ANI Pharmaceuticals reported record revenues and significant growth across Rare Disease and Generics sectors for 2025.
Quiver AI Summary
ANI Pharmaceuticals, Inc. reported record financial results for the fourth quarter and full year of 2025, with net revenues reaching $247.1 million for the quarter and $883.4 million for the year, representing year-over-year increases of 29.6% and 43.8%, respectively. The Rare Disease segment saw significant growth, particularly from Purified Cortrophin® Gel, which recorded quarterly revenues of $111.4 million (up 87.6%) and full-year revenues of $347.8 million (up 75.6%). The company also achieved net income of $27.5 million for the quarter, compared to a loss in the prior year, and a full-year adjusted non-GAAP EBITDA of $229.8 million, marking a 47.3% increase. Looking ahead, ANI forecasts continued growth with expected total revenues between $1.055 billion and $1.115 billion for 2026, driven largely by further expansion in their Rare Disease and Generics businesses.
Potential Positives
- Record quarterly net revenues of $247.1 million, up 29.6% year-over-year.
- Full year net revenues of $883.4 million, representing a 43.8% increase over the previous year.
- Significant growth in Rare Disease segment, with quarterly revenues increasing by 50.8% to $131.3 million.
- Record adjusted non-GAAP EBITDA of $65.4 million for the fourth quarter, up 30.6% year-over-year.
Potential Negatives
- Brands net revenues decreased by 37.9% in the fourth quarter compared to the same period in 2024, indicating a significant drop in demand for certain products.
- Non-GAAP gross margin decreased from 63.5% to 59.6%, which may signal challenges in maintaining profitability as higher sales of royalty-bearing products and lower Brands revenues impacted margins.
- The company has a substantial amount of outstanding debt at $629.1 million, which could pose financial risks if the company's revenue growth does not translate into sufficient cash flow or profitability in the future.
FAQ
What were ANI Pharmaceuticals' net revenues for Q4 2025?
ANI Pharmaceuticals reported record net revenues of $247.1 million for the fourth quarter of 2025, up 29.6% year-over-year.
How much did Rare Disease revenues increase in 2025?
Rare Disease revenues increased by 50.8% to $131.3 million for the fourth quarter and 84.1% to $422.6 million for the full year.
What is the growth outlook for Cortrophin Gel?
ANI expects Cortrophin Gel to generate over $1 billion in revenue in 2026, with significant growth opportunities in specialty indications.
What were adjusted non-GAAP EBITDA figures for Q4 2025?
Adjusted non-GAAP EBITDA for Q4 2025 was $65.4 million, reflecting a 30.6% increase from the previous year.
What is the company's guidance for total revenue in 2026?
ANI Pharmaceuticals estimates total revenue for 2026 will be between $1,055 million and $1,115 million, reflecting a growth of 19% to 26%.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ANIP Insider Trading Activity
$ANIP insiders have traded $ANIP stock on the open market 17 times in the past 6 months. Of those trades, 0 have been purchases and 17 have been sales.
Here’s a breakdown of recent trading of $ANIP stock by insiders over the last 6 months:
- CHAD GASSERT (SVP - CORP. DEV. & STRATEGY) has made 0 purchases and 2 sales selling 14,736 shares for an estimated $1,312,434.
- CHRISTOPHER MUTZ (HEAD OF RARE DISEASE) has made 0 purchases and 2 sales selling 12,355 shares for an estimated $953,600.
- PATRICK D WALSH sold 8,643 shares for an estimated $750,903
- ANTONIO R PERA sold 7,292 shares for an estimated $692,302
- KRISTA DAVIS (SVP, CHIEF HR OFFICER) has made 0 purchases and 4 sales selling 6,436 shares for an estimated $528,188.
- MEREDITH COOK (SR. VP, GENERAL COUNSEL & SEC.) has made 0 purchases and 6 sales selling 2,600 shares for an estimated $223,805.
- RENEE P TANNENBAUM sold 1,800 shares for an estimated $146,070
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$ANIP Revenue
$ANIP had revenues of $227.8M in Q3 2025. This is an increase of 53.58% from the same period in the prior year.
You can track ANIP financials on Quiver Quantitative's ANIP stock page.
$ANIP Hedge Fund Activity
We have seen 158 institutional investors add shares of $ANIP stock to their portfolio, and 124 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- CITADEL ADVISORS LLC removed 559,670 shares (-96.5%) from their portfolio in Q4 2025, for an estimated $44,180,349
- MILLENNIUM MANAGEMENT LLC added 474,420 shares (+727.1%) to their portfolio in Q4 2025, for an estimated $37,450,714
- UBS GROUP AG removed 439,095 shares (-74.4%) from their portfolio in Q4 2025, for an estimated $34,662,159
- RUBRIC CAPITAL MANAGEMENT LP removed 343,414 shares (-100.0%) from their portfolio in Q4 2025, for an estimated $27,109,101
- MACQUARIE GROUP LTD removed 291,129 shares (-100.0%) from their portfolio in Q4 2025, for an estimated $22,981,723
- POINT72 ASSET MANAGEMENT, L.P. removed 277,881 shares (-69.6%) from their portfolio in Q4 2025, for an estimated $21,935,926
- DIVISADERO STREET CAPITAL MANAGEMENT, LP removed 234,219 shares (-100.0%) from their portfolio in Q4 2025, for an estimated $18,489,247
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$ANIP Analyst Ratings
Wall Street analysts have issued reports on $ANIP in the last several months. We have seen 3 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Guggenheim issued a "Buy" rating on 11/10/2025
- JP Morgan issued a "Overweight" rating on 09/24/2025
- HC Wainwright & Co. issued a "Buy" rating on 09/17/2025
To track analyst ratings and price targets for $ANIP, check out Quiver Quantitative's $ANIP forecast page.
$ANIP Price Targets
Multiple analysts have issued price targets for $ANIP recently. We have seen 5 analysts offer price targets for $ANIP in the last 6 months, with a median target of $115.0.
Here are some recent targets:
- Vamil Divan from Guggenheim set a target price of $124.0 on 01/16/2026
- Glen Santangelo from Barclays set a target price of $100.0 on 12/09/2025
- Gregory Fraser from Truist Securities set a target price of $90.0 on 10/09/2025
- Ekaterina Knyazkova from JP Morgan set a target price of $115.0 on 09/24/2025
- Brandon Folkes from HC Wainwright & Co. set a target price of $121.0 on 09/17/2025
Full Release
- Record quarterly and full year net revenues of $247.1 million and $883.4 million, up 29.6% and 43.8% year-over-year, respectively
-
Total Rare Disease quarterly and full year net revenue of
$131.3
million and
$422.6
million, up
50.8%
and
84.1%
year-over-year, respectively
- Quarterly and full year Purified Cortrophin ® Gel net revenues of $111.4 million and $347.8 million, up 87.6% and 75.6% year-over-year, respectively
- Quarterly and full year ILUVIEN ® and YUTIQ ® net revenues of $19.8 million and $74.9 million, respectively (1 )
- Quarterly and full year GAAP net income available to common shareholders of $27.5 million and $77.2 million, respectively
- Record quarterly and full year adjusted non-GAAP EBITDA of $65.4 million and $229.8 million, u p 30.6% and 47.3% year-over-year, respectively
- Quarterly diluted GAAP income per share of $1.18 and adjusted non-GAAP diluted earnings per share of $2.33 ; full year diluted GAAP income per share of $3.32 and adjusted non-GAAP diluted earnings per share of $7.89
PRINCETON, N.J., Feb. 27, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the fourth quarter and year ended December 31, 2025.
“2025 was a year of significant growth for our Rare Disease and Generics businesses, which drove expansion to both our top- and bottom-line,” said Nikhil Lalwani, President and CEO of ANI. “We are building on this momentum as we continue to focus on our key 2026 priority of accelerating our transformation into a leading Rare Disease company, supported by strong execution in Generics and disciplined capital deployment.”
Mr. Lalwani continued, “We see a significant multi-year growth opportunity for Cortrophin Gel as we expand in underpenetrated specialty indications and launch a dedicated organization for acute gouty arthritis flares. With a proven track record, we expect to deliver more than $1 billion in revenue in 2026, with Rare Disease representing approximately 60% of total revenue, while continuing to fulfill our purpose of Serving Patients, Improving Lives.”
(1) NIU-PS indication was merged into the ILUVIEN label in mid-2025; full-year 2025 results include YUTIQ revenue
Fourth Quarter and Recent Business Highlights:
Rare Disease
-
Cortrophin Gel:
- Cortrophin Gel net revenues were $111.4 million for the fourth quarter of 2025, an increase of 87.6% over the same period in 2024. Cortrophin Gel net revenues were $347.8 million for full year 2025, an increase of 75.6% over the same period in 2024.
- Growth in both periods was driven by record new patient starts, continued momentum across target indications, the expanded sales force for neurology, rheumatology and nephrology, and synergies from the combined ophthalmology sales force.
- Prescribing for acute gouty arthritis flares, for which Cortrophin Gel is the only approved ACTH therapy, remained a significant growth driver, representing over 15% of Cortrophin Gel use.
- In January, the Company announced a planned expansion of its Rare Disease organization by ~90 people to capture the unique opportunity for Cortrophin Gel in acute gouty arthritis flares. The expanded organization is expected to deploy in mid-2026 and target appropriate patients in Podiatry and Primary Care.
-
ILUVIEN:
- ILUVIEN net revenues were $19.8 million for the fourth quarter of 2025 and $74.9 million for full year 2025.
- The Company continues to execute commercial and patient access initiatives established in 2025, including strategic investments in marketing and medical affairs, expanded multi-indication coverage to streamline care, growth of alternative access channels, and strengthened commercial execution.
Generics
- Generics net revenues were $100.8 million in the fourth quarter of 2025, an increase of 28.2% over the same period in 2024. The increase was driven by continued strength in the partnered generic launch that commenced in the second half of the third quarter of 2025. Generics net revenues were $384.1 million for full year 2025, an increase of 27.6% year-over-year, reflecting the Company’s strong R&D capabilities, execution, and steady cadence of new product launches.
Brands
- Brands net revenues were $12.3 million for the fourth quarter of 2025, a decrease of 37.9% over the same period in 2024. Brands net revenues were $61.3 million for full year 2025, a decrease of 5.3% year-over-year. Both periods reflect a normalization in demand for certain products.
Fourth Quarter 2025 Financial Results
| Three Months Ended December 31, | |||||||||||||
| (in thousands) | 2025 | 2024 | Change | % Change | |||||||||
| Rare Disease and Brands | |||||||||||||
| Cortrophin Gel | $ | 111,431 | $ | 59,400 | $ | 52,031 | 87.6 | % | |||||
| ILUVIEN (2) | 19,843 | 27,643 | (7,800 | ) | (28.2 | )% | |||||||
| Rare Disease total net revenues | $ | 131,274 | $ | 87,043 | $ | 44,231 | 50.8 | % | |||||
| Brands | 12,315 | 19,842 | (7,527 | ) | (37.9 | )% | |||||||
| Rare Disease and Brands total net revenues | $ | 143,589 | $ | 106,885 | $ | 36,704 | 34.3 | % | |||||
| Generics and Other | |||||||||||||
| Generic pharmaceutical products | 100,760 | 78,600 | 22,160 | 28.2 | % | ||||||||
| Royalties and other pharmaceutical services | 2,711 | 5,089 | (2,378 | ) | (46.7 | )% | |||||||
| Generics and Other total net revenues | $ | 103,471 | $ | 83,689 | $ | 19,782 | 23.6 | % | |||||
| Total net revenues | $ | 247,060 | $ | 190,574 | $ | 56,486 | 29.6 | % | |||||
( 2 ) NIU-PS indication was merged into the ILUVIEN label in mid-2025; fourth quarter 2024 results include YUTIQ revenue
All comparisons are made versus the same period in 2024 unless otherwise stated.
Total net revenues for the fourth quarter of 2025 were $247.1 million, an increase of 29.6% over the prior year period.
Net revenues for Rare Disease, which includes Cortrophin Gel and ILUVIEN, increased 50.8% to $131.3 million. Cortrophin Gel net revenues increased 87.6% to $111.4 million driven by increased volume. ILUVIEN net revenues were $19.8 million.
Net revenues for Brands decreased 37.9% to $12.3 million driven by normalization in demand for certain products.
Net revenues for Generic pharmaceutical products increased 28.2% to $100.8 million driven by continued strength in the partnered generic launch that commenced in the third quarter of 2025 and contribution from new product launches.
On a GAAP basis, gross margin increased from 57.9% to 59.4%, driven by the non-recurrence of costs of goods related to Alimera purchase accounting. On a non-GAAP basis, gross margin decreased from 63.5% to 59.6%, primarily due to higher sales of royalty bearing products, including Cortrophin Gel and a partnered generic product that launched in the third quarter, and lower Brands revenues.
On a GAAP basis and non-GAAP basis, research and development expenses decreased 26.3% to $12.3 million and 27.5% to $11.7 million, respectively, driven by timing associated with ongoing and new projects to support future growth of our Rare Disease and Generics businesses.
On a GAAP and non-GAAP basis, selling, general, and administrative expenses increased 18.7% to $82.8 million and 28.1% to $70.2 million, respectively, due to increased employment related costs, investment in Rare Disease sales and marketing infrastructure including the Company’s new, larger ophthalmology sales and marketing team and activities, legal expenses, and an overall increase in activities to support the growth of our business.
On a GAAP basis, the Company reported net income attributable to common shareholders of $27.5 million, or $1.18 per diluted share, for the fourth quarter of 2025 compared to net loss of $10.7 million, or $0.55 per diluted share, in the prior year period. On a non-GAAP basis, the Company reported adjusted diluted earnings per share of $2.33 for the fourth quarter of 2025 compared to $1.63 in the prior year period.
Adjusted non-GAAP EBITDA for the fourth quarter of 2025 was $65.4 million, an increase of 30.6% from the fourth quarter of 2024, driven by increased net revenues and gross profit.
For reconciliations of adjusted non-GAAP EBITDA and adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure, please see Table 3 and Table 4 below, respectively.
Liquidity
As of December 31, 2025, the Company had $285.6 million in unrestricted cash and cash equivalents, $281.1 million in net accounts receivable and $629.1 million in principal value of outstanding debt (inclusive of our senior convertible notes). The Company generated cash flow from operations of $185.2 million in 2025.
Full Year 2026 Financial Guidance:
The Company reaffirms its full year 2026 financial guidance.
|
Full Year 2026
Guidance |
2025 Actual | Growth | ||
| Net Revenue (Total Company) | $1,055 million - $1,115 million | $883 million | 19% - 26% | |
| Cortrophin Gel Net Revenue | $540 million - $575 million | $348 million | 55% - 65% | |
| ILUVIEN Net Revenue | $78 million - $83 million | $75 million | 4% - 11% | |
| Adjusted Non-GAAP EBITDA | $275 million - $290 million | $230 million | 20% - 26% | |
| Adjusted Non-GAAP Diluted EPS | $8.83 - $9.34 | $7.89 | 12% - 18% | |
ANI expects full year total company adjusted non-GAAP gross margin between 59.3% and 60.3%. The Company will continue to tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share as a tax rate of 26%, unless the item being adjusted is not tax deductible in whole or in part.
The Company anticipates approximately 21.5 million and 21.8 million shares outstanding for the purpose of calculating full year adjusted non-GAAP diluted EPS and expects its annual U.S. GAAP effective tax rate to be between 26% and 28%.
Conference Call
The Company’s management will host a conference call today to discuss its fourth quarter and fiscal year ended December 31, 2025 results.
| Date | Friday, February 27, 2026 |
| Time | 8:00 a.m. ET |
| Toll free (U.S.) | 800-274-8461 |
| Conference ID | 5230834 |
| Webcast (live and replay) | www.anipharmaceuticals.com, under the “Investors” section |
The live and archived webcast and accompanying slide presentation will be accessible from the Company’s website at www.anipharmaceuticals.com, under the Investors section under Events and Presentations. The replay of the webcast will be accessible for 12 months following the event.
Non-GAAP Financial Measures
Adjusted non-GAAP EBITDA
ANI’s management considers adjusted non-GAAP EBITDA to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation and differences in capital structures, tax structures, capital investment cycles, ages of related assets, and compensation structures among otherwise comparable companies. Management uses adjusted non-GAAP EBITDA when analyzing Company performance.
Adjusted non-GAAP EBITDA is defined as net income (loss), excluding tax expense (benefit), interest expense, net, other (income) expense, net, depreciation and amortization expense, non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized (gain) loss on our investment in equity securities, loss (gain) on disposal of assets, intangible asset impairment charges, litigation expenses related to certain matters, amortization of certain purchase price adjustments, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Adjusted non-GAAP EBITDA should be considered in addition to, but not in lieu of, net income or loss reported under GAAP. A reconciliation of adjusted non-GAAP EBITDA to the most directly comparable GAAP financial measure is provided below.
ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted EBITDA guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.
Adjusted non-GAAP Net Income
ANI’s management considers adjusted non-GAAP net income to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, litigation expenses related to certain matters, amortization of certain purchase price adjustments, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP net income when analyzing Company performance.
Adjusted non-GAAP net income is defined as net income (loss), plus the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, loss (gain) on disposal of assets, intangible asset impairment charges, litigation expenses related to certain matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations, less the tax impact of these adjustments calculated using an estimated statutory tax rate. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP net income should be considered in addition to, but not in lieu of, net income reported under GAAP. A reconciliation of adjusted non-GAAP net income to the most directly comparable GAAP financial measure is provided below.
Adjusted non-GAAP Diluted Earnings per Share
ANI’s management considers adjusted non-GAAP diluted earnings per share to be an important financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized (gain) loss on our investment in equity securities, loss (gain) on disposal of assets, intangible asset impairment charges, litigation expenses related to certain matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses adjusted non-GAAP diluted earnings per share when analyzing Company performance.
Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding excludes certain dilutive shares related to the 2029 senior convertible notes as they are intended to be covered by our capped call transactions. Our outstanding capped call transactions are intended to offset the dilutive effect of the 2029 convertible senior notes recognized in the calculation of GAAP diluted EPS in this reporting period in full, and therefore 588,000 shares and 692,000 shares for the three and twelve months ended December 31, 2025, have been excluded from the calculation of the Non-GAAP Adjusted Diluted Weighted-Average Shares outstanding, respectively.
Adjusted non-GAAP diluted earnings per share is defined as adjusted non-GAAP net income, as defined above, divided by the diluted weighted average shares outstanding during the period. Management will continually analyze this metric and may include additional adjustments in the calculation in order to provide further understanding of ANI’s results. Adjusted non-GAAP diluted earnings per share should be considered in addition to, but not in lieu of, diluted earnings (loss) per share reported under GAAP. A reconciliation of adjusted non-GAAP diluted earnings per share to the most directly comparable GAAP financial measure is provided below.
ANI is not providing a reconciliation for the forward-looking full year 2026 adjusted diluted earnings per share guidance because it does not currently have sufficient information to accurately estimate all of the variables and individual adjustments for such reconciliation, including “with” and “without” tax provision information. As such, ANI’s management cannot estimate on a forward-looking basis without unreasonable effort the impact these variables and individual adjustments will have on its reported results.
Other non-GAAP metrics
ANI’s management considers non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses to be financial indicators of ANI’s operating performance, providing investors and analysts with useful measures of operating results unaffected by non-cash stock-based compensation expense, M&A transaction and integration expenses, litigation expenses related to certain matters, inventory step-up amortization, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations.
Management uses adjusted non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses when analyzing Company performance. Non-GAAP research and development expenses is defined as research and development expenses, excluding non-cash stock-based compensation expense, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations.
Non-GAAP selling, general, and administrative expenses is defined as selling, general, and administrative expenses, excluding non-cash stock-based compensation expense, M&A transaction and integration expenses, litigation expenses related to certain matters, severance expense, and certain other items that vary in frequency and impact on ANI’s results of operations.
Each of adjusted non-GAAP research and development expenses and non-GAAP selling, general, and administrative expenses should be considered in addition to, but not in lieu of, research and development expenses, and selling, general, and administrative expenses reported under GAAP, respectively.
A reconciliation of each of non-GAAP research and development expenses and non-GAAP selling, general and administrative expenses to the most directly comparable GAAP financial measure is provided below.
ANI’s management also considers non-GAAP gross margin to be a financial indicator of ANI’s operating performance, providing investors and analysts with a useful measure of operating results unaffected by non-cash stock-based compensation expense, inventory step-up amortization, and certain other items that vary in frequency and impact on ANI’s results of operations. Management uses non-GAAP gross margin when analyzing Company performance.
Non-GAAP gross margin is defined as adjusted non-GAAP net revenues less non-GAAP cost of sales (excluding depreciation and amortization) divided by non-GAAP net revenues. Non-GAAP gross margin should be considered in addition to, but not in lieu of, gross margin reported under GAAP.
About ANI
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit www.anipharmaceuticals.com.
Forward-Looking Statements
To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the Company’s strategy; its expectations regarding its future operations, financial position or revenues, including 2026 financial guidance; the commercialization and potential sales of the Company’s products, including current and planned product launches and any additional product launches from the Company’s generic pipeline; expansion plans for the Rare Disease business, including with respect to the planned expansion of the Company’s sales force for acute gouty arthritis, and with respect to the transformation of ANI into a leading rare disease company; anticipated growth opportunities for Cortrophin Gel and ILUVIEN; anticipated R&D developments and clinical trial advances; and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates.
Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of the Company’s approved products, including Cortrophin Gel and ILUVIEN, to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; the Company’s ability to complete or achieve any or all of the intended benefits of acquisitions and investments, in a timely manner or at all; delays and disruptions in the production of the Company’s approved products; increased costs and potential loss of revenues if the Company needs to change suppliers due to the limited number of suppliers for its raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in the production of the Company’s approved products as a result of its reliance on single source third party contract manufacturing supply for certain of its key products, including Cortrophin Gel and ILUVIEN; delays or failure to obtain or maintain approvals by the FDA of the Company’s products; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies, and the focus of the current U.S. presidential administration, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; risks that the Company may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of the Company’s products from both domestic and overseas sources due to supply chain disruptions or for any other reason, including increased costs due to tariffs; the ability of the Company’s manufacturing partners to meet its product demands and timelines; the impact of changes or fluctuations in exchange rates; the Company’s ability to develop, license or acquire, and commercialize new products; the Company’s obligations in agreements under which it licenses, develops or commercializes rights to products or technology from third parties and its ability to maintain such licenses; the level of competition the Company faces and the legal, regulatory and/or legislative strategies employed by its competitors to prevent or delay competition from generic alternatives to branded products; the Company’s ability to protect its intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which the Company is, or may become, a party; the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; the Company’s ability to maintain the services of its key executives and other personnel; the potential impact of new U.S. tax legislation on the Company’s business; and general business and economic conditions, such as inflationary pressures, geopolitical conditions.
More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, and other periodic reports, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Relations:
Courtney Mogerley, Argot Partners
T: 646-368-8014
E: [email protected]
SOURCE: ANI Pharmaceuticals, Inc.
FINANCIAL TABLES FOLLOW
|
ANI Pharmaceuticals, Inc. and Subsidiaries
Table 1: US GAAP Statements of Operations (unaudited, in thousands, except per share amounts) |
|||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Net Revenues | $ | 247,060 | $ | 190,574 | $ | 883,366 | $ | 614,376 | |||||||
| Operating Expenses | |||||||||||||||
| Cost of sales (excluding depreciation and amortization) | 100,269 | 80,280 | 341,310 | 250,210 | |||||||||||
| Research and development | 12,261 | 16,646 | 51,664 | 44,581 | |||||||||||
| Selling, general, and administrative | 82,790 | 69,719 | 317,745 | 249,636 | |||||||||||
| Depreciation and amortization | 22,613 | 22,600 | 91,417 | 67,731 | |||||||||||
| Contingent consideration fair value adjustment | (5,727 | ) | (1,893 | ) | (31,012 | ) | (619 | ) | |||||||
| Loss (gain) on disposal of assets | 87 | — | 382 | (5,347 | ) | ||||||||||
| Intangible asset impairment charge | — | 7,600 | 767 | 7,600 | |||||||||||
| Total Operating Expenses, net | 212,293 | 194,952 | 772,273 | 613,792 | |||||||||||
| Operating income (loss) | 34,767 | (4,378 | ) | 111,093 | 584 | ||||||||||
| Other Expense, net | |||||||||||||||
| Unrealized gain (loss) on investment in equity securities | 273 | (1,991 | ) | 2,824 | 6,307 | ||||||||||
| Interest expense, net | (4,411 | ) | (6,015 | ) | (20,060 | ) | (17,602 | ) | |||||||
| Other income (expense), net | 850 | (1,378 | ) | 1,934 | (4,033 | ) | |||||||||
| Loss on extinguishment of debt | — | — | — | (7,468 | ) | ||||||||||
| Income (Loss) Before Income Tax Expense (Benefit) | 31,479 | (13,762 | ) | 95,791 | (22,212 | ) | |||||||||
| Income tax expense (benefit) | 3,989 | (3,486 | ) | 17,454 | (3,690 | ) | |||||||||
| Net Income (Loss) | $ | 27,490 | $ | (10,276 | ) | $ | 78,337 | $ | (18,522 | ) | |||||
| Dividends on Series A Convertible Preferred Stock | — | (406 | ) | (1,157 | ) | (1,625 | ) | ||||||||
|
Net Income (Loss) Available to Common
Shareholders |
$ | 27,490 | $ | (10,682 | ) | $ | 77,180 | $ | (20,147 | ) | |||||
| Basic and Diluted Income (Loss) Per Share: | |||||||||||||||
| Basic Income (Loss) Per Share | $ | 1.24 | $ | (0.55 | ) | $ | 3.50 | $ | (1.04 | ) | |||||
| Diluted Income (Loss) Per Share | $ | 1.18 | $ | (0.55 | ) | $ | 3.32 | $ | (1.04 | ) | |||||
| Basic Weighted-Average Shares Outstanding | 20,686 | 19,445 | 20,053 | 19,318 | |||||||||||
| Diluted Weighted-Average Shares Outstanding | 21,774 | 19,445 | 21,228 | 19,318 | |||||||||||
|
ANI Pharmaceuticals, Inc. and Subsidiaries
Table 2: US GAAP Balance Sheets (unaudited, in thousands) |
|||||||
|
December 31,
2025 |
December 31,
2024 |
||||||
| Current Assets | |||||||
| Cash and cash equivalents | $ | 285,585 | $ | 144,861 | |||
| Restricted cash | 36 | 33 | |||||
| Accounts receivable, net | 281,082 | 221,726 | |||||
| Inventories | 143,067 | 136,782 | |||||
| Prepaid income taxes | 11,027 | 772 | |||||
| Prepaid expenses and other current assets | 23,189 | 17,975 | |||||
| Investment in equity securities | 9,131 | 6,307 | |||||
| Total Current Assets | 753,117 | 528,456 | |||||
| Non-current Assets | |||||||
| Property and equipment, net | 62,476 | 56,863 | |||||
| Deferred tax assets, net of deferred tax liabilities and valuation allowance | 69,072 | 85,106 | |||||
| Intangible assets, net | 479,526 | 541,834 | |||||
| Goodwill | 62,480 | 59,990 | |||||
| Derivatives and other non-current assets | 13,706 | 12,220 | |||||
| Total Assets | $ | 1,440,377 | $ | 1,284,469 | |||
| Current Liabilities | |||||||
| Income taxes payable | $ | 1,291 | $ | 5,622 | |||
| Income taxes payable - foreign | 948 | 1,899 | |||||
| Current debt, net of deferred financing costs | 17,268 | 9,172 | |||||
| Accounts payable | 62,583 | 45,656 | |||||
| Accrued royalties | 48,497 | 22,626 | |||||
| Accrued compensation and related expenses | 37,897 | 37,725 | |||||
| Accrued government rebates | 43,154 | 18,714 | |||||
| Returned goods reserve | 49,504 | 39,274 | |||||
| Current contingent consideration | 167 | 29 | |||||
| Accrued expenses and other | 16,803 | 13,735 | |||||
| Total Current Liabilities | 278,112 | 194,452 | |||||
| Non-current Liabilities | |||||||
| Non-current debt, net of deferred financing costs and current component | 291,840 | 309,108 | |||||
| Non-current convertible notes, net of deferred financing costs | 307,927 | 305,812 | |||||
| Non-current contingent consideration, net of current | 9,610 | 19,825 | |||||
| Accrued licensor payments due | — | 20,961 | |||||
| Other non-current liabilities | 12,164 | 5,781 | |||||
| Total Liabilities | $ | 899,653 | $ | 855,939 | |||
| Mezzanine Equity | |||||||
| Convertible Preferred Stock, Series A | — | 24,850 | |||||
| Stockholders’ Equity | |||||||
| Common Stock | 3 | 2 | |||||
| Class C Special Stock | — | — | |||||
| Preferred Stock | — | — | |||||
| Treasury stock | (33,249 | ) | (21,040 | ) | |||
| Additional paid-in capital | 596,036 | 519,653 | |||||
| Accumulated deficit | (23,099 | ) | (100,279 | ) | |||
| Accumulated other comprehensive income, net of tax | 1,033 | 5,344 | |||||
| Total Stockholders’ Equity | 540,724 | 403,680 | |||||
| Total Liabilities, Mezzanine Equity, and Stockholders’ Equity | $ | 1,440,377 | $ | 1,284,469 | |||
|
ANI Pharmaceuticals, Inc. and Subsidiaries
Table 3: Adjusted non-GAAP EBITDA Calculation and US GAAP to Non-GAAP Reconciliation (unaudited, in thousands) |
||||||||||||||||||||||||||||||||||||||||
| Reconciliation of certain adjusted non-GAAP accounts: | ||||||||||||||||||||||||||||||||||||||||
| Net Revenues | Cost of sales (excluding depreciation and amortization) | Selling, general, and administrative | Research and development | |||||||||||||||||||||||||||||||||||||
| Three Months Ended December 31, | Three Months Ended December 31, | Three Months Ended December 31, | Three Months Ended December 31, | Three Months Ended December 31, | ||||||||||||||||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | 2025 | 2024 | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||||||||||||||
| Net Income (Loss) | $ | 27,490 | $ | (10,276 | ) | As reported: | $ | 247,060 | $ | 190,574 | $ | 100,269 | $ | 80,280 | $ | 82,790 | $ | 69,719 | $ | 12,261 | $ | 16,646 | ||||||||||||||||||
| Add/(Subtract): | ||||||||||||||||||||||||||||||||||||||||
| Interest expense, net | 4,411 | 6,015 | ||||||||||||||||||||||||||||||||||||||
| Other (income) expense, net | (850 | ) | 1,378 | |||||||||||||||||||||||||||||||||||||
| Income tax expense (benefit) | 3,989 | (3,486 | ) | |||||||||||||||||||||||||||||||||||||
| Depreciation and amortization | 22,613 | 22,600 | ||||||||||||||||||||||||||||||||||||||
| Contingent consideration fair value adjustment | (5,727 | ) | (1,893 | ) | ||||||||||||||||||||||||||||||||||||
| Unrealized (gain) loss on investment in equity securities | (273 | ) | 1,991 | |||||||||||||||||||||||||||||||||||||
| Intangible asset impairment charge | — | 7,600 | ||||||||||||||||||||||||||||||||||||||
| Loss on disposal of assets | 87 | — | ||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | 9,768 | 7,061 | Stock-based compensation | — | — | (507 | ) | (367 | ) | (8,741 | ) | (6,233 | ) | (520 | ) | (461 | ) | |||||||||||||||||||||||
| M&A transaction and integration expenses | 607 | 5,965 | M&A transaction and integration expenses | — | — | — | — | (607 | ) | (5,965 | ) | — | — | |||||||||||||||||||||||||||
| Litigation expenses | 3,241 | 1,657 | Litigation expenses | — | — | — | — | (3,241 | ) | (1,657 | ) | — | — | |||||||||||||||||||||||||||
| Inventory step-up amortization | — | 10,375 | Inventory step-up amortization | — | — | — | (10,375 | ) | — | — | — | — | ||||||||||||||||||||||||||||
| Severance | — | 1,057 | Severance | — | — | — | — | — | (1,057 | ) | — | — | ||||||||||||||||||||||||||||
| Adjusted non-GAAP EBITDA | $ | 65,356 | $ | 50,044 | As adjusted: | $ | 247,060 | $ | 190,574 | $ | 99,762 | $ | 69,538 | $ | 70,201 | $ | 54,807 | $ | 11,741 | $ | 16,185 | |||||||||||||||||||
| Reconciliation of certain adjusted non-GAAP accounts: | ||||||||||||||||||||||||||||||||||||||||
| Net Revenues | Cost of sales (excluding depreciation and amortization) | Selling, general, and administrative | Research and development | |||||||||||||||||||||||||||||||||||||
| Twelve Months Ended December 31, | Twelve Months Ended December 31, | Twelve Months Ended December 31, | Twelve Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | 2025 | 2024 | 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||||||||||||||
| Net Income (Loss) | $ | 78,337 | $ | (18,522 | ) | As reported: | $ | 883,366 | $ | 614,376 | $ | 341,310 | $ | 250,210 | $ | 317,745 | $ | 249,636 | $ | 51,664 | $ | 44,581 | ||||||||||||||||||
| Add/(Subtract): | ||||||||||||||||||||||||||||||||||||||||
| Interest expense, net | 20,060 | 17,602 | ||||||||||||||||||||||||||||||||||||||
| Other (income) expense, net | (1,934 | ) | 4,033 | |||||||||||||||||||||||||||||||||||||
| Loss on extinguishment of debt | — | 7,468 | ||||||||||||||||||||||||||||||||||||||
| Income tax expense (benefit) | 17,454 | (3,690 | ) | |||||||||||||||||||||||||||||||||||||
| Depreciation and amortization | 91,417 | 67,731 | ||||||||||||||||||||||||||||||||||||||
| Contingent consideration fair value adjustment | (31,012 | ) | (619 | ) | ||||||||||||||||||||||||||||||||||||
| Unrealized gain on investment in equity securities | (2,824 | ) | (6,307 | ) | ||||||||||||||||||||||||||||||||||||
| Intangible asset impairment charge | 767 | 7,600 | ||||||||||||||||||||||||||||||||||||||
| Loss (gain) on disposal of assets | 382 | (5,347 | ) | |||||||||||||||||||||||||||||||||||||
| Stock-based compensation | 37,929 | 29,344 | Stock-based compensation | — | — | (1,803 | ) | (1,277 | ) | (33,982 | ) | (26,533 | ) | (2,144 | ) | (1,534 | ) | |||||||||||||||||||||||
| M&A transaction and integration expenses | 3,823 | 20,163 | M&A transaction and integration expenses | — | — | — | — | (3,823 | ) | (20,163 | ) | — | — | |||||||||||||||||||||||||||
| Litigation expenses | 15,278 | 6,395 | Litigation expenses | — | — | — | — | (15,278 | ) | (6,395 | ) | — | — | |||||||||||||||||||||||||||
| Inventory step-up amortization | — | 13,599 | Inventory step-up amortization | — | — | — | (13,599 | ) | — | — | — | — | ||||||||||||||||||||||||||||
| Severance | 105 | 6,365 | Severance | — | — | — | — | (105 | ) | (6,365 | ) | — | — | |||||||||||||||||||||||||||
| Equity payout | — | 10,190 | Equity payout | — | — | — | — | — | (9,171 | ) | — | (1,019 | ) | |||||||||||||||||||||||||||
| Adjusted non-GAAP EBITDA | $ | 229,782 | $ | 156,005 | As adjusted: | $ | 883,366 | $ | 614,376 | $ | 339,507 | $ | 235,334 | $ | 264,557 | $ | 181,009 | $ | 49,520 | $ | 42,028 | |||||||||||||||||||
|
ANI Pharmaceuticals, Inc. and Subsidiaries
Table 4: Adjusted non-GAAP Net Income and Adjusted non-GAAP Diluted Earnings per Share Reconciliation (unaudited, in thousands, except per share amounts) |
|||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Net Income (Loss) Available to Common Shareholders | $ | 27,490 | $ | (10,682 | ) | $ | 77,180 | $ | (20,147 | ) | |||||
| Add/(Subtract): | |||||||||||||||
| Non-cash interest expense | 238 | 232 | 974 | 149 | |||||||||||
| Depreciation and amortization | 22,613 | 22,600 | 91,417 | 67,731 | |||||||||||
| Contingent consideration fair value adjustment | (5,727 | ) | (1,893 | ) | (31,012 | ) | (619 | ) | |||||||
| Loss (gain) on disposal of assets | 87 | — | 382 | (5,347 | ) | ||||||||||
| Unrealized (gain) loss on investment in equity securities | (273 | ) | 1,991 | (2,824 | ) | (6,307 | ) | ||||||||
| Intangible asset impairment charge | — | 7,600 | 767 | 7,600 | |||||||||||
| Stock-based compensation | 9,768 | 7,061 | 37,929 | 29,344 | |||||||||||
| M&A transaction and integration expenses | 607 | 5,965 | 3,823 | 20,163 | |||||||||||
| Litigation expenses | 3,241 | 1,657 | 15,278 | 6,395 | |||||||||||
| Inventory step-up amortization | — | 10,375 | — | 13,599 | |||||||||||
| Severance | — | 1,057 | 105 | 6,365 | |||||||||||
| Equity payout | — | — | — | 10,190 | |||||||||||
| Loss on extinguishment of debt | — | — | — | 7,468 | |||||||||||
| Other (income) expense | (878 | ) | 1,335 | (2,093 | ) | 3,869 | |||||||||
| Less: | |||||||||||||||
| Estimated tax impact of adjustments | (7,716 | ) | (15,021 | ) | (29,834 | ) | (38,154 | ) | |||||||
| Adjusted non-GAAP Net Income Available to Common Shareholders (1) | $ | 49,450 | $ | 32,277 | $ | 162,092 | $ | 102,299 | |||||||
| Diluted Weighted-Average | |||||||||||||||
| Shares Outstanding | 21,774 | 19,445 | 21,228 | 19,318 | |||||||||||
| Adjusted Diluted Weighted-Average (2) | |||||||||||||||
| Shares Outstanding | 21,186 | 19,785 | 20,536 | 19,668 | |||||||||||
| Adjusted non-GAAP | |||||||||||||||
| Diluted Earnings per Share | $ | 2.33 | $ | 1.63 | $ | 7.89 | $ | 5.20 | |||||||
(1)
Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistributed earnings to participating securities.
(2)
Non-GAAP Adjusted Diluted Weighted-Average Shares Outstanding excludes certain dilutive shares related to the 2029 senior convertible notes as they are intended to be covered by our capped call transactions. Our outstanding capped call transactions are intended to offset the dilutive effect of the 2029 convertible senior notes recognized in the calculation of GAAP diluted EPS in this reporting period in full, and therefore approximately 588,000 shares and 692,000 shares for the three and twelve months ended December 31, 2025, have been excluded from the calculation of the Non-GAAP Adjusted Diluted Weighted-Average Shares outstanding, respectively.