Amneal Pharmaceuticals, Inc.

Hello and welcome to Amniel's fourth quarter and full year 2021 earnings call. My name is Alex and I will be coordinating the call today. If you would like to ask a question at the end of the presentation, you can press star one on your telephone keypad. If you would like to withdraw your question, you can press star two. I would like to turn the call over to Amniel's head of investor relations, Tony Demare. Over to you, Tony.

Good morning. And thank you for joining AMNIL's fourth quarter and full year 2021 earnings call. Today, we issued a press release reporting our financial results. The press release and presentation are available at amnil.com. We are conducting a live webcast of this call, a replay of which will be available on our website after the call. 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 the presentation that applies to this call. Also, please refer to our SEC filings on our website and the SEC's website for a discussion of numerous factors that may impact our future performance. We also discussed 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 in the appendix of the presentation. On the call this morning are Chirag and Shintzu Patel, co-CEOs, Tasos Konideres, CFO, Andy Boyer and Joe Tedisco, chief commercial officers for the generics and specialty segments, and Jason Daly, our Chief Legal Officer and Corporate Secretary. I will now turn the call over to Chirag.

Thank you, Tony, and good morning, everyone. Yesterday, we were so thrilled to announce the approval of Reluptio, our biosimilar version of Philgraston. This is truly a watershed moment for MNEO. and reflects the team's tireless effort to bring this important oncology biosimilar to the market. On the call, we'll discuss our broader growth strategy in biosimilars. Turning to results, Amnil delivered solid results in the fourth quarter, capping off a year of exceptional performance and execution. For the full year 2021, revenue grew 5% and adjusted EBITDA grew 18%. Before we go forward, let us look back for a moment. Since Chintu and I returned two and a half years ago, MNIL is now a much stronger company with a more diversified portfolio. We are driven by our R&D engine with a rich innovation pipeline and talented global team in place that is executing well. Since 2019, revenue is up 468 million or 29%. And adjusted EBITDA is up $182 million, 51%. As we have grown, our innovation pipeline is as deep as ever. Also, we have added key capabilities through the acquisition of Kashi's specialty, Punishka Healthcare, and Sol's Baclofenic franchise that we believe will power our next chapter of growth. Now looking forward, our 2022 guidance reflects continued top and bottom line growth that includes investments ahead of launches in higher growth areas of business such as injectables, specialty, and biosimilar. Our ability to continue growing while making long-term investments reflects the diversity and sustainability of our growth profile. We believe We have the right strategy to be successful and the right team to continue executing and innovating. And we are well positioned in several key growth areas. As the core of the strategy is our focus on affordability, unmet patient needs, and providing access as a global essential medicine company. Overall, we see Amneem's growth profile accelerating over the next several years. as we increasingly shift our business mix towards higher growth and higher growth and markets. Let me now walk through our key business areas at a high level, both where we are today and our strategy for growth in each. Starting with our retail generics business, which has grown consistently over the last few years, as our robust R&D engine has significantly diversified the portfolio with new complex products. In 2021, we delivered 1.37 billion in net revenue and launched 28 new products. We see the $20 billion U.S. retail genetics market continue to expand and grow. The pipeline for the industry remains robust with approximately $284 billion in total brand product revenues facing loss of exclusivity in the next decade. We are confident that our core competencies in R&D, manufacturing, quality, and commercial excellence will drive our continued momentum in retail genetics for years. About half of our 2021 genetics revenue came from non-oral solids, and 87% of our pipeline is non-oral solids, which underscores our shift to more durable and complex portfolio. With a clear line of sight to continued innovation and the increasing complexity of our portfolio, we expect continued growth in our retail genetics business going forward. Regarding our injectable genetics, we announced the acquisitions of Punishka Healthcare in Q4 As a reminder, the acquisition adds key manufacturing infrastructure, capabilities, and capacity to support the U.S. and international markets. Building on that, we were pleased to announce another tuck-in transaction in January with the acquisitions of Sol Therapeutics' Baclofenic franchise, which advances our strategy in a few key ways. It expands our neurology presence into specificity with an established durable institution product in Lyosol and expands our annual institutional injectables business to about $150 million. Second, it also adds the recently approved Lyvespa to a specialty bag with commercial launch planned in June. And third, It adds a specialized institutional commercial team in advance of our biosimilar launches this year. We expect strong growth in the $5 billion institutional injectable market. As we scale the injectable business with a remarkably larger portfolio, over time, over the end of our expanded global capabilities, we expect injectable revenues will ramp up substantially in the later part of 2023 on our way to annual revenues in excess of $300 million by 2025, as we aspire to be the top five in the United States and also become a global player. Now in biosimilars, we expect to enter the market in 2022 with our initial oncology portfolio of three products. The total addressable market for these products is 6.3 billion, with 2.9 billion representing the biosimilar portion. Beyond those, we're also actively looking at additional partnership opportunities where we can be early to market, preferably first or second. The pipeline for the industry remains robust with approximately $148 billion in total biologics products revenue, facing loss of exclusivity in the next decade. After the initial launches, gaining share and adding to the portfolio, we expect biosimilar revenues will build over time. Our goal is to build a global business through in-licensing and being vertically integrated as we look to become a meaningful player in biosimilars. In our healthcare business, we saw solid performance in 2021. With $349 million in net revenue, we are focused on a strong commercial and operational execution as we expand across multiple channels, including the federal government healthcare market, distribution channel, and unit dose. We expect substantial growth in this durable business going forward. Especially, we see multiple growth opportunities over the next several years. In 2021, our commercial organization executed very well, delivering 378 million in net revenue. A year ago, we invested to expand our endocrinology sales force, which led to significant growth this year in Unitroid, our branded product for treating hypothyroidism. Thyroid, our branded Carbidopa-Levodopa product for Parkinson's, also had a strong year, while at the same time, team did an excellent job advancing our IPX203 pipeline product. Positive phase three data showed that this innovation has the potential to achieve more good on time and less frequent dosing for Parkinson's patients. We expect high single digit growth in the $7 billion brand market for our products and pipelines. As we execute on our existing portfolio and rich pipeline, we see the specialty business expanding meaningfully over the next several years. And international, we are advancing our global expansion plans in key several markets. As you know, in China, we have our Fosun partnership and look to be commercial starting next year. in the second largest pharmaceutical market. In India, we have a small hospital business today that came through the Punishka Healthcare Acquisition, and we look to build our in-market presence in the estimated $25 billion Indian pharmaceutical market today, projected to go to $36 billion by 2025. Also, in other geographies, We are pursuing distribution agreements to leverage our portfolio to enter certain emerging markets. I hope you share our excitement as we see several businesses that are healthy, expanding, and growing through innovation and new capabilities and execution. As we progress and implement our strategy, we expect MNIL will be increasingly durable, diversified, and differentiated. With that overview, I'll pass it over to Chindu.