ANI Pharmaceuticals, Inc. (ANIP) is a diversified biopharmaceutical company dedicated to developing, manufacturing, and commercializing innovative and high-quality therapeutics. The company operates across rare disease, generics, and branded pharmaceutical markets, focusing on improving patient lives. ANIP's offerings include rare disease treatments, generic prescription drugs, and branded products, supported by U.S.-based manufacturing facilities.
- Generics and Other - Produces high-quality generic pharmaceutical products sold through wholesale and retail channels, along with contract manufacturing, royalties, and product development services.
- Rare Disease and Brands - Markets therapeutics for rare diseases and branded products, including treatments for ophthalmology, rheumatology, and other specialized areas.
- Rare Disease Products - Includes Cortrophin Gel, ILUVIEN, and YUTIQ for conditions like diabetic macular edema and non-infectious uveitis.
- Branded Products - Comprises a portfolio of approximately 16 branded products sold in highly genericized markets.
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Given the headwinds observed in the U.S. for ILUVIEN and YUTIQ—especially regarding Medicare co-pay support challenges—can you provide more details on the timeline and specific steps you plan to take to address these issues and ensure that U.S. sales rebound as forecasted?
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In light of the recent turnover in the ophthalmology sales team, what measures are you implementing to restore full strength rapidly, and how do you anticipate this transition impacting both ILUVIEN and Cortrophin Gel’s short-term performance in the U.S. market?
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With your generics business showing strong performance and the prucalopride launch achieving solid initial results, how do you plan to manage inventory and revenue impact as its 180-day exclusivity concludes, and what are your expectations for sequential quarterly performance?
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Considering the competitive dynamics in the ACTH therapeutic category, particularly with a competitor raising guidance to high single digits, what specific strategic initiatives will ANI undertake to differentiate Cortrophin Gel and expand its addressable patient base?
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As you explore alternative pathways like transitioning ILUVIEN provision through specialty pharmacies under Medicare Part D, can you outline the significant challenges that remain in overcoming market access hurdles and quantify how these initiatives might impact overall U.S. market share?
Research analysts who have asked questions during ANI PHARMACEUTICALS earnings calls.
David Amsellem
Piper Sandler Companies
4 questions for ANIP
Gary Nachman
Raymond James
4 questions for ANIP
Faisal Khurshid
Leerink Partners
3 questions for ANIP
Vamil Divan
Guggenheim Securities
3 questions for ANIP
Ekaterina Knyazkova
Cantor Fitzgerald
2 questions for ANIP
Leszek Sulewski
Truist Securities
2 questions for ANIP
Brandon Folkes
Rodman & Renshaw
1 question for ANIP
Daniel Krizay
Guggenheim Partners, LLC
1 question for ANIP
Glen Santangelo
Jefferies
1 question for ANIP
Jeevan Larson
Truist Securities
1 question for ANIP
Les Sulewski
Truist Securities
1 question for ANIP
Oren Livnat
H.C. Wainwright
1 question for ANIP
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
This company is listed as a principal competitor in the generic pharmaceutical markets where the company operates, competing on factors such as pricing, contract terms, service levels, and reliability. | |
Apotex Inc. | This company is identified as a key competitor in the generic pharmaceutical sector, which is characterized by competition on pricing and other factors. |
Aurobindo Pharma | This company is mentioned as one of the main competitors in the generic pharmaceutical industry, which involves challenges such as pricing and market share. |
Camber Pharmaceuticals Inc. | This company is highlighted as a competitor in the generic pharmaceutical markets, where competition is intense and based on various factors including pricing. |
Hikma Pharmaceuticals plc | This company is noted as a competitor in the generic pharmaceutical industry, which requires companies to compete on pricing and other operational factors. |
Lupin Pharmaceuticals, Inc. | This company is listed among the competitors in the generic pharmaceutical markets, competing on pricing and other key factors. |
Rising Pharmaceuticals, Inc. | This company is identified as a competitor in the generic pharmaceutical sector, which involves competition on pricing and other operational aspects. |
Strides Pharma Inc. | This company is mentioned as a competitor in the generic pharmaceutical markets, where competition is based on pricing and other factors. |
This company is noted as a competitor in the generic pharmaceutical industry, which is characterized by competition on pricing and other factors. | |
This company is listed as a competitor in the generic pharmaceutical markets, competing on pricing and other operational factors. | |
This company is identified as a competitor in the generic pharmaceutical sector, which involves challenges such as pricing and market share. | |
Zydus Pharmaceuticals USA | This company is highlighted as a competitor in the generic pharmaceutical markets, where competition is intense and based on various factors including pricing. |
Mallinckrodt Pharmaceuticals | This company markets Acthar® Gel, which is identified as the principal competitor for the company's Cortrophin Gel product. |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
Alimera Sciences, Inc. | 2024 | ANI Pharmaceuticals acquired Alimera Sciences in a completed merger on September 16, 2024, with each share converted into $5.50 in cash plus a contingent value right (CVR) tied to milestone revenue targets, financed partly by $325 million borrowings and available cash. The acquisition adds key Rare Disease products (ILUVIEN and YUTIQ), repays $72.5 million of Alimera’s debt, and is projected to drive high single-digit to low double-digit EPS accretion, thereby strengthening ANI’s portfolio. |
Recent press releases and 8-K filings for ANIP.
- On August 14, 2025, Ampersand 2020 Limited Partnership converted 5,000 shares of ANI Pharmaceuticals, Inc.'s Series A Convertible Preferred Stock into 120,580 Common Shares at a conversion price of $41.4662 per Common Share.
- On September 26, 2025, ANI Pharmaceuticals, Inc. mandatorily converted the remaining 20,000 outstanding Preferred Shares into 482,320 Common Shares at the same conversion price of $41.4662 per Common Share.
- As a result of these conversions, all 25,000 Series A Convertible Preferred Shares have been converted into an aggregate of 602,900 Common Shares, and no Preferred Shares remain outstanding as of September 26, 2025.
- ANI Pharmaceuticals, Inc. (ANIP) announced the results of its NEW DAY Study for ILUVIEN in patients with early Diabetic Macular Edema (DME) on July 23, 2025.
- While the study's primary endpoint in the Intent-to-Treat (ITT) population was not statistically significant (mean supplemental aflibercept injections of 2.4 for ILUVIEN vs. 2.5 for aflibercept, p=0.756), the Per-Protocol (PP) population showed a statistically significant reduction in supplemental injections for ILUVIEN (1.8 vs. 2.5, p=0.029), resulting in a lower total number of injections needed over the study (2.8 for ILUVIEN vs. 7.5 for aflibercept).
- ILUVIEN also demonstrated a statistically significant increase in the mean time to first supplemental therapy in the ITT population (185.4 days vs. 132.8 days, p=<0.001).
- The safety profile indicated a higher incidence of treatment-related adverse events (40.9% for ILUVIEN vs. 3.3% for aflibercept) and intraocular pressure (IOP) increase events (15.6% vs. 3.3%) for ILUVIEN, though no retinal detachments or endophthalmitis were observed in the ILUVIEN arm.
- ANI Pharmaceuticals updated its 2025 guidance on May 9, 2025, projecting net revenue between $768 - $793 million, representing 25-29% year-over-year growth, and Adjusted Non-GAAP EBITDA of $195 - $205 million.
- The company delivered record results in Q1 2025, with total revenues of $197 million and Adjusted Non-GAAP EBITDA of $51 million, setting a strong foundation for the full year.
- Growth is primarily driven by the Rare Disease segment, including Cortrophin Gel, which is expected to reach $265 - $274 million in net revenue for 2025, and the expanded franchise from the Alimera acquisition in Q3 2024. The Generics business also saw its largest revenue quarter to date in Q1 2025, up 41% year-over-year.
- As of March 31, 2025, the company reported $150 million in cash and a net leverage of 2.7x.
- At its Annual Meeting on May 22, 2025, ANI Pharmaceuticals, Inc. stockholders approved an amendment to the company's Restated Certificate of Incorporation, increasing the number of authorized common shares from 33,333,334 to 66,000,000.
- The company's total authorized stock is now 68,447,948 shares, consisting of 66,000,000 common shares, 781,281 Class C special stock shares, and 1,666,667 preferred stock shares.
- Stockholders also approved the Amended and Restated 2022 Stock Incentive Plan and the Amended and Restated 2016 Employee Stock Purchase Plan.
- ANI Pharmaceuticals delivered record results in Q1 2025, with total revenues of $197 million and Adjusted Non-GAAP EBITDA of $51 million, representing 43% and 35% year-over-year growth, respectively.
- The company raised its full-year 2025 guidance for the second time, projecting net revenue of $768-$793 million and Adjusted Non-GAAP EBITDA of $195-$205 million.
- The Rare Disease segment and Generics business are key growth drivers, with Cortrophin Gel revenues reaching $53 million in Q1 2025 (up 43% year-over-year) and Generics achieving its largest revenue quarter to date (up 41% year-over-year).
- The company's Rare Disease franchise expanded with the acquisition of Alimera in Q3 2024, which added ILUVIEN and YUTIQ to its portfolio and increased its geographic footprint.
- ANI Pharmaceuticals reported record quarterly net revenues of $197.1 million, representing 43.4% year-over-year growth, and record adjusted non-GAAP diluted earnings per share of $1.70 for the first quarter ended March 31, 2025.
- The company's lead Rare Disease product, Purified Cortrophin® Gel, generated $52.9 million in net revenues, an increase of 43.1% year-over-year, while Generics net revenues increased 40.5% year-over-year to $98.7 million.
- ANI Pharmaceuticals increased its 2025 guidance for total net revenues to $768.0 million to $793.0 million, adjusted non-GAAP EBITDA to $195.0 million to $205.0 million, and adjusted non-GAAP diluted earnings per share to $6.27 to $6.62.