Amneal Pharmaceuticals, Inc.

Good morning and welcome to the Amniel Pharmaceuticals' fourth quarter 2024 earnings conference call. I'll now like to turn the call over to Amniel's head of investor relations, Tony DiMeo. Please go ahead.

Good morning, and thank you for joining Amniel Pharmaceuticals' fourth quarter 2024 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 facts, 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 this 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 Konideris, 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. Thank you, Tony.

Good morning, everyone. I'm Neil. We're much more than another genetics company. We are an American biopharmaceutical company with a track record of excellence in delivering high quality, complex pharmaceuticals at speed and scale. We are a leader in an essential industry, providing millions of patients with access to affordable and innovative medicines. 2024 was an exceptional year. where MNIL delivered stellar financial performance with double-digit revenue and adjusted EBITDA growth and reducing net leverage below four times. All segments grew revenues double digits. This broad-based performance reflects the strength of our diversified business, strong execution, and continued investment in growth areas. Beyond financial results, we took major strategic steps in 2024 to enhance our long-term growth profile and expand our future potential, including launching Crexant, establishing our GLP-1 collaboration, and adding to our biosimilars pipeline. The first important milestone we achieved in 2024 was the successful launch of Crexant. We are so excited by the strong response from prescribers and inspiring patient testimonials. Early traction has exceeded expectations, with market share reaching about 1% in just four months and on track to exit the year at 3% plus. As a point of reference, RITERI has 6% market share currently, 10 years since its launch. We are very confident in achieving U.S. peak sales of 300 to 500 million for Crexant. Our specialty business grew 14% in 2024, and our goal is to grow specialty to over 500 million by 2027. This growth will be driven by Crexant, Unitroid, Ungentis, and upcoming launch of DHE and other branded products. We aim to add more branded opportunities to our portfolio over time. Second, in 2024, we entered the high growth weight loss and obesity space, a new category for MNEO. Through a strategic collaboration with Medcera, a clinical stage biotech company developing next generation therapies. This unique collaboration represents a new integrated business model to drive innovation at scale between two organizations. It is a logical extension of MNIL's strategy that leverages our expertise in complex manufacturing and track record of delivering high-quality innovation at scale. MNIL is MetSERA's preferred global supplier for the US, Europe, and other markets. In addition, we look to commercialize Metcera products in 20 emerging markets, including India. To support this effort, we will leverage our existing peptide capabilities and building two new high volume peptide manufacturing facilities. With the global weight loss market projected to exceed 150 billion by 2030, this initiative is a powerful New long-term growth driver for MEO. Over time, we see this as a very large opportunity for MEO with three avenues for value creation. One, the METSA collaboration, which is our top priority. Two, providing CMO offerings to other large companies. Three, providing skill to deliver on generics weight loss therapies. Third, our affordable medicine segment. historically referred to as generics includes retail products and our rapidly growing injectable and biosimilar products the affordable medicine segment generated revenues of 1.7 billion in 2024 as growth accelerated to 15 percent fueled by new launches and a diversified complex portfolio over three components of the segment this is a massive business that remains the foundation of MNU, and we expect it will continue to grow tremendously going forward. Within this segment, our injectables business is expanding quickly. We have a growing portfolio of over 40 injectable products and launched our first 355 injectables in 2024. These differentiated, ready-to-use solutions improve hospital efficiency, by eliminating medication preparation steps and errors. In addition, we see biosimilars as the next major way of affordable medicines. For patients, biosimilars improve the affordability of and access to key therapies. For MNIL, we see biosimilars as a long-term growth factor where we are well positioned to lead. Our first three biosimilars generated $126 million revenue in 2024, just their second year on the market. We have built our pipeline with five additional biosimilars expected to be filed this year and commercial launches planned for 2026 and 2027. In 2024, we added our largest opportunity, Omalizumab, a biosimilar for Zolaire, targeting $2.8 billion U.S. market. By 2027, we expect to have six commercial biosimilars in the United States market. Looking forward, the global biosimilar is projected to grow from about 33 billion today to 75 billion by 2030. Given the cost, complexity, and development timelines, we see a relatively limited number of market participants. A recent IQVA report highlighted the significant white space opportunity in biosimilars. There are over 100 biologic products with patents expiring over the next 10 years, and only 10% currently have biosimilars in development. The report estimates that biosimilars for the other 90% would save American patients about $100 billion per year. We believe success in biosimilars will be driven by product selection, speed to market, R&D, manufacturing, and customer service. Similar to complex genetics where MNIL is a leader, we are well positioned to be a major biosimilar player. Our strategic focus has been in licensing an initial portfolio and building a commercial platform to start. Next, our goal is to be vertically integrated and leverage our proven ability to develop, manufacture, and commercialize complex pharmaceuticals at scale. Finally, our healthcare segment is a highly durable business with long-term contracts and recurring revenue streams across three channels, distribution, government, and unit dose. In 2024, healthcare revenue grew 25%, and we expect continued double-digit growth, reaching over $900 million in revenue by 2027. This business adds stability and diversification to MNIL's portfolio. Overall, MNIL is an essential player in an essential industry. Over 90% of prescriptions in the United States are for affordable medicines, yet account for only 10% of commercial value. MNIL fulfills over 162 million scripts for American patients each year. We are the largest US manufacturer of affordable medicines. Currently, MNIL is number four in the US retail market based on value, and our goal is to become top five in the U.S. injectables and U.S. biosimilars market in coming years. Over our company's history, we have built a successful track record of innovation, execution, and growth. MNIL is uniquely positioned in the pharmaceutical industry with a broad and differentiated portfolio across affordable medicines, specialty, and distribution to drive sustainable growth. I'll now pass it to Chintu.