• Total Revenue: $190.6 million in Q4 2024, up 45% year-over-year.
• Rare Disease Revenue: $87 million in Q4 2024, more than doubled from the prior year.
• Cortrophin Gel Revenue: $59.4 million in Q4 2024, up 42% year-over-year.
• ILUVIEN and YUTIQ Revenue: $27.6 million in Q4 2024, first full quarter post-acquisition.
• Generics Revenue: $78.6 million in Q4 2024, up 9% year-over-year.
• Adjusted Non-GAAP EBITDA: $50 million in Q4 2024, compared to $30.2 million in the prior year.
• Adjusted Non-GAAP EPS: $1.63 in Q4 2024, compared to $1 in the prior year.
• 2025 Revenue Guidance: $756 million to $776 million, growth of 23% to 26% over 2024.
• 2025 Adjusted Non-GAAP EBITDA Guidance: $190 million to $200 million, growth of 22% to 28% over 2024.
• 2025 Cortrophin Gel Revenue Guidance: $265 million to $274 million, growth of 34% to 38%.
• 2025 ILUVIEN and YUTIQ Revenue Guidance: $97 million to $103 million.
• Non-GAAP Gross Margin: 63.5% in Q4 2024, up 3.9 percentage points year-over-year.
• Debt: $494.3 million at the end of Q4 2024.

• Warning! GuruFocus has detected 6 Warning Signs with ANIP.

Release Date: February 28, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• ANI Pharmaceuticals Inc (NASDAQ:ANIP) reported record fourth quarter and full year 2024 results, leading to an upward revision of their 2025 guidance for total revenues and adjusted non-GAAP EBITDA.
• The rare disease business, particularly Cortrophin Gel, was a primary growth driver, generating close to $200 million in sales in its third year since launch.
• The generics business achieved 12% revenue growth, marking the third consecutive year of double-digit top-line growth.
• The acquisition of Alimera Sciences expanded ANI's rare disease franchise, adding synergistic assets like ILUVIEN and YUTIQ.
• ANI Pharmaceuticals Inc (NASDAQ:ANIP) successfully executed the refinancing of prior debt, establishing a more efficient capital structure.

Negative Points

• ANI Pharmaceuticals Inc (NASDAQ:ANIP) faces challenges with market access dynamics for ILUVIEN and YUTIQ, particularly affecting Medicare patients.
• The transition of YUTIQ manufacturing to Siegfried and the non-renewal of the current supply agreement with IPoint may pose operational risks.
• The company anticipates a typical Q4 to Q1 revenue drop for ILUVIEN and YUTIQ due to insurance resets and purchasing patterns.
• There are uncertainties regarding the impact of reimbursement changes with Medicare, which could affect product access and growth.
• ANI Pharmaceuticals Inc (NASDAQ:ANIP) must navigate potential disruptions in the Cortrophin market from synthetic versions or pipeline products from competitors.

Q & A Highlights

Q: Can you discuss ANI Pharmaceuticals' current deal capacity for business development and M&A, and how high would you take pro forma net leverage to execute a deal? Also, what is the long-term vision for the brand versus generics mix? A: Nikhil Lalwani, President and CEO, explained that ANI Pharmaceuticals focuses its business development and M&A efforts on rare diseases. Historically, the company has maintained a net leverage ratio under 3, even during acquisitions and product launches. The long-term vision is to have a greater percentage of revenue coming from rare diseases and brands, with rare disease being the primary growth driver.

Q: How are you addressing the access issues for ILUVIEN and YUTIQ since January, and what is the long-term impact on growth? A: Nikhil Lalwani noted that some Medicare programs assisting with patient costs have not received adequate funding in 2025. ANI has a patient assistance program in place and is working with healthcare providers to refine their commercial approach. Despite near-term challenges, the addressable patient population for ILUVIEN and YUTIQ is significantly larger, and the company remains confident in long-term growth prospects.

Q: Can you elaborate on the guidance for ILUVIEN and YUTIQ, considering the transition from IPoint to Siegfried and the potential impact of new clinical data? A: Nikhil Lalwani stated that the transition to Siegfried is on track, with initiatives to increase supply security. The company expects preliminary top-line data from clinical trials in the second quarter of 2025, which could expand ILUVIEN's use. The guidance does not assume a tailwind from these results, and the company is focused on driving awareness and refining its commercial strategy.

Q: How important is the launch of the 1 ml prefilled syringe for Cortrophin Gel, and what impact could it have on pricing? A: Nikhil Lalwani emphasized that the prefilled syringe is intended to enhance patient and physician convenience by reducing administration steps. It is expected to drive growth by offering new presentations for different patient segments. The company is also exploring other initiatives to improve convenience and support growth.

Q: Are there any developments that could disrupt the Cortrophin market, such as synthetic versions or pipeline products from overseas competitors? A: Nikhil Lalwani noted that the ACTH market is growing, with significant headroom for expansion. The company believes the market opportunity is substantial, and the outlook remains positive. Both ANI and its competitor have strengthened their intellectual property, and the path to genericization is challenging, suggesting a stable competitive landscape.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.