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BioMarin sets 20% royalties on Ascendis Yuviwel sales

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

BioMarin Pharmaceutical Inc. (BMRN) entered into a binding term sheet with Ascendis Pharma A/S for a global settlement and license related to BioMarin’s C‑type natriuretic peptide patent portfolio. BioMarin will grant Ascendis a non‑exclusive, worldwide, transferable, royalty‑bearing license covering Yuviwel (TransCon CNP/navepegritide) for all current and potential indications, including achondroplasia and hypochondroplasia, and for combination use with other medicines.

In return, Ascendis will pay BioMarin a 20% royalty on annual net sales of licensed products in the U.S. and 18% on annual net sales in the EU, Brazil and South Korea, in each case from first commercial sale (retroactively, as applicable) through May 2030. The settlement provides for dismissal with prejudice of all pending patent-related proceedings between the companies worldwide, includes covenants not to challenge or sue on the relevant patents, and a mutual regulatory non‑interference clause. The term sheet is immediately binding and will remain in force even if a more detailed settlement and license agreement is not finalized by September 24, 2026.

Positive

  • 20%/18% royalty stream through May 2030 establishes a multi‑year revenue opportunity from Yuviwel sales in the U.S., EU, Brazil and South Korea.
  • Global settlement ends patent disputes, including ITC and multiple country litigations, reducing legal uncertainty and potential litigation costs.

Negative

  • None.

Filing Explained

The August 30, 2026 announcement establishes a binding term sheet, not a completed dismissal: although the press release says it resolves all pending proceedings, the filing says the parties will dismiss them, while the term sheet remains binding if no definitive agreement is signed by September 24, 2026.

Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
U.S. royalty rate 20% of annual net sales of Licensed Products in the United States Payable by Ascendis to BioMarin from first commercial sale until May 2030
EU/Brazil/South Korea royalty rate 18% of annual net sales of Licensed Products in the European Union, Brazil and South Korea Payable by Ascendis to BioMarin from first commercial sale until May 2030
Royalty period end date May 2030 End of the stated royalty term on Licensed Product net sales
Effective Date of Term Sheet August 30, 2026 Date on which the binding term sheet between BioMarin and Ascendis became effective
Outside date for definitive agreement September 24, 2026 Date by which the parties aim to enter a definitive settlement and license agreement
Number of jurisdictions with pending IP litigation 5 non-U.S. jurisdictions plus the Northern District of California and ITC Brazil, Denmark, Germany, South Korea, Northern District of California, and ITC Section 337 investigation to be resolved
non-exclusive, worldwide, transferable, royalty-bearing license financial
"BioMarin will grant to Ascendis and its affiliates a non-exclusive, worldwide, transferable, royalty-bearing license"
C-type natriuretic peptide medical
"any product, method, or service that includes the C-type natriuretic peptide known as"
C-type natriuretic peptide is a small, naturally occurring protein the body uses to relax blood vessels and regulate cell growth, especially in blood vessel walls and bone. Think of it as a local traffic cop that calms traffic and tells cells when to slow down dividing. For investors, it matters because drugs or tests that mimic or measure this peptide can become treatments or diagnostics for heart, vascular and growth disorders, affecting market value and regulatory risk.
achondroplasia medical
"including achondroplasia and hypochondroplasia, and in combination with other medicines"
A genetic condition that causes the most common form of short stature, where a specific change in a growth-control gene makes the long bones grow more slowly, producing a distinct body proportion and sometimes breathing, spinal or joint issues. It matters to investors because it defines a clear patient population, predictable medical needs and regulatory pathways for drugs or devices—similar to a niche market with steady, long-term demand for effective treatments or supportive care.
Section 337 investigation regulatory
"dismiss the pending Section 337 investigation before the ITC and the parties will resolve"
A Section 337 investigation is a U.S. International Trade Commission (ITC) inquiry into whether certain imported goods violate U.S. trade laws, most often by infringing intellectual property or engaging in unfair competition. The ITC can order import bans or other remedies, which can immediately block products from entering U.S. markets; that outcome can materially affect a company’s sales, supply chains, and competitive position, making the probe important to investors.
International Trade Commission (ITC) regulatory
"including before the U.S. International Trade Commission (ITC) concerning Ascendis’s Yuviwel"
royalty payments financial
"including anticipated royalty payments; expectations regarding future commercialization of Licensed Products"
Payments made to the owner of an asset, patent, trademark, mineral right, or creative work in exchange for permission to use it; they are typically a percentage of sales or a fixed fee per unit sold. For investors, royalty payments represent a steady income stream tied to the underlying product’s sales performance, similar to collecting rent from tenants — predictable cash flow that can reduce risk or add value when evaluating a company’s revenue sources.

FAQ

What agreement did BioMarin (BMRN) announce with Ascendis Pharma A/S?

BioMarin entered into a binding term sheet granting Ascendis a non-exclusive, worldwide, royalty-bearing license to patents covering Yuviwel (TransCon CNP) and related CNP technology, in exchange for royalties and global resolution of all pending patent-related proceedings between the companies.

What royalty rates will BioMarin (BMRN) receive under the Ascendis agreement?

Ascendis will pay BioMarin a 20% royalty on annual net sales in the U.S. and 18% on annual net sales in the EU, Brazil and South Korea on licensed products, starting from the first commercial sale in each territory and continuing until May 2030.

How does the settlement affect ongoing litigation involving BioMarin (BMRN) and Ascendis?

The settlement provides that all pending litigation relating to the covered BioMarin patent rights, including a Section 337 investigation before the ITC and cases in Brazil, Denmark, Germany, South Korea and the Northern District of California, will be dismissed or resolved under the agreement.

What products and indications are covered by the BioMarin–Ascendis license?

The license covers products that include the C-type natriuretic peptide known as TransCon CNP, navepegritide, or Yuviwel for all current and potential indications, including achondroplasia and hypochondroplasia, and for use in combination with other medicines.

How long is the BioMarin (BMRN) royalty period on Yuviwel sales?

Royalties apply from each territory’s first commercial sale of the licensed products, retroactively as applicable, and continue until May 2030, after which the royalty obligations described in the filing end.

Is the BioMarin–Ascendis term sheet already binding, and what happens if a final agreement is not signed?

Yes. The term sheet is binding as of August 30, 2026. The parties intend to negotiate a definitive settlement and license agreement, but if none is executed by September 24, 2026, all provisions of the term sheet remain binding on both parties.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Learn about SEC filing dates
BIOMARIN PHARMACEUTICAL INC false 0001048477 0001048477 2026-08-30 2026-08-30
 
 

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): August 31, 2026 (August 30, 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 class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.001   BMRN   The 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 1.01 Entry into a Material Definitive Agreement.

On August 30, 2026 (the “Effective Date”), BioMarin Pharmaceutical Inc. (“BioMarin”) entered into a binding term sheet (the “Term Sheet”) with Ascendis Pharma A/S (“Ascendis”) that sets forth the terms and conditions for a global settlement and license agreement (the “Agreement”) that resolves all pending proceedings relating to the BioMarin Patent Rights (as defined below).

In accordance with the Term Sheet, BioMarin will grant to Ascendis and its affiliates a non-exclusive, worldwide, transferable, royalty-bearing license to certain patents (the “BioMarin Patent Rights”) to research, develop, manufacture, use, sell, and commercialize any product, method, or service that includes the C-type natriuretic peptide known as “TransCon CNP,” “navepegritide,” or “Yuviwel” (collectively, the “Licensed Products”) for all current and potential indications, including achondroplasia and hypochondroplasia, and in combination with other medicines. In consideration for the rights and licenses granted to Ascendis, Ascendis will pay to BioMarin a royalty equal to 20% of annual net sales of Licensed Products in the United States and 18% of annual net sales of Licensed Products in the European Union, Brazil and South Korea, in each case, from the date of the first commercial sale in each territory (applied retroactively, as applicable) until May 2030.

Pursuant to the Term Sheet, the parties will also dismiss with prejudice all pending litigation between them relating to the BioMarin Patent Rights.

The Term Sheet also contains a mutual regulatory non-interference clause, a covenant by Ascendis to not challenge BioMarin’s Patent Rights, a release by BioMarin of claims against Ascendis for infringement of BioMarin’s Patent Rights prior to the Effective Date and a covenant not to sue Ascendis for infringement of BioMarin’s Patent Rights, and certain other terms that are customary for transactions of this nature.

The provisions of the Term Sheet are binding on the parties as of the Effective Date. The parties agreed to negotiate in good faith the terms of the Agreement, which, when executed by the parties will supersede and replace in its entirety the Term Sheet. In the event the parties are unable to enter into the Agreement incorporating the terms and conditions set forth in the Term Sheet by September 24, 2026, all provisions in the Term Sheet will continue to be binding on the parties.

Item 7.01 Regulation FD Disclosure.

On August 30, 2026, BioMarin issued a press release announcing the execution of the Term Sheet. A copy of the press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.

The information contained in this Item 7.01 of this report, including Exhibit 99.1 attached hereto, is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section. The information shall not be deemed incorporated by reference into any other filing with the SEC made by BioMarin regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.   

Description

99.1    Press release dated August 30, 2026
104    Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document

 


Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements about the entry into the Term Sheet with Ascendis and the transactions contemplated therein, including, without limitation, statements about: the expected benefits of such transactions, including anticipated royalty payments; expectations regarding future commercialization of Licensed Products; plans and expectations regarding the dismissal of the pending legal proceedings; and the anticipated entry into a settlement and license agreement incorporating the terms and conditions set forth in the Term Sheet. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: BioMarin’s ability to enforce the Term Sheet or the Agreement; actual sales of Licensed Products; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as such factors may be updated by any subsequent reports. Investors are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

     

BioMarin Pharmaceutical Inc.,

a Delaware corporation

Date: August 31, 2026     By:  

/s/ G. Eric Davis

      G. Eric Davis
      Executive Vice President, Chief Legal Officer

Exhibit 99.1

 

LOGO

Contacts:

 

Investors    Media
Traci McCarty    Andrew Villani
BioMarin Pharmaceutical Inc.    BioMarin Pharmaceutical Inc.
(415) 455-7558    (628) 269-7393

BioMarin Announces Global Settlement with Ascendis Pharma A/S; Ascendis Will Pay Royalties to BioMarin on Yuviwel Sales in U.S., EU, Brazil and South Korea

Agreement Resolves all Pending Patent-Related Proceedings Between BioMarin and Ascendis

SAN RAFAEL, Calif., August 30, 2026 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that it has entered into binding terms with Ascendis Pharma A/S, resolving the patent and ancillary disputes pending globally, including before the U.S. International Trade Commission (ITC) concerning Ascendis’s Yuviwel. As part of the agreement, Ascendis will pay BioMarin a royalty equal to 20% of net sales of Yuviwel in the U.S., retroactive to the first commercial sale, and 18% of net sales in the European Union, Brazil and South Korea until May 2030.

“This outcome incentivizes companies like BioMarin to keep investing in the kind of long-term innovation that is critical to bringing breakthrough treatments to the people who need them,” said Alexander Hardy, President and Chief Executive Officer of BioMarin. “We have spent decades focused on understanding the underlying biology of rare genetic conditions, building the deep scientific expertise that led to our development of six first-in-disease medicines for patients. We look forward to continuing to innovate, bringing forward the next generation of medicines for people with serious genetic conditions, and building on our ongoing momentum for children with achondroplasia.”

The scope of the settlement includes a license for BioMarin’s patents that relate to Yuviwel for all current and potential indications, including achondroplasia and hypochondroplasia. It also covers the use of Yuviwel in combination with other medicines. Under the terms of the agreement, BioMarin will dismiss the pending Section 337 investigation before the ITC and the parties will resolve all claims relating to the asserted intellectual property, including litigation pending in Brazil, Denmark, Germany, South Korea and the Northern District of California.

Reaching this agreement recognizes the value of BioMarin’s pioneering innovations in C-type natriuretic peptide (CNP) technology, including the development of VOXZOGO® (vosoritide), while providing a framework that enables continued access to medicine for children with achondroplasia around the world.


About BioMarin

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with nine commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients. To learn more, please visit www.biomarin.com.

Forward-Looking Statements

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about: the settlement and license agreement with Ascendis Pharma A/S, including expected benefits of such agreement and anticipated royalty payments, and future commercialization of licensed products and BioMarin’s expectations to continue to innovate, bringing forward the next generation of medicines for people with serious genetic conditions, and building on its momentum for children with achondroplasia. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: BioMarin’s ability to enforce the agreement; actual sales of licensed products; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as such factors may be updated by any subsequent reports. Investors are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.

BioMarin® and VOXZOGO® are registered trademarks of BioMarin Pharmaceutical Inc.

Filing Exhibits & Attachments

4 documents