Amneal Pharmaceuticals, Inc.

Good morning and welcome to the Amniel Pharmaceuticals' second quarter 2024 earnings call. I'll now like to turn the call over to Amniel's Head of Investor Relations, Tony DiMeo.

Good morning, and thank you for joining Amniel Pharmaceuticals' second quarter 2024 earnings call. Today, we issued a press release reporting Q2 results. The earnings press release and presentation are available on 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 this section entitled Cautionary Statements on Forward-Looking Statements for Factors that May Impact Future Performance. We also discussed non-GAAP measures. Information on use of these measures and reconciliations to GAAP are in the earnings release and presentation. On the call today are Chirag and Shintu Patel, co-founders and co-CEOs, Tasos Konideras, 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. We are delighted to report strong Q2 results, raise 2024 guidance, and share the recent approval of Crexon for Parkinson's disease. Today, MNIL is a global diversified pharmaceutical company that provides access to high quality, affordable, and essential medicines for patients, providers, and payers. We're a deeply purpose-driven company on a remarkable journey of expanding in key areas of medicine, and delivering sustainable long-term growth. MNIL has grown consistently each of last five years. Revenues are up from 1.6 billion in 2019 to over 2.7 billion expected in 2024. Adjusted EBITDA is up from 339 million in 2019 to about 620 million expected in 2024. We could not be more proud of this progress and the strong foundation we have built. Let me now discuss how well we are positioned for sustainable growth, long-term growth in each of our business. Starting with specialty business, we continue to grow our key branded products in neurology and endocrinology. This week's U.S. FDA approval of Crexant, formerly known as IPX203, is a watershed moment for MNEO. We're excited to launch CREXON in September. Our launch plan and market access strategy leverages 10 years of regulatory commercial experience and our deep market understanding of patients, providers, and payers. We expect 300 to 500 million in US peak sales in total, With the addition of Crexon, we expect specialty revenues of over $500 million in 2027. We continue to evaluate branded opportunities to add to our pipeline, and we are excited about the future of this segment. Next, our affordable medicines business, which is our generic segment, has grown consistently every year since 2019. This durable growth Profile is driven by ever expanding portfolio of retail, injectable and biosimilar products. For the first half of 2024, revenue growth has accelerated to 14% due to our diverse portfolio of complex and high demand medicines. Robust supply chain and regular cadence to 30 new launches each year. We're number one in quality, complex new product portfolio and customer fulfillment in the United States. In injectable, we have expanded our portfolio to over 40 products for the hospital market with a deep pipeline. We have now tripled our manufacturing capacity to 60 million units to drive growth at scale. Importantly, we are helping to address market shortages in hospitals and clinics. as we provide 12 commercial injectables currently on the shortage list. We're also focused on providing unique ready-to-use 55B2 products that can improve hospital pharmacy efficiency by eliminating medication preparation steps. We have launched over three 55B2 ready-to-use injectables with more to come. Turning to biosimilars, we have built a strong business with a successful launch of our first three products, and we are on track for over 125 million in revenue in 2024. The next phase of biosimilar growth will come from five additional pipeline products we have added in the past few quarters. They're all expected to launch between 2025 to 2027. With our most recent addition, omalizumab, we have now expanded beyond onco to allergy. This product represents $2.6 billion of U.S. market today, and we see a significant biosimilar opportunity for this molecule with less competition. Overall, the U.S. biosimilar market is estimated to grow from 4 to 5 billion today to 20 to 30 billion by 2030 from a manufacturer's perspective. We see biosimilars as the next wave of affordable medicines. With adoption rates over 80%, biosimilars are increasing access and driving affordability to important biologic therapy for patients. We look to build a significant biosimilar portfolio through in-licensing and vertical integration over time to be one of the top global biosimilar players. Next, internationally, we are just beginning to gain traction. In India, we're building a customized portfolio of specialty products. In other geographies, we are working with partners to commercialize select MNIL products in key markets, and we'll start supplying products in the fourth quarter. We expect international revenues will add $20 to $30 million in 2025, build to $50 to $100 million by 2027, and rapidly scale after that. This represents the new growth factor for MNIL in the long term. Finally, our EVCARE distribution business has more than doubled since we acquired it in 2020. This robust growth is driven by ongoing expansion across all three of EVCARE's channels, distribution, government, and unit dose. We are especially proud to serve military veterans through EVCARE's government channel. Now we expect over $675 million in AFCAT revenue in 2025. Overall, as we continue to grow and further diversify, we are providing more patient providers and payers with access to high quality, affordable and essential medicines as we are having a profoundly positive societal impact. We have demonstrated that Our growth is durable and sustainable over long term. We believe the true potential and value of MNIL is yet to be realized. I'll now hand it to my brother, Chintu.