HALO - Halozyme sees no impact on royalties after EU body revokes J&J's Darzalex patent

2023-03-15 09:32:54 ET

Halozyme Therapeutics ( NASDAQ: HALO ) said the Opposition Division of the European Patent Office revoked a Janssen's European Patent related to cancer Darzalex, but the company noted that it expects no impact on its royalty revenue from the drug.

"Today's decision in Europe on a single co-formulation patent has no impact on our current full year 2023 revenue guidance. Janssen will continue to pay royalties to Halozyme on U.S. and European sales of DARZALEX FASPRO and SC, in line with our total royalty revenue projection of approximately $1 billion by 2027, and thereafter to at least 2030," said Halozyme President and CEO Helen Torley.

Janssen, a unit of Johnson & Johnson ( NYSE: JNJ ), pays royalty to Halozyme for using Halozyme's enzyme technology used in the subcutaneous formulation of daratumumab (marketed as Darzalex Faspro in the U.S.).

Torley added that the EU regulator's decision has no impact on the composition of matter patents in the U.S. and Europe for ENHANZE.

Halozyme said on Wednesday that it is reiterating its  2023 revenue outlook range of $815M to $845M ( consensus $828.99M) and royalty revenue guidance range of $445M to $455M.

Torley said the company expects a written decision to be provided in the next several months. If an appeal is filed, it would suspend today's decision and the patent would remain in force until the case is decided on the appeal.

Last year, J&J, Genmab and Halozyme were embroiled in matters related to royalty payments linked to Darzalex.

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