"Continued strong growth of VOXZOGO and solid contributions from our other franchises drove record revenues exceeding $1 billion in the first half of the year, leading us to increase our full-year 2022 top and bottom-line guidance," said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin. "We also achieved many other significant milestones in the second quarter, including the CHMP's positive opinion for conditional marketing authorization of Roctavian, the first gene therapy to be recommended for approval in Europe for hemophilia A. Assuming a positive decision from the European Commission, BioMarin's commercial organization is ready to launch Roctavian in Europe in the third quarter. Based on the updated multi-year hemostatic efficacy observed to date following treatment with a single intravenous administration of Roctavian, we are on-track to resubmit the BLA in the U.S. to the FDA this September."
Mr. Bienaimé added, "In addition to continued robust demand for Voxzogo throughout the United States and Europe, underscored by today's significant increase in full-year 2022 guidance for Voxzogo net product revenues to between $130 million and $160 million, we were thrilled to receive commercial approval in both Japan and Australia in the quarter. As we said previously, in 2022 we expect to return to double-digit revenue growth and profitability, and we are tracking to plan as demonstrated by record revenues in both the first and second quarters of this year."
2022 Full-Year Financial Guidance (in millions, except %)
Item | Provided April 27, 2022 | Revised August 3, 2022 | ||||||||||
Total Revenues | $2,050 | to | $2,150 | $2,060 | to | $2,160 | ||||||
Vimizim Net Product Revenues | $650 | to | $700 | $655 | to | $700 | ||||||
Naglazyme Net Product Revenues | $400 | to | $440 | $415 | to | $450 | ||||||
Palynziq Net Product Revenues | $280 | to | $310 | $250 | to | $275 | ||||||
Kuvan Net Product Revenues | $225 | to | $250 | $210 | to | $235 | ||||||
Brineura Net Product Revenues | $145 | to | $160 | Unchanged | ||||||||
Voxzogo Net Product Revenues | $100 | to | $125 | $130 | to | $160 | ||||||
Cost of Sales (% of Total Revenues) | 23.0 % | to | 25.0 % | 22.5 % | to | 24.5 % | ||||||
Research and Development Expense | $665 | to | $715 | Unchanged | ||||||||
Selling, General and Administrative Expense | $790 | to | $840 | Unchanged | ||||||||
GAAP Net Income | $95 | to | $135 | $105 | to | $145 | ||||||
Non-GAAP Income (1) | $350 | to | $390 | Unchanged | ||||||||
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