BAD VILBEL, Germany - STADA Arzneimittel AG and Alvotech have announced the launch of Uzpruvo®, a biosimilar to the immunology medicine Stelara®, across the majority of European countries. The release of Uzpruvo® follows the expiration of exclusivity rights for the reference molecule, ustekinumab, used in treating certain conditions within gastroenterology, dermatology, and rheumatology.
Uzpruvo® is the first approved biosimilar to Stelara® in Europe, and its availability is expected to facilitate broader patient access to this treatment and contribute to cost control in a market with indications valued at around €2.4 billion. The European Commission approved Uzpruvo® in January 2024, recognizing its equivalent efficacy, safety, pharmacokinetics, and immunogenicity to the Stelara® reference product.
The launch of Uzpruvo® is particularly significant as it creates competition in the market at the earliest opportunity. STADA's CEO, Peter Goldschmidt, emphasized the importance of this move in improving patient access to biological treatments. Alvotech's CEO, Robert Wessman, also expressed pride in being first-to-market with Uzpruvo®, highlighting the robustness of their platform and the value of their partnership with STADA.
Uzpruvo® is indicated for Crohn’s disease, psoriatic arthritis in adults, and plaque psoriasis in adults and children aged six years and older. It is not yet approved for ulcerative colitis due to ongoing exclusivity for the originator in that indication. The biosimilar is presented in a pre-filled syringe with a thinner needle and is latex-free, features that are expected to benefit patients with a lower risk of allergic reactions and a more comfortable administration experience.
The product has been developed, manufactured, and packaged within Europe and has a shelf life of 36 months. STADA and Alvotech's partnership has previously brought to market another immunology biosimilar, Hukyndra®, a high-concentration adalimumab brand, in 2022. The partnership also includes a proposed biosimilar to Prolia®/Xgeva® (denosumab), AVT03.
STADA specializes in consumer healthcare products, generics, and specialty pharma, with sales in around 115 countries. Alvotech is solely focused on the development and manufacture of biosimilar medicines and has a portfolio and pipeline covering various indications. This launch is part of their strategic efforts to expand access to high-quality, cost-effective biosimilar treatments.
The information in this article is based on a press release statement from Alvotech.
In other recent news, Alvotech reported positive results from a patient study of AVT03, a biosimilar candidate for osteoporosis treatment. These results met primary endpoints, indicating possible additional indications for AVT03. Furthermore, Alvotech is planning to file marketing applications for AVT03 in major global markets later this year.
In terms of financial performance, Alvotech's first quarter in 2024 saw a 132% increase in total revenues year-over-year to $36.9 million, prompting the company to raise its full-year revenue guidance to between $400 million and $500 million.
Despite these encouraging developments, analysts forecast a loss with estimated earnings per share for the first fiscal year at around -$0.27, improving in the second fiscal year to -$0.07. Barclays (LON:BARC) Capital Inc. maintains an overweight stock rating for Alvotech with a price target increase to $22.00.
Alvotech also recently issued stock options and restricted share units (RSUs) to its Board of Directors, aligning the interests of its directors with those of the shareholders. Additionally, the company entered strategic partnerships with RDY and CIGNA, which have significantly contributed to its growth.
The anticipated launch of Alvotech's biosimilar Selardsi in February 2025 is expected to impact a $7 billion U.S. market due to limited competition.
These are some of the recent developments in Alvotech's business strategy and financial outlook.
InvestingPro Insights
As Alvotech (ALVO) celebrates the launch of Uzpruvo® across Europe, investors are closely watching the company's financial metrics and market behavior. According to InvestingPro data, Alvotech has a market capitalization of $3.6 billion USD, reflecting the market's substantial interest in the company's growth potential.
InvestingPro Tips suggest that analysts are optimistic about Alvotech's sales growth in the current year, which could be further bolstered by the new launch of Uzpruvo®. However, it's also notable that the company is not expected to be profitable this year and has not been profitable over the last twelve months as of Q1 2023. This is echoed in the reported revenue growth of 14.27% during the same period, indicating a positive trajectory despite the lack of immediate profitability.
The company's stock price volatility is considered low, which may provide some stability for investors despite the fact that the stock often moves in the opposite direction of the market. This could suggest that Alvotech's performance is more company-specific and less influenced by broader market trends, which can be advantageous in volatile market conditions.
In terms of valuation, Alvotech is trading at a high revenue valuation multiple. While this may raise questions about the stock's current valuation, the anticipated sales growth and the strategic launch of Uzpruvo® could justify the premium for forward-looking investors.
For those interested in deeper analysis, InvestingPro offers additional insights and metrics, with a total of 7 InvestingPro Tips available at https://www.investing.com/pro/ALVO. Readers looking to explore these metrics and tips can use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, providing a comprehensive toolkit for informed investment decisions.
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