Core Viewpoint - Alvotech (ALVO) is set to announce its Q2 2025 earnings results, with expectations of a loss per share of 26 cents and total revenues of $115.4 million [1][5]. Group 1: Revenue Segments - Alvotech recognizes revenues from two segments: Product revenue and License and other revenue [2]. - Product revenue comes from the sale of two approved biosimilars, Simlandi and Selarsdi, which are biosimilars to AbbVie's Humira and JNJ's Stelara, respectively [3]. Group 2: Market Performance - Investors are particularly interested in the sales figures for Simlandi and Selarsdi, which were launched in the U.S. in 2024 and Q1 2025, respectively, but have yet to gain significant market traction [4]. - Year-to-date, ALVO's shares have decreased by 26.5%, contrasting with the industry's growth of 0.6% [4]. Group 3: Pipeline Developments - Alvotech's pipeline includes AVT05, AVT06, and AVT03, with multiple regulatory filings currently under review in the U.S. and EU [5]. - AVT05 is being developed as a proposed biosimilar to JNJ's Simponi, with regulatory decisions expected by the end of the year [7]. - AVT06 is a proposed biosimilar to Bayer and Regeneron's Eylea, with decisions anticipated by the end of 2025 [8]. - AVT03 is a biosimilar candidate to Amgen's Prolia and Xgeva, with the FDA accepting a regulatory filing for review in March 2025 [9]. Group 4: Partnership Expansions - Alvotech and Dr. Reddy's Laboratories have expanded their partnership to co-develop a biosimilar candidate to Merck's Keytruda [10]. Group 5: Earnings Surprise History - Alvotech has a strong earnings surprise history, having beaten estimates in the last three quarters with an average surprise of 244.18% [11]. - In the last reported quarter, the company achieved an earnings surprise of 305.88% [12]. Group 6: Earnings Predictions - Alvotech currently has an Earnings ESP of 0.00%, indicating no predictive advantage for an earnings beat this time [14].

Core Viewpoint - Alvotech and Advanz Pharma announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending approval for AVT06, a proposed biosimilar to Eylea® [1][5] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes eight disclosed candidates targeting various therapeutic areas [11][12] - Advanz Pharma is a UK-based global pharmaceutical company specializing in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [13] Product Details - AVT06 is intended for treating adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization [4][8] - In 2024, global sales of Eylea® were approximately US$9 billion, with one-third of these sales occurring in Europe [5] Clinical Study Results - A confirmatory clinical study (AVT06-GL-C01) demonstrated therapeutic equivalence between AVT06 and Eylea®, meeting its primary endpoint [6] Commercialization Rights - Alvotech is responsible for the development and commercial supply of AVT06, while Advanz Pharma holds exclusive commercialization rights for most European countries [5][7]

Core Viewpoint - Alvotech and Advanz Pharma have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending approval for AVT06, a proposed biosimilar to Eylea® [1][5] Group 1: Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines [11] - Advanz Pharma is a UK-based pharmaceutical company specializing in specialty, hospital, and rare disease medicines [13] Group 2: Product Details - AVT06 is intended for treating various eye disorders, including neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME) [4][8] - The global sales of Eylea® were approximately US$9 billion in 2024, with one-third of these sales occurring in Europe [5] Group 3: Clinical Study and Development - A confirmatory clinical study (AVT06-GL-C01) demonstrated therapeutic equivalence between AVT06 and Eylea®, meeting its primary endpoint [6] - Alvotech is also developing AVT29, a proposed biosimilar to Eylea® HD, with Advanz holding distribution rights for both biosimilar candidates [7]

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].

Full Year 2024 Earnings and Business Update March 27, 2025 Disclaimer This presentation ("Presentation") does not contain or constitute an offer to sell, a solicitation of an offer to buy, or a recommendation to purchase any security of Alvotech (the "Company") to any person in the United States or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Any trademarks, servicemarks, trade names and copyrights of the Company and other companies contained in this Presentation are the p ...