Amneal Pharmaceuticals, Inc.

Hello, everyone, and welcome to the Amniel Third Quarter 2022 Conference Call. My name is Emily, and I'll be your operator today. At the end of the presentation, we will have the opportunity for questions, and you can do so by pressing Start, followed by the number 1 on your telephone keypad. I'll now turn the call over to Maria Licuri, Amniel Investor Relations.

Please go ahead. Good morning, and thank you for joining Amniel's Third Quarter 2022 earnings call. Today, we issued a press release reporting our financial results. The press release and presentation are available at amniel.com, and a replay of this call will be posted after the call. 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 review the section entitled Cautionary Statements on Forward-Looking Statements in the earnings presentation and on our SEC filings for discussion of factors that may impact our future performance. We also discussed non-GAAP measures. Important information on our use of these measures and reconciliation to U.S. GAAP can be found in the earnings presentation. On the call today are Chirag and Shintu Patel, co-CEOs, Tasos Canidares, CFO, Andy Boyer, Generics, Harsher Singh, Biosciences, Gustavo Peskin, Specialty, and Jason Daly, Chief Legal Officer. I'll now turn the call over to Chirag.

Thank you, Maria, and good morning, everyone. Our third quarter results reflect solid performance across our diverse business portfolio. Q3 revenues were $546 million and adjusted EBITDA was $126 million. We are on track to achieve our full year 2022 guidance. Let me now walk through our strategy and how we have been executing towards our key priorities since Chintu and I returned to MNIL a bit over three years ago. First, in generics, our goal was to stabilize and grow our complex generics business. We have done that. Over the last two years, through Q3 2022, generic stock line has grown at a 3% target. New launches and our diversified portfolio of increasingly complex medicines are driving durable top line performance and growth. With our focus on complex and higher barrier products, where we now expect 56% of 2022 genetics revenue will be non-oral solids. That is a clear proof point of success. This has increased remarkably from 35% in 2019. We see that shifting further as 88% of our pipeline is non-oral solids. We expect continued top-line growth in generics driven by our portfolio of complex products. Second, in injectables, the strategic focus has been on scaling our business. With an expanded portfolio, additional capacity, and new capabilities, we expect over $170 million in revenue this year, and we are well our way to achieving our goal of over $300 million in injectables revenue by 2025, which represents 24% CAGR from 2021. Third, in specialty, we have been driving substantial growth of our key branded products with Rytorink for Parkinson's and Unitroid for hypothyroidism. Over the last two years, through Q3 2022, These two brands have grown at a 13% CAGR combined. At the same time, we are advancing our specialty pipeline of new CNS and endocrinology products. IPX203 is expected to launch in mid-2023 upon approval, followed by DHE Auto Injector and K127. Whether organically, or inorganically, we look to further expand our portfolio and drive meaningful growth in our specialty business going forward. Fourth, we are building our biosimilar business. We were delighted to launch our first biosimilar, LIMSIS, in October. RULUCO is launching this month, followed by FILNETRA in January. Commercial team is fully deployed and focused across payers, providers, and channels to ensure effective uptake of our products. In terms of reimbursement, we have a Q code already in place for Luco, and our Q code for Ellimstance is approved and will go live on January 1st, with Phil Netra expected to follow. For these first three products, we see peak sales of over 200 million in the next two to three years. Beyond these, we are working to expand our biosimilar portfolio with additional molecules where we can be early to market and are working to be vertically integrated over time. We look to be in top five in this past growing $28 billion U.S. biosimilar market over the next five to seven years and a global player. Fifth, We are driving growth in our healthcare distribution business. We're expanding across multiple channels, including distribution, the federal government healthcare market, and unit doors. There is a good momentum in that business, and we expect it to continue. Sixth, internationally, we are looking to leverage our diverse product portfolio globally. We believe this strategy will add considerable revenue and profits in time as we work with distribution partners such as Fosun in China, or utilize our own sales and marketing infrastructure to be direct in select markets such as in India. Around the rest of the world, including Europe, we are pursuing targeted distribution opportunities with strategic partners. Overall, we are very excited about the momentum that is building across MNEO. With the recent additions of new leaders, Meryl and Gustavo, we have a deep and talented leadership team. As we progress in implementing our strategy, MNIL is becoming increasingly durable, diversified, and differentiated. We are launching new products in high-growth areas such as complex generics, injectables, specialty, and biosimilars that are additive to our current strong position. As these new catalysts come to market, We expect the growth drivers to build and generate higher levels of financial performance. With that overview of key strategic priorities and progress, I'll hand it over to Chintu.