BioMarin Hires Genentech CEO Alexander Hardy to Replace Jean-Jacques Bienaimé as CEO

Genentech Inc. CEO Alexander Hardy is stepping down immediately, the company said Wednesday, to take the top job at rare disease drug pioneer BioMarin Pharmaceutical Inc.

Hardy, 55, who took the CEO role at South San Francisco-based Genentech in March 2019, will replace Jean-Jacques Bienaimé, who is retiring effective Dec. 1 as chairman and CEO after 18 transformative years at San Rafael’s BioMarin (NASDAQ: BMRN).

At Genentech — the North American biotech unit of Switzerland health care conglomerate Roche — Ashley Magargee, head of U.S. commercial portfolio, was named interim CEO.

Bienaimé, 70, not only led BioMarin through a tremendous period of growth but helped transform how commercial biotech companies approach rare diseases. The company has grown through shrewd transactions and internal research from a series of enzyme replacement therapies for crippling rare diseases targeting lysosomal storage issues — such as mucopolysaccharidosis type 1, or MPS 1 — to a gene therapy, called Roctavian, for the bleeding disorder hemophilia A, and Voxzogo, a once-daily injection for children with achondroplasia, the leading cause of dwarfism.

Roctavian and Voxzogo have received key Food and Drug Administration approvals over the past four months.

In all, BioMarin has eight FDA-approved drugs, an enviable track record in an industry in which companies seize on one or two drug approvals to sell their companies. Still, BioMarin for years has been among stock analysts’ top targets for a buyout.

Hardy’s move from a groundbreaking biotech company on the Peninsula to another in the North Bay comes with a full set of questions around 26-year-old BioMarin’s likelihood now to be swept into an acquisition and how investors would view the loss of Bienaimé and the company’s decision to go outside the organization for his replacement.

It also raises questions about the atmosphere at Genentech, which has seen sweeping changes and multiple CEOs since Roche in 2009 bought the portion of the company it didn’t already own. The company is known for its culture, often leading the way on human resources, but has seen changes over the past several years, including its decisions to end commercial manufacturing at its South San Francisco campus and sell its massive manufacturing site in Vacaville.

BioMarin said it engaged in a multi-year succession planning process.

“We focused on candidates with experience driving commercial growth and operational excellence, as well as a strong understanding of science and product development,” BioMarin’s lead independent director, Richard Meier, said in a company statement. “Based on these criteria, the board identified Alexander as the right leader to bring BioMarin into the future, advancing care for patients with serious genetic conditions and driving industry-leading growth.”

BioMarin’s stock was down more than 3.5%, or $3.07, to $80.94 in after-hours trading Wednesday.

Hardy joined Genentech from Novartis AG in 2005 and took on several management positions before heading up the Asia Pacific region for Roche Pharmaceuticals. He headed Roche’s global product strategy starting in August 2016 before succeeding Bill Anderson as CEO in March 2019.

Genentech has 10,000 employees in South San Francisco and another 800 in Vacaville. BioMarin, with revenue of expected to hit $2 billion this year and $3 billion next year, has 3,000 employees globally. It reported a profit of $141.6 million last year and $147.3 million through Sept. 30 of this year.

When Bienaimé — known by his peers simply as “JJ” — in 2005 took over at BioMarin, the company had 300 employees and was largely a developer of small-market drugs in disarray. A proxy fight and poor management decisions, such as buying a drug that soon had generic competition, had exacted a toll on the company and its stock, according to a 2007 profile of him.

The company had a single FDA-approved product and $26 million in annual revenue.

BioMarin’s stock price hit a low of $3.87 after the previous CEO’s departure. But Bienaimé, who had been chairman and CEO at Genencor, refocused the company on drugs that could win “orphan” status, treating diseases affecting fewer than 200,000 people in the United States, and the company won approval of its enzyme replacement therapy Naglazyme to treat the connective tissue disorder MPS VI.

Bienaimé will remain a member of BioMarin’s board until the company’s annual shareholder meeting in spring 2024. He also will be an advisor to the company through the end of 2024.

At Genentech, Magargee served as interim CEO during Hardy’s recent sabbatical and will continue in the role until a successor is named. Magargee joined Genentech in 2004 and previously held senior management roles at Roche and Genentech in lifecycle management, digital customer experience, market access and as general manager in Singapore.