Amneal Pharmaceuticals, Inc.

Good morning and welcome to the Amniel Pharmaceuticals first quarter 2024 earnings call. I will now turn the call over to Amniel's Habit Investor Relations, Tony DeMille.

Good morning and thank you for joining Amniel Pharmaceuticals first quarter 2024 earnings call. Today, we issued a press release reporting Q1 results. The earnings press release and presentation are available at amniel.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 and Forward-Looking Statements for factors that may impact future performance. We also discussed non-GAAP measures. Information on use of these measures and reconciliation to GAAP are in the earnings release and presentation. On the call today are Chirag and Shintu Patel, co-founders and co-CEOs, Tasos Konidera, CFO, our commercial leaders, Andy Boyer for Generics, Joe Renda for Specialty, and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag. Thank you, Tony.

Good morning to everyone. Our first quarter performance was outstanding. Record Q1 revenues of $659 million grew 18%. For the first time, all three of our segments generated double digit growth in the same quarter. Q1 adjusted EBITDA of $152 million grew by 31%. As strong execution continues to drive sustainably higher levels of profits. As momentum builds across MNIL, we are confident in our ability to achieve our financial commitments for 2024 and beyond. Our strategic vision for MNIL is to be a global, diversified pharmaceutical company that provides patients, providers, and payers with access to high quality, affordable, and essential medicines In the United States, Amniel fills approximately 175 million prescriptions per year. In retail pharmacies, we provide complex genetics medicines such as transdermals, topicals, oral solids, and ophthalmics. For hospitals and clinics, we supply important acute care injectables where there are chronic shortages. In biosimilars, We are expanding access to oncology therapies and adding more to our portfolio. In specialty, our innovative medicines advance the standard of care, such as in Parkinson's disease. In our healthcare distribution business, we provide military veterans with access to high-quality medicines. Globally, we are addressing unmet healthcare needs in developing and developed countries. As we continue to grow larger, amni is a leading new era of affordable medicines and having a significant societal impact. Nowhere in our commitment to this mission more evident than our recent approval of Naloxone. Opioid overdose remains a US public healthcare emergency. We are expanding access to this critical rescue medicine as an OTC product at pharmacies and for the public interest through states and cities across the United States. We were pleased to finalize our partnership with the state of California with more to come. We are so proud that this essential life-saving medicine is made in America and manufactured here in New Jersey by MNEO. Let me now walk through our business at a high level. where we remain confident in our strategy, our ability to execute well, and drive growth and the opportunity to have a tremendous impact. First, our affordable medicines business, which is our generic segment, has consistently grown each year since 2019. We are seeing this growth accelerate in 2024, driven by our diverse portfolio of retail, injectables, and biosimilars. MNIL has a track record of quality, innovation, and customer service. Those hallmarks continue to resonate in the U.S. pharmaceutical market plagued by supply shortages with perpetual demand for high quality medicines. The durability of our complex portfolio and regular cadence of new launches each year position MNIL well to continue expanding our leadership position in affordable medicines and driving sustainable long-term growth. In the retail pharmaceutical market, our portfolio of around 240 medicines is complex and diversified, with industry-wide supply chain disruption due to site inspections and manufacturer discontinuations Price erosion in the United States generic industry remains lower than it has been in several years. In injectables, we're expanding our portfolio and have a significant capacity to help address drug shortages in hospitals and clinics. Our injectable strategy focuses on providing unique ready-to-use products like our recent launch of FemReady RTU for the treatment of certain lung cancers. Across retail and injectables, we are on track to launch over 30 new products this year, following our record 39 new launches last year. In biosimilars, we are seeing the next wave of affordable medicines. From 2024 to 2028, an estimated $192 billion in annual branded biologics value will lose exclusivity. we expect most biosimilar markets to be less competitive. Given the inherent complexities of these molecules and the investment required to bring them to market, adoption rates for early biosimilars are now 80%, particularly in oncology where we operate. Our excellent commercial team is driving strong adoption at both community oncology and hospital integrated delivery networks. That, coupled with our pipeline and with trusted partners, gives us confidence in continued momentum. We are well on our way to achieving over $125 million of revenue in 24 with $90 million in biosimilars revenue over the last 12 months. We look to in-license one to two biosimilars each year or more and to be vertically integrated over time. Internationally, we will continue to expand our reach and build a strong foundation. This is happening most notably in India, where we are building a customized portfolio of therapies for unmet needs like critical care, ophthalmology, oncology, and diagnostics. In other geographies, we are working with partners to register and commercialize select MNIL products. We expect international expansion will add 5,200 million revenues by 2027 and rapidly scale up to that. Next in our specialty business, we continue to make good progress with our key neurology and endocrinology branded products as revenues are growing double digits. In Q1, we successfully launched Ongentis, an objective therapy for Parkinson's disease, which we recently licensed to our specialty portfolio. Next up is IPX203 with our action date is on August 7th. Carbidopa levodopa has been the main therapy for Parkinson's disease for over five decades. We believe IPX203 meaningfully advances that standard of care with a broad application for all patients. In our out-care distribution business, we have more than doubled revenues and profits since our acquisition in 2020. We are expanding all three channels, distribution, government, and unit dose, driven by new products from suppliers, including Amnio. We now expect over $650 million in healthcare revenue next year as we expect this to remain a high growth business. In short, we're starting 2024 with very strong momentum. Our diversified growth profile is sustainable and our financial performance is accelerating remarkably. I'll now hand it to Chintu.