ANI Pharmaceuticals, Inc. 2026 Q2 Earnings Call

Please go ahead. Thank you, Daniel.

Welcome to ANI Pharmaceuticals' second quarter 2026 earnings results call. This is Irina Koffler, Vice President, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer, Stephen Carey, Senior Vice President, Finance and Chief Financial Officer, and Chris Mutz, Senior Vice President and Head of ANI's Rare Disease Business. Earlier this morning, on August seventh, 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 investor's 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, anipharmaceuticals.com. 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 ANI into a leading rare disease company. We reported record second quarter 2026 revenues of $266 million for the overall business, record Cortrophin 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 generics businesses with incremental contribution from the Harmony intellectual property out-licensing 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 two durable branded rare disease medicines, Cortrophin Gel and ILUVIEN. We delivered $117.1 million in Cortrophin 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 been seeing 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 Cortrophin Gel have only increased over time since our 2022 launch. Cortrophin 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 Cortrophin 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 Cortrophin Gel revenue guidance to $520 million-$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%-55% growth for Cortrophin compared to 2025, and the addition of the gout expansion creates a strong new growth trajectory for Cortrophin. 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 cases in July and the strong demand generation from the gout expansion. For ILUVIEN, we delivered $18.7 million of revenue in the second quarter. We announced the top-line results from the phase IV open-label SYNCHRONICITY trial in NIU-PS 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.

Uveitis 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 NIU-PS represent at least 10x the number of patients treated with ILUVIEN 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. Driven 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 U.S. Bringing high-quality generics and rare disease products made in the U.S. 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 Cortrophin commercial footprint in acute gouty arthritis 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%-55% Cortrophin revenue growth in 2026, and are pleased that our gout expansion is off to a strong start. Taken together, these initiatives are expected to create operational leverage in 2027 and beyond as we maximize the Cortrophin 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-$300 million.

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 gouty arthritis flares.

Chris? Thank you, Nikhil, and good morning, everyone.