Sanofi Sells Rare Autoimmune Drug to Recordati in $1B Deal

Italian pharmaceutical company Recordati has entered into an agreement with Sanofi to acquire the global rights to Enjaymo, a biologic treatment for cold agglutinin disease (CAD), for an upfront payment of $825 million. The deal, which could potentially exceed $1 billion with additional milestone payments up to $250 million, represents a significant investment for Recordati. The transaction is expected to be finalized by the end of 2024, pending regulatory and antitrust approvals.

Recordati plans to finance the acquisition using its current cash reserves and new bank debt, ensuring that its capital and dividend allocation policies remain unaffected. CEO Rob Koremans highlighted that this strategic move will enhance the company's presence in the rare diseases market across the U.S., Japan, and Europe, while addressing the critical needs of patients suffering from CAD. Koremans also noted that the acquisition is poised to benefit both the top and bottom lines of Recordati’s financial statements.

Cold agglutinin disease is a rare autoimmune condition characterized by the production of autoantibodies by B-cells, which attack and destroy red blood cells at low temperatures, typically between 3°C to 4°C. This results in symptoms such as severe fatigue and weakness, common in anemia. Approximately 11,000 patients across the U.S., Japan, and Europe are affected by this condition.

Enjaymo, a humanized monoclonal antibody, selectively targets the C1 complement protein to inhibit the complement cascade, thereby preventing the destruction of red blood cells. Unlike other treatments, Enjaymo does not affect the lectin and alternative complement pathways. It is currently the only approved targeted therapy for CAD, having received FDA approval in February 2022.

Despite its potential, Enjaymo’s commercial performance has been moderate. In 2023, the therapy generated nearly $80 million in sales, which represented a growth of more than 200% from the previous year at constant exchange rates. The first half of 2024 saw further growth, with sales increasing by almost 73% to approximately $60 million.

Sanofi's decision to sell Enjaymo is part of a broader strategic realignment under CEO Paul Hudson, aimed at regaining investor confidence. The company has shifted its focus after abandoning a previous target of achieving a 32% operating profit margin by 2025. In December 2023, Sanofi revealed at an R&D event that it has 12 investigational assets with the potential to achieve blockbuster status in the coming years.

This acquisition marks a significant step for Recordati, as it continues to expand its portfolio in the field of rare diseases. With the addition of Enjaymo, the company aims to provide a viable treatment option for CAD patients, addressing an unmet medical need and enhancing its market presence globally.