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Ascendis, BioMarin agree YUVIWEL royalties up to 20%

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Ascendis Pharma A/S (ASND) announced a binding term sheet for a global settlement and license agreement with BioMarin Pharmaceutical related to the sale of YUVIWEL and other navepegritide-related products. The term sheet sets out terms to resolve all litigation and disputes between the companies.

BioMarin will grant Ascendis a non-exclusive, worldwide, royalty-bearing license allowing continued research, development, manufacturing and commercialization of navepegritide-related products without restriction, and will waive certain regulatory rights and exclusivities, dismiss all proceedings, and provide a covenant not to sue on the covered intellectual property. Ascendis will dismiss its proceedings and pay BioMarin royalties on net sales of navepegritide-related products of 20% in the United States and 18% in the European Union, South Korea and Brazil from the first commercial sale of YUVIWEL in each country through May 20, 2030.

Positive

  • Global dispute resolution and IP certainty: The binding term sheet provides for resolution of all litigation and disputes with BioMarin and grants Ascendis a non-exclusive, worldwide, royalty-bearing license to continue researching, developing, manufacturing and commercializing navepegritide-related products without restriction, plus a covenant not to sue on the covered intellectual property.
  • Regulatory rights waived by BioMarin: BioMarin has agreed to waive certain regulatory rights and exclusivities and dismiss all proceedings, which reduces potential regulatory and legal obstacles for YUVIWEL and other navepegritide-related products.

Negative

  • High ongoing royalty burden: Ascendis will pay BioMarin royalties on net sales of navepegritide-related products of 20% in the United States and 18% in the European Union, South Korea and Brazil from first commercial sale of YUVIWEL in each country through May 20, 2030, which reduces future net economics from these products.
Royalty rate on net sales in the United States 20% Royalty on net sales of navepegritide-related products from first commercial sale of YUVIWEL in the United States through May 20, 2030
Royalty rate on net sales in EU, South Korea and Brazil 18% Royalty on net sales of navepegritide-related products from first commercial sale of YUVIWEL in each of these countries through May 20, 2030
Royalty period end date May 20, 2030 End date for royalty obligations on net sales of navepegritide-related products in the specified territories
global settlement and license agreement legal
"entered into a binding term sheet for a global settlement and license agreement"
non-exclusive, worldwide, royalty-bearing license legal
"grant Ascendis a non-exclusive, worldwide, royalty-bearing license"
covenant not to sue legal
"and provide a covenant not to sue relating to the covered intellectual property"
A covenant not to sue is a legal agreement in which one party promises not to bring a lawsuit against another party over specified claims or actions. It matters to investors because such covenants can limit future legal exposure, settle disputes without admitting liability, and affect a company’s risk profile and potential costs—similar to signing a truce that removes a particular legal threat but does not necessarily resolve all underlying issues.
regulatory rights and exclusivities regulatory
"agreed to waive certain regulatory rights and exclusivities"
forward-looking statements regulatory
"This report contains forward-looking statements that involve substantial risks"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

FAQ

What did Ascendis Pharma (ASND) announce regarding BioMarin?
Ascendis announced a binding term sheet for a global settlement and license agreement with BioMarin Pharmaceutical, under which the companies plan to resolve all litigation and disputes related to YUVIWEL and other navepegritide-related products.

How does the BioMarin agreement affect ASND’s rights to navepegritide products?
BioMarin will grant Ascendis a non-exclusive, worldwide, royalty-bearing license, allowing Ascendis to continue researching, developing, manufacturing and commercializing navepegritide-related products without restriction, alongside a covenant not to sue on the covered intellectual property.

What royalty rates will Ascendis Pharma (ASND) pay under the BioMarin term sheet?
Ascendis will pay BioMarin royalties on net sales of navepegritide-related products of 20% in the United States and 18% in the European Union, South Korea and Brazil, starting from the first commercial sale of YUVIWEL in each country.

How long will ASND’s royalty payments to BioMarin last?
Royalty payments to BioMarin at 20% in the United States and 18% in the European Union, South Korea and Brazil will run from the first commercial sale of YUVIWEL in each country through May 20, 2030.

What happens to existing litigation between Ascendis (ASND) and BioMarin?
Under the term sheet, both parties agree to dismiss all proceedings. BioMarin also agrees to provide a covenant not to sue related to the covered intellectual property, while Ascendis dismisses its proceedings against BioMarin.

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

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of August 2026

Commission File Number: 001-36815

 

 

Ascendis Pharma A/S

(Translation of registrant’s name into English)

 

 

Tuborg Boulevard 12

DK-2900 Hellerup

Denmark

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒    Form 40-F ☐

 

 
 

 

INCORPORATION BY REFERENCE

This report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-203040, 333-210810, 333-211512, 333-213412, 333-214843, 333-216883, 333-228576, 333-254101, 333-261550, 333-270088, 333-277519, 333-281916, 333-285322 and 333-293854) and Form F-3 (Registration Numbers 333-209336 and 333-282196) of Ascendis Pharma A/S (the “Company” or “Ascendis”) (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

 

 

On August 31, 2026, the Company announced that it has entered into a binding term sheet for a global settlement and license agreement with BioMarin Pharmaceutical Inc. (“BioMarin”) related to the sale of YUVIWEL® and navepegritide-related products. The binding term sheet provides the terms and conditions upon which the companies agree to resolve all litigation and disputes between the companies. Under the terms, BioMarin has agreed to grant Ascendis a non-exclusive, worldwide, royalty-bearing license, allowing Ascendis to continue researching, developing, manufacturing, and commercializing navepegritide-related products without restriction. Furthermore, BioMarin has agreed to waive certain regulatory rights and exclusivities, dismiss all proceedings, and provide a covenant not to sue relating to the covered intellectual property. In exchange, the Company has agreed to dismiss all proceedings against BioMarin and to make royalty payments to BioMarin based on net sales of navepegritide-related products equal to 20% in the United States and 18% in the European Union, South Korea and Brazil from the first commercial sale of YUVIWEL in the specific country through May 20, 2030.

Forward-Looking Statements

This report contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this report regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Examples of such statements include, but are not limited to, statements relating to (i) the resolution of litigation and disputes between Ascendis and BioMarin pursuant to the binding term sheet and anticipated definitive agreement, and (ii) the continued research, development, manufacturing and commercialization of navepegritide-related products. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including, without limitation: dependence on third-party manufacturers, distributors, and service providers for Ascendis’ products and product candidates; risks related to regulatory review and approval, including the possibility of delays, requests for additional data or analyses, restrictions or limitations on use, approval with labeling that is more limited than expected, or failure to obtain approval in the United States, European Union, or other jurisdictions; clinical development risks, including that results from ongoing or future trials may not confirm earlier data; unforeseen safety or efficacy findings in development programs or on-market products; manufacturing, supply chain, quality, or logistics issues that could delay development or commercialization; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen research and development or selling, general and administrative expenses and other costs impacting Ascendis’ business generally; market acceptance, pricing, and reimbursement challenges, including payer coverage decisions and health technology assessments; competitive developments, including new or improved therapies; intellectual property protection, freedom-to-operate, and litigation risks; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; cybersecurity, data privacy, and information

technology disruptions; and the impact of international economic, political, legal, compliance, public health, and business factors, including tariffs, trade policies, currency fluctuations, and geopolitical events. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 11, 2026, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

SIGNATURES

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

 

    Ascendis Pharma A/S
Date: August 31, 2026     By:  

/s/ Michael Wolff Jensen

      Michael Wolff Jensen
      Executive Vice President, Chief Legal Officer

Source: View Original Filing on SEC EDGAR