AG˹ٷ

STOCK TITAN

ANI Pharmaceuticals Reports Record First Quarter 2025 Financial Results and Raises 2025 Guidance

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)
Tags
ANI Pharmaceuticals (ANIP) reported exceptional Q1 2025 financial results and raised its full-year guidance. The company achieved record quarterly revenues of $197.1 million, up 43.4% year-over-year. Key highlights include Rare Disease revenues of $69.0 million, with Cortrophin Gel generating $52.9 million (+43.1% YoY) and ILUVIEN/YUTIQ contributing $16.1 million. Generics revenue grew 40.5% to $98.7 million. The company delivered record adjusted EBITDA of $50.7 million (+34.9% YoY) and adjusted EPS of $1.70. Based on strong performance, ANI raised its 2025 guidance, now expecting revenues of $768-793 million and adjusted EPS of $6.27-6.62. The company maintains a strong U.S. footprint with over 90% of revenues from U.S.-manufactured goods.
ANI Pharmaceuticals (ANIP) ha riportato risultati finanziari eccezionali per il primo trimestre 2025 e ha rivisto al rialzo le previsioni per l'intero anno. La società ha raggiunto ricavi trimestrali record di 197,1 milioni di dollari, in crescita del 43,4% rispetto all'anno precedente. Tra i punti salienti figurano ricavi da Malattie Rare pari a 69,0 milioni di dollari, con Cortrophin Gel che ha generato 52,9 milioni di dollari (+43,1% su base annua) e ILUVIEN/YUTIQ che ha contribuito con 16,1 milioni. I ricavi da farmaci generici sono cresciuti del 40,5% raggiungendo 98,7 milioni di dollari. L'azienda ha registrato un EBITDA rettificato record di 50,7 milioni di dollari (+34,9% su base annua) e un utile per azione rettificato di 1,70 dollari. Grazie alle solide performance, ANI ha aggiornato le previsioni per il 2025, prevedendo ora ricavi tra 768 e 793 milioni di dollari e un utile per azione rettificato tra 6,27 e 6,62 dollari. L'azienda mantiene una forte presenza negli Stati Uniti, con oltre il 90% dei ricavi derivanti da prodotti fabbricati negli USA.
ANI Pharmaceuticals (ANIP) reportó resultados financieros excepcionales en el primer trimestre de 2025 y elevó sus previsiones para todo el año. La compañía alcanzó ingresos trimestrales récord de 197,1 millones de dólares, un aumento del 43,4% interanual. Entre los aspectos más destacados se incluyen ingresos por Enfermedades Raras de 69,0 millones de dólares, con Cortrophin Gel generando 52,9 millones (+43,1% interanual) e ILUVIEN/YUTIQ aportando 16,1 millones. Los ingresos por genéricos crecieron un 40,5% hasta 98,7 millones. La empresa registró un EBITDA ajustado récord de 50,7 millones (+34,9% interanual) y un BPA ajustado de 1,70 dólares. Basándose en este sólido desempeño, ANI elevó sus previsiones para 2025, esperando ahora ingresos entre 768 y 793 millones y un BPA ajustado entre 6,27 y 6,62. La compañía mantiene una fuerte presencia en Estados Unidos, con más del 90% de sus ingresos provenientes de productos fabricados en EE.UU.
ANI Pharmaceuticals(ANIP)� 2025� 1분기 뛰어� 재무 실적� 발표하고 연간 가이던스를 상향 조정했습니다. 회사� 분기� 매출� 1� 9,710� 달러� 전년 동기 대� 43.4% 증가하며 기록� 세웠습니�. 주요 성과로는 희귀질환 매출 6,900� 달러가 있으�, Cortrophin Gel� 5,290� 달러(+43.1% YoY)�, ILUVIEN/YUTIQ가 1,610� 달러� 기여했습니다. 제네� 의약� 매출은 9,870� 달러� 40.5% 성장했습니다. 회사� 조정 EBITDA 5,070� 달러(+34.9% YoY)와 조정 주당순이�(EPS) 1.70달러� 기록했습니다. 강력� 실적� 바탕으로 ANI� 2025� 매출 전망� 7� 6,800만~7� 9,300� 달러, 조정 EPS� 6.27~6.62달러� 상향 조정했습니다. 회사� 미국 � 생산 제품에서 90% 이상� 매출� 올리� 강력� 미국 시장 입지� 유지하고 있습니다.
ANI Pharmaceuticals (ANIP) a publié des résultats financiers exceptionnels pour le premier trimestre 2025 et a relevé ses prévisions annuelles. La société a atteint un chiffre d'affaires trimestriel record de 197,1 millions de dollars, en hausse de 43,4 % par rapport à l'année précédente. Parmi les points forts figurent des revenus liés aux maladies rares de 69,0 millions de dollars, avec Cortrophin Gel générant 52,9 millions de dollars (+43,1 % en glissement annuel) et ILUVIEN/YUTIQ contribuant pour 16,1 millions. Le chiffre d'affaires des génériques a augmenté de 40,5 % pour atteindre 98,7 millions de dollars. L'entreprise a enregistré un EBITDA ajusté record de 50,7 millions de dollars (+34,9 % en glissement annuel) et un BPA ajusté de 1,70 dollar. Sur la base de ces solides performances, ANI a relevé ses prévisions pour 2025, s'attendant désormais à un chiffre d'affaires compris entre 768 et 793 millions de dollars et à un BPA ajusté entre 6,27 et 6,62 dollars. La société conserve une forte présence aux États-Unis, avec plus de 90 % de ses revenus provenant de produits fabriqués aux États-Unis.
ANI Pharmaceuticals (ANIP) meldete herausragende Finanzergebnisse für das erste Quartal 2025 und hob seine Jahresprognose an. Das Unternehmen erzielte rekordverdächtige Quartalsumsätze von 197,1 Millionen US-Dollar, ein Plus von 43,4 % gegenüber dem Vorjahr. Zu den wichtigsten Highlights zählen Umsätze im Bereich Seltene Krankheiten von 69,0 Millionen US-Dollar, wobei Cortrophin Gel 52,9 Millionen US-Dollar (+43,1 % YoY) und ILUVIEN/YUTIQ 16,1 Millionen US-Dollar beisteuerten. Der Umsatz mit Generika stieg um 40,5 % auf 98,7 Millionen US-Dollar. Das Unternehmen erreichte ein Rekord-Adjusted-EBITDA von 50,7 Millionen US-Dollar (+34,9 % YoY) und einen bereinigten Gewinn je Aktie von 1,70 US-Dollar. Aufgrund der starken Performance hob ANI seine Prognose für 2025 an und erwartet nun Umsätze zwischen 768 und 793 Millionen US-Dollar sowie einen bereinigten Gewinn je Aktie zwischen 6,27 und 6,62 US-Dollar. Das Unternehmen hält eine starke Präsenz in den USA mit über 90 % der Umsätze aus in den USA hergestellten Produkten.
Positive
  • Record quarterly revenues of $197.1M, up 43.4% YoY
  • Strong Cortrophin Gel performance with 43.1% YoY revenue growth to $52.9M
  • Generics business grew 40.5% to $98.7M
  • Record adjusted EBITDA of $50.7M, up 34.9%
  • Raised 2025 guidance for revenue and earnings
  • FDA approval received for Cortrophin Gel prefilled syringe
  • Strong U.S. manufacturing footprint with minimal China exposure
Negative
  • U.S. retina assets faced Medicare-related market access challenges
  • Turnover in ophthalmology sales team affecting performance
  • Brands revenue decreased 2.2% YoY to $25.1M
  • Gross margin declined from 64.2% to 62.9% due to product mix
  • Uncertainty around potential pharmaceutical industry-specific tariffs

Insights

ANI Pharma delivered exceptional Q1 results with 43.4% revenue growth and raised 2025 guidance, driven by Cortrophin and generics momentum.

ANI Pharmaceuticals has delivered an exceptionally strong first quarter with revenue reaching $197.1 million, representing substantial 43.4% year-over-year growth. The performance was propelled by multiple growth engines across its portfolio, most notably its flagship rare disease asset Cortrophin Gel which generated $52.9 million in revenue, increasing 43.1% year-over-year with record new patient starts.

The company's generics business was equally impressive, achieving record quarterly revenue of $98.7 million, up 40.5% from the prior year. This growth came from both new product launches (including first-to-market prucalopride tablets with 180-day exclusivity) and strong execution across their established portfolio.

Profitability metrics were robust with adjusted EBITDA of $50.7 million (up 34.9%) and adjusted EPS of $1.70. However, GAAP earnings per share decreased to $0.69 from $0.82 in the prior year period, primarily reflecting increased expenses related to the Alimera Sciences acquisition and investments in sales and marketing capabilities.

There were some challenges with their retina assets (ILUVIEN and YUTIQ), which were impacted by Medicare-related market access issues and sales force turnover. Despite these headwinds, management expressed confidence that demand is accelerating in Q2.

Most significantly, ANI raised its full-year 2025 guidance, now projecting total revenue between $768-$793 million (up from $756-$776 million), adjusted EBITDA of $195-$205 million (up from $190-$200 million), and adjusted EPS of $6.27-$6.62 (up from $6.12-$6.49). This guidance increase after just one quarter signals strong management confidence in the company's growth trajectory.

The company maintains a solid financial position with $149.8 million in cash, $220.3 million in accounts receivable, and $637.2 million in debt. ANI generated $35 million in operating cash flow during the quarter, demonstrating good cash conversion of its strong operating results.

  • Generated record quarterly net revenues of $197.1 million, representing year-over-year growth of 43.4%
  • Total Rare Disease quarterly net revenues of $69.0 million, which includes:
    • Purified Cortrophin® Gel net revenues of $52.9 million, an increase of 43.1% year-over-year, and
    • ILUVIEN® and YUTIQ® net revenues of $16.1 million
  • Record Generics net revenues of $98.7 million, an increase of 40.5% year-over-year
  • Delivered record quarterly adjusted non-GAAP EBITDA of $50.7 million, an increase of 34.9% year-over-year
  • Diluted GAAP income per share of $0.69 and record adjusted non-GAAP diluted earnings per share of $1.70
  • Increased 2025 guidance with expected net revenues of $768.0 million to $793.0 million, adjusted non-GAAP EBITDA of $195.0 million to $205.0 million, and adjusted non-GAAP diluted earnings per share of $6.27 to $6.62
  • Rare Disease net revenues expected to represent 47% to 48% of total Company net revenues in 2025, including:
    • Purified Cortrophin Gel net revenues of $265.0 million to $274.0 million, representing year-over-year growth of 33.8% to 38.3%, and
    • ILUVIEN and YUTIQ net revenues of $97.0 million to $103.0 million

BAUDETTE, Minn., May 09, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced financial results and business highlights for the first quarter ended March 31, 2025.

“We are pleased to report another strong quarter, with record revenue, adjusted EBITDA and adjusted EPS driven by continued strong demand for Cortrophin Gel, exceptional performance for our Generics business, and increased demand for our Brands portfolio,� said Nikhil Lalwani, President and CEO of ANI. “Our lead Rare Disease product Cortrophin Gel continued to perform well delivering a record number of prescriptions and new patient starts in the first quarter.�

Mr. Lalwani continued, “While our core franchises outperformed, demand for our retina assets ILUVIEN and YUTIQ was impacted by Medicare-related market access challenges, turnover in our ophthalmology sales team, and seasonality. We remain focused on growing our retina franchise and are pleased to report that demand has accelerated in the second quarter.

Based on our first quarter performance and favorable demand trends for Cortrophin Gel and our Generics and Brands portfolio, we are raising our 2025 guidance for total revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP EPS. While we await more visibility on potential pharmaceutical industry-specific tariffs, we believe we are well positioned based on our strong U.S. footprint with over 90% of our revenues coming from finished goods manufactured in the U.S. and less than 5% of our revenues with direct reliance on China.�

First Quarter and Recent Business Highlights:

Rare Disease and Brands

Revenues for ANI’s lead Rare Disease asset Cortrophin Gel totaled $52.9 million for the first quarter of 2025, an increase of 43.1% over the same period in 2024. During the quarter, the Company saw increasing demand with the highest number of new patient starts and new cases initiated since launch. Cortrophin Gel experienced growth across existing and new prescribers, and ANI continued to expand the overall base of Cortrophin Gel prescribers. Notably, approximately 40% of Cortrophin Gel prescribers since launch were naïve to the ACTH category prior to prescribing Cortrophin Gel. The Company saw growth across all targeted specialties � ophthalmology, neurology, rheumatology nephrology and pulmonology. Growth in ophthalmology volume was particularly strong, increasing approximately 50% quarter-over-quarter. Prescribing for acute gouty arthritis flares, for which Cortrophin Gel is the only approved ACTH therapy, continued to increase and now accounts for over 15% of Cortrophin Gel usage.

In February, ANI received U.S. Food and Drug Administration (FDA) approval for a prefilled syringe presentation of Cortrophin Gel. The prefilled syringe provides enhanced convenience by reducing the steps required for patients to administer Cortrophin Gel. The Company launched the prefilled syringe in April and early feedback has been positive.

Revenues for ILUVIEN and YUTIQ were $16.1 million for the first quarter. Performance for our retina assets outside the U.S. was in line with our expectations. Performance in the U.S. was impacted by reduced access for Medicare patients due to a lack of funding for third-party co-pay assistance programs, turnover in our sales force and seasonality. The Company’s multi-pronged approach to addressing these factors are yielding positive results in the second quarter. ANI reiterated its commitment and confidence in the value of the retina portfolio by buying out of a royalty obligation on ILUVIEN and YUTIQ in March.

ANI made substantial progress towards enhancing supply security for the ILUVIEN and YUTIQ franchise. In March, the Company received FDA approval for an expanded label for ILUVIEN that includes YUTIQ’s indication of chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS). ANI plans to begin marketing ILUVIEN under the combined label for diabetic macular edema (DME) and chronic NIU-PS this quarter.

Revenues for Brands decreased 2.2% year-over-year to $25.1 million. During the first quarter, ANI identified and captured increased demand for certain products, as it has done periodically over the past three consecutive years. The Company anticipates a return to a more normalized level of demand during the second quarter.

Generics and Other

ANI’s Generics revenues increased 40.5% year-over-year to $98.7 million in the first quarter, driven by contribution from new product launches, including the first-to-market launch of prucalopride tablets with 180 days of exclusivity, and strong execution in the base business.

First Quarter 2025 Financial Results

Three Months Ended March 31,
(in thousands)20252024Change% Change
Rare Disease and Brands
Cortrophin Gel$52,850$36,937$15,91343.1%
ILUVIEN and YUTIQ16,109-16,109n/m
Rare Disease total net revenues$68,959$36,937$32,02286.7%
Brands25,12325,679(556)(2.2)%
Rare Disease and Brands total net revenues$94,082$62,616$31,46650.3%
Generics and Other
Generic pharmaceutical products98,67870,21728,46140.5%
Royalties and other pharmaceutical services4,3624,597(235)(5.1)%
Generics and Other total net revenues$103,040$74,814$28,22637.7%
Total net revenues$197,122$137,430$59,69243.4%
n/m - not meaningful percentage due to the acquisition of ILUVIEN and YUTIQ in the third quarter of 2024.

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

Total net revenues for the first quarter of 2025 were $197.1 million, an increase of 43.4% over the prior year period. On an organic basis, excluding the acquisition of Alimera, total net revenues grew 31.7% year-over-year.

Net revenues for Rare Disease, which includes Cortrophin Gel, ILUVIEN and YUTIQ, increased 86.7% to $69.0 million. Cortrophin Gel net revenues increased 43.1% to $52.9 million driven by increased volume. ILUVIEN and YUTIQ generated net revenues of $16.1 million.

Net revenues for Brands decreased 2.2% to $25.1 million driven by a modest net decrease in volume.

Net revenues for Generic pharmaceutical products increased 40.5% to $98.7 million driven by increased volumes in the base business and contribution from new product launches.

On a GAAP basis, gross margin decreased from 64.2% to 62.9%, and on a non-GAAP basis, gross margin decreased from 64.4% to 63.1%, primarily due to mix including a significant growth of royalty bearing products, including Cortrophin Gel.

On a GAAP basis, research and development expenses increased 0.5% to $10.6 million. On a non-GAAP basis, research and development expenses decreased 1.9% to $10.0 million, relatively in-line with prior year.

On a GAAP basis, selling, general, and administrative expenses increased 59.4% to $76.5 million, resulting from the expenses related to the acquisition of Alimera Sciences in September 2024, including our expanded ophthalmology sales and marketing team, continued investment in Rare Disease sales and marketing activities, increased employment-related costs, and an overall increase in activities required to support the growth of our business. On a non-GAAP basis, selling, general, and administrative expenses increased 56.5% to $63.7 million.

On a GAAP basis, the Company reported net income attributable to common shareholders of $15.3 million, or $0.69 per share, for the first quarter of 2025 compared to net income of $17.8 million, or $0.82 per share, in the prior year period, on a diluted basis. On a non-GAAP basis, the Company reported diluted earnings per share of $1.70 for the first quarter of 2025 compared to $1.21 in the prior year period.

Adjusted non-GAAP EBITDA for the first quarter of 2025 was $50.7 million, an increase of 34.9% from the first quarter of 2024.

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 March 31, 2025, the Company had $149.8 million in unrestricted cash and cash equivalents, $220.3 million in net accounts receivable and $637.2 million in principal value of outstanding debt (inclusive of our senior convertible notes). The Company generated year-to-date cash flow from operations of $35.0 million.

Full Year 2025 Guidance:

Full Year 2025 GuidancePrevious Full Year 2025
Guidance
2024 ActualGrowth
Net Revenue (Total Company)$768 million - $793 million$756 million - $776 million$614 million25% - 29%
Cortrophin Gel Net Revenue$265 million - $274 million$265 million - $274 million$198 million34% - 38%
ILUVIEN and YUTIQ Net Revenue$97 million - $103 million$97 million - $103 million$32 millionn/m
Adjusted Non-GAAP EBITDA$195 million - $205 million$190 million - $200 million$156 million25% - 31%
Adjusted Non-GAAP Diluted EPS$6.27 - $6.62$6.12 - $6.49$5.2021% - 27%
n/m - not meaningful percentage due to comparison of only a partial year of ILUVIEN and YUTIQ Net Revenue in 2024.

ANI expects total company adjusted non-GAAP gross margin between 63% and 64%. 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 20.1 million and 20.4 million shares outstanding for the purpose of calculating adjusted non-GAAP diluted EPS and expects its annual U.S. GAAP effective tax rate to be approximately 25%.

Upcoming Events

ANI plans to participate in the following investor event:

Jefferies Global Healthcare Conference
June 4, 2025
New York, NY

Conference Call

The Company’s management will host a conference call today to discuss its first quarter 2025 results.

DateFriday, May 9, 2025
Time8:00 a.m. ET
Toll free (U.S.)800-225-9448
Conference ID4921902


This conference call will also be webcast and can be accessed from the “Investors� section of ANI’s website at . The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A replay of the conference call will be available within two hours of the call’s completion and will remain accessible for two weeks by dialing 800-753-8591 and entering access code 4921902.

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 (loss) income, excluding tax provision or benefit, interest expense, net, other expense, net, loss on extinguishment of debt, depreciation and amortization expense, non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, 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 2025 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 on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, loss on extinguishment of debt, 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 (loss) income, plus the non-cash stock-based compensation, non-cash interest expense, depreciation and amortization, M&A transaction and integration expenses, contingent consideration fair value adjustment, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, loss on extinguishment of debt, amortization of certain purchase price adjustments, 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 on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, litigation expenses related to certain matters, loss on extinguishment of debt, 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 diluted earnings per share when analyzing Company performance.

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 2025 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, contingent consideration fair value adjustments, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, 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 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, M&A transaction and integration expenses, 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 impact of Canada operations, 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 unaffected by non-cash stock-based compensation expense, M&A transaction and integration expenses, contingent consideration fair value adjustments, unrealized gain on our investment in equity securities, gain on sale of the former Oakville, Ontario manufacturing site, 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 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 .

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, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, 2025 guidance, 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 our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, to achieve commercialization at levels of market acceptance that will continue to allow us to achieve continued profitability; our ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the limitation of our cash flow as a result of the indebtedness and liabilities incurred from the acquisition of Alimera; the risks that our acquisitions and investments, including the acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays and disruptions in production of our approved products, increased costs and potential loss of revenues if we need to change suppliers due to the limited number of suppliers for our raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in production of our approved products as a result of our reliance on single source third party contract manufacturing supply for certain of our key products, including Cortrophin Gel, ILUVIEN and YUTIQ; delays or failure in obtaining and maintaining approvals by the FDA of the products we sell; 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 we 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 our 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 our manufacturing partners to meet our product demands and timelines; the impact of changes or fluctuations in exchange rates; our ability to develop, license or acquire, and commercialize new products; our obligations in agreements under which we license, develop or commercialize rights to products or technology from third parties and our ability to maintain such licenses; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict in the Middle East, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies, and other risks and uncertainties that are described in ANI’s Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission.

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 Contact Lisa M. Wilson, In-Site Communications, Inc.
212-452-2793

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 March 31,
20252024
Net Revenues$197,122$137,430
Operating Expenses
Cost of sales (excluding depreciation and amortization)73,03749,157
Research and development10,56410,511
Selling, general, and administrative76,52848,021
Depreciation and amortization22,89114,686
Contingent consideration fair value adjustment(12,092)90
Gain on sale of building-(5,347)
Total Operating Expenses, net170,928117,118
Operating income26,19420,312
Other (Expense) Income, net
Unrealized (loss) gain on investment in equity securities(921)9,655
Interest expense, net(5,484)(4,600)
Other income (expense), net198(32)
Income Before Income Tax Expense19,98725,335
Income tax expense4,3067,128
Net Income$15,681$18,207
Dividends on Series A Convertible Preferred Stock(406)(406)
Net Income Available to Common Shareholders$15,275$17,801
Basic and Diluted Income Per Share:
Basic Income Per Share$0.70$0.84
Diluted Income Per Share$0.69$0.82
Basic Weighted-Average Shares Outstanding19,60719,099
Diluted Weighted-Average Shares Outstanding20,04619,422


ANI Pharmaceuticals, Inc. and Subsidiaries
Table 2: US GAAP Balance Sheets
(unaudited, in thousands)
March 31,
2025
December 31,
2024
Current Assets
Cash and cash equivalents$149,802$144,861
Restricted cash3433
Accounts receivable, net220,334221,726
Inventories137,408136,782
Prepaid expenses and other current assets23,32617,975
Investment in equity securities5,3866,307
Total Current Assets536,290527,684
Non-current Assets
Property and equipment, net58,17956,863
Deferred tax assets, net of deferred tax liabilities and valuation allowance88,48985,106
Intangible assets, net538,495541,834
Goodwill60,66259,990
Derivatives and other non-current assets10,31312,220
Total Assets$1,292,428$1,283,697
Current Liabilities
Current debt, net of deferred financing costs$11,193$9,172
Accounts payable53,05845,656
Accrued royalties23,71322,626
Accrued compensation and related expenses22,29737,725
Accrued government rebates22,64418,714
Income taxes payable14,1886,749
Returned goods reserve42,46439,274
Current contingent consideration22929
Accrued expenses and other12,02913,735
Total Current Liabilities201,815193,680
Non-current Liabilities
Non-current debt, net of deferred financing costs and current component305,294309,108
Non-current convertible notes, net of deferred financing costs306,335305,812
Non-current contingent consideration, net of current17,42619,825
Accrued licensor payments due11,06820,961
Other non-current liabilities7,0205,781
Total Liabilities$848,958$855,167
Mezzanine Equity
Convertible Preferred Stock, Series A24,85024,850
Stockholders� Equity
Common Stock22
Class C Special Stock--
Preferred Stock--
Treasury stock(31,043)(21,040)
Additional paid-in capital531,055519,653
Accumulated deficit(85,004)(100,279)
Accumulated other comprehensive income, net of tax3,6105,344
Total Stockholders� Equity418,620403,680
Total Liabilities, Mezzanine Equity, and Stockholders� Equity$1,292,428$1,283,697


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 RevenuesCost of sales (excluding depreciation and amortization)Selling, general, and administrativeResearch and development
Three Months Ended March 31,Three Months Ended March 31,Three Months Ended March 31,Three Months Ended March 31,Three Months Ended March 31,
2025202420252024202520242025202420252024
Net Income$15,681$18,207As reported:$197,122$137,430$73,037$49,157$76,528$48,021$10,564$10,511
Add/(Subtract):
Interest expense, net5,4844,600
Other (income) expense, net(198)32
Provision for income taxes4,3067,128
Depreciation and amortization22,89114,686
Contingent consideration fair value adjustment(12,092)90
Gain on sale of building-(5,347)
Unrealized loss (gain) on investment in equity securities921(9,655)
Stock-based compensation8,8686,934Stock-based compensation(375)(280)(7,967)(6,371)(526)(283)
M&A transaction and integration expenses1,793713M&A transaction and integration expenses(1,793)(713)
Litigation expenses2,990245Litigation expenses(2,990)(245)
Severance105Severance(105)
Adjusted non-GAAP EBITDA$50,749$37,633As adjusted:$197,122$137,430$72,662$48,877$63,673$40,692$10,038$10,228


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 March 31,
20252024
Net Income Available to Common Shareholders$15,275$17,801
Add/(Subtract):
Non-cash interest expense259(10)
Depreciation and amortization22,89114,686
Contingent consideration fair value adjustment(12,092)90
Gain on sale of building(5,347)
Unrealized loss (gain) on investment in equity securities921(9,655)
Stock-based compensation8,8686,934
M&A transaction and integration expenses1,793713
Litigation expenses2,990245
Severance105
Other expense(236)
Less:
Estimated tax impact of adjustments(6,630)(1,991)
Adjusted non-GAAP Net Income Available to Common Shareholders (1)$34,144$23,466
Diluted Weighted-Average
Shares Outstanding20,04619,422
Adjusted Diluted Weighted-Average
Shares Outstanding20,04619,422
Adjusted non-GAAP
Diluted Earnings per Share$1.70$1.21
(1) Adjusted non-GAAP Net Income Available to Common Shareholders excludes undistributed earnings to participating securities.

FAQ

What were ANI Pharmaceuticals' (ANIP) Q1 2025 revenue and earnings?

ANI reported Q1 2025 revenue of $197.1M (+43.4% YoY), GAAP EPS of $0.69, and adjusted non-GAAP EPS of $1.70.

What is ANI's updated revenue guidance for 2025?

ANI raised its 2025 guidance to $768-793M in revenue, up from previous guidance of $756-776M.

How did Cortrophin Gel perform in Q1 2025?

Cortrophin Gel generated $52.9M in revenue, up 43.1% YoY, with record new patient starts and prescriptions.

What were the main challenges for ANI's retina business in Q1 2025?

The retina business faced Medicare-related market access challenges, sales team turnover, and seasonality impacts.

How much did ANI's Generics business grow in Q1 2025?

Generics revenue increased 40.5% YoY to $98.7M, driven by new product launches and strong base business execution.
Ani Pharmaceutic

NASDAQ:ANIP

ANIP Rankings

ANIP Latest News

ANIP Stock Data

1.42B
18.02M
11.22%
97.42%
11.74%
Drug Manufacturers - Specialty & Generic
Pharmaceutical Preparations
United States
BAUDETTE