Amneal Pharmaceuticals, Inc.

Hello, everyone, and welcome to the Emanuel Fourth Quarter 2022 Earnings Conference Call. My name is Bruno, and I'll be operating your call today. During this presentation, you can register to ask a question by pressing star followed by one on your telephone keypad. I will now turn the call over to Emanuel's Head of Investor Relations, Tony DeMell. Please go ahead.

Good morning, and thank you for joining AMUIL's fourth quarter 2022 earnings call. Today, we issued a press release reporting our Q4 results. The press release and presentation are available at amuil.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 the section entitled Cautionary Statements on Forward-Looking Statements in the earnings presentation and our SEC filings for a discussion of factors that may impact our future performance. We also discuss non-GAAP measures. Information on our use of these measures and reconciliations to U.S. GAAP are in the earnings presentation. On the call today are Shirag and Chintu Patel, co-CEOs, Tatas Konideris, CFO, Andy Boyer, Generics, Harsher Singh, Biosciences, and Jason Daly, Chief Legal Officer. I will now turn the call over to Shiraz.

Thank you, Tony, and good morning, everyone. We delivered strong fourth quarter results with $610 million of revenue and adjusted it with $154 million. We saw growth across all three business segments in Q4 and closed out 2022 well. Looking forward, our 2023 outlook reflects continued resilient top- and bottom-line performance. Overall, we believe Amir is uniquely positioned for sustainable long-term growth. The generics business is robust and growing each year. We are shifting towards more complex, high-growth, and high-impact products. With each new launch in injectables, complex generics, and biosimilars, our portfolio of affordable medicine is increasingly diversified. In specialty, we are focused on expanding our branded business through the upcoming IPX2 relaunch and advancing our pipeline. Together with the consistently growing healthcare business, we see multiple vectors of growth and value creation. At the heart of our strategy is the focus on unmet patient needs affordability, and providing access to essential medicines globally. Let me now talk about how we are advancing our key strategic priorities. First, in genetics, we are constantly innovating, moving up the value chain of product complexity and expanding our impact on patients. Our strategic focus has been and continues to be developing complex innovations such as cancer moves and injectables, That creates tremendous value for patients. The next frontier of affordable medicines journey is biologics and international. Since 2019, the team has done an extraordinary job re-regulating our R&D engine, driving strong operational execution and ensuring the commercial success of our business. As a result, Our increasingly diversified portfolio is generating durable top-line growth. Over the last three years, we have consistently grown faster than the overall U.S. genetics market. Today, Ammeen is the fourth-largest U.S. genetics company in the terms of annual prescriptions and is responsible for saving American patients over $10 billion every year. We expect our top-line growth algorithm in genetics will endure long-term. In injectable, we're focused on expanding our product portfolio, adding capacity, and building key capabilities. In 2022, the business was very successful, generating 181 million MW. Today, we have about 30 institutional products with over 30 new launches expected by 2025. From an operations standpoint, We are more than doubling our capacity with our two newest sites. As we launch new products and bring new capacity online during 2023, we expect the next inflection of revenues will come in 2024. We are on track to achieving our goal of over $300 million in projectable revenue by 2025. Next, biosimilars represent the next wave of affordable medicines and are highly aligned with our mission of providing access to high-quality, affordable medicines. So, we are so excited about the growth prospects for biosimilars, as the U.S. market alone is expected to approach 40 billion in net sales by 2027, with a long-term horizon We see a very strong ROI as the cost to develop new biologics continue to come down. We expect this market to be less competitive than others. In June 4, we launched Azensys, our biosimilar of Avacyn, Luco, our biosimilar of Nucurgen. We expect to launch our third product, Rilnetra, our biosimilar of Neolesta, in the next few months in conjunction with our reimbursement coverage. Similar to the first-year adoption curve of other biosimilars, we expect 2023 will be a good year as the commercial team works across pairs, providing end channels to drive uptake. For these three biosimilars, We hope to expand our portfolio and be strategically vertically integrated over time. Our goal is to be top five in U.S. biosimilars market and a global player over time, like U.S. Genetics, we expect to get there. To expand access to essential medicines globally, we are leveraging our diverse U.S. FDA-approved product portfolio of complex genetics, injectables, specialty, and biosimilars. We believe our international expansion strategy will add considerable revenues and profits in time. In the past going $25 billion Indian commercial market, we're expanding our presence with a new brand and leveraging our local commercial team as we focus on the hospital market in India. In Europe, we signed a long-term distribution agreement with Orion at the end. We will register complex genetic products starting this year and look to begin commercializing in Europe late next year. In addition, we are pleased to share that we have recently signed another long-term distribution partner agreement in Canada. We are partnering with Sterimex to bring our injectable portfolio to Canada. We will continue to pursue additional partnership opportunities around the world. Second, in specialties. We expect to be much bigger and more sustainable player over time. Our strategy focuses on 55B2 opportunities that leverage our reformulation technologies to improve existing medicines and provide new, innovative therapies for patients. Today, our T-branded products, Ritory for Parkinson's and Unifor for hypothyroidism, continue to grow in multiple digits combined. Next up is IPX203. We are so excited about the potential of IPX203 to be a best-in-class therapy for Parkinson's patients. Beyond IPX203, we're advancing the pipeline of neurology and endocrinology programs. We look to expand over $500 million in specialty revenue by 2027. Correct. In healthcare, we look to expand across multiple channels, distribution, the federal government, and UNICORPS. To date, since its acquisition in 2022, the revenue of the business has grown double digits. We expect momentum in this durable $400 million-plus revenue business will continue going forward. In summary, we're very excited about NEA's future. There are key catalysts happening now across our business, such as bar simulators, with more ahead, particularly the planned launch of IPX203 in specialty. As we execute our strategy and launch new products in high-growth areas, our durable and resilient business continues to grow. We believe these growth drivers will accumulate and generate higher levels of financial performance over time. I will now hand it over to Chirag.