ANI Pharmaceuticals, Inc.

Good day, everyone, and welcome to today's ANI Pharmaceuticals, Inc., first quarter 2026 earnings results call. Please note this call is being recorded. After the speaker's prepared remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star 1-1 on your telephone keypad. If you'd like to withdraw your question, please press star 1-1 on your telephone keypad again. It is now my pleasure to turn the conference over to Irina Koffler.

Thank you, Liz. Welcome to ANI Pharmaceuticals' first quarter 2026 earnings results call. This is Irina Koffler, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer, Stephen Carey, Senior Vice President and Chief Financial Officer, and Chris Mutt, Senior Vice President and Head of ANI's Rare Disease Business. You can also access the webcast of this call through the Investors section of the ANI website at anifarmaceuticals.com. This call is accompanied by a slide deck that can be accessed by going to the Events section of the Investors page of our website. You can turn to our forward-looking statements on slide two. Before we begin, I would like to remind everyone that some statements we make today may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. ANI cautions that these forward-looking statements are subject to risks and uncertainties, including those noted in our press release issued this morning and our filings with the SEC that may cause actual results to 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. During this call, we will also refer to certain non-GAAP financial measures. These non-GAAP financial measures should not be considered as an alternative to financial measures required by GAAP. The non-GAAP financial measures referenced on this call are reconciled to the most directly comparable GAAP financial measures in a table available in the slide deck accompanying this call. 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 8, 2026. 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.

Thank you, Irina, and welcome again to ANI. Good morning, everyone, and thank you for joining us for ANI's first quarter 2026 earnings call. Starting on slide four, in the first quarter, we continue to deliver on our goal of accelerating our transformation into a leading rare disease company and meaningfully further our commitment to serving patients, improving lives. Specifically, in the first quarter, we grew total net revenues 20% year over year, driven by strong performance across our rare disease and genetic businesses, along with contributions from an innovative intellectual property out licensing agreement that will provide us with royalty revenues for years going forward. We also grew adjusted EBITDA 24% year over year while making strategic investments into our rare disease business to accelerate its growth. These strong first quarter results enabled us to raise our 2026 financial guidance for total revenue to the range of 1.08 billion to $1.14 billion, and adjusted EBITDA to the range of $285 million to $300 million. I'm highly encouraged by our first quarter performance, which positions us well to drive meaningful growth in 2026 and beyond. Turning to slide five, this year we outlined top three priorities for 2026. And I'm proud of all of the hard work our team has put in to generate strong momentum as we execute against these priorities. The first priority is to accelerate our transformation into a leading rare disease company. Central to this effort is maximizing the multi-year growth opportunity for cortofan gel, our lead rare disease asset. We delivered 75.1 million in cortofan gel net revenues for the first quarter, up 42% year over year, and consistent with the expectations we outlined during our last quarterly call. The fundamentals remain strong, and we exited the quarter with clear traction across our target indications. We saw accelerating momentum across our new patient starts and monthly volumes dispensed in February and March. This momentum has persisted in the second quarter, with April having the highest number of new patient starts and monthly volumes dispensed since launch. We have also made significant strides this quarter in expanding our rare disease organization to capture the sizable and unique opportunity in acute gouty arthritis flares by targeting podiatry and primary care. We recently hired and onboarded the majority of our new dedicated commercial team who will be in the field in the second quarter. We expect to have our full organizational expansion completed and operational by the end of June. This, together with the continued strong demand across other core indications, provides a solid foundation to drive significant revenue growth in the back half of the year. We believe we are well positioned to achieve our 2026 guidance of $540 million to $575 million in cortofan gel revenues. For Elluvian, we delivered $19.3 million of revenue in the first quarter, up 20% year over year, as we continue to execute on the commercial and patient access initiatives we established in 2025. In particular, we made meaningful progress on generating and sharing clinical data with the retina community, including our recent publication of New Day results in DME. We're also on track to announce results from the phase four synchronicity clinical trial in NIUPS at a medical conference in the third quarter of 2026. Over the long term, we continue to believe the addressable patient populations in DME and NIUPS represent at least 10x the number of patients treated with Elluvian today, representing a significant and durable opportunity for value creation. Turning to slide six. We entered into a transaction with Harmony Biosciences, under which we exclusively licensed certain intellectual property to Harmony, which expands its intellectual property estate for Pitolisant. In addition, we provided Harmony a co-exclusive license with which Harmony and Novidium, a subsidiary of ANI, intend to develop a novel formulation of Pitolisant in broad CNS indications. In the first quarter, we received a $15 million upfront license fee. Additionally, we have the potential to receive an additional $10 million milestone payment upon achievement of certain development milestones and expect these development milestones to be achieved in the second and third quarters of 2026. We will also receive low single-digit royalties on Pitocin-based products. Harmony's guidance has WCAG delivering net revenues of $1 billion to $1.04 billion in 2026. Turning to slide seven, our second priority is continued execution in our generic business by leveraging our superior R&D capabilities, operational execution, and U.S.-based manufacturing footprint, as well as maintaining our current cadence of 10 to 15 launches annually. Similar to Rare Disease, similar to our Rare Disease franchise, we are able to report meaningful progress on this front. Year-to-date, we have already launched six new generics products and continue holding our position as the number two player in overall CGT approvals. Our third priority is managing a disciplined capital allocation strategy. We continue to explore inorganic opportunities to expand the scope and scale of our rare disease business. We also focused, we are also focused on driving organic growth by investing in our dedicated organization for cotrophin in acute gouty arthritis players and investing a high single digit percentage of generics revenues into generics R&D. Our confidence in the business is further evidenced by our new $100 million share repurchase program authorized by our board. Turning to slide eight, we are encouraged by our first quarter performance and the important progress we made against our strategic priorities. We are seeing strong momentum coming out of the quarter and are well positioned to achieve our newly raised 2026 financial guidance. In 2026, we expect to deliver over a billion dollars in revenue, representing 26% growth over 2025 at the midpoint of our guidance range. And rare disease is expected to account for approximately 60% of our total revenues in 2026, with cortofan gel growing 60% year over year. We also expect to expand the bottom line with adjusted EBITDA forecasted to go 27% year over year. Our balance sheet is healthy with the capacity to support future business development opportunities to expand scope and scale of our rare disease business. With all of this recent progress, we are continuing our virtual cycle of growth with which our generics and brands businesses generate meaningful cash flows to support our rare disease business as we accelerate our transformation into a leading rare disease company. And now turn the call over to Chris to discuss our rare disease business in more detail. Chris.