Amneal Pharmaceuticals, Inc.

Good morning, and welcome to the Amniel Pharmaceuticals Second Quarter 2025 Earnings Call. I will now turn the call over to Amniel's Head of Investor Relations, Tony DiMeo.

Good morning, and thank you for joining Amniel Pharmaceuticals Second Quarter 2025 Earnings Call. Today, we issued a press release reporting Q2 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 Sharad and Shintu Patel, co-founders and co-CEOs, Carlos 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 Sharad.

Thank you, Tony. Good morning, everyone. The second quarter was another consecutive quarter of strong performance and growth, with revenues of 720 million and adjusted EBITDA of $184 million. At the halfway point of the year, and with confidence in our outlook, we are pleased to raise 2025 guidance. I'm so excited to walk you through the multiple growth drivers that are shaping the future of MNIL. At MNIL, we focus each day on delivering innovative and affordable medicines that are essential for patients. Since our founding in 2002, we have methodically diversified beyond genetics to build a broad and differentiated portfolio of branded and complex products. MNIL has stood out from the pack by generating consistent growth in each of the last six years. and we expect growth will continue in the years ahead. In the process, we have transformed amnio and have entered the most exciting chapter yet. In this new chapter, there are a number of new growth drivers, including Trexon for Parkinson's disease, brachial autoinjector for severe migraine, new biosimilars such as biosimilar of Zolaire, our continued cadence of 20, 30 new generic launches each year, particularly complex products including unique 55B2 injectables for hospitals, and our GLP-1 opportunity with MedSara. These new medicines and new opportunities are designed to create substantial value by, one, advancing the standard of care and increasing access to medicines for patients. Two, further expanding and differentiating our portfolio for providers. And three, adding to our growth story for investors. Over time, MNIL has strategically evolved from generics to innovative and complex medicines. And we are entering our next phase of growth with strong momentum and clear confidence in growth ahead. First, in our specialty segment, The launch of Crexon for Parkinson's disease continues to exceed our expectations in the first year of the launch. Uptake has been very strong, with U.S. market share about at 2% and on track for over 3% by the end of the year. Notably, about 80% of Crexon scripts are coming from IR patients, which is a strong indicator of our successful strategy to pursue the broader Parkinson's market. The patient testimonials have been inspiring, and we have highlighted a few in our earnings presentations. We are highly confident that Trexon will achieve U.S. peak sales of $300 million to $500 million. Let me now turn to our newest specialty branded product, Brachia Auto Injector, which received U.S. FDA approval in May. Brachia is the first and only auto-injector form of DHE, a therapy that has been trusted for over 70 years for the acute treatment of migraine and cluster headaches in adults. In the migraine treatment landscape, there is significant unmet need for patients who do not respond to existing therapies. This new product gives patients sustained headache relief when they need it the most, and eliminates the need for time-consuming hospital visits. We are excited to launch Vrakia with a commercial rollout in October. We continue to see this as a 50 to 100 million peak sales opportunity. Second, in GLP-1s, we are advancing our partnership with MedSara to help deliver innovative therapies at scale. MNIL is Metzera's preferred global supplier for developed markets, including the U.S. and Europe. We will also commercialize their products in 20 emerging markets, including India. We see GLP-1 as a long-term opportunity, and we look forward to sharing more on this key catalyst over time. Third. In our affordable medicine segment, growth continues to be fueled by our diversified portfolio of complex products and addition of new differentiated offerings. Broadly, we continue to see favorable macro trends across all three pillars, retail genetics, injectables, and biosimilars, and remain confident in our ability to execute advanced new innovations and drive sustainable growth long-term. Within biosimilars specifically, we see a favorable long-term outlook for the U.S. market. Over the next decade, the number of biologic patent expirations is expected to double compared to the past 10 years, creating significant opportunity as approximately 90% of these products do not have biosimilars in development. At the same time, Development timelines and costs are trending lower with fewer Phase III study requirements and generally less competition per molecule, excluding some of the largest biologics such as Humira and Stellara. Against this backdrop, our biosimilars in-licensing strategy has enabled us to build an initial portfolio with three biosimilars already commercialized and five more in development We anticipate having six marketed biosimilars across eight presentations by 2027. Specifically, biosimilar Zola represents our largest biosimilar opportunity to date. As we have said in the past, our strategic intention is to be vertically integrated in biosimilars over time. Finally, performance in the healthcare segment continues to be driven by a broad portfolio of products and new launches delivered across three distinct channels, government distribution and unit dose. This business, which adds stability and diversification to MNIL's portfolio, is expected to drive revenue of over $900 million by 2027. In summary, MNIL has a diverse array of growth drivers that build upon our distinct market position, drive sustainable value creation, and improve access and care for patients. Our strategic goal is to be America's number one affordable medicines company, and we are well on our way.