BioNTech Settles NIH Dispute, Reinvesting in Oncology and Infectious Disease Pipelines

BioNTech announced on Monday that it has reached a settlement agreement with the National Institutes of Health (NIH), resolving a dispute over royalty payments for its COVID-19 vaccine. The biotech company will pay $791.5 million to the NIH, with Pfizer reimbursing $364.5 million of the claimed royalties for the 2020-2023 period. This settlement allows BioNTech to focus on its core competencies and strategic priorities, particularly its oncology and infectious disease pipelines.

The settlement includes an Amended and Restated License Agreement, which provides BioNTech with a clear path forward in its collaboration with the NIH. This agreement will enable the company to continue leveraging the NIH's intellectual property and expertise in its ongoing research and development efforts. Additionally, the settlement resolves any alleged noncompliance under the Amended License Agreement for the period up to and including January 1, 2024, including any claimed historical royalty payments allegedly owed by BioNTech.

Shares of BioNTech's American depositary receipts were up 2.5% in after-hours trading on Monday. The stock has risen 17.7% so far this year and 64.2% over the past 12 months. "This settlement allows us to focus on our core competencies and strategic priorities, particularly our oncology and infectious disease pipelines," said Ugur Sahin, CEO of BioNTech. "We see a tremendous opportunity to reinvest the proceeds from this settlement into extending and accelerating the research and development of new vaccines and therapeutics to improve the health of people worldwide by harnessing the full potential of the immune system."

BioNTech and Pfizer have already delivered over 200 million doses of their COVID-19 vaccine to more than 65 countries and regions, with orders for 1.4 billion doses to be delivered in 2021. The company reported a net profit of $17.8 million in 2020. In its earnings report, BioNTech outlined plans to conduct a trial beginning in April, in partnership with Pfizer, of a version of its COVID-19 vaccine that has been turned into a freeze-dried substance and then back into a usable form. This version would have less stringent storage requirements compared to the current vaccine, which needs to be shipped under extremely cold conditions.



BioNTech also plans to file for full regulatory approval of the vaccine from the U.S. Food and Drug Administration in 2021. Currently, the vaccine has only received emergency use authorization.

In addition to its COVID-19 vaccine, BioNTech has a robust pipeline of other programs, particularly in oncology. The company has 13 oncology product candidates in 14 ongoing trials and expects four data updates on its oncology programs this year. Some of these programs utilize the same messenger RNA technology on which the COVID-19 vaccine was based, while others employ different approaches.



The settlement with the NIH allows BioNTech to reinvest the proceeds into its oncology and infectious disease pipelines, accelerating the development of new vaccines and therapeutics. This focus on strategic priorities will enable BioNTech to bring innovative therapies to market more quickly and improve the health of people worldwide.