Amneal Pharmaceuticals, Inc.

Hello, everyone, and a warm welcome to Amniel's Third Quarter 2021 Earnings Conference Call. I would now like to turn the call over to Amniel's Head of Investor Relations, Tony DiMeo.

Good morning, and thank you for joining Amniel's Third Quarter 2021 Earnings Call. Today, we issued a press release reporting our financial results. The press release and a presentation are available on our website at amniel.com. We are conducting a live webcast of this call, a replay of which will also be available on our website after its conclusion. Please note that certain statements made during this call regarding matters that are not historical facts, including but not limited to management outlook or predictions for future periods, are forward-looking statements. These statements are based solely on information that is now available to us. We encourage you to review the section entitled Cautionary Statements on Forward-Looking Statements in our press release and presentation, which applies to this call. Also, please refer to our SEC Files, which can be found on our website and the SEC's website, for a discussion of numerous factors that may impact our future performance. We also discuss certain non-GAAP measures. Important information on our use of these measures and reconciliation to U.S. GAAP may be found in our earnings release and the appendix of today's presentation. On the call this morning are Chirag and Shintu Patel, co-CEOs, Tasos Conidera, CFO, Andy Boyer and Joe Tedisco, Chief Commercial Officers for the Generics and Specialty Segments, and Steve Manzano, General Counsel and Corporate Secretary. I will now turn the call over to Chirag. Thank you, Tony, and good morning, everyone.

MNILA achieved a solid third quarter results with net revenue of 529 million, existed EBITDA of 135 million, and existed EPS of 21 cents. Our third quarter performance builds on the strong momentum we have seen these last two years, and we believe the best is yet to come. Let me provide a few updates across the business. I'll start with our genetics business, which is built on our core competencies in R&D, manufacturing, and commercial excellence. Over the last several years, our robust innovation engine has significantly strengthened our portfolio with increasingly complex products. Our extensive manufacturing and operational capabilities allows us to manufacture most of these products in-house. which accelerates our time to market and improves margins. Our commercial teams have done an excellent job working with customers to bring these impactful products to market and provide access to these affordable medicines for patients. As a result, strong execution is driving performance, including sustained high levels of profitability. Notably, adjusted GenX gross margins were 45% in 2021, year-to-date, which is a remarkable increase from 36% in 2019. Last quarter, we highlighted what makes our GenX business wearable and different, including the pace of new launches and our increasingly complex portfolio. First, a third of our current genetics revenue comes from products launched since 2019. Second, half of our current revenues and over 85% of our pipeline is non-oral solids, demonstrating how our business is increasingly diversifying with more complex products, leading to more durable revenues and a higher profitability. Aligned with our ending 2.0 strategy to expand our portfolio with increasingly complex products, we are so excited to announce the acquisition of Punishka Healthcare, which is a pivotal step in growing our injectable business. Today, the overall U.S. institutional market, from a manufacturer's perspective, is around $5 billion in size and growing. While at the same time, there's a history of supply shortages for sterile injectables and need for more capacity. Currently, Amnil is 15th in this market with about 125 million in annual revenue. We shared last quarter that our goal is to more than double by 2025 and our aspiration is to be in the top five. This acquisition allows us to accelerate our injectable strategy for the United States and the international markets. Moving to our specialty business, we are continuing to advance our strategy and expand our portfolio. We remain focused on growing the business organically, advancing our pipeline, and pursuing inorganic opportunities focused in neurology and endocrinology. First, the team is driving strong commercial execution, leveraging our expanded endocrinology cells for this year. In the third quarter, we saw continued strong performance of our two largest specialty products . Second, we continue to advance our specialty pipeline. Most notably, we are pleased with the data for IPX203 and the potential this technology has We do not view IPX203 as a line extension of writery, but rather we believe IPX203 will be a distinct innovative therapy for the treatment of Parkinson's disease that will have a broader market appeal with patients and prescribers. We are advancing our pre-market work, and we are excited about the commercial opportunity that IPX203 represents. We continue to advance the program across our specialty portfolio And Chidu will discuss these in more detail. Third, we continue to actively pursue complementary commercial stage assets and late-stage clinical programs to leverage our existing specialty infrastructure. In our healthcare distribution business, we saw continued solid performance this quarter. With healthcare, we are focused on strong commercial and operational execution, growing our presence in the large federal healthcare market, federal government healthcare market, and expanding our unit dose offerings to drive sustainable growth and profitability. Finally, as a mission-driven company focused on providing affordable essential medicines for patients, we were delighted to release our inaugural sustainability report yesterday. The report highlights our ongoing efforts in driving environmental, social, and governance initiatives at MDN, and provides important insights on our business and its impact on stakeholders. For example, in terms of access and affordability, our genetics medicines were responsible for saving patients nearly $10 billion in the United States last year alone. In addition, on the environmental stewardship side, reminded a clean, renewable geothermal energy system at our Brookhaven New York facility to reduce our environmental impact significantly. With that, I'll turn the call over to Chandu.