Amneal Pharmaceuticals, Inc.

Good morning, and welcome to the Amniel Third Quarter 2023 Earnings Call. I will now turn the call over to Amniel's Head of Investor Relations, Tony DiMeo.

Good morning, and thank you for joining Amniel Pharmaceutical's Third Quarter 2023 Earnings Call. Today, we issued a press release reporting our Q3 results. We announced certain unaudited preliminary results for Q3 on October 23rd. Our earnings press release and presentation are available at annual.com. Certain statements made on this call regarding matters that are not historical facts, including but not limited to management 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 and Forward-Looking Statements in the earnings presentation. and our SEC filings for a discussion of factors that may impact our future performance. We also discussed 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 Ponideres, CFO, our commercial leaders, Andy Boyer for Generics, Joe Renda for Specialty, Harsha Singh for Biosciences, and Jason Daly, Chief Legal Officer. I will now hand the call over to Shiraz. Thank you.

Thank you, Tony. And good morning, everyone. We delivered another very strong quarter with $620 million of revenue, which is up 14%, adjusted a bit of $154 million, up 22%. and adjusted EPS of 19 cents, up 36%. We saw growth in all three of our business segments and reduced net leverage to 4.6 times. Given the strength of our year-to-date performance, we are pleased again to raise our full year 2023 guidance. We are excited about our continued momentum, which underscores the strength of our strategy and solid execution. As we have discussed throughout the year, we believe MNIL is at an inflection point or is to drive significant top and bottom line in 2024 and beyond. I'll start with a quick overview of our company and then walk through what we saw in each of our businesses during the third quarter. At a high level, MNIL is a world-class, global, diversified pharmaceutical company fulfilling our mission to provide access to high-quality and affordable essential medicines. In our affordable medicines business, our generic segment, we have retail, injectables, biosimilars, and international. Our strategy continues to focus on expanding our portfolio with impactful, complex, and high-value products. For the first nine months of 2023, generics revenues were up 7% compared to last year, reflecting a meaningful acceleration from the steady 3% CAGR we delivered from 2019 to 2022. We expect high-level digit, high single-digit top-line growth in generics to continue, driven by our diverse portfolio and cadence of over 30 new product launches every year. In injectable, our goal is to be top five in the United States institutional market. There are two key factors that we believe differentiate MNEO and will drive our success. The first is expanding capacity and capabilities, and the second is an expanding portfolio. In 2023, we have executed on both. We successfully brought online two new sites, which doubled our manufacturing capacity. Currently, we have 35 commercial injectables, with over 25 new launches planned by 2025 as we continue increasing production and expanding our portfolio. In a market plagued by shortages, we are well positioned for higher injectables revenues in 2024 and over $300 million by 2025. In biosimilars, our three commercial products continue to see strong uptake. Our largest product, Olympsis was at 6% market share as of September, which is remarkable in the first three quarters post-launch. We expect 60 million in biosimilar cells this year, more than double that next year, and over 200 million in 2025. In addition, we expanded our partnership with MapScience, who we work with on Olympsis, to add two formulations of denosumab and oncology biosimilar to our pipeline. This is part of the next basket of biosimilars for MNEO. By 2024, we look to add two to three more biosimilars to the pipeline. We see biosimilars as the next wave of affordable medicines and are committed to being a leader in this space. Internationally, We're leveraging our US FDA-approved portfolio to expand our reach and drive profitable growth. In India, we have our local infrastructure and are expanding our local portfolio. In other geographies, we are working with partners to commercialize our products. For example, we now have two products approved in China. We expect international expansion will add 50 to 100 million revenues by 2027 and scale further over time. In our affordable innovations business, our specialty segment, we are focused on neurology and endocrinology therapeutic areas. Our commercial teams continue to drive growth in our key branded products, dietary for Parkinson's and Unitroid for hypothyroidism. As you know, we received a CRL for IPX203 seeking additional data in July. I'm pleased to report that we had a successful Taipei meeting with FDA last month, and we are working diligently towards the 2024 approval and launch, which Chintu will discuss shortly. We expect specialty revenues to be over $500 million by 2027. Finally, in our evcare segment, we continue to see robust growth across all three channels, distribution government, VADOD, unit dose. We expect evcare revenue of $500 million in 2023 and over $600 million by 2025.