10/30/2025

speaker
Operator
Conference Operator

Good morning, and welcome to the AMNEW Pharmaceuticals Third Quarter 2025 Earnings Call. I will now turn the call over to AMNEW's Head of Investor Relations, Tony Daimio. Please go ahead.

speaker
Tony Daimio
Head of Investor Relations

Good morning, and thank you for joining AMNEW Pharmaceuticals Third Quarter 2025 Earnings Call. Today, we issued a press release reporting Q3 results. The earnings press release and presentation are available at amneal.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 discuss non-GAAP measures. Information on use of these measures in reconciliation to GAAP are in the earnings release and presentation. On the call today are Chirag and Shintzu Patel, co-founders and co-CEOs, Tasos Ponideros CFO, our commercial leaders, Andy Boyer for affordable medicines, and Joe Renda for specialty. I will now hand the call over to Chirag.

speaker
Chirag Patel
Co‐Founder and Co‐CEO

Thank you, Tony. Good morning, everyone. We are pleased with our strong third quarter performance. which represents another consecutive quarter of growth with revenues of $785 million and adjusted EBITDA of $160 million. At Amneal, we focus on delivering innovative and affordable medicines that make a difference for patients and providers. Since our founding in 2002, we have strategically expanded from generics into specialty, injectables, biosimilars, GLP-1, and complex medicines. This portfolio diversification has driven significant and sustainable top and bottom line growth. From 2019 through now, annual revenues have grown 11% and adjusted EBITDA has grown 13% on a CAGR basis. with growth in each of the last six consecutive years. We're very confident our momentum will continue in the years ahead. Today, there are multiple growth drivers that are shaping the future of Amnio. First, in specialty segment, Prexon for Parkinson's disease continue to outperform expectations. One year post-launch, Trexant is delivering strong results across all key indicators. Notably, about 80% of prescriptions are coming from IR patients, underscoring the success of our strategy to expand into the broader patient population. We're confident in peak US sales of $300 million to $500 million for Trexant. Next. our Brachial Autoinjector for Migraine and Cluster Headache has now launched. This is the first and only product allowing patients to self-administer with the same medication used in hospitals. It addresses an unmet need for patients who have historically had to go to the hospital ER for relief. Second, in GLP-1s, our strategic collaboration with Medcera positions us very well to play a meaningful role in this very large therapeutic category over the time. Medcera's broad portfolio of injectable and oral weight loss programs continue to quickly advance through the clinical phase. Third, In biosimilars, we are on track to have six marketed biosimilar products by 2027. Led by our biosimilars to Zola, the U.S. market over 4 billion for this key allergy and asthma product. This represents our largest current biosimilar opportunity. Last month, we submitted our BLA for Zola biosimilar, and we are well positioned to be among in this growing market. Both in complex generics and injectables, in our affordable medicine segment, we continue to receive approval for meaningful new products, including Respiradone injectable, sodium oxalate, and B-mycobrost ophthalmic QR, among others. We expect this segment will continue to grow, driven by our diversified portfolio of complex products and steady cadence of impactful new launches. Finally, our healthcare segment continues to provide diversification, stability, and growth with a broad portfolio for government distribution and unit dose channels. In summary, our growing portfolio is creating meaningful value for patients by expanding access and advancing standards of care. and for providers by delivering a broader and more differentiated portfolio, and for investors by driving consistent growth and margin expansion. Over time, we have strategically evolved from genetics to innovative and complex medicines, and our current chapter of growth is the most exciting one yet. As we grow and expand our portfolio, We are advancing towards our strategic goal of becoming America's number one affordable medicines company. I'll turn the call over to Chintu now.

Disclaimer

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