Amneal Pharmaceuticals, Inc.

Good morning and welcome to the Amniel Pharmaceuticals First Quarter 2025 Earnings Call. I'd now like to turn the call over to Amniel's Head of Investor Relations, Tony DiMaio.

Good morning, and thank you for joining Amniel Pharmaceuticals First Quarter 2025 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. We 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 Conidera, CFO. Our commercial leaders, Andy Boyer for Affordable Medicines, Joe Renda for Specialty, and Jason Daly, Chief Legal Officer. I will now hand the call over to Chirag. Thank you, Tony.

Good morning, everyone. In Q1, we delivered another quarter of strong performance and continued growth, driven by the successful execution of our strategy. Q1 revenues of $695 million grew 5% and adjusted EBITDA of $170 million grew 12%. Over the years, we have made deliberate decisions and investments across our business. and delivered on our commitments. Over time and through market cycles, we have differentiated MNIL from our peers by delivering sustainable growth, driven by our leadership in quality, innovation, and execution. Today, MNIL is in as strong a position as ever. We are embarking on our next phase of growth with momentum and confidence in our ability to deliver on our goals in 2025 and beyond. Big picture, MNIL is a trusted leader in an essential industry, providing millions of Americans with access to affordable and innovative treatments each year. We fill over 162 million scripts for American patients. MNIL has one of the largest US pharmaceutical manufacturing footprints in the industry. With a broad portfolio of over 280 products, over 150 of our medicines are made in the United States, from antibiotics, antivirals, to medicines that treat Alzheimer's, cancer, Parkinson's disease. What M.Neal made in America isn't just a label. It's been a cornerstone of our strategy since our founding in 2002 in Paterson, New Jersey. Let me now walk you through the key areas of our business. First, in our specialty segment, The launch of Crexon for Parkinson's disease continues to exceed expectations in its first year of commercialization. Market uptake has been strong, with market share already surpassing 1% and on track to reach over 3% by end of this year. We have received remarkable feedback from patients and providers as one key opinion leader who is also a patient, shared the following. Crexon has made me feel and move tremendously better compared to Rytary. I have concrete examples of how Crexon has changed my life. It has made a huge difference. In addition, we are pleased with the continued progress and momentum in expanding market access. This year so far, Crexon has been added to several major insurance plans, including the Veteran Administration, United Healthcare, CVS Health, and Cigna Commercial. This doubles the total U.S. coverage from approximately 30% at the end of 2024 to approximately 60% of U.S. covered lives today. To put that in perspective, Trexon has achieved in six months that rightly took years to accomplish in market excess coverage. We are highly confident in achieving US peak sales of 300 to 500 million for Trexon. Overall, we are focused on expanding our specialty branded portfolio over time. Next, with the anticipated launch of our DHE auto injector, later this year. Second, in GLP-1s, we continue to advance our partnership with Metzera in the weight loss and obesity space, which represents a new integrated business model to drive innovation at scale in GLP-1s. Metzera is rapidly advancing its pipeline of ultra-long-acting injectable and oral candidates. As they have shared, MEDSERA's lead program, MED-097i, a monthly ultra-long-acting injectable, is expected to deliver Phase 2b trial results mid-year. MNIL is MEDSERA's preferred global supplier across the United States, Europe, and other markets. Also, MNIL will commercialize their products in 20 emerging markets, including India. To support this plan, we are leveraging our existing infrastructure while constructing a high-volume peptide manufacturing facility and an advanced sterile fill-and-finish production facility. Over time, we expect GLP-1s will be a long-term growth driver for MNIL with three avenues of value creation. First and foremost, our collaboration with Metcera second potential cmo offerings for other large companies and lastly manufacturing capacity we can provide for generic weight loss therapies globally third in our affordable medicine segment which includes retail genetics injectables and biosimilars growth continues to be driven by our diversified complex portfolio and new launches In particular, our injectables portfolio is expanding. Last month, we launched Beruzu, which is our fourth 55B2 injectable launch over the last year. These ready-to-use solutions improve hospital efficiency by eliminating medication preparation steps and have unique reimbursement coding for hospitals. Fourth, turning to biosimilars. This represents a next major wave of affordable medicines in the United States. According to an IQIA report, more than 100 biologics will lose exclusivity over the next decade. Yet, only 10% have biosimilars in development. Biosimilars for the remaining 90% could save approximately $189 billion over 10 years. For patients, biosimilars improve affordability and access to essential therapies. For MNIL, they represent a compelling long-term growth opportunity that we are well positioned to lead. Today, our strategic focus has been in licensing our biosimilar portfolio and establishing a commercial platform. Our first three biosimilars generated 125 million revenue. In addition, we have expanded our pipeline with regulatory applications for five additional biosimilars being filed this year. By 2027, we expect to have six biosimilars on the market across eight product presentations. Our strategic goal is to be vertically integrated in biosimilars and leverage our proven ability and expertise to develop, manufacture, and commercialize complex biopharmaceuticals at scale. Finally, growth in our FCA segment continues to be driven by new launches across these channels, distribution, government, and unit dose. We expect out-care revenue to reach over $900 million by 2027. This business adds stability and diversification to MNIL's portfolio. In summary, MNIL has diverse array of growth drivers that enhance our competitive differentiation, drive sustainable value creation, and improve access and care for patients. Our strategic focus and long-term investments have been intentional and thoughtful. We could not be more excited about what the future holds as we advance our vision to be America's number one affordable medicines company. I will now turn it over to Chintu.