ANI Pharmaceuticals delivered a third quarter marked by substantial year-over-year growth, with management attributing performance to strong momentum across its Rare Disease and Generics segments. CEO Nikhil Lalwani highlighted that Cortrophin Gel nearly doubled net revenue compared to the prior year and that a significant partner generic launch further bolstered results. The company also saw record new patient starts and expanded prescriber adoption, especially in new therapeutic areas such as pulmonology and ophthalmology. Lalwani pointed to “the strong underlying demand and the addressable patient populations across key indications” as core drivers behind the quarter’s success.
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ANI Pharmaceuticals (ANIP) Q3 CY2025 Highlights:
- Revenue: $227.8 million vs analyst estimates of $214.1 million (53.6% year-on-year growth, 6.4% beat)
- Adjusted EPS: $2.04 vs analyst estimates of $1.77 (15.2% beat)
- Adjusted EBITDA: $59.6 million vs analyst estimates of $55.24 million (26.2% margin, 7.9% beat)
- The company lifted its revenue guidance for the full year to $863.5 million at the midpoint from $830.5 million, a 4% increase
- Management raised its full-year Adjusted EPS guidance to $7.51 at the midpoint, a 4.7% increase
- EBITDA guidance for the full year is $224.5 million at the midpoint, above analyst estimates of $221.9 million
- Operating Margin: 15.9%, up from -13.8% in the same quarter last year
- Market Capitalization: $1.77 billion
While we enjoy listening to the management's commentary, our favorite part of earnings calls are the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention.
Our Top 5 Analyst Questions From ANI Pharmaceuticals’s Q3 Earnings Call
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Yuchen Ding (Jefferies) asked about the sustainability of Cortrophin Gel growth given recent Medicare policy changes. CEO Nikhil Lalwani replied the company expects growth to be increasingly driven by prescriber expansion and underpenetrated patient populations rather than policy-driven tailwinds.
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Faisal Khurshid (Leerink Partners) inquired about the specifics and future outlook of the partnered generic product. Lalwani declined to specify the product but confirmed the launch was opportunistic, with competition expected to impact future sales.
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David Amsellem (Piper Sandler) questioned growth prospects in pulmonology and untapped indications. Lalwani emphasized pulmonology’s potential due to higher vial utilization and confirmed ongoing high-ROI investments in expanding prescriber reach.
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Gary Nachman (Raymond James) probed the impact of sales force expansion and prefilled syringe adoption. Lalwani described both as key drivers of recent growth and indicated further expansion could occur if returns remain favorable.
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Ekaterina Knyazkova (JPMorgan) asked about the long-term durability of Cortrophin Gel versus potential generic competition. Lalwani noted significant barriers to generic entry due to complex formulation and reinforced intellectual property protections extending into the 2040s.
Catalysts in Upcoming Quarters
In the quarters ahead, the StockStory team will monitor (1) the pace of Cortrophin Gel adoption in new specialties and the impact of ongoing clinical trials, (2) efforts to stabilize and grow ILUVIEN sales as education and market access initiatives ramp up, and (3) the launch and competitive dynamics of future generics. Progress in business development and the potential for additional Rare Disease asset acquisitions will also be key signposts.
ANI Pharmaceuticals currently trades at $84.11, down from $90.34 just before the earnings. Is there an opportunity in the stock?The answer lies in our full research report (it’s free for active Edge members).
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