ANI Pharmaceuticals, Inc.

And welcome to today's A&I Pharmaceuticals, Inc. first quarter 2025 earnings results call. Please note this call is being recorded. After the speaker's opening remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press the star, then the number one on your telephone keypad. If you would like to withdraw your question, please press the star key, then number two on your telephone keypad. It is now my pleasure to turn the conference over to Lisa Wilson.

Thank you, Operator. Welcome to A&I Pharmaceuticals Q1 2025 Earnings Results Call. This is Lisa Wilson, Investor Relations for A&I. With me on today's call are Nikhil Lawani, President and Chief Executive Officer, Stephen Carey, Chief Financial Officer, and Chris Mutz, Senior Vice President and Head of A&I's Rare Disease Business. You can also access the webcast of this call through the investor section of the ANI website at ANIFarmaceuticals.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to ANI Pharmaceuticals management as of today and involve risks and uncertainties, including those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. The archived webcast will be available for 30 days on our website, anifarmaceuticals.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on May 9, 2025. Since then, ANI may have made announcements related to the topics discussed. So please reference the company's most recent press releases and SEC filings. And with that, I'll turn the call over to Nikhil Lalwani.

Nikhil Lalwani Thank you, Lisa. Good morning, everyone, and thank you for joining us. I'll start by discussing our first quarter performance and highlights, along with our updated 2025 guidance. Chris will provide additional color on our rare disease business, including our lead asset, cortofan gel, and our retina assets, Illuvian and Utique. Finally, Steve will review our first quarter results and updated 2025 guidance in more detail. Following our remarks, we'll take your questions. We had a very strong start to the year with record revenue, adjusted EBITDA, and adjusted EPS. The first quarter reflected particularly strong performance for our generics business, continued solid demand for cortofan gel, and increased demand for our brands portfolio. The top line upside was partially offset by near-term factors impacting our retina products that I will expand on in a moment. We were pleased with the strength across our overall company. Based on our first quarter performance and favorable demand trends across generics, cortofan gel, and brands, we are raising our 2025 guidance for total revenues and adjusted non-gap EBITDA. We now expect 2025 revenues of $768 million to $793 million, which represents growth of 25 to 29% over 2024 versus our prior guidance of $756 million to $776 million. We expect adjusted non-GAAP EBITDA of $195 million to $205 million, which reflects growth of 25 to 31% over 2024 versus our prior guidance of $190 million to $200 million. Steve will provide more specifics on our updated guidance later in the call. Turning now to our first quarter results, total revenues were $197.1 million, representing a year-over-year increase of 43% on an as-reported basis and 32% on an organic basis, driven by exceptional performance for generics, continued strong growth for cortofan gel, and continued demand for our brand's portfolio. Adjusted non-GAAP EBITDA was $50.7 million, and adjusted non-GAAP EPS was $1.70. Protrophin gel generated $52.9 million in revenues during the quarter, up 43% over the first quarter of 2024. We continue to see growth across our targeted specialties, urology, nephrology, rheumatology, ophthalmology, and pulmonology. Notably, we had a record number of new patient starts and new cases initiated despite the insurance resets that typically impact branded drugs in the first quarter. We continue to believe that cortofan gel remains on a strong multiyear growth trajectory. Based on reported sales of cortofan gel and the other ACTH product on the market, the overall ACTH category grew 27% to approximately 684 million in 2024. While the overall ACTH category returned to strong growth in 2024, the number of patients on ACTH therapy today is still substantially lower than several years ago, providing plenty of headroom for expansion. It is worth noting that approximately 40% of cortofan gel prescribers are new to the ACTH category, which illustrates the need for our therapy and our ability to expand the market. we expect 2025 portrophine gel revenues to increase 34% to 38% to $265 million to $274 million for the year. Our retina products, Illuvian and UT, generated revenues of $16.1 million in the first quarter. Performance of our retina assets outside the U.S. was in line with our expectations, but performance in the U.S. was impacted by several factors, including market access challenges for Medicare patients Typical first quarter dynamics for branded drugs and turnover in our sales force as we optimized our field team to sell our complete rare disease ophthalmology portfolio. As we discussed in our fourth quarter call at the end of February, we saw an impact in the first quarter due to reduced access for Medicare patients. Patient support foundations such as Good Days did not receive sufficient funding in the first quarter of 2025, affecting their ability to assist patients with co-pay support. This change broadly impacted products reimbursed under Medicare Part B, and has been particularly important for alluvium syndication for diabetic macular edema, or DME, as also reflected by other players with therapeutics in DME. After working with HCPs to understand their response to the market access challenges, we've refined our commercial approach. We're also exploring pathways to improve access for appropriate patients through a specialty pharmacy and Medicare Part D. We've also had some turnover in our U.S. Ophthalmology Salesforce as we took steps to optimize and elevate the quality of our team. We are adding best-in-class talent to our sales team and expect to be back to full strength during the second quarter. Our plans to address the near-term challenges in Retina are yielding positive results. In April, end-user demand was higher than any month in the first quarter and almost back to fourth quarter 2024 end-user demand levels. Given the recent promising trends we've seen, we are maintaining our 2025 outlook for Illuvian and Utique revenues of 97 to 103. Our commitment and confidence in the value of our ERECNA portfolio is further reflected in our recent buyout of our royalty obligation on Illuvian and Utique. Turning next to our generics business, we delivered an exceptionally strong first quarter revenues of 98.7 million. an increase of 41% over the first quarter of 2024 and 26% over the fourth quarter of 2024, which had previously been our highest quarter ever for generics. The robust growth was driven by contribution from new product launches, including our first market launch of Focalipri Travelets with 180 days of exclusivity that runs to late June, coupled with strong execution in the base business. With a strong start, we now expect mid-double-digit growth from our genetics business for the full year, up from our prior estimate of low double-digit growth. Our brands portfolio continued to perform well. As discussed on our last earnings call, we were able to identify and capture increased demand in the first quarter for certain products, as we have done periodically for three consecutive years. Our revised full-year guidance reflects a return to a more normalized level of demand during the second quarter. Finally, I will say a few words on the evolving Terra situation. While we await the administration's pharmaceutical industry-specific framework, it is worth highlighting ANI's longstanding commitment to the U.S. pharmaceutical industry and our positive and unique positioning relative to our peers. We are a U.S. domicile pharmaceutical company with over 90% of total company revenues coming from finished goods manufactured in the U.S. Less than 5% of our total company revenues has a direct reliance on China. In addition, we have a strong balance sheet that enables us to carry healthy levels of finished goods and raw material inventories, and we look forward to maintaining our strong commitment to the U.S. pharmaceutical industry. I'll now turn the call over to Chris Motz to discuss our rare disease business in more detail. Chris?