2/27/2026

speaker
Operator
Conference Operator

Thank you all for your patience. The conference call titled Amneal Pharmaceuticals Fourth Quarter and Full Year 2025 Earnings Call will begin shortly. During the presentation, you'll have the opportunity to ask a question by pressing star followed by the number one on your telephone keypads. Again, please stand by and we will begin in a few minutes. Thank you. Thank you. Good morning, and welcome to the Amniel Pharmaceuticals fourth quarter and full year 2025 earnings call. I'll now hand the call over to Amniel's head of investor relations, Tony DiMeo. Go ahead, please, sir.

speaker
Tony DiMeo
Head of Investor Relations

Good morning, and thank you for joining Amniel Pharmaceuticals fourth quarter 2025 earnings call. Today, we issued a press release reporting Q4 results. The earnings press release and presentation are available at amniel.com. Certain statements made on this call regarding matters that are not historical flags, including but not limited to management's outlook or predictions, are forward-looking statements that are based solely on information that is now available to us. Please see the section entitled Cautionary Statements on Forward-Looking Statements for factors that may impact future performance. We also discussed non-GAAP measures, information on use of these measures and reconciliations to GAAP, are in the earnings release and presentation. On the call today are Chirag and Shintu Patel, co-founders and co-CEOs. Tasos Konideras, CFO. Our commercial leaders, Andy Boyer for Affordable Medicines, Joe Renda for Specialty, and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag.

speaker
Chirag Patel
Co-Founder & Co-CEO

Thank you, Tony, and good morning, everyone. 2025 was a defining year of excellent execution and portfolio expansion at MU. As a diversified biopharmaceutical company, across specialty, complex products, injectables, and biosimilars, we're building category leadership positions in large and growing markets. In 2025, revenue grew 8%, adjusted EBITDA increased 10%, Adjusted EPS rose 43%. 2025 marks our sixth consecutive year of growth. In our industry, that consistency of growth stands out. What's most exciting is not only what we have achieved so far, which we are truly proud of, but the even greater opportunity that lies ahead. We entered 2026 with a strong foundation and exciting strategic growth opportunities. Whether we are advancing the standard of care with innovative therapies like Crexon or expanding access to affordable complex medicines, our mission is clear, to become America's number one affordable medicines company. Since our founding over 20 years ago, MNIL has always been driven by the deep passion and responsibility to serve the millions of patients who rely on our medicines every day. And we're just getting started. Let me begin with our largest segment, affordable medicines. The business continues to grow year after year, driven by an expanding portfolio of complex, differentiated, and durable products. 2025 was an exceptional year for approvals and launches, particularly in complex generics and injectables. These launches are not one-time events. They are multi-year value drivers. As a result, we expect meaningful acceleration in our affordable medicine segment, revenue growth in 2026 and 2027. In injectables, we are executing with a clear ambition to become a top five player in the U.S. institutional market. Over the years, we have significantly expanded our R&D and manufacturing capabilities, adding the technical capabilities required for long-term leadership. Our strategy focuses on providing differentiated offerings for hospitals, including ready-to-use specialty injectables. With over 40 products and a pipeline of differentiated launches, we expect this business to scale substantially over time. In biosimilars, we're building a long-term growth engine. We begin with in-licensing and creating a strong commercial platform. In December, we received approval for our data biosimilars, our fourth and fifth products. With biosimilar Zola under review, we remain on track to have six biosimilars in the U.S. market by 2027. Strategically, our goal remains to be vertically integrated in biosimilars across development, manufacturing, and commercialization, which we believe is essential for long-term success. From a macro perspective, the opportunity is remarkable. Over the next decade, About 234 million of biologic cells will lose exclusivity, more than double the prior 10 years. And only about 10% of those products have biosimilars in development. This creates a significant long-term opportunity to dramatically expand patient access and drive very meaningful growth for our company. Next. In GLP-1, our cooperation with Pfizer is progressing well, and both teams are working together. We are here to assist Pfizer in a meaningful way. This initiative builds on what we do best, develop, manufacture, and commercialize complex medicines at scale, and position us to play a meaningful long-term role in one of the largest and fastest growing therapeutic categories in healthcare. Now, let's turn to the specialty segment. We're very pleased with the take of Crexon. At the end of 2025, about 23,000 patients were on therapy, reflecting over 3% market share one year post-launch. For context, Ryderi reached roughly 42,000 patients and 6% market share 10 years after launch. In December, interim phase four data reinforced that what physicians and patients are already seeing, Trexon delivers more good on time than other therapies. We remain confident in peak U.S. cells of 300 to 500 million for Trexon, which we believe is setting a new standard of care for Parkinson's patient. In the fourth quarter, we launched Brachia, first and only auto-injector for severe migraine and cluster headache patients. For many of these patients, the prior option was an emergency room visit. Rankia gives them control, delivering the same hospital medication in a ready-to-use auto-injector. Rankia is our next growth catalyst in specialty, with expected peak sales of $5,200 million. Lastly, Evcare continues to provide diversification and strategic advantage. Through government and distribution channels, Evcare strengthens our direct access to key end markets and provides an efficient path for new launches, including biosimilars, complex generics, and specialty products. Overall, we are building a diversified biopharmaceutical company that expands access and provides new therapies for patients and delivers consistent growth for investors. With that, I'll turn it over to Chintu.

Disclaimer

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