BioMarin与Ascendis达成Yuviwel全球专利和解，Ascendis将向BioMarin支付净销售额18%至20%特许权使用费

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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): 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

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EX-99.1
2
d110137dex991.htm
EX-99.1
EX-99.1
Exhibit 99.1
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.