USA — BioMarin Pharmaceutical, a leading biopharmaceutical company, is set to undergo a leadership transition as CEO Jean-Jacques Bienaimé, who has been at the helm for nearly two decades, announces his retirement.

The transition is scheduled for December 1, with Alexander Hardy, CEO of Roche subsidiary Genentech, stepping in as his successor.

Bienaimé will remain on the BioMarin board of directors until the company’s 2024 annual meeting of stockholders and serve as an advisor through the end of next year.

During his tenure, Bienaimé has significantly expanded BioMarin’s portfolio, guiding the company from a single commercialized asset to multiple marketed products, including a groundbreaking approval in gene therapy. His departure marks the end of an era for the company.

In this new phase, Hardy will face the challenge of guiding BioMarin through a pivotal period in its development.

Despite securing U.S. approval for Roctavian, the first gene therapy for treating hemophilia A, the company has faced complex negotiations with payers, hindering patient access to the therapy with a list price of US$2.9 million in the U.S. and European approval.

The sluggish launch of Roctavian and fluctuations in BioMarin’s recent performance may have contributed to the leadership change.

Stifel analyst Paul Matteis described Roctavian’s initial results as “a clear disappointment.” BioMarin now expects Roctavian to generate less than US$10 million in revenue this year, a significant reduction from the previous estimate of US$50 million to US$150 million.

However, there is some positive news for BioMarin. Sales of Voxzogo, a therapy for achondroplasia, a condition affecting bone growth, have exceeded expectations.

The company has revised its sales estimate for Voxzogo to a range of US$435 million to US$455 million for the year.

Hardy, in BioMarin’s statement, acknowledged the challenges ahead but also emphasized “the opportunity that lies ahead in unlocking the full value of Voxzogo and Roctavian.”

His extensive experience in the biopharmaceutical industry, including his role as CEO of Genentech since 2019, positions him well for the task.

BioMarin has also reported progress in reimbursement negotiations for Roctavian in the U.S. and other parts of the world.

The company is in the final stages of price negotiations with Italian officials and has a tentative agreement on Roctavian’s price in Germany.

Bienaimé leaves behind a remarkable legacy, overseeing BioMarin’s transformation from a single-product company with 300 employees and US$26 million in revenue to a global player expecting to surpass US$2 billion in revenue this year.

The company now boasts a workforce of over 3,000 employees in numerous countries. The leadership transition includes Richard Meier taking over as chairman, replacing Bienaimé in that role.

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