Amneal Pharmaceuticals, Inc.

Hello everyone and welcome to the Amniel Pharmaceuticals First Quarter 2023 Earnings Conference Call. My name is Emily and I'll be your moderator for today's call. After the presentation, you'll have the opportunity to ask any questions by pressing start followed by the number one on your telephone keypads. I'll now turn the call over to Amniel's Head of Investor Relations, Tony DiMaio. Please go ahead.

Good morning and thank you for joining Amniel's First Quarter 2023 Earnings Call. Today, we issued a press release reporting our full Q1 results. We announced certain unaudited preliminary results for the first quarter on April 17, 2023. The press release and presentation are available at amneal.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 Chirag and Shintzu Patel, co-founders and co-CEOs, Tasos Conideras, CFO, Our commercial leaders, Andy Boyer for Generics, Joe Renda for Specialty, Harsher Singh for Biosciences, and Jason Daly, Chief Legal Officer. I will now turn the call over to Shirab. Thank you, Tony.

Good morning, everyone. We delivered a very strong first quarter results with $558 million of revenue, growing 12%, and adjusted EBITDA of $116 million, growing 16%. We saw robust stop-line growth in Q1 across all three business segments, generics, specialty, and out-care, reduced our net leverage to 4.9 times, and affirmed our full year 2023 guidance. Taking a step back, for those who are newer to the MNIL story, we are a global pharmaceutical company with an expanding portfolio of approximately 270 products. Our strategy focuses on launching new products in high-growth and high-impact areas of medicines, such as complex generics, injectables, biosimilars, and specialty. Since 2019, we have significantly diversified our business, fueled by the productivity of our R&D pipeline and strategic investments to build our global platform. As a result of MNE's diversification, We have seen continuous strong financial performance since 2019, as we have delivered substantial revenue and EBITDA growth. In 2022, approximately 500 million of our top-line performance came from products launched since 2019. We see our momentum accelerating in 2023 and beyond, underscored by our strong Q1 results and 2023 outlook. In short, we are very well positioned for sustainable long-term growth, accelerating profitability, and continued deleveraging. I'll now briefly walk through how are we executing on our key strategic priorities across our businesses. First, in the generic segment, our diverse portfolio of approximately 230 retail generic products is continually expanding. moving up the value chain of complexity and generating durable top line growth since 2019. Our strategy to diversify with more complex products has been deliberate over the years. To give you context, we expect about 55% of 2023 generics revenue will be from complex products, up from 35% in 2019. We feel great about the breadth and depth of our R&D pipeline, which we expect will continue to deliver 20 to 30 new product launches every year and continue to differentiate our business as we move towards complex products. We have been on a remarkable journey these last four years, and the team has been hard at work focusing on the highest value products and complex generics, with many nearing the finish line. Altogether, we expect continued strong execution and growth of our business. In injectables, similar to where we are today in U.S. generics, our goal is to be a top five U.S. injectable business and also a global player. Today, we have about 30 institutional products with over 30 new launches expected by 2025. We are executing very well on our injectables growth strategy by expanding our portfolio, building key capabilities, and adding capacity. Our commercial strategy centers on our ability to be a differentiated supplier of a growing portfolio of injectables for hospitals with a resilient supply chain in a market impacted by shortages. To that end, Today we are pleased to share a major milestone with the successful USFD inspection this week of our fourth and largest injectable site. As we ramp up commercial production later this year, in line with our plan, we expect the next revenue inflection point in 2024. We remain on track for over 300 million injectables revenue by 2025. Next, in biosimilars, We're very pleased with the initial market penetration of our first two biosimilars, Alemsys and Ruluko. Since their launch in Q4, our commercial team is executing very well by adding new customers outlets for both products and driving substantial pull through as usage rates of our biosimilars have doubled month over month since launch. In particular, we are seeing strong market adoption of our Olympsis product, which is our Bevazizumab biosimilar referencing Avastin. This month, we plan to launch our third biosimilar, Filnetra, and we'll have three U.S. oncology biosimilars in the market. Based on our strong commercial execution and trajectory, we are well on our way of achieving this year's target of $40 to $60 million. More next year and over 200 million in peak cells. Beyond these three initial biosimilars, we are working to expand our portfolio with additional molecules where we can be early to the market and vertically integrated from development to commercialization over time. Our goal is to be a top five biosimilar player in the United States over time. Internationally, We are leveraging our diverse portfolio of US FDA-approved products to expand into new geographies. In India, we're expanding MNIL's brand presence and leveraging our local teams and infrastructure as we focus on the hospital market. Around the rest of the world, we are working with distribution partners. We expect meaningful incremental revenue and profits over time. Next, in the specialty segment, We continue to grow our branded products in dietary in Parkinson's and unithroid in hypothyroidism, delivering strong growth again in Q1. In parallel, we are advancing our pipeline of new CNS and endocrinology products. On IPX203, we are one step closer to delivering a new impactful therapy for Parkinson's patients as we head towards the June 30th PRDUFA date. As we expand our portfolio, we expect over $500 million in specialty revenue by 2027. In the third segment, AvCare, we see continued momentum across the multiple channels, distribution, federal government, and unit dose. We expect this business will continue to deliver durable, double-digit growth going forward, driven by the ongoing expansion of the distribution channels. Overall, we are proud of the strong momentum across MNIL. Each quarter, our portfolio is incrementally larger and more diverse as we launch new, increasingly complex products. We are leveraging our key capabilities and global footprint to operate at scale across our business. As we execute, we look to build upon our sustainable growth profile and drive higher adjusted EBITDA levels. I want to touch briefly on our capital allocation strategy, which Tasos will discuss further. To be clear, reducing debt and strengthening our balance sheet has been always our key priority. Our net leverage has reduced from 7.4 times in 2019 to 4.9 times this quarter. And our goal is to be below four times net leverage by the end of 2025. I'll now hand it over to Chintu.