01—Abstract
Summary
Summary of the 8-K filed August 7, 2024. Cited figures are marked; the original filing is the authoritative source.
Royalty Pharma plc reported in this Form 8-K, filed August 7, 2024 under Item 7.01 (Regulation FD Disclosure), that the U.S. Food and Drug Administration approved a New Drug Application for Voranigo (vorasidenib) on August 6, 2024, as announced by Servier.
Voranigo is described as a first-in-class targeted therapy for patients with isocitrate dehydrogenase 1 and 2 (IDH1/2) mutant diffuse glioma. Under the May 2024 royalty agreement with Agios Pharmaceuticals, Royalty Pharma agreed to pay $905 milliona to Agios upon FDA approval of Voranigo. In exchange, Royalty Pharma receives a 15% royalty on annual U.S. net sales of Voranigo up to $1 billion and a 12% royalty on annual U.S. net sales above $1 billion.
Royalty Pharma projects peak annual sales potential greater than $1 billionb for Voranigo, which it expects to generate royalties greater than $150 million annually to the Company. The Company anticipates royalties from Voranigo through 2038.
02—Key points
Key Highlights
- FDA approved the New Drug Application for Voranigo (vorasidenib) on August 6, 2024, announced by Servier.
- Voranigo is a first-in-class targeted therapy for IDH1/2 mutant diffuse glioma.
- Royalty Pharma agreed to pay Agios Pharmaceuticals $905 million upon FDA approval under the May 2024 royalty agreement.
- Royalty Pharma receives a 15% royalty on annual U.S. net sales of Voranigo up to $1 billion and a 12% royalty on annual U.S. net sales above $1 billion.
- Royalty Pharma projects Voranigo peak annual sales potential greater than $1 billion.
- Royalty Pharma expects Voranigo to generate royalties greater than $150 million annually.
- Royalty Pharma anticipates Voranigo royalties will continue through 2038.
03—Questions
Frequently Asked Questions
What did the FDA approve on August 6, 2024?
The FDA approved a New Drug Application for Voranigo (vorasidenib), a first-in-class targeted therapy for patients with IDH1/2 mutant diffuse glioma. The approval was announced by Servier.
How much did Royalty Pharma pay for the Voranigo royalty?
Under the May 2024 royalty agreement with Agios Pharmaceuticals, Royalty Pharma agreed to pay $905 million to Agios upon FDA approval of Voranigo.
What royalty rates does Royalty Pharma receive on Voranigo sales?
Royalty Pharma receives a 15% royalty on annual U.S. net sales of Voranigo up to $1 billion and a 12% royalty on annual U.S. net sales greater than $1 billion.
How much royalty revenue does Royalty Pharma expect from Voranigo?
Royalty Pharma projects greater than $1 billion in peak annual sales potential for Voranigo, which is expected to generate royalties of greater than $150 million annually to the Company.
How long does Royalty Pharma expect to receive Voranigo royalties?
Royalty Pharma anticipates Voranigo will generate royalties through 2038.
04—Continue