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BioMarin Flags $320 Million Alesta Charge for 2026

The biologic-therapies company said the August 31 deal will add about $1.55 of pre-tax charges to full-year results and that it will issue updated 2026 guidance with third-quarter figures.

BioMarin Pharmaceutical Inc. (BMRN) said the August 31 acquisition of Alesta Therapeutics B.V. will add about $320 million of pre-tax charges to full-year 2026 results, including an estimated $283 million of acquired in-process research and development expense in the third quarter, and that it expects to issue updated full-year guidance with third-quarter results.

The San Rafael, California, biologic therapies company said the IPR&D charge and related ongoing operating expenses represent an unfavorable impact of about $1.50 to both GAAP diluted earnings per share and non-GAAP diluted EPS for the quarter ended September 30, 2026. For the full year, the company expects the acquisition to produce total pre-tax charges of approximately $320 million, consisting of the acquired IPR&D charges and ongoing operating expenses, including transaction and transition costs, with an unfavorable impact of about $1.55 to both GAAP diluted EPS and non-GAAP diluted EPS.

Full-year 2026 guidance previously announced on August 6, 2026, did not reflect the Alesta deal. BioMarin does not forecast acquired IPR&D charges because the occurrence, magnitude, and timing of such transactions are inherently uncertain. Results for the quarter ended September 30, 2026, have not been finalized and remain subject to financial-statement closing procedures.

The Alesta charge lands in a year in which the company had already been lifting its commercial outlook. In the second quarter ended June 30, 2026, total revenues increased 20% year over year to $990 million. On August 6, the company said stronger growth expectations drove increased guidance for full-year 2026 total revenues, VOXZOGO, and non-GAAP diluted EPS, and it raised 2026 VOXZOGO revenue guidance to at least $1 billion.

President and Chief Executive Officer Alexander Hardy said the company executed across its portfolio while integrating Amicus Therapeutics and advancing plans to accelerate GALAFOLD and POMBILITI + OPFOLDA. He said strong global demand led to the higher VOXZOGO outlook and that the company is positioned to deliver additional growth and increased profitability with a larger, more diversified commercial portfolio.

Earlier in the year, first-quarter 2026 total revenues increased year over year to $766 million. On May 4, BioMarin had already increased full-year 2026 total-revenue guidance to between $3.825 billion and $3.925 billion, representing an accelerated growth rate of 20% year over year at the midpoint and reflecting the addition of GALAFOLD and POMBILITI + OPFOLDA after the Amicus acquisition closed. Hardy said those high-growth assets were expected to support the company’s strongest financial performance yet in 2026.

Pipeline work continued through the summer. In May, the Phase 3 CANOPY-HCH-3 study of VOXZOGO in children with hypochondroplasia met its primary endpoint, with a statistically significant increase in annualized growth velocity at week 52 versus placebo. The company submitted a supplemental new drug application for VOXZOGO in hypochondroplasia and said it would update the application’s status with third-quarter earnings. In July, the FDA accepted its sNDA for full approval of VOXZOGO in children with achondroplasia, with a PDUFA target action date of February 28, 2027.

BioMarin also presented Phase 1 data for BMN 333, its long-acting C-type natriuretic peptide for achondroplasia, in a single-ascending-dose study in healthy adults. The company said the Phase 2/3 study is enrolling, with a data update expected in 2027.

The company expects to provide updated full-year 2026 guidance in connection with its third-quarter 2026 financial results, after the preliminary Alesta-related charges are folded into a year that had already been re-rated higher on VOXZOGO demand and the Amicus franchise.

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