Genentech Veteran Named New BioMarin CEO as Gene Therapy Launch Ramps Up

Jean-Jacques Bienaimé, who over the course of nearly two decades grew BioMarin Pharmaceutical’s portfolio from a single commercialized asset to multiple marketed products—including a landmark approval in gene therapy—is retiring. He will be succeeded by Alexander Hardy, CEO of Roche subsidiary Genentech.

The transition will happen Dec. 1, though Bienaimé will stay on the BioMarin board of directors until the company’s 2024 annual meeting of stockholders. He will also serve as an advisor to the San Rafael, California-based company through the end of next year.

In the announcement, BioMarin’s lead independent director, Richard Meier, said the hiring of Hardy is the culmination of a multi-year succession planning process and candidate search. Hardy has more than 30 years of healthcare and biotech industry experience. Before becoming Genentech’s CEO in 2019, Hardy held several senior roles at Roche and Genentech. His experience also includes posts at Novartis, PathoGenesis, and GSK.

BioMarin develops drugs for rare diseases. When Bienaimé joined BioMarin in 2005, the company’s only approved product was the enzyme replacement therapy Naglazyme, which treats mucopolysaccharidosis VI. The therapy generated about $26 million in revenue. With a portfolio that now spans eight commercialized products, BioMarin projects its 2023 revenue will top $2 billion.

“It has been a privilege leading BioMarin’s exceptionally talented team over the past 18 years, as we’ve worked together to deliver medicines that have transformed care for people with genetic diseases, building BioMarin into the successful company it is today,” Bienaimé said in a prepared statement. “Alexander brings an impressive track record of successfully commercializing new products for patients and prioritizing operational efficiency.”

Hardy is joining BioMarin as focus turns to the company’s newest product, the hemophilia A gene therapy Roctavian. The therapy won its long-awaited FDA approval in June and BioMarin is currently in the early stages of the product’s launch. No patients have received the one-time treatment in the U.S. yet, though the company notes that a second patient has received the therapy in Germany, where the company has a tentative agreement on price. European regulators approved Roctavian in 2022, and the company said it expects to also finalize pricing in Italy by the end of this year.

Roctavian carries a wholesale price of $2.9 million in the U.S. BioMarin had previously estimated the product could achieve $50 million to $150 million in sales this year. But in its report of third quarter 2023 financial results released Wednesday, BioMarin said delays securing pricing and reimbursement for Roctavian have led the company to lower that revenue guidance to less than $10 million.

In a note sent to investors Thursday, William Blair analyst Tim Lugo acknowledged the slow start for Roctavian, but added that his firm expects sales will ramp up in 2024. Lugo said Bienaimé is leaving BioMarin in a good position. Beyond the company’s commercialized products, it also has a deep rare-disease drug pipeline of seven disclosed programs.

“We assume there may be some pipeline prioritization as new management makes its imprint felt on the organization,” Lugo said. “While the retirement of Chairman and CEO J.J. Bienaimé represents a major change for the company, we think it was not wholly unexpected, and believe the company has identified an impressive replacement in Alexander Hardy, CEO of Genentech, who is more than capable of continuing to drive BioMarin’s growth.”

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