ANI Pharmaceuticals' first quarter results were marked by substantial top-line growth, but the market responded negatively, with shares falling sharply after the report. Management attributed the quarter’s revenue strength to a surge in generics sales, ongoing robust demand for Cortrophin Gel, and increased activity in branded products. CEO Nikhil Lalwani said, “The first quarter reflected particularly strong performance for our generics business, continued solid demand for Cortrophin Gel, and increased demand for our brands portfolio.” However, margin pressures and near-term challenges in the retina segment weighed on investor sentiment.
Is now the time to buy ANIP? Find out in our full research report (it’s free).
ANI Pharmaceuticals (ANIP) Q1 CY2025 Highlights:
- Revenue: $197.1 million vs analyst estimates of $179.6 million (43.4% year-on-year growth, 9.8% beat)
- Adjusted EPS: $1.70 vs analyst estimates of $1.38 (23% beat)
- Adjusted EBITDA: $50.75 million vs analyst estimates of $42.4 million (25.7% margin, 19.7% beat)
- The company lifted its revenue guidance for the full year to $780.5 million at the midpoint from $766 million, a 1.9% increase
- Management raised its full-year Adjusted EPS guidance to $6.45 at the midpoint, a 2.2% increase
- EBITDA guidance for the full year is $200 million at the midpoint, above analyst estimates of $195.8 million
- Operating Margin: 13.3%, down from 14.8% in the same quarter last year
- Market Capitalization: $1.31 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 ANI Pharmaceuticals’s Q1 Earnings Call
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Gary Nachman (Raymond James) pressed on whether the new pre-filled syringe for Cortrophin Gel could materially expand use and asked about the impact of added sales reps. CEO Nikhil Lalwani said early feedback was positive and that the expanded field force is gaining traction, but no further rep additions are planned for now.
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Faisal Khurshid (Leerink Partners) sought clarity on commercial access barriers affecting the retina segment, particularly regarding Medicare. Lalwani explained that lack of foundation funding for co-pay support in Q1 reduced access but the company is exploring alternative pathways and expects improvement.
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Vamil Divan (Guggenheim Securities) asked about the potential impact of upcoming clinical trial results for retina therapies and the significance of Prucalopride exclusivity for generics. Management confirmed that positive trial outcomes could broaden ILUVIEN’s use, and that generics revenue will dip post-exclusivity before rebounding.
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David Amsellem (Piper Sandler) questioned the sustainability of payer dynamics as the Cortrophin category grows and inquired about surprises in the Alimera acquisition. Lalwani asserted that payers value competition in ACTH and expressed confidence in resolving challenges related to the retina portfolio.
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Ekaterina Knyazkova (J.P. Morgan) probed which indications are driving Cortrophin Gel growth and whether ANI’s U.S. manufacturing footprint could be leveraged if tariffs are enacted. Lalwani detailed broad-based growth across specialties and confirmed spare capacity to meet potential tariff-driven demand.
Catalysts in Upcoming Quarters
In the coming quarters, StockStory analysts will monitor (1) the pace of Cortrophin Gel adoption enabled by the pre-filled syringe and outreach to new prescribers, (2) the recovery in retina segment sales as commercial changes and market access initiatives take effect, and (3) sustained momentum in generics following the expiration of Prucalopride exclusivity. Any developments regarding pharmaceutical tariffs and the ongoing CG Oncology royalty litigation may also influence results.
ANI Pharmaceuticals currently trades at $65.50, down from $71.67 just before the earnings. Is the company at an inflection point that warrants a buy or sell? Find out in our full research report (it’s free).
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