued compensation and related expenses 27,154   37,897 
Accrued government rebates 41,392   43,154 
Returned goods reserve 44,013   49,504 
Accrued expenses and other 16,575   16,970 
Income taxes payable 3,532   2,239 
Current debt, net 21,329   17,268 
Total Current Liabilities 283,655   278,112 
Non-current Liabilities   
Debt, net 280,155   291,840 
Convertible notes, net 309,009   307,927 
Contingent consideration 8,546   9,610 
Other non-current liabilities 15,535   12,164 
Total Liabilities$896,900  $899,653 
Stockholders’ Equity   
Common Stock 3   3 
Class C Special Stock     
Preferred Stock     
Treasury stock (53,817)  (33,249)
Additional paid-in capital 620,249   596,036 
Retained earnings (Accumulated deficit) 31,104   (23,099)
Accumulated other comprehensive (loss) income, net of tax (327)  1,033 
Total Stockholders’ Equity 597,212   540,724 
Total Liabilities and Stockholders’ Equity$1,494,112  $1,440,377 



ANI Pharmaceuticals, Inc. and Subsidiaries
Table 3: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation
(unaudited, in thousands)
                       
                       
        Reconciliation of certain adjusted non-GAAP accounts:
        Net Revenues Cost of sales (excluding depreciation and amortization) Selling, general, and administrative Research and development
  Three Months Ended
June 30,
   Three Months Ended
June 30,
 Three Months Ended June 30, Three Months Ended June 30, Three Months Ended June 30,
   2026   2025     2026  2025  2026   2025   2026   2025   2026   2025 
Net Income $24,711  $8,549  As reported: $266,044 $211,371 $100,158  $74,615  $91,661  $81,771  $14,747  $16,535 
                       
Add/(Subtract):                      
Interest expense, net  3,636   5,438                   
Other expense (income), net  468   (1,739)                  
Income tax expense  12,386   1,976                   
Depreciation and amortization  19,640   23,281                   
Contingent consideration fair value adjustment  (622)  1,277                   
Unrealized gain on investment in equity securities  (741)  (332)                  
Stock-based compensation  11,406   9,603  Stock-based compensation      (552)  (405)  (10,238)  (8,615)  (616)  (583)
M&A transaction and integration expenses  40   823  M&A transaction and integration expenses            (40)  (823)      
Litigation expenses  673   5,201  Litigation expenses            (673)  (5,201)      
Adjusted non-GAAP EBITDA $71,597  $54,077  As adjusted: $266,044 $211,371 $99,606  $74,210  $80,710  $67,132  $14,131  $15,952 
                       


        Reconciliation of certain adjusted non-GAAP accounts:
        Net Revenues Cost of sales (excluding depreciation and amortization) Selling, general, and administrative Research and
development
  Six Months Ended
June 30,
   Six Months Ended
June 30,
 Six Months Ended
June 30,
 Six Months Ended
June 30,
 Six Months Ended
June 30,
   2026   2025     2026  2025  2026   2025   2026   2025   2026   2025 
Net Income $54,203  $24,230  As reported: $503,506 $408,493 $193,740  $147,652  $165,316  $158,299  $25,347  $27,099 
                       
Add/(Subtract):                      
Interest expense, net  7,405   10,922                   
Other expense (income), net  1,119   (1,937)                  
Income tax expense  23,115   6,282                   
Depreciation and amortization  40,559   46,172                   
Contingent consideration fair value adjustment  (804)  (10,815)                  
Unrealized (gain) loss on investment in equity securities  (6,494)  589                   
Stock-based compensation  21,597   18,470  Stock-based compensation      (1,047)  (780)  (19,310)  (16,581)  (1,240)  (1,109)
M&A transaction and integration expenses  301   2,617  M&A transaction and integration expenses            (301)  (2,617)      
Litigation expenses and settlement proceeds  (6,407)  8,192  Litigation expenses and settlement proceeds            6,407   (8,192)      
Severance     105  Severance               (105)      
Adjusted non-GAAP EBITDA $134,594  $104,827  As adjusted: $503,506 $408,493 $192,693  $146,872  $152,112  $130,804  $24,107  $25,990 



ANI Pharmaceuticals, Inc. and Subsidiaries
Table 4: US GAAP Gross Margin to Non-GAAP Gross Margin Reconciliation
(unaudited, in thousands)
    
 Three Months Ended June 30, Six Months Ended June 30,
  2026   2025   2026   2025 
GAAP net revenues$266,044  $211,371  $503,506  $408,493 
GAAP cost of sales (excluding depreciation and amortization) 100,158   74,615   193,740   147,652 
GAAP gross profit$165,886  $136,756  $309,766  $260,841 
Stock-based compensation 552   405   1,047   780 
Non-GAAP gross profit$166,438  $137,161  $310,813  $261,621 
GAAP gross margin 62.4%  64.7%  61.5%  63.9%
Non-GAAP gross margin 62.6%  64.9%  61.7%  64.0%



ANI Pharmaceuticals, Inc. and Subsidiaries
Table 5: Adjusted non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per Share Reconciliation
(unaudited, in thousands, except per share amounts)
    
 Three Months Ended June 30, Six Months Ended June 30,
  2026   2025   2026   2025 
Net Income Available to Common Shareholders$24,711  $8,142  $54,203  $23,417 
        
Add/(Subtract):       
Non-cash interest expense 137   252   354   511 
Depreciation and amortization 19,640   23,281   40,559   46,172 
Contingent consideration fair value adjustment (622)  1,277   (804)  (10,815)
Unrealized (gain) loss on investment in equity securities (741)  (332)  (6,494)  589 
Stock-based compensation 11,406   9,603   21,597   18,470 
M&A transaction and integration expenses 40   823   301   2,617 
Litigation expenses and settlement proceeds 673   5,201   (6,407)  8,192 
Severance          105 
Other expense (income) 442   (1,773)  1,104   (2,009)
Less:       
Estimated tax impact of adjustments (8,054)  (9,966)  (13,055)  (16,596)
        
Adjusted non-GAAP Net Income Available to Common Shareholders(1)$47,632  $36,508  $91,358  $70,653 
Diluted Weighted-Average       
Shares Outstanding 21,915   20,308   21,785   20,177 
Adjusted Diluted Weighted-Average(2)       
Shares Outstanding 21,575   20,308   21,440   20,177 
        
Adjusted non-GAAP       
Diluted Earnings per Share$2.21  $1.80  $4.26  $3.50 

(1) Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistributed earnings to participating securities.
(2) Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding exclude certain dilutive shares related to the senior convertible notes as they are intended to be covered by our capped call transactions. Our outstanding capped call transactions are intended to fully offset the dilutive effect of the senior convertible notes recognized in the calculation of GAAP diluted EPS, and therefore 340,000 shares and 345,000 shares, for the three and six months ended June 30, 2026, respectively, have been excluded from the calculation of Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding.


FAQ

How did ANI Pharmaceuticals (ANIP) perform in Q2 2026?

ANI Pharmaceuticals reported Q2 2026 net revenues of $266.0 million, up 25.9% year-over-year. According to ANI, growth was led by Cortrophin Gel and Generics, with adjusted non-GAAP EBITDA rising 32.4% to $71.6 million and adjusted diluted EPS reaching $2.21.

What were ANI Pharmaceuticals' Q2 2026 earnings per share (ANIP)?

ANI reported Q2 2026 GAAP diluted EPS of $1.05 and adjusted non-GAAP diluted EPS of $2.21. According to ANI, this compares with GAAP diluted EPS of $0.36 and adjusted EPS of $1.80 in Q2 2025, reflecting higher net revenues and gross profit.

How much did Cortrophin Gel contribute to ANI Pharmaceuticals' Q2 2026 results?

Cortrophin Gel generated Q2 2026 net revenues of $117.1 million, up 43.5% year-over-year. According to ANI, growth was driven primarily by increased volume in existing specialties, with the Rare Disease sales force expansion for acute gout flares fully operational by the end of June 2026.

What 2026 guidance did ANI Pharmaceuticals (ANIP) provide after Q2 2026 earnings?

ANI reaffirmed 2026 total net revenue guidance of $1.08–$1.14 billion and adjusted non-GAAP EBITDA of $285–$300 million. According to ANI, Cortrophin Gel net revenue guidance was revised to $520–$540 million, while adjusted non-GAAP diluted EPS guidance remained $9.19–$9.69.

Did ANI Pharmaceuticals change its Cortrophin Gel outlook for 2026 (ANIP)?

Yes. ANI now expects 2026 Cortrophin Gel net revenues of $520–$540 million, down from prior guidance of $540–$575 million. According to ANI, this revised range still implies 50–55% full-year growth compared with 2025 Cortrophin Gel revenues of $348 million.

What is ANI Pharmaceuticals' cash and debt position after Q2 2026?

As of June 30, 2026, ANI held $360.2 million in unrestricted cash and cash equivalents and $620.9 million in principal value of outstanding debt. According to ANI, net accounts receivable totaled $274.5 million, and operating cash flow reached $115.0 million year-to-date.

How did ILUVIEN and Brands perform in ANI Pharmaceuticals' Q2 2026 results?

ILUVIEN net revenues were $18.7 million, down 16.1% year-over-year, mainly from timing of international shipments. According to ANI, Brands revenues declined 10.5% to $11.8 million, reflecting normalization in demand, partly offset by $17.7 million from brand royalties and other revenues.