Release Date: February 28, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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.
This article first appeared on GuruFocus.Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.