AI Earnings Predictions for BioMarin Pharmaceutical Inc. (BMRN)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 6, 2026

BioMarin Pharmaceutical Inc.

(Exact name of registrant as specified in its charter)

Delaware 000-26727 68-0397820

(State or other jurisdiction of incorporation or organization) (Commission File Number) (I.R.S. Employer Identification No.)

770 Lindaro Street

San Rafael

California

94901

(Address of Principal Executive Offices)

(Zip Code)

(415) 506-6700

(Registrant's telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered

Common Stock, par value $0.001BMRNThe Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition

Estimated Financial Impact of the Alesta Acquisition

In connection with its acquisition of Alesta Therapeutics B.V. (Alesta), a Dutch private limited liability company (besloten vennootschap met beperkte aansprakelijkheid), which was completed on August 31, 2026, BioMarin Pharmaceutical Inc. (BioMarin) expects its GAAP and non-GAAP financial results for the third quarter of 2026 to include pre-tax charges of approximately $283 million of acquired in-process research and development (IPR&D) expense. The IPR&D charge and the ongoing operating expenses represent an unfavorable impact of approximately $1.50 to both GAAP Diluted earnings per share (EPS) and Non-GAAP Diluted EPS for the third quarter of 2026.

While acquired IPR&D charges may be incurred upon execution of acquisitions, collaborations, licensing agreements, and other business development transactions, BioMarin does not forecast acquired IPR&D charges because the occurrence, magnitude, and timing of these transactions are inherently uncertain. Accordingly, BioMarin’s full-year 2026 guidance previously announced on August 6, 2026, did not reflect the acquisition of Alesta. BioMarin expects the acquisition to result in total pre-tax charges of approximately $320 million for the full year 2026, consisting of the acquired IPR&D charges mentioned above and ongoing operating expenses, including transaction and transition costs. These charges represent an unfavorable impact of approximately $1.55 to both GAAP Diluted EPS and Non-GAAP Diluted EPS for the full year 2026. BioMarin expects to provide updated full-year 2026 guidance in connection with its third quarter 2026 financial results.

BioMarin’s results for the quarter ended September 30, 2026, have not been finalized and are subject to BioMarin’s financial statement closing procedures. There can be no assurance that actual results will not differ from the preliminary estimates described herein. The preliminary, unaudited financial information in this Current Report on Form 8-K (this Report) does not present all information necessary for a complete understanding of BioMarin’s results for the quarter ended September 30, 2026, and should not be viewed as a substitute for full financial statements prepared in accordance with GAAP.

The information in this Report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities under that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the Securities Act), nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Forward-L

EX-99.1

2 earningsrelease-4may26ex991.htm

EX-99.1

Document

Exhibit 99.1

Contact:

Investors:Media:

Traci McCartyMarni Kottle

BioMarin Pharmaceutical Inc.BioMarin Pharmaceutical Inc.

(415) 455-7558(650) 374-2803

BioMarin Reports First Quarter 2026 Financial and Operating Results

First Quarter 2026 Total Revenues Increased Year-over-year to $766 million

Increased Full-year 2026 Total Revenues Guidance to between $3.825 billion and $3.925 billion, Representing Accelerated Growth Rate of 20% Y/Y at the Midpoint, and Reflecting the Addition of GALAFOLD® and POMBILITI® + OPFOLDA® to BioMarin’s Portfolio

Conference Call and Webcast Scheduled Today at 4:30 p.m. ET

SAN RAFAEL, Calif., May 4, 2026 – BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced financial results for the first quarter ended March 31, 2026.

“With the acquisition of Amicus Therapeutics complete, the addition of GALAFOLD and POMBILITI + OPFOLDA to our commercial portfolio allows us to reach patients with Fabry and Pompe diseases and meaningfully strengthens and accelerates our near-to-mid-term growth rates,” said Alexander Hardy, President and Chief Executive Officer of BioMarin. “We expect these high-growth assets to support our strongest financial performance yet in 2026. Next quarter, we look forward to updating you on the longer‑term outlook of the Amicus integration based on our plans to leverage our global scale to expand the potential of these transformative therapies. With a faster-growing commercial portfolio, together with two near-term Phase 3 data readouts and ongoing pipeline progress expected over the coming quarters, we are well-positioned to drive innovation, create shareholder value, and improve outcomes for patients worldwide.”

2026 Business and Pipeline Highlights

Innovation

•In February, U.S. FDA approved PALYNZIQ® for adolescents 12 years of age and older with phenylketonuria (PKU); EU approval for adolescents 12 years of age and older is expected in 2026.

•In March, the company presented initial Phase 1/2 data for BMN 351 at the Muscular Dystrophy Association (MDA) Clinical & Scientific Congress demonstrating dose-dependent increases in dystrophin expression at Week 25 biopsy in both the 6 and 9 mg/kg dose cohorts. Clinical biomarkers, including decreases in creatine kinase, suggested improvements in overall muscle health beyond the Week 25 time point, and longer-term outcomes from both NSAA and 6MWT suggested a prevention of functional decline when compared to historical matched controls. The 12 mg/kg dose cohort continues to enroll, with a data update expected by year-end.

•In April, the first patient was enrolled in the registration-enabling Phase 2/3 study of BMN 333, BioMarin’s long-acting C-type natriuretic peptide (CNP) for achondroplasia. A data update from this study is expected in 2027.

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•In April, the company submitted its U.S. supplemental new drug application (sNDA) for full approval of VOXZOGO® for achondroplasia. The company expects to be notified of sNDA acceptance by Q3 2026.

•In May, at the Pediatric Endocrine Society’s (PES) annual meeting, BioMarin reported new data demonstrating the benefits of long-term treatment with VOXZOGO, including improvements in arm span, bone health, and quality of life. Data from ongoing long-term extension clinical trials showed that children who initiated VOXZOGO treatment after age 5 achieved mean height gains of +10.60cm after six years and +13.59cm (p<0.0001 for both) after eight years of treatment, as compared to natural history data.

•In the second quarter, BioMarin expects to share BMN 401 Phase 3 topline data in children ages 1-to-12 year-old with ENPP1 deficiency. Regulatory submissions are anticipated in 2H’26 should the data be supportive, with a potential first-in-disease launch in 2027.

•In the second quarter, the company expects to share Phase 3 topline data for VOXZOGO for hypochondroplasia. Regulatory submissions are anticipated in 2H’26 should the data be supportive, with a potential first-in-class launch in 2027. Enrollment is progressing in the Phase 2 study of VOXZOGO in children under 3 years old with hypochondroplasia.

Growth

•Increased full-year 2026 Total Revenues guidance, accelerating anticipated growth rate to 20% Y/Y, as a result of the addition of GALAFOLD for Fabry disease and POMBILITI + OPFOLDA to BioMarin’s commercial portfolio.

•Enzyme Therapies revenue grew 6% Y/Y in the first quarter, driven by revenue growth for VIMIZIM®, NAGLAZYME®, and BRINEURA®. Continued underlying patient demand in Q1 for PALYNZIQ was driven by an increase in enrollments and new starts in the under-18-year age group following label expansion in February. PALYNZIQ revenue is expected to increase over time with continued patient demand and as new adult and adolescent patients titrate up to maintenance dosing. As a result, full-year 2026 PALYNZIQ revenue is expected to increase year-over-year.

•The number of children being treated with VOX