ANI Pharmaceuticals, Inc.

Good morning, everyone, and welcome to today's A&I Pharmaceuticals third 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 star, then the number one on your telephone. We ask that you please limit yourself to one question. If you would like to withdraw your question, please press star, then the number two. It is now my pleasure to turn the conference over to Ms. Courtney Mogerly, Investor Relations. Please go ahead, ma'am.

Thank you, operator. Welcome to ANI Pharmaceuticals Q3 2025 Earnings Results Call. This is Courtney Mogerly, Investor Relations for ANI. With me on today's call are Nikhil Awani, President and Chief Executive Officer, Stephen Carey, Chief Financial Officer, and Chris Mutz, Senior Vice President and Head of ANI'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 A&I 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 November 7th, 2025. Since then, A&I 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 will turn the call over to Nikhil Alwani.

Nikhil Alwani Thank you, Courtney. Good morning, everyone, and thank you for joining us. The third quarter was another remarkable quarter for A&I Pharmaceuticals, marked by record revenue, adjusted EBITDA, and adjusted EPS, all driven by continued momentum across our rare disease and genetics business units. We grew total company revenues by 54% year-over-year and 46% on an organic basis. In addition, we nearly doubled cortofan gel net revenue compared to the third quarter of 2024, and generated adjusted EBITDA growth of 70% year over year. Based on our very strong third quarter performance and future outlook, we are pleased to raise our top and bottom line 2025 financial guidance. Compared to 2024, we now expect to grow 2025 net revenues 39% to 42% and 34% to 37% on an organic basis. with rare disease becoming essentially half of our total revenues for the year. We expect our lead rare disease asset, cortofen gel, to grow 75% to 78% year-over-year to generate revenues of $347 million to $352 million. We expect to grow adjusted EBITDA between 42% and 46% compared to 2024. Later in the call, Steve will provide more detail on our increased guidance. Growing our rare disease business is a top strategic priority for us, creating long-term value for our stakeholders and advancing our purpose of serving patients, improving lives. Turning to our lead rare disease asset, cortofan gel. To drive strong multi-year growth, we're focused on clinical evidence generation to support physician decision-making, investments to enhance patient convenience, and high ROI commercial efforts to drive growth. Our team has made significant progress on these initiatives to grow cortofan gel across our target specialties. In the first quarter, we expanded our portfolio sales team, and we're seeing very positive results highlighted by our strong momentum in new cases initiated and growth in new patient starts. We also launched the pre-fill syringe in the second quarter, reducing administration steps for patients. We're seeing sizable increased demand for the pre-fill syringe and expect it to be an important growth driver. Importantly, to support our commercial team's efforts to drive awareness for cortofan gel, we are committed to generating data to help clinicians, patients, and payers make informed treatment decisions, including a Phase IV clinical trial in acute gouty arthritis flares, preclinical data on cortofan gel's mechanism of action across multiple disease states, and presentations and publications at prominent medical meetings. We remain confident in the strong multi-year growth trajectory of cortofin based on multiple factors. The ACTH market has returned to growth following the launch of cortofin in 2022 and is expected to increase approximately 40% to $957 million in 2025, with cortofin growing by 75% to 78%. Despite this growth, we believe that the addressable patient populations across key indications are significantly under-penetrated. For example, the addressable patient population for acute gaudy arthritis alone is 285,000 patients, an indication that is unique to cortofan gel's label. Importantly, the number of cortofan gel prescribers who were previously naive to ACTH represent approximately half of our total prescriber base, and this group continues to grow. Turning now to our retina portfolio. Illuvian sales in the third quarter were lower due to the further impact from the continued reduced access for Medicare patients and the utilization of the remaining UT units as physician offices. In addition, adoption of Illuvian for NIUPS began in the third quarter, and the company continued to make tangible progress toward full adoption of the label transition. We see 2025 as a reset year for alluvian and believe that we can grow in 2026 and beyond for several reasons. First, we believe the addressable patient populations for alluvian in both BME and NIUPS are at least 10x the current number of patients treated with alluvian. second we expect to see the ensuing results of our strengthened and more experienced ophthalmology organization that is coalescing and deploying an expanded peer-to-peer education program speaker education program and new marketing initiatives in addition we continue to disseminate and contextualize findings of the new day clinical study and create greater awareness on the potential use of alluvium lastly we are seeing signs that there is a growing number of physician offices exploring alternative access pathways including medicare part d through specialty pharmacy this is the path we use for cotrophin moving now to our genetics business we had a very strong third quarter performance due to an opportunistic partner generic launch that occurred in the second half of the third quarter This launch once again highlights our strength in creativity, R&D, business development, operations, and execution intrinsic to A&I's genetics business. And we will continue to leverage these strengths to unlock future opportunities. Based upon upside from this launch, we expect genetics growth for the full year in the low 20% range. We're proud of the continued execution of our genetics business and how it provides ongoing foundational support that enables us to invest in our initiatives to grow our rare disease business. In summary, we delivered another record quarter, given by strong performance across our rare disease and genetics business. As we head into 2026, we expect our virtuous cycle of growth to persist. Rare disease is our primary focus area and largest driver of growth. In addition, we expect continued strong momentum in cortofen and positive impact from multiple initiatives outlined to grow Elluvian in 2026. In addition, we will continue to explore inorganic opportunities to expand the scope and scale of our rare disease business. These efforts will be supported by continued performance in our generics and branch business. I'll now turn the call over to Chris Mutz to discuss our rare disease business in more detail.