Financial Data and Key Metrics Changes - Alvotech raised its full-year revenue guidance for 2025 to $600 million to $700 million and adjusted EBITDA guidance to $200 million to $280 million [7][39] - The company achieved $110 million in product revenues during Q1 2025, an increase of $97 million or 784% compared to the same period in the prior year [30][31] - Adjusted EBITDA for Q1 2025 was $21 million, compared to negative adjusted EBITDA of $38 million for the same period in the prior year [39] Business Line Data and Key Metrics Changes - The Stellara biosimilar was launched in the U.S. market in late February 2025, following successful launches in Europe, Japan, and Canada [8][9] - Alvotech's biosimilar to Humira saw strong uptake in the U.S. market, with a penetration rate of at least 21% by year-end 2024 [20][21] - The company expects to move from two marketed biosimilars to six by early 2026, with three biosimilar filings under review in major markets [11][27] Market Data and Key Metrics Changes - In the U.S. market, Alvotech's Humira biosimilar represented about 12% of total demand for Humira and Humira biosimilars in 2024 [19][21] - The European Stellara market expanded by 9% year-over-year due to the entry of biosimilars, with Alvotech aiming for a double-digit market share by the end of 2025 [23] - Alvotech is the only developer to launch a Stellara biosimilar in Japan, indicating a strong competitive position in that market [24] Company Strategy and Development Direction - Alvotech plans to significantly increase the pace of development, moving four to six new biosimilar candidates into in-house process development each year [12] - The company is focused on a B2B model, which allows it to address a global patient population through 20 strategic commercial partnerships across 90 markets [12] - Alvotech aims to maintain a focus on quality and reliability rather than sacrificing value for market share in a competitive environment [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the Stellara biosimilar in the U.S. market, especially after receiving the interchangeable designation [45] - The company anticipates that if tariffs on pharmaceuticals are applied, they will not disrupt operations or competitiveness in the U.S. market [13] - Management expects to be free cash flow positive in 2025, marking a significant milestone for the company [40] Other Important Information - Alvotech's net debt stood at $1.058 billion as of March 31, 2025, with expectations of mid-single-digit leverage by year-end [41] - The company closed the period with 301.9 million shares outstanding, including unvested earn-out shares [42] Q&A Session Summary Question: Can you clarify the interchangeable exclusivity and its implications? - Management confirmed the receipt of the interchangeable designation and noted that while some competitors may also obtain it, this designation is expected to drive faster uptake of their product [45][46] Question: What is the impact of stocking on the Stellara biosimilar sales? - Management clarified that the sales figures are driven by timing of orders rather than stocking, as they operate on a B2B model [50][51]

Alvotech (ALVO) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 and thank you for standing by. Welcome to the Alvotech Q1 twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Benedict Stephenson. Please go ahead. Speaker1 Thank you. Welcome to Ab ...