Alvotech(ALVO) - 2025 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported a 30% year-on-year increase in revenues for the first half of 2025, reaching $306 million compared to $236 million in the same period last year [23] - Product revenues grew over 200% in the first half of the year, with a 77% year-on-year increase in Q2 2025 [9][23] - Adjusted EBITDA for the first half was $54 million, down from $64 million in the same period last year, with Q2 adjusted EBITDA at $18 million compared to $102 million in Q2 last year [26] Business Line Data and Key Metrics Changes - The biosimilar to Humira, marketed as Simlanti in the US, achieved over 40% market share in the US Humira market as of July, with expectations to reach 50% by year-end [11][12] - The biosimilar to Stellara, marketed as Selarsty in the US, reached over 20% market share in the US as of July, with strong performance in Europe [14][52] Market Data and Key Metrics Changes - The company has gained marketing approvals in 67 markets globally, with biosimilars to Humira being sold in 33 markets [13] - The company continues to expand its market presence, particularly in Europe, where it has seen significant growth in biosimilar penetration [49] Company Strategy and Development Direction - The company plans to ramp up R&D efforts significantly, expanding its pipeline with new partnerships and acquisitions [17][19] - The focus is on product margin rather than volume, with a strategy to maintain sustainable pricing in competitive markets [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong momentum going into the second half of the year, despite expected softness in Q3 revenues [36] - The company anticipates a stronger Q4, driven by new product launches and milestone revenues [36][62] Other Important Information - The company completed the acquisition of IVS Lee in Switzerland, enhancing its capabilities in assembly and packaging [19][28] - The listing on NASDAQ Stockholm has broadened the shareholder base and increased trading liquidity [20] Q&A Session Summary Question: Confidence in top line guidance going forward - Management indicated strong momentum in Q2 and the first half, but expects Q3 to be softer with a stronger Q4 anticipated [34][36] Question: Growth potential for Simlanti in the US - Management confirmed a valid contract with Qualant, but noted that the focus is on value rather than volume, expecting challenges in the second half [37] Question: FDA inspections and approval timelines - Management stated that they will keep the market informed about FDA inspection outcomes and remain confident in targeting approval dates [39][60] Question: Guidance on revenue and EBITDA for the year - Management reiterated that guidance remains intact, with expectations for a strong Q4 to offset any softness in Q3 [46][62] Question: Market share expectations for Humira and Stellara - Management expects continued growth in market share for both products, particularly in Europe and the US [48][52]