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BioMarin (BMRN) Starts Restructuring Moves to Increase Efficiency

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BioMarin Pharmaceutical Inc. (BMRN - Free Report) announced that it will implement a restructuring initiative to save up to $50 million beginning next year. Management plans to use these savings by redirecting them toward the company’s operational activities.

This initiative is being taken up by BioMarin to efficiently allocate its cash resources and redirect them towards its R&D activities as well as support the upcoming commercial launches of its new drugs Roctavian (for hemophilia A) and Voxzogo (for achondroplasia) across multiple countries. Management also expects cost savings to improve the company’s operating margins.

To achieve these targets, BioMarin intends to reduce its workforce by nearly 4% or approximately 120 employees. The reduction is mainly expected from the company’s U.S. operations and a major portion of this workforce reduction is expected to be completed by this year’s end.

As a result of this workforce reduction, management expects to incur nearly $20-$25 million in pre-tax charges during this year in the third and fourth quarters as one-time cash expenses for severance and employee termination benefits. This restructuring intends to simplify BioMarin’s organizational structure and increase efficiency by minimizing the unnecessary management layers in the company’s chain of command.

Shares of BioMarin have risen 3.5% in the year-to-date period against the industry’s 25.3% decline.

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BioMarin is currently focused on introducing new gene therapy treatments in its portfolio. The newest drug in BioMarin’s portfolio is Roctavian (valoctocogene roxaparvovec, or valrox), gene therapy for severe hemophilia A, which received conditional marketing authorization in the European Union in August 2022.

Last month, management completed the refiling of the biologics license application (BLA) to the FDA, seeking approval for valrox gene therapy to treat adult patients with severe hemophilia A. BioMarin had previously submitted a BLA in 2019 for valrox to address hemophilia A. However, the FDA issued a complete response letter (CRL) to the BLA in 2020 citing dissatisfaction with the available data.

While resubmissions to the FDA are followed by a six-month review procedure, BioMarin also expects to submit additional data to strengthen its BLA filing. Based on these data submissions, management expects the review procedure to extend by three months.

If valrox is approved by the FDA, it will be the first gene therapy in the United States for hemophilia A. The gene therapy has been granted Regenerative Medicine Advanced Therapy (RMAT), Breakthrough Therapy and orphan drug designations by the FDA.

Another important candidate in the company’s pipeline is BMN 307, a gene therapy for phenylketonuria (PKU). In this regard, a phase I/II study on BMN 307 is currently ongoing.

 

Zacks Rank & Stocks to Consider

BioMarin currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Codiak BioSciences , Morphic (MORF - Free Report) and Novartis (NVS - Free Report) . While Morphic sports a Zacks Rank #1 (Strong Buy) at present, both Codiak BioSciences and Novartis carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Morphic’s 2023 loss per share have narrowed $3.77 to $3.61 during the same period. Shares of Morphic have lost 35.9% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.

In the past 60 days, estimates for Codiak BioSciences’ 2022 loss per share have narrowed from $1.94 to $1.81. During the same period, the loss estimates per share for 2023 have narrowed from $2.14 to $1.53. Shares of Codiak BioSciences have lost 93.3% in the year-to-date period.

Earnings of Codiak BioSciences beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 35.40%, on average. In the last reported quarter, CDAK delivered an earnings surprise of 61.54%.

In the past 60 days, estimates for Novartis’ 2022 earnings per share have increased from $6.06 to $6.07. Shares of Novartis have lost 13.1% in the year-to-date period.

Earnings of Novartis beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 1.39%, on average. In the last reported quarter, NVS delivered an earnings surprise of 3.31%.


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