Core Insights - Alvotech announced positive top-line results from a pharmacokinetic study for AVT80, a biosimilar candidate to Entyvio, meeting all primary endpoints [1][2][3] Group 1: Study Details - The pharmacokinetic study (AVT80-GL-P01) was a randomized, double-blind, single-dose, parallel-group design involving healthy adult participants, demonstrating PK similarity and investigating safety, tolerability, and immunogenicity profiles of AVT80 compared to Entyvio after a single 108 mg/0.68 mL subcutaneous injection [2][4] - The study results are pivotal for supporting the demonstration of clinical similarity for both AVT16 and AVT80, which are proposed biosimilars to Entyvio for intravenous and subcutaneous administration, respectively [4] Group 2: Company Overview - Alvotech is a biotechnology company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline that includes nine disclosed biosimilar candidates targeting various diseases [8] - The company has already approved and marketed two biosimilars, Humira and Stelara, in multiple global markets and has formed strategic commercial partnerships to enhance its global reach [8] Group 3: Market Context - Entyvio (vedolizumab) is indicated for treating moderate to severe Ulcerative Colitis and Crohn's disease, with combined net revenues from its sales reaching approximately US$6.4 billion in 2025 [5][6]

The study, which assessed the pharmacokinetics, safety, tolerability and immunogenicity of AVT80 compared to Entyvio® in healthy adult participants, met all its primary endpoints REYKJAVIK, ICELAND (February 5, 2026) – Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for AVT80, a biosimilar candidate to Entyvio® (vedolizumab). The ...

Financial Performance - In 2024, the company achieved revenues of $492 million, representing a growth of over 400% compared to the previous year [20][70] - Adjusted EBITDA for 2024 was approximately $108 million, a significant improvement from a loss of $300 million in 2023 [20][69] - Product revenues exceeded milestone revenues for the first time, totaling just over $273 million, an increase of 460% year-on-year [20][66] - Product gross margins improved from negative in Q1 to 45% in Q4, driven by scale, process improvements, and a better product mix [22][67] Business Lines and Market Performance - The company has ten products in advanced development and 18 molecules have passed cell line development, targeting a total addressable market of over $185 billion [12][13] - The launch of AVT02 in the U.S. and AVT04 in Europe were highlighted as significant achievements, with AVT02 capturing about 12% of the total U.S. demand for Humira by the end of 2024 [16][34] - The company expects to launch several new biosimilars in 2025, including AVT03 and AVT06, with anticipated approvals in Q4 2024 [24][78] Strategic Direction and Industry Competition - Alvotech aims to leverage its R&D capabilities and expand its pipeline, with a goal of reaching $1.5 billion in revenues and a 40% to 45% EBITDA margin by 2028 [25][90] - The acquisition of Xbrane's R&D operations in Sweden is expected to enhance the company's development capabilities and attract talent [28][61] - The company is positioned to be first to market with several biosimilars, including those for Cimzia and high-dose Eylea, which are expected to launch in 2028 [30][88] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in the growth of biosimilars, particularly in the U.S. market, where they expect significant market share conversion in 2025 [35][36] - The company anticipates a strong performance in 2025, projecting revenues between $570 million and $670 million, representing a 25% year-on-year growth [74][75] - Management highlighted the importance of maintaining a strong supply chain and quality focus to capitalize on market opportunities [40][41] Other Important Information - The company raised over $300 million in capital in 2024, simplifying its capital structure and removing all 2025 maturities [19][72] - Alvotech closed the year with $1.069 billion in debt and $51 million in cash, with plans to achieve free cash flow positive status in 2025 [72][73] Q&A Session Summary Question: Thoughts on Stelara pricing and potential private label deals - Management indicated that it is too early to comment on U.S. pricing for Stelara due to its recent launch, but they are optimistic about market position [100][102] - In Europe, established pricing trends were noted, with expectations of some price pressure as competition increases [101][102] Question: Cadence of milestone revenues and future expectations - Management expressed confidence in achieving milestone revenues in 2025 due to signed contracts and progress in R&D [99][103] - They expect about 75% of milestone revenues to be recognized in the second half of 2025, driven by approvals and launches [104][105]