ANI Pharmaceuticals, Inc.

Good day, everyone, and welcome to today's Annie Pharmaceuticals, Inc. Second 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 would like to ask a question during this time, simply press star, then 11 on your telephone keypad. If you would like to withdraw your question, please press the star key, then 11 again on your telephone keypad. It is now my pleasure to turn the conference Over to Irina Koffler. Please go ahead.

Thank you, Daniel. Welcome to ANI Pharmaceuticals' second 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 Mutz, Senior Vice President and Head of ANI's Rare Disease Business. Earlier this morning on August 7, 2026, we released our results for the second quarter 2026 via a press release that is available on our website. This call is also available via webcast and is accompanied by a slide deck that can be accessed by going to the events section of the investors page of our website. Before we begin, I would like to remind you that we will be making forward-looking statements and discussing certain non-GAAP measures. Forward-looking statements are subject to substantial risks and uncertainties, speak only to the call's original date, and we take no obligation to update or revise any of the statements. During this call, we will also refer to certain non-GAAP financial measures to describe our performance and have provided a reconciliation to the most directly comparable GAAP financial measures within the materials that accompany this call. The archived webcast will be available for 30 days on our website, anifarmaceuticals.com. And with that, I'll turn the call over to Nikhil Lalwani.

Thank you, Irina. Good morning, everyone, and thank you for joining us for ANI's second quarter 2026 earnings call. Starting on slide five, our entire organization demonstrated outstanding focus during the second quarter as we continued to transform E&I into a leading rare disease company. We reported record second quarter 2026 revenues of $266 million for the overall business, record cortofan revenues of 117.1 million, and record adjusted EBITDA of 71.6 million. In the second quarter, we grew total net revenues 26% year-over-year driven by persistent execution across our rare disease and genetics businesses with incremental contribution from the Harmony Intellectual Property Outlicensing Deal we announced last quarter. We also grew adjusted EBITDA 32% year-over-year to an all-time high and above our prior expectations. Furthermore, we achieved all of this while executing the single largest rare disease sales force expansion in our history, where we increased our sales force by 50% to approximately 180 reps. Our strategic plan is on track, and we are well positioned to drive meaningful growth in 2026 and beyond. Turning to slide six. Our first area of focus in our transformation into a rare disease company is delivering organic growth for our Q durable branded rare disease medicines, Cortofan gel and Ellusion. We delivered 117.1 million in Cortofan gel net revenues for the second quarter, up 43% year over year, and 56% over quarter one, 2026, consistent with the expectations we outlined during our last quarterly call. Second quarter revenues from our existing specialties of rheumatology, nephrology, neurology, ophthalmology, and pulmonology was healthy, and we are seeing significant momentum in demand in the third quarter, with July representing the highest month for new cases initiated. We expect our existing specialty sales force to continue its strong trajectory in the second half of 2026. We completed our gout-focused organization expansion and the team was fully operational at the end of June, as expected. We are pleased that we have seen strong demand driven by the high unmet need for patients who are most severely impacted by acute gouty arthritis flares and who need an additional treatment option. Our leading indicators are very positive, such as total new cases initiated, cases initiated per sales rep, and a number of prescribers with multiple new cases. We believe we are at the start of a sizable inflection for this business and look forward to updating you on our progress. Taking a step back, our conviction in the growth and durability of cortofan gel have only increased over time since our 2022 launch. Cortofan has grown at a compounded annual growth rate of 103% to 348 million in sales in 2025, and we're just getting started. We believe Cortofin will serve as the key building block catalyzing our transformation into a rare disease company. Now that we are midway through the year, we are modestly revising our Cortofin Gel revenue guidance to $520 million to $540 million, primarily to account for results in the first half of 2026. Our expectations for the back half remain largely intact with what we had expected at the start of the year. Importantly, this still represents 50% to 55% growth for quatrophin compared to 2025, and the addition of the gout expansion creates a strong new growth trajectory for quatrophin. We believe we are well-positioned to achieve our revised 2026 guidance based on the continued momentum in existing specialties as evidenced by the highest new case in July and the strong demand generation from the gout expansion. For Alluvion, we delivered 18.7 million of revenue in the second quarter. We announced the top line results from the phase four open label synchronicity trial in NIUPS and plan to unveil detailed results and additional analysis at a medical conference in the fourth quarter of 2026. These results are particularly relevant for retina specialists who see a large population of uveitis patients. UVitis remains a category in which steroids are the standard of care and where we see an opportunity to build an increasing share of voice over time. 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 Illuvian today, a significant and durable opportunity for value creation. Turning to slide seven, our second strategic priority is continued execution in generics. To date, we have launched 12 generics in 2026 and are on track to launch at least 15 in the full year. We also continue to hold our position as the number two player in overall CGT filings. Given by our superior R&D capabilities and operational execution, we delivered another strong quarter with generics revenue of $99.1 million, up 10% year-over-year. As a reminder, ANI is uniquely positioned to capitalize on opportunities in the evolving tariff landscape that may arise, with approximately 95% of our revenues coming from finished goods manufactured in the US. Bringing high-quality generics and rare disease products made in the US to our patients plays an important role in our success. Third, we remain focused on executing a disciplined capital allocation strategy. We are investing in organic growth that have expanded our cortofan commercial footprint in acute cardiothoracic flares. We continue to deploy a high single-digit percentage of generics revenue into generics R&D programs. We are also evaluating attractive inorganic growth opportunities to expand the scope and scale of our rare disease business. Turning to slide eight, our strong second quarter performance demonstrates the steadfast execution of our strategic priorities as we deploy the cash created by generics and brands in our virtuous cycle towards our transformation to becoming a leading rare disease company. We are confident in delivering 50 to 55% quattrofen revenue growth in 2026 and are pleased that our gout expansion is off to a strong start. Taking together, these initiatives are expected to create operational leverage in 2027 and beyond as we maximize the Coprofin growth opportunity. In 2026, we expect to deliver $1.1 billion in revenue, representing 26% growth over 2025 at the midpoint of our guidance range, with rare disease as the primary driver of that growth. We also expect to expand the bottom line with adjusted EBITDA forecasted to grow 27% year-over-year to $285 million to $300 billion. Our balance sheet is healthy with the capacity to support future potential business development opportunities to expand the scope and scale of our rare disease business. I'll now turn the call to Chris to discuss our rare disease business and provide color from the ongoing launch in acute cardiothoracic flares.