Alvotech Announces Q1 2024 Financial Results and Business Update

In the first quarter of 2024, Alvotech reported a notable increase in total revenues, reaching $37 million compared to $16 million in the same period the previous year. The company also saw a significant rise in gross margin to $17 million, an increase of $40 million compared to the same period last year.

Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines, announced several key developments. The company signed new commercialization agreements for its high concentration interchangeable biosimilar to Humira® in the U.S., as well as agreements for its proposed biosimilar to Prolia® and Xgeva® in the U.S. and Europe. Furthermore, Alvotech adjusted its revenue guidance for 2024, projecting topline revenue between $400 million and $500 million, and tightened its EBIDTA guidance to a range of $100 million to $150 million.

In terms of corporate milestones, Alvotech secured FDA approval of AVT04, a biosimilar to Stelara®, in the U.S. Additionally, they entered a strategic partnership with Quallent Pharmaceuticals for the commercialization of their Humira® biosimilar under a private label. The company’s partner, Teva Pharmaceuticals, is actively working to position this biosimilar on U.S. formularies. Alvotech also signed a commercial partnership with Dr. Reddy’s Laboratories for AVT03, a biosimilar candidate to Prolia® and Xgeva®.

Pipeline development at Alvotech progressed swiftly. The company announced positive top-line results from confirmatory patient studies for two of their biosimilar candidates: AVT06, a proposed biosimilar to Eylea®, and AVT05, a proposed biosimilar to Simponi®. The company is on track to file marketing applications for at least three biosimilar candidates in the latter half of the year.

In terms of financial performance for the first three months of 2024, Alvotech had a cash position of $64.8 million as of March 31, excluding $25.0 million in restricted cash. The company’s borrowings totaled $978.1 million, including $37.6 million of current portion of borrowings. Product revenue was $12.4 million in this period, compared to $15.7 million in the same timeframe in 2023. Revenue was derived from sales of AVT02 in select European countries and Canada, launch of AVT02 in the U.S, and the launch of AVT04 in Canada.

License and other revenue for the three months ended March 31, 2024, amounted to $24.4 million, primarily due to research and development milestones. The cost of product revenue was $20.0 million, a decrease from $39.1 million in the same period of 2023, influenced by lower production-related charges and costs associated with FDA inspection readiness.

Research and development (R&D) expenses were $49.9 million, a slight decrease from $50.9 million in the same period of 2023. This was mainly due to a one-time charge in the previous year and increased direct program expenses for several biosimilar candidates. General and administrative (G&A) expenses decreased to $15.5 million from $22.2 million, mainly due to reduced third-party services, lower insurance premiums, and a decrease in share-based payment expenses.

Finance income dropped to $0.8 million from $1.2 million, while finance costs decreased to $184.1 million from $207.6 million, largely due to a decrease in the fair value of derivative liabilities. Exchange rate differences generated a gain of $6.5 million, compared to a loss of $1.7 million in the previous year. The income tax benefit for the period was $6.4 million, down from $29.4 million.

Alvotech reported a net loss of $218.7 million, or ($0.89) per share, compared to a net loss of $276.2 million, or ($1.24) per share, in the same period the previous year. This loss was significantly influenced by fair value costs associated with derivative liabilities.

Alvotech remains focused on its mission to develop and manufacture biosimilar medicines, leveraging strategic partnerships and a robust pipeline to drive future growth and financial stability.