Roche acquired Spark Therapeutics in 2019 for $4.8 billion.
Roche is currently enacting a “fundamental reorganisation” of its gene therapy subsidiary Spark Therapeutics amid broader shifts in its pharmaceuticals business.
The move, first revealed in the company’s financial report published in January 2025, comes after a strategic review of Spark’s prospects in the second half of 2024. Roche at the time was simultaneously implementing “restructuring activities” at Spark, which cost the company about $185 million last year.
Roche has yet to settle on the specifics of the reorganization initiative, though it will involve the integration of some of Spark’s operations into the group’s broader Pharmaceuticals Division, as per the financial report. Roche’s preliminary estimate puts its restructuring costs at around $341 million.
In connection with Spark’s overhaul, Roche will incur approximately $2.4 billion in goodwill impairment costs. This sum takes into consideration the $4.8 billion it paid to acquire the gene therapy specialist in 2019, as well as the current and future revenues and costs associated with the unit.
“There was no surplus from the estimated future revenues of the Spark Therapeutics business to support the carrying value of the goodwill,” Roche wrote in its financial report, “neither were there any significant future synergistic benefits to other products within the Pharmaceuticals Division.”
Roche’s decision to acquire Spark in 2019 rested heavily on two assets: the FDA-approved gene therapy Luxturna, indicated for a rare and heritable form of blindness, and the investigational SPK-8011, a one-time treatment for hemophilia A. At the time, SPK-8011 had just elicited a 97% response rate in patients with the bleeding disorder, giving Spark the push it needed to take the asset into late-stage studies.
In December 2024, however, Roche shelved SPK-8011, as per an update to its federal clinical trials page that tags the Phase III trial of the asset as “withdrawn.” In a statement to Fierce Biotech at the time, a Roche spokesperson said that the decision to discontinue the SPK-8011 study is connected to a newer investigational therapy with an “enhanced function FVIII variant.”
Roche also previously axed the Spark assets SPK-8016 for hemophilia A and SPK-3006 for Pompe disease, a rare genetic condition that damages muscles and nerves. Spark is also conducting research into eye, liver and neurodegenerative diseases, according to its pipeline.
Luxturna has similarly been disappointing. In 2024, the gene therapy brought in just under $20.5 million, representing a 59% year-on-year decline in sales.
Elsewhere in its gene therapy efforts, Roche in October 2024 put $1 billion on the line—on top of a $50 million upfront payment—in a back-heavy deal with Dyno Therapeutics to develop next-generation gene therapies for neurological indications.
