Core Insights - Alvotech reported strong financial results for Q1 2025, with significant increases in product revenue and adjusted EBITDA, indicating robust growth and operational efficiency [2][7][17]. Financial Performance - Total revenues for Q1 2025 reached $132.8 million, a 260% increase from $36.9 million in Q1 2024 [7]. - Product revenue was $109.9 million, representing a 786% increase compared to $12.4 million in the same period last year [7]. - Adjusted EBITDA for Q1 2025 was $20.5 million, a significant recovery from a negative $38.4 million in Q1 2024 [7]. - The company had cash and cash equivalents of $39.5 million as of March 31, 2025, with total borrowings of $1,096.7 million [6]. Business Developments - Alvotech launched SELARSDI™, a biosimilar to Stelara®, in the U.S., and received interchangeability status effective April 30, 2025 [3]. - The company announced the acceptance of U.S. Biologics License Applications (BLAs) for AVT05 and AVT06, proposed biosimilars to Simponi® and Eylea®, respectively [3]. - Alvotech acquired Xbrane's R&D operations in Sweden and all rights to a biosimilar candidate referencing Cimzia® [5]. Pipeline Expansion - The company is focused on launching four new biosimilars as key near-term priorities and is expanding its development pipeline [2]. - Alvotech's acquisition of Xbrane is expected to enhance its R&D capabilities and strengthen its position in the biosimilar market [2]. Cost Management - Cost of product revenue increased to $65.4 million in Q1 2025 from $20.0 million in Q1 2024, driven by higher sales [10]. - Research and development expenses decreased to $38.2 million in Q1 2025 from $49.9 million in Q1 2024, reflecting a shift towards commercialization [11]. Profitability - Operating profit for Q1 2025 was $10.6 million, a turnaround from an operating loss of $48.4 million in the same period last year [13]. - Reported net profit was $109.7 million, or $0.39 per share, compared to a net loss of $218.7 million, or ($0.89) per share, in Q1 2024 [17].

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025SELARSDI is approved for all indications matching the reference productSELARSDI is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 years and older, and the treatment of adult patients with moderately to severely active ...