ANI Pharmaceuticals, Inc.

Good day, everyone, and welcome to today's ANI Pharmaceuticals Inc. 2Q 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 keypad. If you would like to withdraw your question, please press the star key, then the number two on your telephone keypad. It is now my pleasure to turn the conference over to Lisa Wilson. Please go ahead.

Thank you, operator. Welcome to ANI Pharmaceuticals Q2 2025 Earnings Results Call. This is Lisa Wilson, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer, Steve Carey, Chief Financial Officer, Chris Mutz, Senior Vice President and Head of ANI's Rare Disease Business, and Dr. Mary Powell, our Chief Medical Officer. You can also access the webcast of this call through the Investor section of the ANI website at ANIPharmaceuticals.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's 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 Archive webcast will be available for 30 days on our website, ANIPharmaceuticals.com. For the benefit of those who may be listening to the replay or Archive webcast, this call was held and recorded on August 8, 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 Lawani.

Thank you, Lisa. Good morning, everyone, and thank you for joining us. I'll start by discussing our second quarter performance and highlights along with our raised 2025 guidance. Chris Mutz will then provide additional color on our rare disease business, including our lead asset, crocrophin gel, and our retina assets, Illusion and Utique. Finally, Steve Carey, our CFO, will review our second quarter results and updated 2025 guidance in more detail. Following our remarks, our Chief Medical Officer, Dr. Mary Powell, will join us and we will take your questions. This was a record-setting quarter for our company. With all-time overall company highs in net revenue, adjusted non-GAAP EBITDA, and adjusted non-GAAP EPS, reflecting very strong momentum across both our rare disease and genetic business units. Our rare disease team delivered exceptional -over-year and sequential quarterly growth, with crocrophin gel demand accelerating and both new patient starts and new cases initiated reaching new highs. We continue to pursue initiatives to improve the performance of our retina franchise, yielding positive results. And our genetics business delivered another solid quarter given by new product launches and strong operational executions. Based on our very strong second quarter performance and broad-based momentum across rare disease and generics, we are raising our 2025 guidance for total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP EPS. We now expect 2025 revenues of $818 million to $843 million, which represents growth of 33 to 37 percent over 2024, versus our prior guidance of $768 million to $793 million. We expect rare disease to account for approximately 57 percent of total company net revenues in the second half of 2025. We expect adjusted non-GAAP EBITDA of $213 million to $223 million, which reflects growth of 37 percent to 43 percent over 2024, versus our prior guidance of $195 million to $205 million. Lastly, we expect adjusted non-GAAP earnings per share between $6.98 and $7.35, up from our prior guidance of $6.27 and $6.62. CEE will provide more specifics on our increased guidance later in the call. Turning now to our second quarter results. Total net revenues were $211.4 million, representing -over-year growth of 53 percent on an as-reported basis and 37 percent on an organic basis, driven by strong growth for our lead rare disease asset, Cortrophin Gel, in our genetics business. Adjusted non-GAAP EBITDA was $54.1 million, and adjusted non-GAAP EPS was $1.80. Cortrophin Gel had an exceptional quarter, with revenues of $81.6 million, up 66 percent -over-year and 54 percent from the first quarter of 2025. Strong execution by our commercial teams, including our newly expanded portfolio sales team, the successful launch of our pre-filled syringe, and continued momentum across our target therapeutic areas contributed to record demand in the second quarter. As a reminder, in the first quarter, we expanded our portfolio sales team, which promotes Cortrophin Gel in neurology, nephrology, and rheumatology, from 52 to 70 members. Remapping and increasing the number of sales territories led to a meaningful increase in productivity, as the smaller territories allowed all of our reps to spend more time detailing Cortrophin and less time traveling. As a result, the team was able to produce a meaningful sequential quarterly growth in new cases initiated and new patient starts that exceeded our prior expectations. We also saw strong interest and demand for our new Cortrophin Gel pre-filled syringe presentation, which we launched in April. The pre-filled syringe offers advantages to both patients and physicians by reducing the number of steps required for self-administration, which is especially important for patients with impaired vision or limited hand mobility. We expect the pre-filled syringe to remain an important driver of prescription demand going forward. Based on continued growth in Cortrophin Gel, prescribers and patients, as well as broad adoption across therapeutic areas, we are increasingly confident that Cortrophin is on a strong multi-year growth trajectory. The ACTH market grew 27% to $684 million in 2024 and is expected to grow 36% to $933 million in 2025 based on the midpoints of our new guidance and the competitor's guidance. While recent growth in the ACTH market has been strong, the current number of patients on ACTH therapy remains significantly below historical levels, offering substantial room for expansion. We estimate that today's patient base is still roughly half of what it was at the market's peak in 2017. In addition, today's ACTH market covers a broader set of indications, including acute gouty arthritis flares, which was not there in 2017. Further, based on our epidemiological analysis, we believe that the addressable patient population for ACTH therapy could be many times larger than the previous high of eight years ago. Importantly, a large and growing group of our prescribers were previously naive to ACTH. We believe that that number now exceeds 50%. We remain confident in our rare disease team's ability to sustain robust multi-year growth for Cortrophin gels. Based on our first half performance and continued strong underlying demand trends, we are increasing our 2025 Cortrophin gel guidance to $322 million to $329 million from our prior guidance of $265 million to $274 million. Our new guidance reflects -over-year growth of 63% to 66%. Turning now to our RECNA portfolio. Our RECNA portfolio, Illuminating Utique, generated revenues of $22.3 million in the second quarter. Consistent with our expectations. Our commercial team progressed several key initiatives during the second quarter. We executed on the addition of the chronic NIUPS indication to Illuvian's label and fully transitioned our U.S. promotional focus to Illuvian. At the same time, we remain committed to supporting physician offices in navigating ongoing Medicare market access challenges, particularly for patients who previously relied on foundational support. We also took important steps to strengthen our U.S. ophthalmology sales team. As noted earlier, we remain on track to realize meaningful revenue synergies for Cortrophin within ophthalmology. Our international Illuvian business, accounting for over one-third of Illuvian revenues, continues to perform well across both our direct markets and those served by distribution partners. We also completed the New Day clinical trial of Illuvian in earlier stage DME and presented the results at the American Society of Reckon Specialists, or ASRS, annual meeting. New Day was the first clinical test study that tested a long-acting steroid against anti-VEGF standard of care treatment. Feedback on the New Day results from study investigators and Reckon physicians at ASRS was positive and reinforced our view that the data could help support the use of Illuvian earlier in the DME patient journey. Chris will speak more on New Day and our next steps with the data. While the second quarter was productive for our ophthalmology team and we successfully executed against our objectives, externally the market access challenges that have impacted prescribing of retinol drugs for Medicare patients since January have persisted. We previously assumed that some funding for Medicare patient support foundations would resume and Medicare access would improve in the second half after a large ophthalmology company launched its matching program for donations to the Good Day Fund. Unfortunately, this has not yet happened, so we made the decision to update our guidance to reflect this dynamic. We now expect 2025 revenues for our retina franchise of 87 million to 93 million versus our prior guidance of 97 million to 103 million. Moving now to our genetics business, which also delivers strong performance in the second quarter with revenues of 90.3 million, an increase of 22% over the prior year period. The quarter reflected strong execution in our base business and contribution from new product launches, including Procalipride, tablets with 180-day exclusivity. Based on the performance of our genetics business in the first half of the year, we continue to expect growth for the full year in the mid-teens. Our brand portfolio also had a strong quarter with revenues of 13.2 million up 32% year over year. We were able to identify and capture increased demand for certain products during the second quarter and anticipate a return to a more normalized level of demand during the second half. Next, I will review a few points regarding ANI standing in the evolving tariff situation. While we await the administration's pharmaceutical industry specific framework, it is worth reiterating 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. Products representing less than 5% of our total company revenues rely directly on imports from China. In addition, we have a strong balance sheet that enables us to carry healthy levels of finished goods and raw material inventories. We look forward to maintaining our strong commitment to the U.S. pharmaceutical industry. Before I turn the call over to Chris, I'd like to comment on the recent trial with CG Oncology. As a reminder, under an assignment and technology transfer agreement dated November 15, 2010, ANI had sold CG0070, creatostimagine and related assets such as the Investigational New Drug Application or IND, Phase 1, Phase 2 clinical data, know-how and IP to CG Oncology. ANI commenced a civil action against CG Oncology in the Superior Court of the State of Delaware in March 2024 alleging that CG Oncology is liable to pay a running royalty of 5% on the worldwide net sales of their lead product, CG0070 or creatostimagine. The case proceeded to trial on July 21 and the jury returned a verdict in favor of CG Oncology on July 29. We continue to believe in the merits of our position and intend to vigorously challenge the verdict through post trial motions and or an appeal. I'll now turn the call over to Chris to discuss our rare disease business in more detail. Chris?