BMRN Beats on Q4 Earnings, to Withdraw Roctavian From Market

BioMarin Pharmaceutical BMRN reported fourth-quarter 2025 adjusted earnings per share of 46 cents, beating the Zacks Consensus Estimate of 25 cents. However, earnings declined 50% year over year, largely due to a $119.2 million inventory write-off charge tied to the company’s decision to voluntarily withdraw Roctavian from the market.

Total revenues in the fourth quarter were $875 million, up 17% year over year, primarily owing to strong sales of Voxzogo. The figure beat the Zacks Consensus Estimate of $830 million.

Despite the better-than-expected results, shares of BioMarin were down 2.6% in after-hours trading on Monday as the company’s decision to voluntarily withdraw Roctavian from the market might have weighed on investor sentiment.

In the past six months, shares of BioMarin have increased 7.6% compared with the industry’s 22.9% growth.

BMRN’s Q4 Earnings in Detail

Net product revenues totaled nearly $859.3 million, up 17% year over year on higher revenues from Voxzogo as well as other products from the company’s Enzyme Therapies.

Voxzogo, approved for achondroplasia, generated sales of $273 million, up 31% year over year, driven by new patients initiating the therapy across all regions and the favorable timing of large government orders, primarily in Latin America.

Royalty and other revenues totaled over $15.2 million, up 30% year over year.

BioMarin has revised its organizational structure and consolidated revenues from five products — Aldurazyme, Brineura, Naglazyme, Palynziq and Vimizim — under a single segment, “Enzyme Therapies.” Sales from this franchise increased 13% year over year to $549 million in the reported quarter, driven by higher patient demand in all regions and the favorable timing of large government orders.

Palynziq injection sales totaled $125 million in the quarter, up 25% year over year, reflecting strong demand. The drug’s sales beat the Zacks Consensus Estimate of $108 million.

Vimizim sales rose 8% year over year to $206 million, which beat the Zacks Consensus Estimate of $201 million.

Naglazyme sales increased 9% year over year to $120 million. Brineura added sales of $49 million, up 2%.

Product revenues from Aldurazyme totaled $49 million, up 26% year over year.

BioMarin signed a collaboration agreement with Sanofi’s SNY subsidiary, Genzyme, for Aldurazyme. SNY, through Genzyme, is BMRN’s sole customer for Aldurazyme. The Sanofi subsidiary is responsible for marketing and selling Aldurazyme to third parties.

Other Revenues

New gene therapy, Roctavian, generated $13 million in sales compared with $11 million in the year-ago period.

Last October, BioMarin announced plans to divest Roctavian and remove it from its portfolio of marketed products, launching a comprehensive process to identify a potential buyer. Along with the latest earnings release, the company announced that it has failed to identify a qualified buyer and decided to voluntarily withdraw Roctavian from the market.

In the phenylketonuria (PKU) franchise, Kuvan revenues declined 18% to $23 million due to generic competition. The drug lost U.S. market exclusivity in late 2020.

Full-Year 2025 Results

For full-year 2025, BioMarin reported total revenues of $3.22 billion, reflecting an increase of 13% year over year.

The company’s reported earnings for 2025 were $3.15 per share, down 11% from the year-ago period’s level.

BMRN's 2026 Outlook

For 2026, BioMarin expects to record total revenues in the range of $3.33-$3.43 billion. The Zacks Consensus Estimate is pegged at around $3.35 billion. The guidance excludes any contributions from the marketed products of Amicus Therapeutics FOLD.

We remind investors that in December 2025, BioMarin entered into a definitive agreement to acquire all outstanding shares of Amicusfor $14.50 per share in cash, totaling $4.8 billion. The deal is expected to be closed in the second quarter of 2026.

Post-completion of this acquisition, BioMarin will add Amicus’ lead product Galafold and the combo drug Pombiliti to its commercial portfolio. The company will also acquire exclusive U.S. rights to FOLD’s late-stage pipeline candidate DMX-200, which is being developed to treat a rare and fatal kidney disease called focal segmental glomerulosclerosis.

Management expects Voxzogo to be a significant contributor to the top line. It anticipates the drug’s sales to be in the range of $975 million to $1.03 billion. BioMarin expects enzyme therapies revenues to be between $2.23 billion and $2.28 billion. The company expects continued high patient demand across both the enzyme therapies and Voxzogo in 2026.

Adjusted operating margin is expected to be around 40% for 2026, without the Amicus transaction.

BioMarin expects adjusted earnings per share to be in the range of $4.95-$5.15 in 2026. The Zacks Consensus Estimate is pegged at $5.36. The guidance includes an estimated 25 cents per share impact from pre-close integration preparation costs and interest expense related to the acquisition of Amicus.

Management expects the first quarter of 2026 to be the lowest revenue quarter of the year, with both total revenues and Voxzogo sales projected to be roughly in line with the first quarter of 2025.

BMRN's Recent Pipeline Updates

Recently, the FDA accepted and granted a priority review to BioMarin’s supplemental biologics license application (sBLA) seeking the expanded use of Palynziq in adolescents aged 12-17 years, based on positive data from the phase III PEGASUS study. A final decision from the regulatory body is due on Feb. 28, 2026. An approval in Europe is also expected later this year.

BioMarin continues to advance its CANOPY clinical program, which evaluates Voxzogo in a phase III study for a potential second indication — hypochondroplasia, a condition characterized by impaired bone growth. Data from this study is expected in the first half of 2026, while regulatory submissions are expected thereafter in the second half of 2026.

As part of the CANOPY program, BMRN is also evaluating Voxzogo in separate phase II studies for four other short-stature pathway conditions — idiopathic short stature, Noonan Syndrome, Turner Syndrome and SHOX deficiency.

BioMarin is evaluating BMN 333 — a long-acting formulation of CNP — as a potential treatment for multiple growth-related conditions, offering the option for less frequent dosing. The company plans to start a registration-enabling phase II/III study on BMN 333 to treat achondroplasia in the first half of 2026.

BioMarin Pharmaceutical Inc. Price, Consensus and EPS Surprise

BioMarin Pharmaceutical Inc. price-consensus-eps-surprise-chart | BioMarin Pharmaceutical Inc. Quote

BMRN's Zacks Rank & Stock to Consider

BioMarin currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the biotech sector is Harmony Biosciences HRMY, which currently has a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have increased from $3.72 to $4.00. HRMY shares have fallen 28.5% in the past six months.

Harmony Biosciences’ earnings beat estimates in two of the trailing four quarters and missed in the remaining two quarters, with the average earnings surprise being 7.20%.

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