BioMarin Hints Probable Delay For US Approval For Roctavian, But Analyst Convinced For Transformative 2023

Biomarin Pharmaceutical Inc BMRN reported a break-even in Q4 FY22 compared to a loss of $(0.32) a year ago and the consensus of $(0.07).
The company's revenue rose 19% Y/Y to $537.5 million, beating the consensus of $536.97 million.
Adjusted income increased to $67.4 million compared to $7.1 million a year ago, driven by higher gross profit due to increased sales volume partially offset by higher SG&A and R&D expenses.
A PDUFA date of March 31, 2023, for Roctavian, remains in place. While BioMarin has been clear in messaging that additional data from the three-year data of the GENEr8-1 study may constitute a major amendment and trigger a three-month delay. However, a delay has not yet been announced.
Guidance: BioMarin expects FY23 revenues of $2.375-$2.5 billion, vs. the consensus of $2.58 billion.
The guidance includes Roctavian revenues of $100-$200 million, with Voxzogo revenues of $330-$380 million.
It expects an adjusted EPS of $1.80-$2.05 compared to the consensus of $1.61.
Regarding Roctavian in Germany, William Blair writes that management announced that no patients had been treated in the commercial setting in Germany yet, despite initially hoping to do so before the end of 2022.
Management noted that the delay to commercial access in the region had been driven by the lengthy process of finalizing outcomes-based agreements with insurance organizations while the company pursues a federal agreement on reimbursement.
The analyst says BioMarin has an impressive growth profile over the coming years, with the launch of Voxzogo and Roctavian—the two largest potential products in BioMarin's history.
Building on a stable base business, the products can double revenue over the next few years, all supported by a deep pipeline.
Price Action: BMRN shares are down 3% at $100.14 during the premarket session on the last check Tuesday.

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