Amneal Pharmaceuticals, Inc.

Hello, everyone, and thank you for your patience. The Amniel Pharmaceuticals third quarter 2024 earnings call will begin shortly. In the meantime, if you would like to pre-register to ask a question today, please do so by pressing star forward by one on your telephone keypad. And if you change your mind, please press star forward by two. Thank you. Good morning, and welcome to the Amniel Pharmaceuticals Third Quarter 2024 Earnings Call. I'll now turn the call over to Amniel's Head of Investor Relations, Tony DiMeo. Please go ahead.

Good morning, and thank you for joining Amniel Pharmaceuticals Third Quarter 2024 Earnings Call. Today, we issued a press release reporting Q3 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 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 Kondidera, 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're excited to talk about our strong Q3 results. Our entry into obesity and metabolic disease space with MetSERA collaboration and our recent launch of Crexon for Parkinson's disease. Q3 was an excellent quarter as we continue to drive sustainable growth and took actions to solidify our long-term growth profile. First, I'll discuss our recently announced collaboration and entry into the global obesity space. The GLP-1 market is primed for innovation and expanding access to this novel class of therapies. And with Medcera, we are poised to deliver new, high-quality medicines at scale. Medcera is a clinical stage biotech company purpose-built for advancing the next generation of weight loss medicines. They have a rich proprietary library of peptides with a pipeline of innovative injectable and oral therapies. MNIL's high quality manufacturing and operational expertise is complementary to MetSERA's drug discovery capabilities. This collaboration is an important milestone for MNIL and underscores the strength of our capabilities and our reputation as an industry leader. MNIL is MetSERA's preferred global supplier in the United States, Europe, and other markets. and has been granted a license to commercialize Matsara products in select emerging markets, including India and certain countries in Southeast Asia, Africa, and the Middle East. We will leverage our existing infrastructure and build two new world-class manufacturing facilities in India to support this initiative. Importantly, this collaboration creates a new high growth factor for MNILF with multiple avenues for value creation in a rapidly growing space that is estimated to reach over 100 billion by 2030. It is a logical extension of our strategy, deep expertise in complex pharmaceutical manufacturing, and our track record of delivering high-quality innovation at scale. Second, we are incredibly excited about the recent launch of Crexant, which is an important achievement for the company. This new and innovative treatment advances the standard of care for patients with Parkinson's disease, providing a longer duration of good on time with less frequent dosing. Chintu and I met with key opinion leaders and prescribers at the Movement Disorder Society Congress recently, and there is a tremendous excitement for Traxon. As an organization, We have deep expertise working in Parkinson's space for over 10 years as we had commercialized Rytory. The Crexon launch is off to a strong start. We are confident in our ability to further expand our specialty segment, including the potential to add branded opportunities over time. Next, in the affordable medicines business, which is our generic segment, We continue to expand portfolio with new products that are driving continued growth. Year to date, revenue growth is 12%. The first growth area is retail and particularly complex generics. MNIL has been number one in the United States complex generic therapy innovation since 2018. We have launched on average 30 or more new products each year. This has driven tremendous diversification with oral solid genetics decreasing from over half of total companies revenue in 2019 to less than a quarter this year. Our affordable medicines business is foundational to M.Neal and will continue to drive meaningful value for the company. The second growth area is injectables. Our portfolio of over 40 products continue to expand with over 10 new launches expected each year. In 2024, we launched our first 55B2 products, which are differentiated, ready-to-use solution that can improve hospital pharmacy efficiencies by eliminating medication preparation steps. Overall, the U.S. injectable market continues to face supply disruptions, which M. Neal is addressing head on. Today, MNIL provides 13 injectables currently on the shortage list and we are proactively working to help alleviate other market shortages. The third growth area in affordable medicines is biosimilars. We have built a strong foundation with our first three commercial biosimilars. Also, we have planted the seeds for long-term growth by in-licensing five more pipeline biosimilars. all expected to launch by 2027. In Q3, we took an important step in licensing an Omolizumab biosimilar for a brand name Zolaire to our pipeline, another high value therapeutic. This product is roughly 4 billion plus on the global market that expands our portfolio beyond oncology to allergy. Overall, Biosimilars are the next wave of affordable medicines in the United States, as about 60% of upcoming pharmaceuticals LOEs by value are biologics. Accordingly, the U.S. biosimilar market is estimated to grow from 4 to 5 billion today to 20 to 30 billion by 2032, from a manufacturer's net sales perspective. New biosimilars provide enhanced access, affordability, and value for patients. We are building a significant biosimilar portfolio and will be vertically integrated over time as we see biosimilars as a key growth factor for MNEO in the long run. Next, international expansion is a long-term growth area for us. In India, we are building a customized portfolio of products. In other markets, We are registering select products with our partners to start supplying in Q4. We expect international will be adding 5200 million revenues by 2027. Finally, the healthcare distribution business continues to deliver double digit growth, driven by all three channels distribution, government and unit dose. And now we expect over 700 million in healthcare revenue in 2025. Overall, We could not be more excited with how well positioned MNIL is to drive continued growth. Today, MNIL is a diversified global pharmaceutical company that provides access to high-quality, affordable, and essential medicines for patients, providers, and payers. We have purposefully and strategically expanded our business and added new vectors for growth. I will now pass it to Chintu.