ANI Pharmaceuticals Reports Third Quarter 2026 Financial Results
ANI raised adjusted earnings guidance despite lowering its Cortrophin revenue outlook as pharmacy capacity constrained revenue conversion.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
ANI Pharmaceuticals (Nasdaq: ANIP) reported third-quarter 2026 net revenue of $290.8 million, up 27.6% from the prior-year quarter. GAAP net income available to common shareholders rose to $35.1 million, or $1.51 per diluted share, from $26.3 million, or $1.13. Cortrophin Gel revenue increased 36.1% to $138.7 million, although specialty pharmacy capacity constraints slowed revenue conversion.
ANI lowered 2026 Cortrophin guidance to $480–$500 million from $520–$540 million, narrowed total revenue guidance to $1,085–$1,125 million and raised adjusted earnings guidance. It also announced an offer for Egetis Therapeutics at SEK 11.25 per share, with an approximately SEK 5.6 billion offer value including outstanding incentive programs. Completion requires at least 90% shareholder acceptance and necessary regulatory approvals. ANI repurchased approximately $20.0 million of stock through November 2.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major point. Forward-looking: it has not happened yet and may not happen.Proposed Egetis acquisition would add approved MCT8 deficiency treatment EMCITATE, with patent protection into 2045.
- Moderate pointThird-quarter revenue rose 27.6% year over year to $290.8 million.
- Moderate pointGAAP net income available to common shareholders increased to $35.1 million from $26.3 million a year earlier.
- Moderate pointCortrophin Gel revenue increased 36.1% year over year to $138.7 million.
- Moderate pointILUVIEN revenue increased 34.1% year over year to $22.3 million.
- Moderate pointGenerics product revenue increased 10.7% year over year to $104.5 million; 16 products launched year-to-date.
- Moderate pointGAAP gross margin increased to 61.6% from 59.0% in the prior-year quarter.
- Moderate pointAdjusted non-GAAP EBITDA rose 39.8% year over year to $83.3 million.
- Moderate pointAdjusted non-GAAP diluted EPS increased to $2.70 from $2.04 in the prior-year quarter.
- Moderate pointOperating cash flow reached $198.8 million year-to-date; unrestricted cash and cash equivalents totaled $420.8 million at September 30.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Egetis board unanimously recommends acceptance; shareholders holding approximately 42% have conditionally undertaken to accept.
9 minor points
- Minor pointGAAP diluted EPS rose to $1.51 from $1.13 in the prior-year quarter.
- Minor pointHarmony Agreement revenue included $9.5 million in royalties and $2.0 million from development milestones.
- Minor point. Forward-looking: it has not happened yet and may not happen.Low single digit royalties on pitolisant-based product net sales will continue under the Harmony Agreement.
- Minor point. Forward-looking: it has not happened yet and may not happen.2026 revenue guidance of $1,085–$1,125 million implies 23%–27% growth, narrowed from $1,080–$1,140 million.
- Minor point. Forward-looking: it has not happened yet and may not happen.2026 ILUVIEN revenue guidance increased to $80–$85 million from $78–$83 million.
- Minor point. Forward-looking: it has not happened yet and may not happen.2026 adjusted non-GAAP EBITDA guidance increased to $290–$300 million from $285–$300 million.
- Minor point. Forward-looking: it has not happened yet and may not happen.2026 adjusted non-GAAP diluted EPS guidance increased to $9.37–$9.71 from $9.19–$9.69.
- Minor point. Forward-looking: it has not happened yet and may not happen.Specialty pharmacy network and patient support expansion is underway to accelerate conversion of demand into patients on therapy.
- Minor point275,635 shares repurchased for approximately $20.0 million through November 2 under the up to $100.0 million program.
Negative
- Major point. Forward-looking: it has not happened yet and may not happen.2026 Cortrophin guidance fell to $480–$500 million from $520–$540 million, still implying 38%–44% growth over 2025.
- Major point. Forward-looking: it has not happened yet and may not happen.Egetis offer consideration totals approximately SEK 5.6 billion, including outstanding incentive programs, with new debt financing involved.
- Moderate pointSpecialty pharmacy capacity constraints slowed revenue conversion below expectations in existing Cortrophin specialties and gout.
- Moderate pointGAAP selling, general and administrative expenses increased 23.8% year over year to $94.9 million.
- Minor pointBrands revenue declined 6.5% year over year to $10.0 million as demand decreased for certain products.
4 minor points
- Minor pointOther generic revenue declined 7.8% year over year to $3.975 million.
- Minor pointGAAP research and development expenses increased 5.6% year over year to $13.0 million.
- Minor pointOutstanding debt principal totaled $616.9 million at September 30, including senior convertible notes.
- Minor pointEgetis offer requires at least 90% shareholder acceptance and necessary regulatory approvals before completion.
News Explained
Conditional undertakings cover about forty-two percent of Egetis shares versus a ninety-percent acceptance threshold; the offer period is expected from November twentieth to December eighteenth.
ANI’s offer for Egetis has not closed; the company says it is financed with cash on hand and new debt, so completion would use cash and add borrowing.
The board authorized repurchases of up to
By outstanding shares, undertakings to accept the offer, subject to conditions, cover about
Key Figures
- Quarterly net revenue
- $290.8 million, +27.6% year over year
- Third quarter 2026
- Adjusted non-GAAP EBITDA
- $83.3 million, +39.8% year over year
- Third quarter 2026
- Total company revenue guidance
- $1,085 million–$1,125 million
- Revised full-year 2026 guidance; previous range was $1,080 million–$1,140 million
- Cortrophin Gel revenue guidance
- $480 million–$500 million
- Revised full-year 2026 guidance; previous range was $520 million–$540 million
- Adjusted non-GAAP EBITDA guidance
- $290 million–$300 million
- Revised full-year 2026 guidance; previous range was $285 million–$300 million
- Adjusted non-GAAP diluted EPS guidance
- $9.37–$9.71
- Revised full-year 2026 guidance; previous range was $9.19–$9.69
- Egetis offer price
- SEK 11.25 per share; 27% premium to the 60-day VWAP
- Recommended public offer announced November 5, 2026
Previous Earnings Reports
-
Reported revenue and EBITDA growth, reaffirmed total revenue and EBITDA guidance, and lowered Cortrophin guidance.
-
Reported revenue and EBITDA growth, raised 2026 guidance, and authorized a share repurchase program.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
convertible debt financial
warrants financial
orphan drug exclusivity regulatory
priority review voucher regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Quarterly net revenues of
$290.8 million, an increase of27.6% year-over-year - Purified Cortrophin® Gel net revenues of
$138.7 million, an increase of36.1% year-over-year - Quarterly GAAP net income available to common shareholders of
$35.1 million; quarterly adjusted non-GAAP EBITDA of$83.3 million, an increase of39.8% year-over-year - Diluted GAAP income per share of
$1.51 and adjusted non-GAAP diluted earnings per share of$2.70 - Narrows 2026 total company revenue guidance to
$1,085 -$1,125 million , revises Cortrophin Gel revenue guidance to$480 -$500 million and raises both adjusted non-GAAP EBITDA to$290 -$300 million , and adjusted non-GAAP diluted earnings per share to$9.37 t o$9.71 - Announced offer to acquire Egetis Therapeutics, expanding the scope and scale of ANI’s Rare Disease business
- Repurchased
$20 million in common stock year-to-date
PRINCETON, N.J., Nov. 05, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the third quarter ended September 30, 2026.
“In the third quarter, ANI delivered strong financial results, while advancing our transformation into a leading Rare Disease company,” said Nikhil Lalwani, President and CEO of ANI. “Cortrophin Gel delivered solid growth, driven by momentum from the gout expansion and continued progress in our existing specialties, while our Generics business continued to outperform. We also executed on our capital allocation strategy by repurchasing shares and expanding the scope and scale of our Rare Disease business through our offer to acquire Egetis Therapeutics. This acquisition would add an FDA-approved rare disease therapy with significant long-term growth potential, that is poised to address the unmet need of patients with MCT8 deficiency who have no other approved treatment options.”
“As we head into the end of the year, we are focused on delivering our 2026 financial guidance and advancing the proposed acquisition of Egetis toward closing. We are also executing multiple operational and strategic initiatives to achieve approximately
Third Quarter and Recent Business Highlights:
Rare Disease
- Cortrophin Gel:
- Cortrophin Gel net revenues were
$138.7 million for the third quarter of 2026, an increase of36.1% over the same period in 2025. Year-over-year growth in the third quarter of 2026 was driven by momentum from the gout expansion and continued progress in the existing specialty areas of Nephrology, Neurology, Rheumatology, Ophthalmology, and Pulmonology. - Leading indicators of demand in the gout expansion remained strong, with new gout patient cases doubling quarter-over-quarter and an approximately
67% increase in the number of new prescribers. - However, revenue conversion was slower than expected in both existing specialties and gout, due to capacity constraints in the Company’s specialty pharmacy network. The Company is expanding its specialty pharmacy network and patient support capabilities to accelerate the conversion of strong demand into patients on therapy.
- Cortrophin Gel net revenues were
- ILUVIEN:
- ILUVIEN® net revenues were
$22.3 million for the third quarter of 2026, an increase of34.1% over the same period in 2025 due to increased volumes and phasing of international shipments. - The Company announced 6- and 24-month topline data from the Phase 4 open-label single-arm SYNCHRONICITY clinical trial in chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) and presented select secondary endpoint analyses highlighting durable efficacy at the American Academy of Ophthalmology annual conference in October 2026.
- ILUVIEN® net revenues were
Generics
- Generics net revenues were
$104.5 million in the third quarter of 2026, an increase of10.7% over the same period in 2025, driven by strong market demand for our existing products and new product launches in 2025 and 2026. - Launched 16 new Generics products year-to-date.
Brand Royalties and Other Revenues
- The Company recognized
$11.5 million of revenue under the Harmony Agreement, comprised of$9.5 million of royalties on net sales of pitolisant-based products for the third quarter of 2026 and$2.0 million of revenue associated with the achievement of certain development milestones. In addition, the Company will continue to earn low single digit royalties on net sales of pitolisant-based products.
Brands
- Brands net revenues were
$10.0 million for the third quarter of 2026, a decrease of6.5% compared to the same period in 2025, reflecting a net decrease in demand for certain products.
Corporate Highlights
Offer to Acquire Egetis Therapeutics AB
On November 5, 2026, ANI announced a recommended public offer to acquire the shares in Egetis Therapeutics AB (‘Egetis’) for SEK 11.25 per share, representing a
The Board of Directors of Egetis unanimously recommends that Egetis’ shareholders and the holder of the convertible and the warrants accept the Offer. In addition, shareholders representing in total approximately 42 percent of the total number of outstanding shares in Egetis, have undertaken to accept the Offer, under certain conditions.
The Offer is subject to customary closing conditions, including that the Offer is accepted by shareholders representing at least 90 percent of the outstanding shares in Egetis, and that ANI receives necessary regulatory approvals.
The Offer is financed in full through a combination of cash on hand and new debt financing provided by JPMorgan Chase Bank, N.A., on terms customary for financing of public offers on the Swedish market.
The acceptance period in the offer is expected to commence on or around November 20, 2026 and to expire on or around December 18, 2026. For information in relation to the Offer, please refer to the formal offer announcement available on www.biopharma-offer.com.
Share Repurchase Program
Effective on May 8, 2026, ANI’s board of directors authorized a share repurchase program to repurchase up to
Third Quarter 2026 Financial Results
| Three Months Ended September 30, | |||||||||||||
| (in thousands) | 2026 | 2025 | Change | % Change | |||||||||
| Rare Disease and Brands | |||||||||||||
| Cortrophin Gel | $ | 138,655 | $ | 101,850 | $ | 36,805 | 36.1 | % | |||||
| ILUVIEN(1) | 22,254 | 16,600 | 5,654 | 34.1 | % | ||||||||
| Rare Disease total net revenues | $ | 160,909 | $ | 118,450 | $ | 42,459 | 35.8 | % | |||||
| Brands | 9,978 | 10,675 | (697 | ) | (6.5) % | ||||||||
| Brand royalties and other revenues | 11,460 | — | 11,460 | N/M | |||||||||
| Rare Disease and Brands total net revenues | $ | 182,347 | $ | 129,125 | $ | 53,222 | 41.2 | % | |||||
| Generics and Other | |||||||||||||
| Generic pharmaceutical products | 104,455 | 94,375 | 10,080 | 10.7 | % | ||||||||
| Other generic revenues | 3,975 | 4,313 | (338 | ) | (7.8) % | ||||||||
| Generics and Other total net revenues | $ | 108,430 | $ | 98,688 | $ | 9,742 | 9.9 | % | |||||
| Total net revenues | $ | 290,777 | $ | 227,813 | $ | 62,964 | 27.6 | % | |||||
(1) There were no sales of YUTIQ during the three months ended September 30, 2026 and 2025, as the Company transitioned U.S. promotional efforts from YUTIQ to ILUVIEN, which has a combined label of DME and NIU-PS as of the second quarter of 2025.
All comparisons are made versus the same period in 2025 unless otherwise stated.
Total net revenues for the third quarter of 2026 were
Net revenues for Rare Disease, which includes Cortrophin Gel and ILUVIEN, increased
Net revenues for Brands decreased
Net revenues from Brand royalties and other revenues include
Net revenues for Generic pharmaceutical products increased
On a GAAP basis, gross margin increased from
On a GAAP basis and a non-GAAP basis, research and development expenses increased
On a GAAP basis, selling, general, and administrative expenses increased
On a GAAP basis, the Company reported net income available to common shareholders of
Adjusted non-GAAP EBITDA for the third quarter of 2026 was
For reconciliations of adjusted non-GAAP metrics, including non-GAAP research and development expenses, non-GAAP selling, general and administrative expenses, adjusted non-GAAP EBITDA, non-GAAP gross margin, and adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measures, please see Table 3, Table 4, and Table 5 below, respectively.
Liquidity
As of September 30, 2026, the Company had
Full Year 2026 Financial Guidance
| Revised Full Year 2026 Guidance | Previous Full Year 2026 Guidance | 2025 Actual | Growth | |
| Net Revenue (Total Company) | ||||
| Cortrophin Gel Net Revenue | ||||
| ILUVIEN Net Revenue | ||||
| Adjusted Non-GAAP EBITDA | ||||
| Adjusted Non-GAAP Diluted EPS |
ANI expects full year total company adjusted non-GAAP gross margin between
Conference Call
The Company’s management will host a conference call and webcast today, Thursday, November 5, 2026, at 8:00 a.m. ET to discuss its third quarter 2026 results and the proposed Egetis Therapeutics acquisition.
To join the conference call, please dial +1(833) 630-1956 (U.S. and Canada) or +1(412) 317-1837 (International callers). Please reference the “ANI Pharmaceuticals Third Quarter 2026 Earnings Call.”
To view the webcast, please click here. Links to access the webcast will also be available on the “Events & Presentations” page of the Company’s website at https://www.anipharmaceuticals.com, under the “Investors” section. A replay of the event will remain accessible for up to one year.
Non-GAAP Financial Measures
Adjusted non-GAAP EBITDA
ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.
Adjusted non-GAAP EBITDA is defined as net income, excluding tax expense, interest expense, net, other expense (income), net, depreciation and amortization expense, non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized gain (loss) on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expenses, and certain other items that vary in frequency and impact on ANI’s results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided below.
ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted non-GAAP EBITDA guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.
Adjusted non-GAAP Net Income
ANI’s management considers adjusted non-GAAP net income to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP net income when analyzing Company performance.
Adjusted non-GAAP net income is defined as net income available to common shareholders, plus the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP net income should be considered in addition to, but not in lieu of, net income reported under GAAP. A reconciliation of adjusted non-GAAP net income to the most directly comparable GAAP financial measure is provided below.
Adjusted non-GAAP Diluted Earnings per Share
ANI’s management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP diluted earnings per share when analyzing Company performance.
Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding exclude certain dilutive shares related to the senior convertible notes as they are intended to be covered by our capped call transactions. Our outstanding capped call transactions are intended to fully offset the dilutive effect of the senior convertible notes recognized in the calculation of GAAP diluted EPS, and therefore 121,000 shares and 119,000 shares, for the three and nine months ended September 30, 2026, respectively, have been excluded from the calculation of Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding.
Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP diluted earnings per share should be considered in addition to, but not in lieu of, diluted earnings (loss) per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure is provided below.
ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted non-GAAP diluted earnings per share guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.
Other non-GAAP metrics
ANI’s management considers non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses to be financial indicators of ANI’s operating performance, providing investors and analysts with useful measures of operating results unaffected by non-cash stock-based compensation expense, M&A transaction and integration expenses, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations.
Management uses adjusted non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses when analyzing Company performance. Non-GAAP research and development expenses is defined as research and development expenses, excluding non-cash stock-based compensation expense, and certain other items that vary in frequency and impact on ANI’s results of operations.
Non-GAAP selling, general, and administrative expenses is defined as selling, general, and administrative expenses, excluding non-cash stock-based compensation expense, M&A transaction and integration expenses, expenses incurred and settlement payments received in connection with certain litigation matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations.
Each of adjusted non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses should be considered in addition to, but not in lieu of, research and development expenses, and selling, general, and administrative expenses reported under GAAP, respectively.
A reconciliation of each of non-GAAP research and development expenses and non-GAAP selling, general and administrative expenses to the most directly comparable GAAP financial measure is provided below.
ANI’s management also considers non-GAAP gross margin to be a financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses non-GAAP gross margin when analyzing Company performance.
Non-GAAP gross margin is defined as adjusted non-GAAP net revenues less non-GAAP cost of sales (excluding depreciation and amortization) divided by non-GAAP net revenues. Non-GAAP cost of sales is defined as cost of sales (excluding depreciation and amortization), excluding non-cash stock-based compensation expense and certain other items that vary in frequency and impact on ANI’s results of operations. Non-GAAP gross margin should be considered in addition to, but not in lieu of, gross margin reported under GAAP.
ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted non-GAAP gross margin guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.
About ANI
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit https://www.anipharmaceuticals.com/.
Forward-Looking Statements
To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s strategy; its expectations regarding its future operations, financial position or revenues, including its 2026 financial guidance; the public offer to the shareholders of Egetis Therapeutics and statements related to the potential acquisition of Egetis Therapeutics, including the potential addition of EMCITATE to the Company’s asset portfolio through the proposed acquisition and the anticipated timing and expenses related to the acquisition; the anticipated sales potential of EMCITATE; the Company’s expectations regarding its share repurchase program; the results and timing of the Company’s preclinical studies, clinical trials, regulatory submissions and regulatory approvals; the commercialization and anticipated sales of the Company’s products, including current and planned product launches and any additional product launches from the Company’s generic pipeline; the Company’s estimates of the market opportunity and addressable patient populations for its products; the execution capabilities of the Company’s sales representatives for acute gouty arthritis for Cortrophin Gel; the Company’s anticipated growth opportunities, including for Cortrophin Gel and ILUVIEN; the Company’s positioning for continued shareholder value creation; anticipated R&D developments and clinical trial advances; and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates.
Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of the Company’s approved products, including Cortrophin Gel and ILUVIEN, to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; the Company’s ability to complete or achieve any or all of the intended benefits of acquisitions and investments, in a timely manner or at all; delays and disruptions in the production of the Company’s approved products; increased costs and potential loss of revenues if the Company needs to change suppliers due to the limited number of suppliers for its raw materials, active pharmaceutical ingredients, excipients, and other materials; delays and disruptions in the production of the Company’s approved products as a result of its reliance on single source third party contract manufacturing supply for certain of its key products, including Cortrophin Gel and ILUVIEN; delays or failure to obtain or maintain approvals by the FDA of the Company’s products; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies; risks that the Company may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of the Company’s products from both domestic and overseas sources due to supply chain disruptions or for any other reason, including increased costs due to tariffs or macroeconomic disruptions; the ability of the Company’s manufacturing partners to meet its product demands and timelines; the impact of changes or fluctuations in exchange rates; the Company’s ability to develop, license or acquire, and commercialize new products; the Company’s obligations in agreements under which it licenses, develops or commercializes rights to products or technology from third parties and its ability to maintain such licenses; the level of competition the Company faces and the legal, regulatory and/or legislative strategies employed by its competitors to prevent or delay competition from generic alternatives to branded products; the Company’s ability to protect its intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which the Company is, or may become, a party; the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; the Company’s ability to maintain the services of its key executives and other personnel; and general business and economic conditions, such as inflationary pressures and geopolitical conditions.
More detailed information on these and additional factors that could affect the Company’s actual results is included in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, and other periodic reports, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Relations:
Irina Koffler, Vice President, Investor Relations
T: 917-734-7387
E: Irina.koffler@anipharmaceuticals.com
Media Relations:
Argot Partners
T: 212-600-1494
E: ani@argotpartners.com
SOURCE: ANI Pharmaceuticals, Inc.
FINANCIAL TABLES FOLLOW
| ANI Pharmaceuticals, Inc. and Subsidiaries Table 1: US GAAP Statements of Operations (unaudited, in thousands, except per share amounts) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Net Revenues | $ | 290,777 | $ | 227,813 | $ | 794,283 | $ | 636,306 | |||||||
| Operating Expenses | |||||||||||||||
| Cost of sales (excluding depreciation and amortization) | 111,531 | 93,389 | 305,271 | 241,041 | |||||||||||
| Research and development | 12,997 | 12,304 | 38,344 | 39,403 | |||||||||||
| Selling, general, and administrative | 94,862 | 76,656 | 260,178 | 234,955 | |||||||||||
| Depreciation and amortization | 19,552 | 22,632 | 60,111 | 68,804 | |||||||||||
| Contingent consideration fair value adjustment | (538 | ) | (14,470 | ) | (1,342 | ) | (25,285 | ) | |||||||
| Loss on disposal of assets | — | 295 | — | 295 | |||||||||||
| Intangible asset impairment charge | — | 767 | — | 767 | |||||||||||
| Total Operating Expenses, net | 238,404 | 191,573 | 662,562 | 559,980 | |||||||||||
| Operating income | 52,373 | 36,240 | 131,721 | 76,326 | |||||||||||
| Other (expense) income, net | |||||||||||||||
| Unrealized (loss) gain on investment in equity securities | (35 | ) | 3,140 | 6,459 | 2,551 | ||||||||||
| Interest expense, net | (3,056 | ) | (4,727 | ) | (10,461 | ) | (15,649 | ) | |||||||
| Other (expense) income, net | (241 | ) | (853 | ) | (1,360 | ) | 1,084 | ||||||||
| Income Before Income Tax Expense | 49,041 | 33,800 | 126,359 | 64,312 | |||||||||||
| Income tax expense | 13,892 | 7,183 | 37,007 | 13,465 | |||||||||||
| Net Income | $ | 35,149 | $ | 26,617 | $ | 89,352 | $ | 50,847 | |||||||
| Dividends on Series A Convertible Preferred Stock | — | (344 | ) | — | (1,157 | ) | |||||||||
| Net Income Available to Common Shareholders | $ | 35,149 | $ | 26,273 | $ | 89,352 | $ | 49,690 | |||||||
| Basic and Diluted Income Per Share: | |||||||||||||||
| Basic Income Per Share | $ | 1.54 | $ | 1.19 | $ | 3.94 | $ | 2.26 | |||||||
| Diluted Income Per Share | $ | 1.51 | $ | 1.13 | $ | 3.86 | $ | 2.15 | |||||||
| Basic Weighted-Average Shares Outstanding | 21,212 | 20,074 | 21,095 | 19,840 | |||||||||||
| Diluted Weighted-Average Shares Outstanding | 21,675 | 21,093 | 21,598 | 20,911 | |||||||||||
| ANI Pharmaceuticals, Inc. and Subsidiaries Table 2: US GAAP Balance Sheets (unaudited, in thousands) | |||||||
| September 30, 2026 | December 31, 2025 | ||||||
| Current Assets | |||||||
| Cash and cash equivalents | $ | 420,758 | $ | 285,585 | |||
| Restricted cash | 35 | 36 | |||||
| Accounts receivable, net | 304,450 | 281,082 | |||||
| Inventories | 136,411 | 143,067 | |||||
| Prepaid expenses and other current assets | 25,577 | 34,216 | |||||
| Investment in equity securities | 15,590 | 9,131 | |||||
| Total Current Assets | 902,821 | 753,117 | |||||
| Non-current Assets | |||||||
| Property and equipment, net | 81,552 | 62,476 | |||||
| Deferred tax assets, net | 74,668 | 69,072 | |||||
| Intangible assets, net | 433,109 | 479,526 | |||||
| Goodwill | 62,480 | 62,480 | |||||
| Other non-current assets | 13,031 | 13,706 | |||||
| Total Assets | $ | 1,567,661 | $ | 1,440,377 | |||
| Current Liabilities | |||||||
| Accounts payable | $ | 74,415 | $ | 62,583 | |||
| Accrued royalties | 66,054 | 48,497 | |||||
| Accrued compensation and related expenses | 34,950 | 37,897 | |||||
| Accrued government rebates | 56,635 | 43,154 | |||||
| Returned goods reserve | 45,648 | 49,504 | |||||
| Accrued expenses and other | 18,674 | 16,970 | |||||
| Income taxes payable | 8,979 | 2,239 | |||||
| Current debt, net | 23,362 | 17,268 | |||||
| Total Current Liabilities | 328,717 | 278,112 | |||||
| Non-current Liabilities | |||||||
| Debt, net | 274,314 | 291,840 | |||||
| Convertible notes, net | 309,556 | 307,927 | |||||
| Contingent consideration | 7,836 | 9,610 | |||||
| Other non-current liabilities | 10,125 | 12,164 | |||||
| Total Liabilities | $ | 930,548 | $ | 899,653 | |||
| Stockholders’ Equity | |||||||
| Common Stock | 3 | 3 | |||||
| Class C Special Stock | — | — | |||||
| Preferred Stock | — | — | |||||
| Treasury stock | (62,212 | ) | (33,249 | ) | |||
| Additional paid-in capital | 634,239 | 596,036 | |||||
| Retained earnings (Accumulated deficit) | 66,253 | (23,099 | ) | ||||
| Accumulated other comprehensive (loss) income, net of tax | (1,170 | ) | 1,033 | ||||
| Total Stockholders’ Equity | 637,113 | 540,724 | |||||
| Total Liabilities and Stockholders’ Equity | $ | 1,567,661 | $ | 1,440,377 | |||
| ANI Pharmaceuticals, Inc. and Subsidiaries Table 3: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation (unaudited, in thousands) | ||||||||||||||||||||||||||||||||||||||||
| Reconciliation of certain adjusted non-GAAP accounts: | ||||||||||||||||||||||||||||||||||||||||
| Net Revenues | Cost of sales (excluding depreciation and amortization) | Selling, general, and administrative | Research and development | |||||||||||||||||||||||||||||||||||||
| Three Months Ended September 30, | Three Months Ended September 30, | Three Months Ended September 30, | Three Months Ended September 30, | Three Months Ended September 30, | ||||||||||||||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | 2026 | 2025 | 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||||||||||
| Net Income | $ | 35,149 | $ | 26,617 | As reported: | $ | 290,777 | $ | 227,813 | $ | 111,531 | $ | 93,389 | $ | 94,862 | $ | 76,656 | $ | 12,997 | $ | 12,304 | |||||||||||||||||||
| Add/(Subtract): | ||||||||||||||||||||||||||||||||||||||||
| Interest expense, net | 3,056 | 4,727 | ||||||||||||||||||||||||||||||||||||||
| Other expense, net | 241 | 853 | ||||||||||||||||||||||||||||||||||||||
| Income tax expense | 13,892 | 7,183 | ||||||||||||||||||||||||||||||||||||||
| Depreciation and amortization | 19,552 | 22,632 | ||||||||||||||||||||||||||||||||||||||
| Contingent consideration fair value adjustment | (538 | ) | (14,470 | ) | ||||||||||||||||||||||||||||||||||||
| Unrealized loss (gain) on investment in equity securities | 35 | (3,140 | ) | |||||||||||||||||||||||||||||||||||||
| Intangible asset impairment charge | — | 767 | ||||||||||||||||||||||||||||||||||||||
| Loss on disposal of assets | — | 295 | ||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | 11,631 | 9,691 | Stock-based compensation | — | — | (543 | ) | (516 | ) | (10,435 | ) | (8,660 | ) | (653 | ) | (515 | ) | |||||||||||||||||||||||
| M&A transaction and integration expenses | (33 | ) | 599 | M&A transaction and integration expenses | — | — | — | — | 33 | (599 | ) | — | — | |||||||||||||||||||||||||||
| Litigation expenses | 310 | 3,847 | Litigation expenses | — | — | — | — | (310 | ) | (3,847 | ) | — | — | |||||||||||||||||||||||||||
| Adjusted non-GAAP EBITDA | $ | 83,295 | $ | 59,601 | As adjusted: | $ | 290,777 | $ | 227,813 | $ | 110,988 | $ | 92,873 | $ | 84,150 | $ | 63,550 | $ | 12,344 | $ | 11,789 | |||||||||||||||||||
| Reconciliation of certain adjusted non-GAAP accounts: | ||||||||||||||||||||||||||||||||||||||||
| Net Revenues | Cost of sales (excluding depreciation and amortization) | Selling, general, and administrative | Research and development | |||||||||||||||||||||||||||||||||||||
| Nine Months Ended September 30, | Nine Months Ended September 30, | Nine Months Ended September 30, | Nine Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | 2026 | 2025 | 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||||||||||
| Net Income | $ | 89,352 | $ | 50,847 | As reported: | $ | 794,283 | $ | 636,306 | $ | 305,271 | $ | 241,041 | $ | 260,178 | $ | 234,955 | $ | 38,344 | $ | 39,403 | |||||||||||||||||||
| Add/(Subtract): | ||||||||||||||||||||||||||||||||||||||||
| Interest expense, net | 10,461 | 15,649 | ||||||||||||||||||||||||||||||||||||||
| Other expense (income), net | 1,360 | (1,084 | ) | |||||||||||||||||||||||||||||||||||||
| Income tax expense | 37,007 | 13,465 | ||||||||||||||||||||||||||||||||||||||
| Depreciation and amortization | 60,111 | 68,804 | ||||||||||||||||||||||||||||||||||||||
| Contingent consideration fair value adjustment | (1,342 | ) | (25,285 | ) | ||||||||||||||||||||||||||||||||||||
| Unrealized gain on investment in equity securities | (6,459 | ) | (2,551 | ) | ||||||||||||||||||||||||||||||||||||
| Intangible asset impairment charge | — | 767 | ||||||||||||||||||||||||||||||||||||||
| Loss on disposal of assets | — | 295 | ||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | 33,228 | 28,161 | Stock-based compensation | — | — | (1,590 | ) | (1,296 | ) | (29,745 | ) | (25,241 | ) | (1,893 | ) | (1,624 | ) | |||||||||||||||||||||||
| M&A transaction and integration expenses | 268 | 3,216 | M&A transaction and integration expenses | — | — | — | — | (268 | ) | (3,216 | ) | — | — | |||||||||||||||||||||||||||
| Litigation expenses and settlement proceeds | (6,098 | ) | 12,038 | Litigation expenses and settlement proceeds | — | — | — | — | 6,098 | (12,038 | ) | — | — | |||||||||||||||||||||||||||
| Severance | — | 105 | Severance | — | — | — | — | — | (105 | ) | — | — | ||||||||||||||||||||||||||||
| Adjusted non-GAAP EBITDA | $ | 217,888 | $ | 164,427 | As adjusted: | $ | 794,283 | $ | 636,306 | $ | 303,681 | $ | 239,745 | $ | 236,263 | $ | 194,355 | $ | 36,451 | $ | 37,779 | |||||||||||||||||||
| ANI Pharmaceuticals, Inc. and Subsidiaries Table 4: US GAAP Gross Margin to Non-GAAP Gross Margin Reconciliation (unaudited, in thousands) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| GAAP net revenues | $ | 290,777 | $ | 227,813 | $ | 794,283 | $ | 636,306 | ||||||||
| GAAP cost of sales (excluding depreciation and amortization) | 111,531 | 93,389 | 305,271 | 241,041 | ||||||||||||
| GAAP gross profit | $ | 179,246 | $ | 134,424 | $ | 489,012 | $ | 395,265 | ||||||||
| Stock-based compensation | 543 | 516 | 1,590 | 1,296 | ||||||||||||
| Non-GAAP gross profit | $ | 179,789 | $ | 134,940 | $ | 490,602 | $ | 396,561 | ||||||||
| GAAP gross margin | 61.6 | % | 59.0 | % | 61.6 | % | 62.1 | % | ||||||||
| Non-GAAP gross margin | 61.8 | % | 59.2 | % | 61.8 | % | 62.3 | % | ||||||||
| ANI Pharmaceuticals, Inc. and Subsidiaries Table 5: Adjusted non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per Share Reconciliation (unaudited, in thousands, except per share amounts) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Net Income Available to Common Shareholders | $ | 35,149 | $ | 26,273 | $ | 89,352 | $ | 49,690 | |||||||
| Add/(Subtract): | |||||||||||||||
| Non-cash interest expense | 43 | 225 | 397 | 736 | |||||||||||
| Depreciation and amortization | 19,552 | 22,632 | 60,111 | 68,804 | |||||||||||
| Contingent consideration fair value adjustment | (538 | ) | (14,470 | ) | (1,342 | ) | (25,285 | ) | |||||||
| Loss on disposal of assets | — | 295 | — | 295 | |||||||||||
| Unrealized loss (gain) on investment in equity securities | 35 | (3,140 | ) | (6,459 | ) | (2,551 | ) | ||||||||
| Intangible asset impairment charge | — | 767 | — | 767 | |||||||||||
| Stock-based compensation | 11,631 | 9,691 | 33,228 | 28,161 | |||||||||||
| M&A transaction and integration expenses | (33 | ) | 599 | 268 | 3,216 | ||||||||||
| Litigation expenses and settlement proceeds | 310 | 3,847 | (6,098 | ) | 12,038 | ||||||||||
| Severance | — | — | — | 105 | |||||||||||
| Other expense (income) | 166 | 794 | 1,269 | (1,215 | ) | ||||||||||
| Less: | |||||||||||||||
| Estimated tax impact of adjustments | (8,103 | ) | (5,522 | ) | (21,157 | ) | (22,118 | ) | |||||||
| Adjusted non-GAAP Net Income Available to Common Shareholders (1) | $ | 58,212 | $ | 41,991 | $ | 149,569 | $ | 112,643 | |||||||
| Diluted Weighted-Average | |||||||||||||||
| Shares Outstanding | 21,675 | 21,093 | 21,598 | 20,911 | |||||||||||
| Adjusted Diluted Weighted-Average (2) | |||||||||||||||
| Shares Outstanding | 21,554 | 20,591 | 21,479 | 20,318 | |||||||||||
| Adjusted non-GAAP | |||||||||||||||
| Diluted Earnings per Share | $ | 2.70 | $ | 2.04 | $ | 6.96 | $ | 5.54 | |||||||
(1) Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistributed earnings to participating securities.
(2) Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding exclude certain dilutive shares related to the senior convertible notes as they are intended to be covered by our capped call transactions. Our outstanding capped call transactions are intended to fully offset the dilutive effect of the senior convertible notes recognized in the calculation of GAAP diluted EPS, and therefore 121,000 shares and 119,000 shares, for the three and nine months ended September 30, 2026, respectively, have been excluded from the calculation of Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding.
________________
1 Calculated utilizing 30 trading day average USD to SEK exchange rate of 9.9471 as of November 3, 2026.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were ANI Pharmaceuticals' third-quarter 2026 earnings and revenue?
ANI reported $290.8 million in revenue and GAAP net income available to common shareholders of $35.1 million, or $1.51 per diluted share. Revenue increased 27.6% year over year, while diluted GAAP EPS increased from $1.13.
Why did ANI Pharmaceuticals lower its 2026 Cortrophin Gel revenue guidance?
Specialty pharmacy capacity constraints slowed revenue conversion below expectations in both existing specialties and gout. ANI lowered Cortrophin revenue guidance to $480–$500 million from $520–$540 million and is expanding its specialty pharmacy network and patient support capabilities.
How will ANI Pharmaceuticals finance the Egetis offer, and when is acceptance expected?
The Egetis offer is fully financed through cash on hand and new debt financing from JPMorgan Chase Bank. The acceptance period is expected to begin on or around November 20, 2026, and expire on or around December 18, 2026.