ANI Pharmaceuticals delivered a quarter that exceeded Wall Street’s expectations, with management attributing the strong results to rapid growth in its Rare Disease business, especially Cortrophin Gel, and sustained momentum in Generics. CEO Nikhil Lalwani noted that the accelerated adoption of Cortrophin Gel across multiple specialties, including neurology, nephrology, and rheumatology, drove record new patient starts. The launch of a prefilled syringe format also played a significant role in increasing demand, with Lalwani stating, “The team was able to produce a meaningful sequential quarterly growth in new cases initiated and new patient starts that exceeded our prior expectations.” Management emphasized that these gains reflected underlying demand rather than seasonality or one-time benefits.
Is now the time to buy ANIP? Find out in our full research report (it’s free).
ANI Pharmaceuticals (ANIP) Q2 CY2025 Highlights:
- Revenue: $211.4 million vs analyst estimates of $191.5 million (53.1% year-on-year growth, 10.4% beat)
- Adjusted EPS: $1.80 vs analyst estimates of $1.42 (26.8% beat)
- Adjusted EBITDA: $54.08 million vs analyst estimates of $44.05 million (25.6% margin, 22.8% beat)
- The company lifted its revenue guidance for the full year to $830.5 million at the midpoint from $780.5 million, a 6.4% increase
- Management raised its full-year Adjusted EPS guidance to $7.17 at the midpoint, a 11.2% increase
- EBITDA guidance for the full year is $218 million at the midpoint, above analyst estimates of $211.8 million
- Operating Margin: 6.6%, up from 3.7% in the same quarter last year
- Market Capitalization: $1.81 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 Q2 Earnings Call
- Gary Nachman (Raymond James) asked if Cortrophin Gel’s growth reflected underlying demand or any one-time or seasonal factors. CEO Nikhil Lalwani clarified that growth was driven by increased new patient starts and not seasonality or one-time events.
- Faisal Khurshid (Leerink Partners) inquired about the specific drivers behind the ACTH class expansion and the rapid uptake of easier-to-use dosage forms. Lalwani cited the expanded salesforce, uptake in new indications, and rapid adoption of the prefilled syringe as key contributors.
- Daniel Krizay (Guggenheim Securities) pressed for details on specialty adoption rates of the prefilled syringe and whether recent clinical results for ILUVIEN offset market access issues. Lalwani explained adoption spanned all indications, while ILUVIEN’s NEW DAY data would have more long-term impact.
- David Amsellem (Piper Sandler) asked about the future payer landscape for Cortrophin and potential for net pricing erosion. Lalwani noted ongoing engagement with payers and focus on getting therapy to appropriate patients, but avoided specifics on pricing risk.
- Leszek Sulewski (Truist Securities) sought clarification on what drove the raised Cortrophin outlook and Generics pipeline expectations. Lalwani attributed the guidance increase to faster impact from sales team expansion, new indications, and product innovation, while reaffirming a steady cadence of generics launches.
Catalysts in Upcoming Quarters
In upcoming quarters, the StockStory team will monitor (1) continued growth and specialty penetration of Cortrophin Gel—especially in ophthalmology and gout; (2) the company’s ability to resolve or adapt to Medicare market access challenges affecting retina products; and (3) the pace and success of new product launches in Generics as exclusivity periods expire. Progress on clinical evidence generation and maintaining operational discipline will also be important markers for sustained performance.
ANI Pharmaceuticals currently trades at $90, up from $68.93 just before the earnings. Is there an opportunity in the stock?Find out in our full research report (it’s free).
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