Friday, October 7 2022

In its first-half 2022 earnings report, Alvotech announced that its revenue reached $40.1 million, largely driven by Canadian and European launches of its biosimilar adalimumab (AVT02) referencing Humira.

The period lasted from January 1, 2022 to June 30, 2022. During the same period a year earlier, the biosimilars company pureplay generated $2.0 million in revenue.

AVT02’s revenue accounted for $3.9 million of total revenue. The remaining $36.2 million came from licensing and milestone payments related to major clinical programs for AVT04, an ustekinumab biosimilar referencing Stelara.

Compared to the first 6 months of 2021 ($90.4 million), research and development costs were $86.9 million during the same period in 2022. Alvotech said the decrease was due to costs pre-commercial manufacturing costs that are now classified under cost of product revenue. The cost of product revenues for the first half of 2022 was $17.8 million.

AVT02 was approved for the Canadian market in January 2022, where it is marketed as Simlandi. In early June 2022, Alvotech, through its partnership with STADA Arzneimittel, launched AVT02 under the name Hukyndra in France, Germany, Finland and Sweden. Biologics license applications for approval and interchangeability of AVT02 are currently under review with the FDA.

Also in June, shares of Alvotech officially debuted on the Icelandic and US stock markets.

“We have achieved a number of crucial milestones since we first announced our intention to enter the public markets; launching our first biosimilar in Europe and Canada, advancing several biosimilar candidates through clinical trials, and transitioning from a private to a publicly traded company in the United States and Iceland,” said Robert Wessman , founder and executive chairman of Alvotech, in a statement. .

In addition to AVT02 and AVT04, Alvotech is publicly working on 3 other biosimilars: an aflibercept biosimilar referencing Eylea (AVT06), a denosumab biosimilar referencing Prolia/Xgeva (AVT03), and an omalizumab biosimilar referencing Xolair (AVT23).

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