Prothena Strikes $1.26B ALS Deal with Novo Nordisk

TL;DR

Prothena inks $1.26B deal with Novo Nordisk for ALS drug PRX005, gets $60M upfront.

AI Summary

On May 24, 2024, Prothena Corporation plc entered into a material definitive agreement, specifically a collaboration and license agreement with Novo Nordisk A/S. This agreement grants Novo Nordisk an exclusive option to license Prothena's investigational antibody therapeutic, PRX005, for the treatment of amyotrophic lateral sclerosis (ALS). Prothena will receive an upfront payment of $60 million and is eligible for up to $1.2 billion in potential milestone payments, plus royalties.

Why It Matters

This significant deal provides Prothena with substantial upfront capital and potential future revenue, validating their ALS therapeutic candidate and allowing them to advance their pipeline.

Risk Assessment

Risk Level: medium — The deal involves significant potential milestone payments contingent on the success of PRX005, which carries inherent clinical development risks.

Key Numbers

• $60 million — Upfront Payment (Received by Prothena from Novo Nordisk upon signing the agreement.)
• $1.2 billion — Potential Milestone Payments (Maximum amount Prothena could receive if PRX005 development and commercialization milestones are met.)
• $1.26 billion — Total Potential Deal Value (Sum of upfront payment and maximum potential milestone payments.)

Key Players & Entities

• Prothena Corporation plc (company) — Registrant
• Novo Nordisk A/S (company) — Collaborator and potential licensee
• PRX005 (drug) — Investigational antibody therapeutic for ALS
• $60 million (dollar_amount) — Upfront payment from Novo Nordisk
• $1.2 billion (dollar_amount) — Potential milestone payments
• May 24, 2024 (date) — Date of the material definitive agreement
• amyotrophic lateral sclerosis (ALS) (disease) — Indication for PRX005

FAQ

Key Financial Figures

• $0.01 — Registered Ordinary Shares, par value $0.01 per share PRTA The Nasdaq Global Select
• $80 million — ludes an upfront payment to Prothena of $80 million. Prothena will be eligible to receive f
• $242.5 million — gulatory, and sales milestones of up to $242.5 million upon achievement of certain development
• $375 million — roval, of a Licensed Product, and up to $375 million upon BMS achieving certain annual, worl

Filing Documents

• prta-20240524.htm (8-K) — 35KB
• 0001559053-24-000019.txt ( ) — 163KB
• prta-20240524.xsd (EX-101.SCH) — 2KB
• prta-20240524_lab.xml (EX-101.LAB) — 23KB
• prta-20240524_pre.xml (EX-101.PRE) — 13KB
• prta-20240524_htm.xml (XML) — 3KB

01 Entry into a Material Definitive Agreement

Item 1.01 Entry into a Material Definitive Agreement. On May 24, 2024, pursuant to the existing ongoing global neuroscience research and development collaboration (the "Master Collaboration Agreement ") between Prothena Corporation plc (" Prothena ") and Bristol Myers Squibb (" BMS "), BMS exercised its IND Option (as defined in the Master Collaboration Agreement) with respect to the PRX019 research program, and, in lieu of a U.S. License Agreement, the parties entered into a Global License Agreement (" PRX019 Global License Agreement ") granting BMS an exclusive license to develop, manufacture and commercialize antibody products globally targeting a specified target (including PRX019, and collectively, " Licensed Products ") for any and all uses or purposes with respect to any human or animal disease, disorder or condition. The PRX019 Global License Agreement includes an upfront payment to Prothena of $80 million. Prothena will be eligible to receive further development, regulatory, and sales milestones of up to $242.5 million upon achievement of certain development and regulatory milestones, including regulatory approval, of a Licensed Product, and up to $375 million upon BMS achieving certain annual, worldwide net sales thresholds. Prothena also will be eligible to receive tiered royalties on annual, worldwide net sales of Licensed Products, ranging from high single digit to high teen percentages, on a weighted average basis depending on the achievement of certain net sales thresholds. Such milestones and royalty payments (i) would be reduced in the case where BMS is successful in developing a modified version of PRX019 that achieves certain specified improved metrics, and (ii) are subject to certain reductions as specified in the PRX019 Global License Agreement. Prothena is obligated to run the Phase 1 clinical trial for PRX019. Pursuant to the terms of the Master Collaboration Agreement, BMS may elect to exercise its option to take over the Phase 1 clinic

01 Other Events

Item 8.01 Other Events. On May 24, 2024, the research term under the Master Collaboration Agreement expired.

SIGNATURES

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 hereunto duly authorized. Date: May 28, 2024 PROTHENA CORPORATION PLC By: /s/ Tran B. Nguyen Name: Tran B. Nguyen Title: Chief Strategy Officer and Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR